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16506
Chlamydia trachomatis/Neisseria gonorrhoeae RNA, TMA, Rectal - NEW! print

Both Chlamydia trachomatis and Neisseria gonorrhoeae may infect the anal/rectal canal of sexually active individuals. Detection of this organism may be important for determining the risk for disease progression or transmission.

Transcription-Mediated Amplification (TMA)
Not Detected
Rectal swab in Aptima® Combo 2 Transport Media
Room temperature
2 days
87491, 87591
 
34966
Bordetella pertussis/parapertussis Smear, DFA print

Bordetella pertussis is the cause of whooping cough. Bordetella parapertussis is a related organism and causes a similar but milder disease.

This test is approved for New York patient testing.

Direct Immunofluorescence Assay (DFA)
Not detected
Nasopharyngeal swab collected in ESwab Mini-tip transport system (blue-cap)
Nasopharyngeal swab or nasal aspirates collected in Amies or Stuart liquid bacterial transport system or 2 air-dried slides
Nasopharyngeal slide: Room temperature
Nasopharyngeal swab: Refrigerated
1 to 4 days
87265
 
45400
Bordetella pertussis/parapertussis DNA, Qualitative Real-Time PCR print

Despite ongoing global immunization programs, pertussis or ‘whooping cough’ remains a public health concern, as neither acquisition of the disease nor vaccination provides complete or lifelong immunity. This assay is based upon the use of real-time amplification of specific genomic DNA sequences by PCR to differentially detect Bordetella pertussis and Bordetella parapertussis.

This test is approved for New York patient testing.

Real-Time PCR
Not detected
1 mL nasopharyngeal aspirate/wash
(minimum 0.3 mL)
OR
1 nasal swab in M4 Media,
V-C-M medium (green top) or equivalent (UTM) in a plastic transport tube or Amies collection tube (Gel Amies is not acceptable)
2-8° C
1 to 2 days
87798 x 2
 
5260
Bordetella pertussis/parapertussis, Culture print

Bordetella pertussis is the cause of whooping cough. Bordetella parapertussis is a related organism and causes a similar but milder disease.

This test is approved for New York patient testing.

Culture
None isolated
Nasopharyngeal swab collected in ESwab Mini-tip transport system (blue-cap)
Nasopharyngeal swabs in Regan-Lowe transport media
Refrigerated (2-8° C)
7 to 10 days
87081
 
40771
Bartonella henselae Antibodies (IgG, IgM) with Reflex(es) to Titer print

Infection with Bartonella henselae has been associated with cat scratch disease, bacillary angiomatosis, peliosis hepatis, and bacteremia. If the B. henselae IgG Screen is Positive, the B. henselae IgG Titer will be performed at an additional charge (CPT code(s): 86611). If the B. henselae IgM Screen is Positive, the B. henselae IgM Titer will be performed at an additional charge (CPT code(s): 86611).

†This test was developed and its performance characteristics determined by Focus Diagnostics. It has not been cleared or approved by the U.S. Food and Drug Administration. The FDA has determined that such clearance or approval is not necessary. Performance characteristics refer to the analytical performance of the test.

This test is approved for New York patient testing.

IFA (Immunofluorescence Assay)
By report
1 mL serum
(min 0.5 mL)
2-8° C
1 to 3 days
86611 x 2† (Add 86611 x 2† if titered)
 
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40584
Aspergillus Antigen, EIA, Serum print

Invasive aspergillosis occurs mainly in patients with neutropenia subsequent to anti-cancer therapy and in patients treated aggressively with immunosuppressants (particularly transplant recipients). Detection of Aspergillus antigen (galactomannan) in serum has been shown to be a valuable tool in diagnosing invasive aspergillosis when used in conjunction with other diagnostic tools, including culture, histology of biopsy samples, and radiography. It is recommended that high-risk patients be tested prospectively.

This test is approved for New York patient testing.

Immunoassay
<0.50 Not Detected
2 mL serum
(minimum 1 mL)
Refrigerated (2-8° C)
1 to 4 days
87305
 
90376
Aspergillus Antigen, EIA, BAL print

Invasive pulmonary aspergillosis has become one of the most common fungal pulmonary diseases in certain immunocompromised patients. Medical interventions that predispose patients to invasive aspergillosis include treatment with immunosuppressive drugs, radiation, and high doses of corticosteroids, among others.

Immunoassay
<0.50, Not Detected
2 mL bronchoalveolar lavage in a sterile leak proof container
FROZEN
1 to 4 days
87305
 
-100
Haemophilus ducreyi Culture (See Bacterial Culture, Aerobic, Special) print

 
4404
Haemophilus influenzae IgG Parallel Testing, ELISA print

A significant increase in the PRP antibody level between pre- and post-immunization sera is considered evidence of effective vaccination.

ELISA (Enzyme Linked Immunosorbent Assay)
>=1.0 mcg/mL post-vaccination
Pre-Vaccination: 1 mL serum
Post-Vaccination: 1 mL serum
(minimum 0.3 mL)
Note:Please label tubes "Pre-" or "Post-".
2-8° C
1 to 5 days
86684 x 2
 
40165
Haemophilus influenzae, Type B, Antigen Detection, LA print

Specific soluble bacterial capsular polysaccharide antigens accumulate in CSF, serum, or urine. This is a presumptive latex agglutination test for the direct qualitative detection of bacterial antigen. Visible agglutination occurs when a sample containing a bacterial antigen reacts with specific polyclonal antibody-coated latex particles. This test is not intended as a substitute for a properly performed Gram stain and bacterial culture. Confirmatory diagnosis of bacterial meningitis is only possible with appropriate culture procedures. Samples with extremely low levels of antigen may yield negative results. Nonspecific reactions are known to occur, especially with urine samples. Cross-reactions and interference by rheumatoid factor and other substances have also been reported.

This test is approved for New York patient testing.

Latex Agglutination
Not detected
1 mL CSF or serum
(minimum 0.3 mL)
Urine and other body fluids are NOTaccepted.
FROZEN
1 to 2 days
86403
 
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41244
Hantavirus Antibodies (IgG, IgM) with Reflex to Confirmation print

Two major groups of hantaviruses are recognized based on clinical presentation. The first group includes Sin Nombre Virus, which causes hantavirus pulmonary syndrome, a severe and possibly fatal form of acute respiratory distress. A second group of hantaviruses (including Seoul, Hantaan, Dobrava, and Puumala viruses) causes hemorrhagic fever with renal syndrome, a condition not typically seen in the United States. Sera are initially screened for IgG and IgM antibodies recognizing the nucleocapsid protein common to all hantaviruses.
All screen IgM positive samples are then tested for SNV-specific IgM at an additional charge; further, any screen IgM positive samples that are also screen IgG positive are tested for SNV-specific IgG at an additional charge.
A positive result in the screening ELISA but a negative result in confirmatory assays may indicate reactivity to a hantavirus causing hemorrhagic fever with renal syndrome.

If result code Hantavirus IgG is >=2.00 and Hantavirus IgM is >=2.00 then Sin Nombre Virus IgG Confirmation, IBL is performed at an additional charge (CPT 86790).
If Hantavirus IgM is >=2.00 Sin Nombre Virus IgM Confirmation, ELISA will be performed at an additional charge (CPT 86790)

†This test was developed and its performance characteristics determined by Focus Diagnostics. It has not been cleared or approved by the U.S. Food and Drug Administration. The FDA has determined that such clearance or approval is not necessary. Performance characteristics refer to the analytical performance of the test.

This test is approved for New York patient testing.

ELISA (Enzyme Linked Immunosorbent Assay)
<2.00
1 mL serum
(minimum 0.25 mL)
Room temperature: 5 days
1 to 3 days
86790 x 2†
 
-101
HBV (See Hepatitis B Virus) print

 
-102
HCV (See Hepatitis C Virus)
-103
HDV (See Hepatitis D Virus) print

 
40552
Helicobacter pylori Antibodies (IgG, IgA), Immunoblot print

Individuals infected with H. pylori strains expressing Cytotoxinassociated gene A (CagA) protein and/or Vacuolating-Cytotoxin A (VacA) protein are at increased risk for developing gastric or peptic ulcers and/or gastric carcinoma. Detection of antibodies to one or both of these proteins indicates infection with a highly pathogenic strain of H. pylori.

†This test was developed and its performance characteristics determined by Focus Diagnostics. It has not been cleared or approved by the U.S. Food and Drug Administration. The FDA has determined that such clearance or approval is not necessary. Performance characteristics refer to the analytical performance of the test.

This test is approved for New York patient testing.

Immunoblot
Negative
1.0 mL serum
(minimum 0.5 mL)
Room temperature
1 to 5 days
86677 x 2†
 
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40551
Helicobacter pylori Antibody (IgA), Immunoblot print

Individuals infected with H. pylori strains expressing Cytotoxinassociated gene A (CagA) protein and/or Vacuolating-Cytotoxin A (VacA) protein are at increased risk for developing gastric or peptic ulcers and/or gastric carcinoma. Detection of antibodies to one or both of these proteins indicates infection with a highly pathogenic strain of H. pylori.

†This test was developed and its performance characteristics determined by Focus Diagnostics. It has not been cleared or approved by the U.S. Food and Drug Administration. The FDA has determined that such clearance or approval is not necessary. Performance characteristics refer to the analytical performance of the test.

This test is approved for New York patient testing.

Immunoblot
Negative
0.5 mL serum
(minimum 0.2 mL)
Room temperature
1 to 5 days
86677†
 
40324
Helicobacter pylori Antibody (IgG), EIA With Reflex to Blot print

Individuals infected with H. pylori strains expressing Cytotoxinassociated gene A (CagA) protein and/or Vacuolating-Cytotoxin A (VacA) protein are at increased risk for developing gastric or peptic ulcers and/or gastric carcinoma. Detection of antibodies to one or both of these proteins indicates infection with a highly pathogenic strain of H. pylori. If H. pylori IgG result is positive it will reflex to Helicobacter pylori Antibody (IgG), Western Blot at an additional charge.

This test is approved for New York patient testing.

EIA (Enzyme Immunoassay) and Western Blot
Negative
1 mL Serum
(minimum 0.4 mL)
Room temperature
1 to 4 days
86677
 
40550
Helicobacter pylori Antibody (IgG), Immunoblot print

Individuals infected with H. pylori strains expressing Cytotoxinassociated gene A (CagA) protein and/or Vacuolating-Cytotoxin A (VacA) protein are at increased risk for developing gastric or peptic ulcers and/or gastric carcinoma. Detection of antibodies to one or both of these proteins indicates infection with a highly pathogenic strain of H. pylori.

†This test was developed and its performance characteristics determined by Focus Diagnostics. It has not been cleared or approved by the U.S. Food and Drug Administration. The FDA has determined that such clearance or approval is not necessary. Performance characteristics refer to the analytical performance of the test.

This test is approved for New York patient testing.

Immunoblot
Negative
0.5 mL serum
(minimum 0.2 mL)
Room temperature
1 to 5 days
86677†
 
-104
Helicobacter pylori, Susceptibility Testing (See Antimicrobial Susceptibility, Helicobacter) print

 
508
Hepatitis A Antibody, Total print

HAV antibody indicates prior or acute infection with, or immunization to, hepatitis A virus.

Immunoassay
Nonreactive
1 mL (0.5 mL minimum) serum
Room temperature
2 to 4 days
86708
 
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36504
Hepatitis A Antibody, Total with Reflex to IgM print

HAV antibody indicates prior or acute infection with, or immunization to, hepatitis A virus.

Immunoassay
Nonreactive
1 mL (0.5 mL minimum) serum
Room temperature
2 to 4 days
86708
 
512
Hepatitis A IgM print

IgM Antibodies to Hepatitis A suggest a current, acute or recent Hepatitis A infection.

Immunoassay
Nonreactive
1 mL (0.5 mL minimum) serum
Room temperature
2 to 4 days
86709
 
4848
Hepatitis B Core Antibody (IgM) print

Hep B Core-specific IgM has been detected in most acute infections and is a reliable marker for acute disease. In some cases, Hep B Core IgM may be the only specific marker for the diagnosis of acute infection with hepatitis B.

Immunoassay
Nonreactive
1 mL (0.5 mL minimum) serum
Room temperature
2 to 4 days
86705
 
37676
Hepatitis B Core Antibody (Total) with Reflex to IgM print

 

Immunoassay
Nonreactive
1 mL (0.8 mL minimum) serum
Room temperature
2 to 4 days
86704
 
501
Hepatitis B Core Antibody, Total print

 

Immunoassay
Nonreactive
1 mL (0.5 minimum) serum
Room temperature
2 to 4 days
86704
 
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499
Hepatitis B Surface Antibody Qualitative print

The detection of anti-HBS is indicative of a prior immunologic exposure to the antigen or vaccine. To determine immune status as > or = 10 mIU/mL as per CDC guidelines, please order Hepatitis B surface antibody quantitation.

Immunoassay
Nonreactive
1 mL (0.5 mL minimum) serum
Room temperature
2 to 4 days
86706
 
8475
Hepatitis B Surface Antibody Quantitation print

This assay is used to determine immune status for hepatitis B as > or = 10 mIU/mL as per CDC guidelines.

Immunoassay
> or = 10 mIU/mL
1 mL (0.5 mL minimum) serum
Room temperature
2 to 4 days
86317
 
37132
Hepatitis B Surface Antibody Quantitation, Liver Transplant print

This specialized test is used to assess hepatitis B immunoglobulin in pre and post infusion specimens.

Immunoassay
 
1 mL (0.7 mL minimum) serum

EDTA (royal blue-top) and PPT Potassium EDTA (white top) plasma are no longer acceptable
Room temperature
2 to 4 days
86317
 
498
Hepatitis B Surface Antigen with Reflex to Confirmation print

Surface antigen usually appears in the serum after an incubation period of 1-6 months following exposure to hepatitis B virus and peaks shortly after onset of symptoms. It typically disappears within 1-3 months. Persistence of hepatitis B surface antigen for greater than 6 months is a prognostic indicator of chronic hepatitis B infection. Note: When only a single test, hepatitis B surface antigen, is ordered to diagnose hepatitis B in a pregnant woman, additional tests such as liver enzymes should be ordered to confirm the diagnosis.

Immunoassay
Nonreactive
2 mL (1 mL minimum) serum
Room temperature
2 to 4 days
87340
 
47985
Hepatitis B Virus (HBV) DNA, Quantitative, Real-Time PCR print

Quantitative measurement of HBV DNA viral load is based on the real-time PCR amplification and detection of HBV genomic DNA in the presence of a quantitative standard. The quantitative range of this assay is 29 to 110,000,000 HBV IU/mL (169 to 640,200,000 HBV copies/mL).

This test is approved for New York patient testing.

Real-Time PCR
<20 IU/mL
<116 copies/mL
3 mL EDTA plasma preferred, serum acceptable
(minimum 1.3 mL)
FROZEN
1 to 4 days
87517
 
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34181
Hepatitis B Virus DNA, Qualitative, Real-Time PCR print

Determine need to treat chronic HBV infection; indicator of chronic hepatitis when still positive 6 months after diagnosis of acute HBV infection; monitor response to therapy; demostrate viral replication in patients with mutant HBV (eg, in HbeAg- and HbeAb+ individuals).

Real-Time PCR
Not Detected
3 mL (2.5 mL minimum)
plasma (EDTA preferred)
(PPT Potassium EDTA acceptable)
Serum
FROZEN
3 to 5 days
87516
 
16694
Hepatitis B Virus DNA, Quantitative, PCR with Reflex to HBV, Genotype - NEW! print

HBV viral load and resistance tests are used in the management of therapy of HBV-infected individuals. Resistance to any of the antiviral drugs is detected by an increase in the patient’s viral load and detection of viral mutations that confer resistance to the drugs. Sufficient virus is needed to obtain results by the HBV drug resistance assay. Viral quantitation of HBV by Real-Time PCR will determine if there is sufficient virus to perform the resistance test.

Real-Time Polymerase Chain Reaction (RT-PCR), Polymerase Chain Reaction (PCR), Sequencing
Hepatitis B Virus DNA <20 IU/mL
Hepatitis B Virus DNA <1.30 LogIU/mL

 
 
 
87517
 
8369
Hepatitis B Virus DNA, Quantitative, Real Time PCR print

Chronic carriers will persist in producing detectable HBV. Patients with chronic liver disease of unknown origin most commonly have HBV that is detected by Viral DNA testing.

Real-Time PCR
Hepatitis B Virus DNA: <20 IU/mL
Hepatitis B Virus DNA: <1.30 LogIU/mL
3 mL (2.5 mL minimum) plasma
(EDTA preferred)
(PPT Potassium EDTA acceptable)
FROZEN
3 to 5 days
87517
 
10529
Hepatitis B Virus Drug Resistance, Genotype, and BCP/Precore Mutations print

This test is used to:
1. Identify HBV genotype (A-H) for epidemiology or prognostic purposes.
2. Detect hepatitis B virus (HBV) mutations associated with resistance to antiviral agents.

†This test was developed and its performance characteristics determined by Focus Diagnostics. It has not been cleared or approved by the U.S. Food and Drug Administration. The FDA has determined that such clearance or approval is not necessary. Performance characteristics refer to the analytical performance of the test.

PCR, Sequencing
By report
1 mL (0.3 mL minimum) plasma collected in a PPT potassium EDTA (white-top) tube
Plasma collected in an EDTA (lavender-top) tube or serum collected in a serum separator or red-top tube (no gel)
FROZEN (-20° C) on dry ice via overnight transport.
8 days
87912
 
556
Hepatitis Be Antibody print

HBeAb appears in the early convalescence of HBV infection. With carrier state and chronic hepatitis, HBeAb may not develop.

Enzyme Immunoassay
Nonreactive
1 mL serum
(0.5 mL minimum)
Room temperature
2 to 4 days
86707
 
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555
Hepatitis Be Antigen print

HBeAg indicates active HBV replication. Infectivity is evaluated based on HBeAg and HBsAg. When HBeAg persists much longer than 10 weeks, the patient is likely to develop chronic hepatitis and be a carrier.

Enzyme Immunoassay
Nonreactive
1 mL serum
(0.5 mL minimum)
Room temperature
2 to 4 days
87350
 
27
Hepatitis Be Panel print

Panel includes:

  • Hepatitis Be Antigen
  • Hepatitis Be Antibody

Enzyme Immunoassay
Nonreactive
2 mL serum
(1 mL minimum)
Room temperature
 
87350; 86707
 
8472
Hepatitis C Antibody print

Hepatitis C Virus (HCV) is a major cause of hepatitis. Approximately 1% of blood donors are seropositive for anti-HCV. The clinical symptoms of a HCV infection are variable. Exposure to HCV results in a chronic infection in 50 to 80% of cases. The "window" between infection and seroreactivity is highly variable; up to 12 months.

Immunoassay
Immunoassay
1 mL (0.5 mL minimum) serum
Room temperature
2 to 4 days
86803
 
37811
Hepatitis C Viral RNA, Genotype, LiPA® print

Hepatitis C genotype is a predictor of response to interferon alfa-2b (non-type 1 are better responders) and to combination therapy with interferon and ribavirin (all types respond but dosage and duration of treatment is dependent on genotype; type 1 requires extended treatment).

Multi-Probe Reverse Hybridization
By report
2 mL serum or plasma
(minimum 0.6 mL)
Refrigerated
2-3 days
87902
 
37273
Hepatitis C Viral RNA, Qualitative TMA - NEW! print

Qualitative RNA by TMA is useful in confirming HCV infection and to assess response to therapy.

 
2 mL plasma collected in PPT potassium EDTA (white-top) tube
0.6 mL miminum
EDTA (levender-top), sodium heparin (green-top), 3.2% sodium citrate (Light blue-top), or ACD solution B (yellow-top) tube, Serum
Frozen
3-8 days
87521
 
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10051
Hepatitis C Viral RNA, Quantitative Real-Time PCR with Reflex to Qualitative TMA - NEW! print

Useful in monitoring response to therapy and/or disease progression. Reportable range is 15 to 100,000,000 IU/mL (1.18-8.00 log 10 IU/mL).

Polymerase Chain Reaction (PCR)
 
1.5 mL plasma collected in an EDTA (lavender-top) in each of two tubes
0.4 mL in each of two tubes minimum
Serum, Plasma collected in a PPT potassium EDTA (white-top) tube
Frozen (Ship serum refrigerated)
1-3 days
87522
 
35645
Hepatitis C Viral RNA, Quantitative, Real-Time PCR print

Useful in monitoring response to therapy and/or disease progression. Reportable range is 15 to 100,000,000 IU/mL (1.18-8.00 log10 IU/mL)

Real-Time Polymerase Chain Reaction
HCV RNA, Quantitative Real Time PCR <15 IU/mL
HCV RNA, Quantitative Real Time PCR <1.18 Log IU/mL
3 mL (0.8 mL minimum) plasma collected in an EDTA (lavender-top) tube
Frozen or refrigerated plasma collected in two PPT EDTA (white-top) tubes. Separate plasma from whole blood within 24 hours of collection by centrifugation at 800 to 1600 x g for 20 minutes at room temperature. Transfer to a plastic screw-cap vial and freeze or refrigerate.

Serum collected in a serum separator tube or red top tube (no gel). Transfer to a plastic screw-cap vial and refrigerate.
Refrigerated (2-8° C)
1 to 3 days
87522
 
11348
Hepatitis C Viral RNA, Quantitative, Real-Time PCR with Reflex to Genotype LiPA® - NEW! print

Useful in monitoring response to therapy and/or disease progression. Reportable range is 15 to 100,000,000 IU/mL (1.18-8.00 Log 10 IU/mL)

Real-Time Polymerase Chain Reaction (RT-PCR), Reflex: Multi-Probe Reverse Hybridization
HCV RNA, Quantitative, PCR <15 IU/mL
HCV RNA, Quantitative, PCR <1.18 Log IU/mL
 
 
 
87522
 
91707
Hepatitis C-Infected Patient, Baseline Panel 2 - NEW! print

This panel is useful in assessing the risk of any underlying medical conditions prior, during, and after initiation of therapy for Hepatitis C. This baseline profile does not include Hepatitis A or Hepatitis B testing, under the assumption this testing has already been performed. If these tests are desired, consider using 91704 (Hepatitis C-Infected Patient, Baseline Panel 1) or ordering separately. The relevant laboratory monitoring has been defined in the most recent AASLD guidelines.

See individual tests
See individual tests
 
 
 
80076, 85025, 82565, 86703, 87902
 
91706
Hepatitis C-Infected Patient, Treatment Panel - NEW! print

Hepatitis C patients should be monitored during therapy to assess both response to therapy as well as evaluation for side effects.

See individual tests
See individual tests
 
 
 
85025, 82565, 84460, 87522
 
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24310
Hepatitis D Antibody, Total print

Hepatitis D virus (HDV) infection occurs in association with HBV infection. A positive result for HDV total antibody may indicate either acute or chronic HDV infection. HDV antibodies appear transiently during acute infection, and typically disappear with resolution of the infection. In contrast, HDV antibodies usually persist in chronic infection.

*This test was performed using a kit that has not been cleared or approved by the FDA. The analytical performance characteristics of this test have been determined by Focus Diagnostics. This test should not be used for diagnosis without confirmation by other medically established means.

This test is approved for New York patient testing.

EIA (Enzyme Immunoassay)
Negative
1 mL serum
(minimum 0.5 mL)
Room temperature
(Do not reject refrigerated or frozen specimens)
1 to 5 days
86692*
 
24011
Hepatitis D Virus (HDV) IgM Antibody, EIA print

HDV infection occurs only in association with HBV infection. Detection of HDV IgM indicates active HDV replication due to either infection or reactivation of chronic infection.

This test is approved for New York patient testing.

EIA (Enzyme Immunoassay)
Negative
1 mL serum
(minimum 0.5 mL)
2-8° C
1 to 5 days
86692
 
2401
Hepatitis D Virus Antibody Panel, EIA print

See individual assay for description.

Panel Includes:

  • Hepatitis D Antibody Total
  • Hepatitis D Virus (HDV) IgM Antibody, EIA

Hepatitis D virus (HDV) infection occurs in association with HBV infection; the presence of HDV antibodies may indicate either acute or chronic HDV infection. HDV antibodies appear transiently during acute infection, and typically disappear with resolution of the infection but usually persist in chronic infection. Measurement of HDV IgM may help distinguish acute from chronic infection.

*This test was performed using a kit that has not been cleared or approved by the FDA. The analytical performance characteristics of this test have been determined by Focus Diagnostics. This test should not be used for diagnosis without confirmation by other medically established means.

This test is approved for New York patient testing.

EIA (Enzyme Immunoassay)
Negative
1.5 mL serum
Plasma is not acceptable.
(minimum 0.75 mL)
2-8° C
1 to 5 days
86692 x 2*
 
27500
Hepatitis D Virus RNA, Qualitative Real-Time PCR print

Hepatitis D virus (HDV) is an RNA virus whose transmission is dependent on associated hepatitis B viral infection.

This test is approved for New York patient testing.

Real-Time RT-PCR
Not detected
0.7 mL serum
(minimum 0.3 mL)
2-8° C
1 to 2 days
87798
 
20171
Hepatitis E Antibody (IgG) print

HEV infection is responsible for some cases of non-A, non-B, non-C hepatitis. Found primarily in Asia, Africa, Mexico, and Central America, HEV is mainly transmitted via contaminated water.

*This test was performed using a kit that has not been cleared or approved by the FDA. The analytical performance characteristics of this test have been determined by Focus Diagnostics. This test should not be used for diagnosis without confirmation by other medically established means.

This test is approved for New York patient testing.

ELISA (Enzyme Linked Immunosorbent Assay)
Not detected
0.5 mL serum
(minimum 0.1 mL)
Room temperature
(Do not reject refrigerated or frozen specimens)
1 to 5 days
86790*
 
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20173
Hepatitis E Antibody (IgG, IgM) print

HEV infection is responsible for some cases of non-A, non-B, non-C hepatitis. Found primarily in Asia, Africa, Mexico, and Central America, HEV is mainly transmitted via contaminated water.

*This test was performed using a kit that has not been cleared or approved by the FDA. The analytical performance characteristics of this test have been determined by Focus Diagnostics. This test should not be used for diagnosis without confirmation by other medically established means.

This test is approved for New York patient testing.

ELISA (Enzyme Linked Immunosorbent Assay)
Not detected
1 mL serum
(minimum 0.2 mL)
Room temperature
(Do not reject refrigerated or frozen specimens)
1 to 5 days
86790 x 2*
 
20172
Hepatitis E Antibody (IgM) print

HEV infection is responsible for some cases of non-A, non-B, non-C hepatitis. Found primarily in Asia, Africa, Mexico, and Central America, HEV is mainly transmitted via contaminated water.

*This test was performed using a kit that has not been cleared or approved by the FDA. The analytical performance characteristics of this test have been determined by Focus Diagnostics. This test should not be used for diagnosis without confirmation by other medically established means.

This test is approved for New York patient testing.

ELISA (Enzyme Linked Immunosorbent Assay)
Not detected
0.5 mL serum
(minimum 0.1 mL)
Room temperature
(Do not reject refrigerated or frozen specimens)
1 to 5 days
86790*
 
10306
Hepatitis Panel, Acute with Reflex to Confirmation print

Panel Includes:

  • Hepatitis B Surface Antigen with Reflex to Confirmation
  • Hepatitis B Core Antibody (IgM)
  • Hepatitis A IgM
  • Hepatitis C Antibody

Nonreactive
5 mL (2.5 minimum) serum
Room temperature
See individual tests
86803, 87340, 86705, 86709
 
6462
Hepatitis Panel, General print

Panel Includes:

  • Hepatitis A Antibody, Total
  • Hepatitis B Surface Antibody, Qualitative
  • Hepatitis B Surface Antigen with Reflex to Confirmation
  • Hepatitis B Core Antibody, Total
  • Hepatitis C Antibody

Immunoassay
See individual tests
7 mL (3.5 mL minimum) serum
Room temperature
See individual tests
86708, 86706, 87340, 86704, 86803
 
81105
Herpes Simples Virus 1 and 2 Antigen, DFA print

Smears are stained with fluorescent monoclonal antibodies that detect the presence of HSV in specimens. Sensitivity of this test is 60-80%.

This test is approved for New York patient testing.

DFA (Direct Fluorescent Antibody)
Not detected
Mucosal membrane or skin lesion (vesicles) scrapings or aspirate, (oral, genital, skin). Preferred: Collect specimen on swab and To maintain optimum viability, place swab into VCM or equivalent and transport the specimen to the laboratory as soon as possible. Best recovery is obtained when the specimens are refrigerated at 2-8 degrees C or kept on wet ice following collection and while in transit. If there will be a long delay before processing, specimens in VCM or equivalent should be frozen at -70 degrees C or colder and transported on dry ice. Storage or transport at - 20 degrees C is not acceptable.
Air-dried smear of specimen on 2 glass slides
Refrigerated (2-8° C)
1 to 2 days
87273; 87274
 
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4900
Herpes Simplex Virus (HSV) 1/2 and Enterovirus Detection Panel, PCR print

See individual assay for description.

Panel Includes:

  • Enterovirus RNA, Qualitative Real-Time PCR
  • Herpes Simplex Virus (HSV) 1/2 Detection and Differentiation, PCR

Real-Time PCR
Not detected
2 mL CSF
(minimum 1 mL)
OR
Swab in transport medium
FROZEN on dry ice via overnight transport.
1 to 3 days
87498; 87529 x 2
 
40520
Herpes Simplex Virus (HSV) 1/2 IgM and Type-Specific IgG (HerpeSelect®), ELISA print

The HSV IgM ELISA detects type-common as well as type-specific IgM antibodies; thus, the type-specificity of any HSV IgM antibodies detected cannot be reliably determined. All samples giving an equivocal or positive IgM ELISA result are confirmed by an IFA procedure. As with the HSV IgM ELISA, however, IgM reactivity in the IFA is not type-specific.

This test is approved for New York patient testing.



Please see the following technical sheet for more information:
 HerpeSelect® Type-Specific HSV-1 and HSV-2 IgG Antibody Differentiation

ELISA (Enzyme Linked Immunosorbent Assay)
<0.90
1 mL serum
(minimum 0.5 mL)
2-8° C
1 to 4 days
86694; 86695; 86696 (Add 86694 if confirmed)
 
40523
Herpes Simplex Virus (HSV) 1/2 IgM Antibody, ELISA print

The HSV IgM ELISA detects type-common as well as type-specific IgM antibodies; thus, the type-specificity of any HSV IgM antibodies detected cannot be reliably determined. All samples giving an equivocal or positive IgM ELISA result are confirmed by an IFA procedure. As with the HSV IgM ELISA, however, IgM reactivity in the IFA is not type-specific.

This test is approved for New York patient testing.

ELISA (Enzyme Linked Immunosorbent Assay)
<0.90
1 mL serum
(minimum 0.5 mL)
2-8° C
1 to 3 days
86694 (Add 86695; 86696 if confirmed)
 
40521
Herpes Simplex Virus (HSV) 1/2 Type-Specific IgG (HerpeSelect®), IBL (Serum) print

Differentiation of HSV-1 from HSV-2 IgG antibodies can be effectively accomplished using the HerpeSelect® HSV-1 and HSV-2 IgG immunoblot assay, which utilizes recombinant type-specific HSV glycoproteins (gG antigens).

This test is approved for New York patient testing.



Please see the following technical sheet for more information:
 HerpeSelect® Type-Specific HSV-1 and HSV-2 IgG Antibody Differentiation

Immunoblot
Negative
1.5 mL serum
(minimum 1 mL)
2-8° C
1 to 3 days
86695; 86696
 
91154
Herpes Simplex Virus (HSV) Antibody Panel, ELISA/IFA (CSF) print

Detection of HSV type-specific IgG in CSF may indicate central nervous system infection by that HSV type.

If HSV 1 IgM screen is Positive, HSV 1 IgM Titer is performed at an additional charge (CPT code: 86695).

If HSV 2 IgM Screen is Positive, HSV 2 IgM Titer is performed at an additional charge (CPT code: 86696).

This test is not approved for New York patient testing.

Immunofluorescence Assay
Negative
1 mL CSF
Refrigerated (2-8° C)
 
86695 (x2), 86696 (x2)
 
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81555
Herpes Simplex Virus (HSV), Conventional Culture print

Classically, HSV-1 infections are acquired in early childhood and are often asymptomatic or subclinical, but may produce oral lesions while HSV-2 is often acquired post-adolescence and manifests as genital infections with lesions. Current adult sexual behavior has allowed for oral HSV-2 infections and genital HSV-1 infections that are indistinguishable from the classic infections without identification of the virus. This assay uses cell culture methods that allow for HSV-1 and HSV-2 growth and isolation followed by a specific antiserum immunofluoresence assay for virus identification.

This test is approved for New York patient testing.

Tissue Culture/Immunofluorescence
No Herpes Simplex Virus Isolated
Swab or scrapings of vesicular lesion, CSF
Whole blood: Room temperature

All others: 2-8° C within 48 hours of collection;
FROZEN if more then 48 hours of collection.
2 to 8 days
87252
 
3636
Herpes Simplex Virus 1 (IgG), Type-Specific Antibody (HerpeSelect®) print

Herpes Simplex Virus (HSV) is responsible for several clinically significant human viral diseases with severity ranging from inapparent to fatal. Clinical manifestations include genital tract infections, neonatal herpes, meningo-encephalitis, keratoconjunctivitis, and gingivostomatitis. There are two HSV serotypes that are closely related antigenically. HSV Type 2 is more commonly associated with genital tract and neonatal infections, while HSV Type 1 is more commonly associated with infections of non-genital sites. Specific typing is not usually required for diagnosis or treatment. The mean time to seroconversion using the type specific assay is 25 days. The performance of this assay has not been established for use in a pediatric population, for neonatal screening, or for testing of immunocompromised patients.

Immunoassay
<0.90 Negative
0.90-1.10 Equivocal
>1.10 Positive
1 mL (minimum 0.2 mL) serum
Room temperature
2-5 days
86695
 
17169
Herpes Simplex Virus 1/2 (IgG) (HerpeSelect®) with Reflex to HSV-2 Inhibition print

&npsp;

Immunoassay
<0.90 Negative
0.90-1.10 Equivocal
>1.10 Postive
2 mL (0.7 mL minimum) serum
Room temperature
2-5 days
86695, 86696
 
60555
Herpes Simplex Virus 1/2 (IgG) Type-Specific Antibodies, CSF print

Detection of HSV type-specific IgG in CSF may indicate central nervous system (CNS) infection by that HSV type. However, interpretation of results may be complicated by a number of factors, including low antibody levels found in CSF, passive transfer of antibody across the blood-brain barrier, and serum contamination of CSF during CSF collection. PCR detection of type-specific HSV DNA in CSF is the preferred method for identifying HSV CNS infections

This test is not approved for New York patient testing.

ELISA
< or =1.00
1 mL CSF
(minimum 0.1 mL)
Room Temperature
1 to 3 days
86695, 86696
 
6447
Herpes Simplex Virus 1/2 (IgG), Type-Specific Antibodies (HerpeSelect®) print

The HerpeSelect® test system utilizes recombinant type-specific HSV-1 and HSV-2 antigens to detect type-specific IgG antibodies. Detection of IgG to both HSV-1 and HSV-2 in a single specimen therefore indicates dual infection by HSV-1 and HSV-2. In-house validation studies revealed a sensitivity of 100% for both the HSV 1 IgG ELISA and the HSV-2 IgG ELISA when compared to Western blot; specificity was 98% for both assays.

This test is approved for New York patient testing.

Immunoassay Immunoassay
<0.90 Negative
0.90-1.10 Equivocal
>1.10 Positive
1 mL (0.2 mL minimum) serum
2-8° C
2-5 days
86695; 86696
 
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90851
Herpes Simplex Virus 1/2 Antibody (IgM), IFA with Reflex to Titer, CSF print

Detection of HSV IgM in CSF may aid in the diagnosis of encephalitis caused by HSV.

If HSV 1 IgM screen is Positive, HSV 1 IgM Titer is performed at an additional charge (CPT code: 86695).

If HSV 2 IgM Screen is Positive, HSV 2 IgM Titer is performed at an additional charge (CPT code: 86696).

Immunofluorescence Assay
Negative
1 mL CSF
Room Temperature
 
86695, 86696
 
90849
Herpes Simplex Virus 1/2 Antibody (IgM), IFA with Reflex to Titer, Serum print

HSV IgM is detectable in serum from >90% of patients with primary HSV infection; however, HSV IgM is also found in 30% of patients with reactivated HSV.

If HSV 1 IgM Screen is Positive, HSV 1 IgM Titer is performed at an additional charge (CPT code 86695).

If HSV 2 IgM Screen is Positive, HSV 2 IgM Titer is performed at an additional charge (CPT code 86696).

Immunofluorescence Assay
Negative
1 mL serum
Room temperature
 
86695, 86696
 
17170
Herpes Simplex Virus 2 (IgG), HerpeSelect® with Reflex to HSV-2 Inhibition print

 

Immunoassay
<0.90 Negative
0.90-1.10 Equivocal
>1.10 Positive
1 mL (minimum 0.5 mL) serum
Room temperature
2-5 days
86696
 
3640
Herpes Simplex Virus 2 (IgG), Type-Specific Antibody (HerpeSelect®) print

 

Immunoassay
<0.90 Negative
0.90-1.10 Equivocal
>1.10 Positive
1 mL (minimum 0.2 mL) serum
Room temperature
2-5 days
86696
 
34290
Herpes Simplex Virus Antigen Detection, DFA print

 

Direct Immunofluorescence Assay, DFA
Not Detected
Swab of mucosal membrane or skin lesion (vesicle) in VCM medium (green-cap) tube or equivalent.
Air-dried smear on 2 clean glass slides
Refrigerated (2-8° C)
1 to 2 days
87274; 87273
 
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2692
Herpes Simplex Virus Culture print

 

Centrifuge Enhanced Culture, Histochemical Stain
Not Isolated
Nasal/nasopharyngeal swab, endocervical swab, eye swab or lesion (vesicle) aspirate swab, urethral swab, vaginal swab, rectal mucosa swab (without feces) or throat swab collected in VCM (green-cap) tube or equivalent
3 mL (1 mL fluid or 1 g tissue minimum) Bronchial lavage/wash or Nasopharyngeal lavage/wash or fresh (unfixed) tissue collected in VCM (green-cap) tube or equivalent or sterile screw capped container
Refrigerated (2-8° C)
2 to 3 days
 
 
2649
Herpes Simplex Virus Culture with Reflex to Typing print

The combination of centrifugation with sensitive monoclonal antibody staining techniques has both increased the rate of isolation as compared with conventional cultures and reduced the turn-around time to 48 hours. Serotyping of HSV isolates is done routinely.

This test is approved for New York patient testing.

Centrifuge Enhanced Culture, Histochemical Stain, Monoclonal Fluorescent Antibody Typing
Not Isolated
Nasal/nasopharyngeal swab, endocervical swab, eye swab or lesion (vesicle) aspirate swab, urethral swab, vaginal swab, rectal mucosa swab (without feces) or throat swab collected in VCM (green-cap) tube or equivalent
3 mL (1 mL fluid or 1 g tissue minimum) Bronchial lavage/wash or Nasopharyngeal lavage/wash or fresh (unfixed) tissue collected in VCM (green-cap) or equivalent or sterile screw capped container
Refrigerated (2-8° C)
2 to 4 days
87255
 
40597
Herpes Simplex Virus Type 2 (HSV-2) IgG Inhibition, ELISA print

This test is designed to further characterize samples giving low positive or other unexpected results in HSV-2 type-specific IgG assays.
Note: Specimens submitted from another lab for inhibition studies must include the index value of the initial type-specific ELISA test. Inhibition studies are not performed on samples with equivocal or negative results.

This test is approved for New York patient testing.

ELISA (Enzyme Linked Immunosorbent Assay)
N/A
1 mL serum
(minimum 0.5 mL)
2-8° C
1 to 8 days
86696 x 2
 
43220
Herpes Simplex Virus, Type 1 & 2 DNA, Quantitative Real-Time PCR print

The detection of HSV-1 and HSV-2 DNA is based upon the real-time amplification, detection and differentiation of specific HSV-1 and HSV-2 genomic DNA sequences by PCR from total DNA extracted from the specimen. The quantitative range of this assay is 100 - 2,000,000 copies/mL.

This test is approved for New York patient testing.

Real-Time PCR
<100 copies/mL
1 mL CSF, serum, whole blood or plasma
(EDTA, ACD), pleural, pericardial, amniotic or vitreous fluid; swab in M4 or
V-C-M medium
(minimum 0.3 mL)
Vaginal swab in Aptima Vaginal Swab Collection kit.
Whole blood: Refrigerated All others: FROZEN
Next day
87530 x 2
 
43200
Herpes Simplex Virus, Type 1 & 2 DNA, Real-Time PCR print

The detection of HSV-1 and HSV-2 DNA is based upon the real-time amplification, detection and differentiation of specific HSV-1 and HSV-2 genomic DNA sequences by PCR from total DNA extracted from the specimen. PCR is considered the standard for detecting viral nucleic acids in CSF.

This test is approved for New York patient testing.

Real-Time PCR
Not detected
1 mL CSF in a sterile leak proof container; swab in M4 or
V-C-M medium
Minimum: 0.05 mL -CSF and vitreous fluid;
0.3 mL - all other specimen sources
Serum, urine, plasma (EDTA, ACD, or PPT), whole blood (EDTA, ACD); pleural, pericardial, amniotic or vitreous fluid in sterile leak-proof container; 3 mm3 tissue
Vaginal swab in Aptima Vaginal Swab Collection kit.
Whole blood:
Refrigerated Preferred
Room temperature: Acceptable
FROZEN: Unacceptable

All others:
FROZEN
Next day
87529 x 2
 
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90569
Herpes Simplex Virus, Type 1/2 DNA, Real-Time PCR, Pap Vial - NEW! print

Diagnosis of active herpes simplex infection.

Real-Time Polymerase Chain Reaction (PCR)
HSV 1 DNA Not detected
HSV 2 DNA Not detected
1 mL liquid cytology (PreservCyt®) preservative (ThinPrep®) collected in Aptima® vaginal collection kit (orange label) or Aptima® specimen transfer tube (green label)
1 mL mimimum
Aptima® unisex swab collection kit
Room temperature
3-7 days
87529 (x2)
 
17495
Herpes Simplex Virus/Varicella Zoster Virus Rapid Culture print

 

Centrifugation Enhanced Cell Culture, Immunofluorescence
HSV: Not Isolated
VZV: Not Isolated
Lesion (vesicle) aspirate or swab from oral mucosa, skin or conjunctiva collected in VCM (green-cap) tube or equivalent.
Respiratory specimens such as bronchial washings/lavage, tracheal aspirates, tissue, body fluids.
Refrigerated (2-8° C)
 
87254 x2
 
43160
Herpes Virus-6 DNA, Qualitative Real-Time PCR print

Human herpesvirus 6 (HHV-6) is the cause of the common childhood disease exanthem subitum (roseola infantum) and can reactivate after primary infection in immunocompromised adults and children. Focus performs this assay using primers and probe detecting both variants A and B of HHV-6.

This test is not approved for New York patient testing.

Real-Time PCR
Not detected.
1 mL whole blood or plasma (EDTA or ACD)
(minimum 0.3 mL)
1 mL (minimum 0.3 mL) serum, CSF, bone marrow (EDTA, ACD) bronchoalveolar lavage, amniotic fluid or tissue
2-8° C
1 to 2 days
87532
 
43660
Herpes Virus-6 DNA, Quantitative Real-Time PCR print

Human herpesvirus 6 (HHV-6) is the cause of the common childhood disease exanthem subitum (roseola infantum) and can reactivate after primary infection in immunocompromised adults and children. Focus performs this assay using primers and probe detecting both variants A and B of HHV-6. Quantification of HHV-6 DNA is based upon the real-time PCR amplification and detection of HHV-6 genomic DNA. The quantitative range of this assay is 500 to 2,000,000 HHV-6 DNA copies/mL.

This test is not approved for New York patient testing.

Real-Time PCR
<500 copies/mL
1 mL whole blood (EDTA, ACD)
(minimum 0.3 mL)
1 mL (minimum 0.3 mL) serum, plasma (EDTA, ACD), CSF, bone marrow (EDTA, ACD), bronchoalveolar lavage, amniotic fluid or urine
2-8° C
1 to 2 days
87533
 
43166
Herpesvirus 6 (HHV-6) DNA Qualitative Reflex to HHV-6 DNA Quantititave print

If HHV-6 DNA is detected in the qualitative assay, the specimen will reflex to Herpesvirus 6 Quantitative PCR (Focus Unit Code 43660) for an additional charge. The quantitative range if reflexed is 500 - 2,000,000 HHV-6 DNA copies/mL.

This test is not approved for New York patient testing.

Real-Time PCR
Not detected
1.5 mL of whole blood (EDTA OR ACD), serum, plasma (EDTA OR ACD), or CSF
(minimum 0.5 mL)
2-8° C
1 to 2 days
87532 (Add 87533 if refle x ed)
 
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40540
Herpesvirus 6 Antibodies (IgG, IgM) print

Human herpesvirus 6 (HHV-6) infects peripheral blood leukocytes, and is considered the agent of roseola. The normal prevalence of HHV-6 antibody is high; nearly 100% of the population will demonstrate antibody at midlife with titers declining in old age. Immunofluorescence assays are used for serological detection of HHV-6. Crossreactions with other Herpes viruses, i.e., Cytomegalovirus and Herpes Simplex have not been found. In order to demonstrate primary infection, it is necessary to detect a significant change in titer.

†This test was developed and its performance characteristics determined by Focus Diagnostics. It has not been cleared or approved by the U.S. Food and Drug Administration. The FDA has determined that such clearance or approval is not necessary. Performance characteristics refer to the analytical performance of the test.

This test is approved for New York patient testing.

IFA (Immunofluorescence Assay)
IgG <1:10
IgM <1:20
0.5 mL serum
(minimum 0.5 mL)
2-8° C
1 to 4 days
86790 x 2†
 
40530
Herpesvirus 6 Antibody (IgG) print

Human herpesvirus 6 (HHV-6) is found in peripheral blood leukocytes and is considered the agent of roseola. The normal prevalence of HHV-6 antibody is high. Nearly 100% of the population will demonstrate antibody at midlife with titers declining with increasing age. Immunofluorescence assays are used for detection of antibody recognizing HHV-6. Crossreactions with other herpes viruses, i.e., Cytomegalovirus and Herpes Simplex have not been found. In order to serologically demonstrate primary infection, it is necessary to detect a significant change in titer.

†This test was developed and its performance characteristics determined by Focus Diagnostics. It has not been cleared or approved by the U.S. Food and Drug Administration. The FDA has determined that such clearance or approval is not necessary. Performance characteristics refer to the analytical performance of the test.

This test is approved for New York patient testing.

IFA (Immunofluorescence Assay)
<1:10
0.5 mL serum
(minimum 0.1 mL)
2-8° C
1 to 4 days
86790†
 
40535
Herpesvirus 6 Antibody (IgM) print

Human herpesvirus-6 (HHV-6) is considered the agent of roseola. Detection of HHV-6 IgM is indicative of acute infection.

†This test was developed and its performance characteristics determined by Focus Diagnostics. It has not been cleared or approved by the U.S. Food and Drug Administration. The FDA has determined that such clearance or approval is not necessary. Performance characteristics refer to the analytical performance of the test.

This test is approved for New York patient testing.

IFA (Immunofluorescence Assay)
<1:20
0.5 mL serum

(minimum 0.1 mL)
2-8° C
1 to 4 days
86790†
 
43770
Herpesvirus 7 (HHV-7) DNA, Quantitative Real-Time PCR print

HHV-7 is closely related to HHV-6 and CMV, and can cause reactivation disease in transplant patients or other immune-compromised individuals. Quantification of HHV-7 DNA is based upon the real-time PCR amplification and detection of HHV-7 genomic DNA. The quantitative range of this assay is 500 HHV-7 DNA copies/mL (2.7 log10) to 10,000,000 copies/mL (7.0 log10).

This test is not approved for New York patient testing.

Real-Time PCR
<500 copies/mL
1 mL whole blood
(ACD or EDTA), plasma
(ACD, EDTA or PPT) or serum
(minimum 0.3 mL)
2-8° C
1 to 2 days
87799
 
40543
Herpesvirus 7 IgG and IgM Antibody Panel, IFA print

Human Herpesvirus 7 (HHV-7), a close relative of HHV-6, is found in >85% of the population, with transmission occurring in early childhood. Like HHV-6, HHV-7 is a cause of exanthum subitum (roseola infantum). Due to the ubiquitous nature of HHV-7 infection, >80% of individuals in the general population exhibit HHV-7 IgG titers >=1:20; however, only 5% of these individuals exhibit titers >1:80. Thus, HHV-7 IgG titers >=1:160 are suggestive of recent HHV-7 infection. Detection of HHV-7 specific IgM is also indicative of recent infection.

*This test was performed using a kit that has not been cleared or approved by the FDA. The analytical performance characteristics of this test have been determined by Focus Diagnostics. This test should not be used for diagnosis without confirmation by other medically established means.

This test is available for New York patient testing.

IFA (Immunofluorescence Assay)
IgG <1:320
IgM <1:20
1 mL serum
(minimum 0.5 mL)
Room temperature
1 to 8 days
86790 x 2*
 
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40542
Herpesvirus 7 IgG Antibody, IFA print

Human herpesvirus-7 (HHV-7), a close relative of HHV-6, is found in >85% of the population, with transmission occurring in early childhood. Like HHV-6, HHV-7 is a cause of exanthum subitum (roseola infantum). Due to the ubiquitous nature of HHV-7 infection, >80% of individuals in the general population exhibit HHV-7 IgG titers >=1:20; however, only 5% of these individuals exhibit titers >1:80. Thus, single HHV-7 IgG titers >=1:160 are suggestive of recent HHV-7 infection. A four-fold change in titer between acute and convalescent sera is also suggestive of recent HHV-7 infection. For comparison of acute and convalescent sera, titers starting at 1:20 can be measured upon request.

*This test was performed using a kit that has not been cleared or approved by the FDA. The analytical performance characteristics of this test have been determined by Focus Diagnostics. This test should not be used for diagnosis without confirmation by other medically established means.

This test is approved for New York patient testing.

IFA (Immunofluorescence Assay)
<1:320
1 mL serum
(minimum 0.5 mL)
Room temperature
1 to 8 days
86790*
 
40541
Herpesvirus 7 IgM Antibody, IFA print

Human Herpesvirus 7 (HHV-7) has been identified as an etiologic agent of exanthem subitum. Detection of HHV-7-specific IgM provides serologic evidence of acute infection.

This test is approved for New York patient testing.

IFA (Immunofluorescence Assay)
<1:20
1 mL serum
(minimum 0.5 mL)
Room temperature
2 to 8 days
86790
 
43175
Herpesvirus 8 (HHV-8) DNA, Qual to Quant Real-Time PCR Reflex print

Human herpesvirus type 8 (HHV-8) is a DNA virus that was originally detected in biopsies of individuals with AIDS-associated Kaposi's Sarcoma (KS). Experimental evidence suggests that HHV-8 is the etiological agent of KS. If HHV-8 DNA is detected in the qualitative assay, the specimen will reflex to the HHV-8 Quantitative PCR (Focus Unit Code 45700) for an additional charge.

This test is not approved for New York patient testing.

Real-Time PCR
Not detected
0.7 mL whole blood (EDTA, ACD), plasma (EDTA, ACD) or serum
(minimum 0.3 mL)
Whole blood: Room temperature
Plasma or serum: 2-8° C
1 to 2 days
87798 (Add 87799 if refle x ed)
 
43170
Herpesvirus 8 (HHV-8) DNA, Qualitative Real-Time PCR print

Human herpesvirus type 8 (HHV-8) is a DNA virus that was originally detected in biopsies of individuals with AIDS-associated Kaposi's Sarcoma (KS). Experimental evidence suggests that HHV-8 is the etiological agent of KS.

This test is approved for New York patient testing.

Real-Time PCR
Not detected
0.7 mL whole blood (EDTA, ACD), plasma (EDTA, ACD) or serum
(minimum 0.3 mL)
Whole blood: Room temperature
All others: 2-8° C
1 to 2 days
87798
 
45700
Herpesvirus 8 (HHV-8) DNA, Quantitative Real-Time PCR print

Human herpesvirus type 8 (HHV-8) is a DNA virus that was originally detected in biopsies of individuals with AIDS-associated Kaposi's Sarcoma (KS). Experimental evidence suggests that HHV-8 is the etiological agent of KS. This assay detects viral loads down to <1000 copies/mL.

This test is not approved for New York patient testing.

Real-Time PCR
<1000 copies/mL
0.7 mL whole blood (EDTA, ACD), plasma (EDTA, ACD) or serum
(minimum 0.3 mL)
Whole blood: Room temperature
Plasma or serum: 2-8° C
1 to 2 days
87799
 
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40544
Herpesvirus 8 IgG Antibody, IFA print

Human herpesvirus-8 (HHV-8), also known as Kaposi's Sarcoma Herpesvirus (KSHV), is found in most cases of Kaposi's Sarcoma (KS), including classic KS as well as AIDS-related KS. HHV-8 has also been detected in B-cell lymphomas in the abdominal cavity. IgG antibodies recognizing HHV-8 are found in >80% of KS patients and approximately 30% of HIV-seropositive individuals without KS, but less than 5% of healthy blood donors.

*This test was performed using a kit that has not been cleared or approved by the FDA. The analytical performance characteristics of this test have been determined by Focus Diagnostics. This test should not be used for diagnosis without confirmation by other medically established means.

This test is approved for New York patient testing.

IFA (Immunofluorescence Assay)
<1:20
1 mL serum
(minimum 0.1 mL)
Room temperature
2 to 8 days
86790*
 
-105
HGE (See Anaplasma phagocytophilum) print

 
-106
HGV (See Hepatitis G Virus)
-107
HHV-6 (See Herpesvirus 6 ) print

 
-108
HHV-7 (See Herpesvirus 7) print

 
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-109
HHV-8 (See Herpesvirus 8) print

 
20356
Histone Antibody, Qualitative, EIA print

Histone antibodies can be used to verify the diagnosis of drug-induced lupus caused by drugs such as procainamide and hydralazine. Histone antibodies are present in drug-induced lupus (96%), idiopathic SLE (50%), and occasionally, other collagen vascular diseases. Histone antibody in drug-induced lupus is the only specific anti-nuclear antibody detected; therefore the lack of histone antibody or the presence of other specific anti-nuclear antibodies makes the diagnosis of drug-induced lupus unlikely.

Test performed at Quest Diagnostics Nichols Institute.

EIA (Enzyme Immunoassay)
<1.0 units
1 mL serum
(minimum 0.3 mL)
2-8° C
1 to 5 days
83516
 
6485
Histoplasma Antibody Panel, CF and ID (CSF) print

See individual assay for description.

Panel Includes:

  • Histoplasma Antibody, Complement Fixation, CSF
  • Histoplasma Antibody, Immunodiffusion, CSF

CF (Complement Fixation) and ID (immunodiffusion)
By report
1 mL CSF
(minimum 0.6 mL)
2-8° C
2 to 5 days
86698 x 3
 
2485
Histoplasma Antibody, CF and ID, Serum print

See individual assay for description.

Panel Includes:

  • Histoplasma Antibody, Complement Fixation, Serum
  • Histoplasma Antibody, Immunodiffusion, Serum

CF (Complement Fixation) and ID (immunodiffusion)
By report
1 mL serum
(minimum 0.5 mL)
Room temperature
2 to 5 days
86698 x 3
 
60570
Histoplasma Antibody, Complement Fixation, CSF print

Detection of intrathecally-produced organism-specific antibodies in CSF indicates central nervous system infection. However, serum levels of organism-specific antibodies, blood-brain barrier integrity, and possible CSF contamination by blood should be considered when assessing CSF results.

This test is approved for New York patient testing.

Complement Fixation
<1:1
1 mL CSF
(minimum 0.5 mL)
Room Temperature
2 to 5 days
86698 x 2
 
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40570
Histoplasma Antibody, Complement Fixation, Serum print

Complement-fixation (CF) titers >=1:8 are generally considered evidence indicative of histoplasmosis. Higher titers increase the probability of infection. However, positive titers are also seen with fungal infections other than histoplasmosis, and confirmation of antibody specificity with immunodiffusion procedures is recommended. Changing titers are useful both in diagnosis and in assessment of treatment efficacy.

This test is approved for New York patient testing.

Complement Fixation
<1:8
1 mL serum
(minimum 0.5 mL)
2-8° C
2 to 5 days
86698 x 2
 
60575
Histoplasma Antibody, Immunodiffusion, CSF print

Detection of intrathecally-produced organism-specific antibodies in CSF indicates central nervous system infection. However, serum levels of organism-specific antibodies, blood-brain barrier integrity, and possible CSF contamination by blood should be considered when assessing CSF results.

This test is available for New York patient testing.

ID (Immunodiffusion)
Negative
1 mL CSF
(minimum 0.1 mL)
Room Temperature
2 to 5 days
86698
 
40575
Histoplasma Antibody, Immunodiffusion, Serum print

Positive immunodiffusion reactions involve one or more specific precipitin bands. Of these bands the first to appear in active histoplasmosis is the "M" band, which is seen in approximately 70% of proven cases. This band is also seen in some patients with past infections and in 20% of those with recent histoplasmin skin testing. The "H" band is usually seen in active and progressive histoplasmosis and almost always in the presence of the "M" band, although it is found much less often (approximately 10% of proven cases).

This test is approved for New York patient testing.

ID (Immunodiffusion)
Negative
1 mL serum
(minimum 0.1 mL)
2-8° C
2 to 5 days
86698
 
41583
Histoplasma capsulatum DNA, PCR print

The detection of Histoplasma capsulatum DNA is based upon the real-time amplification and detection of specific H. capsulatum genomic DNA sequences by PCR.

This test is not approved for New York patient testing.

Real-Time PCR
Not detected
5mL whole blood (ACD, EDTA);
OR
1mL bronchoalveolar lavage (BAL), CSF, or urine
(minimum 0.5 mL)
OR
>3 mm3 tissue
Whole blood: Room temperature

All others: FROZEN
1 to 2 days
87798
 
19728
HIV Antibodies, HIV-1/-2, EIA, with Reflexes print

 

 
3 mL (2 mL minimum) serum
Plasma collected in an EDTA (lavender-top) tube
 
2-8 days
 
 
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6090
HIV Detection Panel (CSF) print

See individual assay for description.

Panel Includes:

  • HIV-1 IgG Antibody, Western Blot
  • HIV Direct Antigen (ICD) Detection, ELISA

This panel is intended for specimens testing positive in a screening assay for HIV 1/2 antibodies.

*This test was performed using a kit that has not been cleared or approved by the FDA. The analytical performance characteristics of this test have been determined by Focus Diagnostics. This test should not be used for diagnosis without confirmation by other medically established means.

ELISA (Enzyme Linked Immunosorbent Assay) and Western Blot
Negative
2 mL CSF
(minimum 1 mL)
FROZEN
1 to 6 days
86689; 87390*
 
17097
Histoplasma capsulatum Identification, DNA Probe print

Histoplasmosis is usually asymptomatic or mild. Some patients develop chronic pulmonary histoplasmosis or acute disseminated histoplasmosis that is often life-threatening.

This test is approved for New York patient testing.

Nucleic Acid Probe
Not detected
Pure isolate on an agar slant in a double walled container
Room temperature
2-4 days
87149
 
42915
HIV-1 and HIV-2 EIA Antibody Screen with Reflex to HIV-1 WB print

The HIV-1/2 EIA detects antibodies to both Human Immunodeficiency Virus type 1 (HIV-1) and type 2 (HIV-2). This assay utilizes recombinant HIV-1 and HIV-2 proteins and detects both IgG and IgM classes of antibodies; however the assay does not differentiate HIV-1 from HIV-2 infection. Specimens which are repeatedly reactive in the combination HIV-1/HIV-2 EIA will be confirmed using the testing algorithm suggested by the CDC (MMWR 41:RR12, 1992). HIV-Antibody Western blot (Unit Code 41070) will be performed for an additional charge.

This test is approved for New York patient testing.

ELISA (Enzyme Linked Immunosorbent Assay)
Nonreactive
1 mL serum or plasma
(minimum 0.6 mL)
Room temperature
1 to 4 days
86703 (add 86689 if confirmed)
 
90666
HIV-1 Coreceptor Tropism with Reflex to Ultradeep Sequencing - NEW! print

The use of CCR5 antagonists requires screening for viral tropism to exclude patients harboring X4 or dual mixed virus. Detection of X4 virus prior to the initiation of therapy has been associated with a reduced response to maraviroc.

DNA Sequencing, Reverse Transcriptase Polymerase Chain Reaction (RT-PCR)
Reflex: Ultradeep Sequencing
See Laboratory Report
2 mL frozen plasma collected in an EDTA (lavender-top) tube
Minimum Volume: 0.6 mL
 
See individual assays
87906
 
91299
HIV-1 Coreceptor Tropism, Proviral DNA - NEW! print

The use of CCR5 antagonists requires screening for viral tropism to exclude patients harboring X4 or D/M virus. HIV-1 Proviral DNA tropism test is useful for determination of viral tropism in patients with undetectable HIV-1 viral RNA (virologically suppressed). Test FAQ

DNA Sequencing, Polymerase Chain Reaction (PCR)
See Laboratory Report
 
 
 
87906
 
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61080
HIV-1 Direct Antigen (ICD), ELISA (CSF) print

The measurement of HIV-1 p24 (core) antigen is performed by the Immune Complex Dissociation (ICD) modification of the standard p24 antigen assay. This modification results in a significant increase in the sensitivity of the p24 antigen assay. Reactive specimens are confirmed by a neutralization method for an additional charge.

*This test was performed using a kit that has not been cleared or approved by the FDA. The analytical performance characteristics of this test have been determined by Focus Diagnostics. This test should not be used for diagnosis without confirmation by other medically established means.

This test is not approved for New York patient testing.

ELISA (Enzyme Linked Immunosorbent Assay)
Negative
1 mL CSF
(minimum 0.5 mL)
FROZEN
2 to 6 days
87390* (Add 86382 if confirmed)
 
41080
HIV-1 Direct Antigen (ICD), ELISA (Serum) print

The measurement of HIV p24 (core) antigen is performed by the Immune Complex Dissociation (ICD) modification of the standard p24 antigen assay. This modification results in a significant increase in the sensitivity of the p24 antigen assay. All specimens found positive are confirmed by neutralization for an additional charge. Quantitation of p24 antigen has been shown to be useful for detection of circulating, replicating, as well as nonviable HIV. The measurement of p24 antigenemia using the ICD modification may be of significant value for the detection of early infection and as a marker of disease progression and therapeutic response. Furthermore the p24/ICD assay has shown significant value for the early detection of HIV infection in neonates and may supplement other diagnostic tests for neonatal infections, such as HIV-1 PCR. Reactive specimens are confirmed by a neutralization method for an additional charge.

*This test was performed using a kit that has not been cleared or approved by the FDA. The analytical performance characteristics of this test have been determined by Focus Diagnostics. This test should not be used for diagnosis without confirmation by other medically established means.

This test is not approved for New York patient testing.

ELISA (Enzyme Linked Immunosorbent Assay)
Negative
1 mL serum
(minimum 0.5 mL)
FROZEN
2 to 6 days
87390* (Add 86382 if confirmed)
 
8401
HIV-1 DNA, Qualitative PCR print

This assay is a highly specific and sensitive method used to detect the integrated (proviral) form of HIV-1 DNA in clinical specimens.

*This test was performed using a kit that has not been cleared or approved by the FDA. The analytical performance characteristics of this test have been determined by Focus Diagnostics. This test should not be used for diagnosis without confirmation by other medically established means.

Test performed at Quest Diagnostics Nichols Institute, Chantilly, VA.

This test is approved for New York patient testing.

PCR (Polymerase Chain Reaction)
Not detected
1 mL whole blood (ACD, EDTA)
(minimum 0.5 mL)
Room temperature
1 to 4 days
87535*
 
34949
HIV-1 Genotype print

The high replication rate of HIV-1 coupled with its rapid mutation rate drives the accumulation of mutations, some of which confer reduced susceptibility to antiretroviral agents. HIV-1 Genotyping identifies mutations in the HIV-1 reverse transcriptase and protease genes. Genotyping can be used to identify mutations associated with current or evolving resistance and monitor transmission of drugresistant HIV-1.

This test is approved for New York patient testing.

RT-PCR and Sequencing
HIV-1 Genotype: Accompanies report
2 mL plasma EDTA (Lavender top)
(minimum 0.6 mL)
2 mL serum
FROZEN (-20° C)on dry ice via overnight transport. Note:Plasma must remain frozen.
8-11 days
87901
 
91692
HIV-1 GENOTYPE (RTI, PI, INTEGRASE INHIBITORS) - NEW! print

Identify drug resitance mutations in HIV-1 patients failing antiretroviral regimens containing RT, PR or Integrase inhibitors. Identify transmitted drug resistance mutations in the RT, PR or integrase genes in treatment-naive patients prior to initiation of antiretroviral therapy.

Reverse Transcriptase Polymerase Chain Reaction (RT-PCR), Sequencing
See Laboratory Report
 
 
 
87901, 87906
 
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90955
HIV-1 Genotype and Coreceptor Tropism w/Reflex to Ultradeep Sequencing - NEW! print

Select antiretroviral drug regimen for treating HIV-1 patients by assessing reverse transcriptase and protease inhibitor resistance, together with CCR5 antagonist eligibility.

DNA Sequencing, Reverse Transcriptase Polymerase Chain Reaction (RT-PCR), Ultradeep Sequencing
See Laboratory Report
4 mL plasma EDTA (lavender-top) tube
Minimum Volume: 0.2 mL
PPT potassium EDTA (white-top) tube
Frozen
See individual assays
87901, 87906 (x2)
 
45055
HIV-1 Genotype, RT and Protease Genes print

This assay detects mutations in the HIV-1 reverse transcriptase (RT) and protease (Pr) genes and uses proprietary algorithms to interpret the potential for resistance to antiviral agents. The entire protease gene and codons 1-400 of the reverse transcriptase gene are sequences to identify mutations. A minimum HIV-1 viral load of 600 copies/mL is required for HIV-1 genotyping using this assay.

Test performed at Quest Diagnostics Nichols Institute.

This test is approved for New York patient testing.

RT-PCR and Sequencing
HIV-1 Genotype: Accompanies report
2 mL plasma EDTA (Lavender top)
(minimum 0.6 mL)
2 mL serum
FROZEN (-20° C)on dry ice via overnight transport. Note:Plasma must remain frozen.
8 to 12 days
87901
 
11367
HIV-1 GP41 Envelope Genotype - NEW! print

The HIV gp41 envelope genotype test predicts resistance to HIV-1 fusion or entry inhibitors. The synthetic peptide FuzeonTM (generic name enfuvirtide, also formerly known as t-20) is a drug that targets a step in viral entry. FuzeonTM inhibits a conformational change in the HIV-1 trans-membrane lipoprotein (gp41) that is required for fusion between HIV-1 and target cell membrane and thus block viral entry and/or fusion. Mutations in the heptad repeat (HR1) domain of gp41 have been associated with decreased phenotype susceptibility of HIV-1 to FuzeonTM

Reverse Transcription Polymerase Chain Reaction (RT-PCR), DNA Sequencing
See Laboratory Report
2 mL plasma collected in an EDTA (lavender-top) tube
Minimum Volume: 0.6 mL
Plasma collected in a PPT Potassium EDTA (white-top) or ACD solution B (yellow-top) tube, Serum
Frozen
6-7 days
87906
 
61070
HIV-1 IgG Antibody, WB (CSF) print

Detection of intrathecally-produced organism-specific antibodies in CSF indicates central nervous system infection. However, serum levels of organism-specific antibodies, blood-brain barrier integrity, and possible CSF contamination by blood should be considered when assessing CSF results.

This assay is intended for specimens testing positive in a screening assay for HIV 1/2 antibodies.

This test is not approved for New York patient testing.

Western Blot
Negative
1 mL CSF
(minimum 0.25 mL)
Room Temperature
1 to 4 days
86689
 
-111
HIV-1 p24 (See HIV-1 Direct Antigen Assays) print

 
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16868
HIV-1 Integrase Genotype - NEW! print

The emergence of integrase drug resistance mutations has been observed in vitro and in patients experiencing virologic failure on raltegravir in clinical trials. Twenty three percent of patients receiving raltegravir in a clinical trial experienced virologic failure at 48 weeks and genotypic analysis detected raltegravir associated resistance mutations in 68% of virologic failures. This assay amplifies and sequences the HIV-1 integrase gene and reports mutations at positions associated with integrase inhibitor drug resistance.

Reverse Transcriptase Polymerase Chain Reaction (RT-PCR), Sequencing
See Laboratory Report
2 mL frozen plasma collected in an EDTA (lavender-top) tube
Minimum Volume: 0.6 mL
Frozen
3-5 days
87906
 
16185
HIV-1 RNA, Qualitative TMA print

The APTIMA® HIV-1 RNA, Qualitative assay may be used:
1. As an aid in the diagnosis of acute and primary HIV-1 infection.
2. To confirm HIV-1 infection in persons who repeatedly test positive for HIV-1 infection.
3. To resolve indeterminate or inconclusive HIV-1 Western blot results.

 
1.6 mL (0.6 mL minimum) plasma collected in a K2 EDTA (lavender-top) tube
Serum; plasma collected in an ACD-A (yellow-top) tube, Sodium citrate (light blue-top) tube or PPT (white-top) tube
 
2-5 days
 
 
16879
HIV-1 RNA, Qualitative, TMA CSF - NEW! print

This test is intended for use in conjunction with clinical presentation and other laboratory markers of disease progress for the clinical management of HIV-1 infected patients.

Transcription-Mediated Amplification (TMA)
Not detected
1.6 mL CSF in a sterile leak-proof container
Minimum Volume : 0.6 mL
Frozen
2-5 days
87535
 
18967
HIV-1 RNA, Qualitative, TMA with Reflex to Quantitative, Real-Time PCR - NEW! print

The APTIMA® HIV-1 RNA, Qualitative assay may be used:
1. As an aid in the diagnosis of acute and primary HIV-1 infection.
2. To confirm HIV-1 infection in persons who repeatedly test positive for HIV-1 infection.
3. To resolve indeterminate or inconclusive HIV-1 Western blot results.

Transcription-Mediated Amplification (TMA)
HIV-1 RNA, Qualitative, TMA: Not detected
4.6 mL plasma collected in an EDTA K2 (lavender-top) plastic tube
Minimum Volume: 3.1 mL
PPT potassium EDTA (white-top) tube
Frozen
2-6 days
87535
 
91691
HIV-1 RNA, QUANT, REAL-TIME PCR W/REFLEX TO GENOTYPE (RTI, PI, INTEGRASE) - NEW! print

Monitor viral load in HIV-1 patients undergoing antiretroviral therapy and automatically reflex to drug resistance testing for PR, RT and Integrase drugs in patients failing to achieve or maintain virologic suppression.

Real-Time Polymerase Chain Reaction (RT-PCR)
HIV-1 RNA, QN, PCR: <20 Copies/mL
HIV-1 RNA, QN, PCR: <1.30 Log copies/mL
7 mL PLASMA EDTA (LAVENDER-TOP) TUBE
Minimum Volume: 3.7 mL
FROZEN
2-10 DAYS
 
 
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34471
HIV-1 RNA, Quantitative PCR with Reflex to Genotype - NEW! print

Measurement of HIV-1 plasma levels (viral load) provides a direct assessment of viremia and should be used in conjunction with CD4+ T-cell counts. HIV-1 RNA, quantitation is useful in patients to assess prognosis, monitor progression of HIV-1 infection, determine when to initiate therapy, and monitor the effectiveness of antiretroviral therapy.

DNA Sequencing, Real-Time Polymerase Chain Reaction (RT-PCR)
HIV-1 RNA, QN, PCR: <20 copies/mL
HIV-1 RNA, QN, PCR: <1.30 Log copies/mL
HIV-1 Genotype: See Laboratory Report
7 mL plasma collected in an EDTA (lavender-top) tube
Minimum Volume: 3.1 mL
PPT potassium EDTA (white-top) tube
Frozen
2-8 days
87536
 
40085
HIV-1 RNA, Quantitative, Real-Time PCR print

This test is intended for use in conjunction with clinical presentation and other laboratory markers of disease progress for the clinical management of HIV-1 infected patients. The test can be used to assess patient prognosis by measuring the baseline HIV-1 RNA level or to monitor the effects of antiretroviral therapy by measuring changes in EDTA plasma HIV-1 RNA levels during the course of antiretroviral treatment. This test is not intended for use as a screening test for the presence of HIV-1 in blood or blood products or as a diagnostic test to confirm the presence of HIV-1 infection.

Test performed at Quest Diagnostics Nichols Institute.

Real-Time Polymerase Chain Reaction
HIV-1 RNA, Quantitative PCR: <20 copies/mL
HIV-1 RNA, Quantitative PCR: <1.30 Log copies/mL
3 mL frozen plasma collected in an EDTA (lavender-top) tube or a PPT (white-top) VacutainerTM plasma preparation tube
Minimum Volume: 2.5 mL
Frozen
2-4 days
87536
 
16186
HIV-1 RNA, Quantitative, Real-Time PCR, CSF - NEW! print

This test is intended for use in conjunction with clinical presentation and other laboratory markers of disease progress for the clinical management of HIV-1 infected patients. The test can be used to assess patient prognosis by measuring the baseline HIV-1 RNA level or to monitor the effects of antiretroviral therapy by measuring changes in EDTA plasma HIV-1 RNA levels during the course of antiretroviral treatment.

Polymerase Chain Reaction (PCR)
HIV-1 RNA, QN PCR, CSF <20 Copies/mL
HIV-1 RNA, QN PCR, CSF <1.30 Log copies/mL

This test was performed using the Cobas® AmpliPrep/Cobas® Taqman® HIV-1 test kit version 2.0 (Roche Molecular Systems, Inc.).
Use of this test on CSF specimen is a modification of the test's intended use.
3 mL frozen CSF in a sterile leak proof container
Minimum Volume: 1.1 mL
Frozen
2-4 days
87536
 
90926
HIV-1 RNA, Quantitative, Real-Time PCR, with Reflex to Integrase Genotype - NEW! print

This test is intended for use in conjunction with clinical presentation and other laboratory markers of disease progress for the clinical management of HIV-1 infected patients. The test can be used to assess patient prognosis by measuring the baseline HIV-1 RNA level or to monitor the effects of antiretroviral therapy by measuring changes in EDTA plasma HIV-1 RNA levels during the course of antiretroviral treatment. The emergence of integrase drug resistance mutations has been observed in vitro and in patients experiencing virologic failure on Raltegravir in clinical trials. Twenty three percent of patients receiving Raltegravir in a clinical trial experience virologic failure at 48 weeks and genotypic analysis detected raltegravir associated resistance mutations in 68% of virologic failures. This assay amplifies and sequences the HIV-1 integrase gene and reports mutations at positions associated with integrase inhibitor drug resistance.

Real-Time Polymerase Chain Reaction (RT-PCR)
HIV-1 RNA, Quantitative PCR: <20 copies/mL
HIV-1 RNA, Quantitative PCR: <1.30 Log copies/mL
3 mL frozen plasma collected in an EDTA (lavender-top) tube
Minimum Volume: 2.5 mL
Plasma collected in: PPT potassium EDTA (white-top) tube
Frozen
2-4 days
87536
 
91432
HIV-1/2 Antibody Differentiation print

This HIV assay is intended to be used as an aid in discriminating between HIV-1 or HIV-2.

Immunoassay
HIV 1 Antibody: Negative
HIV 2 Antibody: Negative
2 mL (1 mL minimum) serum
Plasma collected in an EDTA (lavender-top) tube
Room temperature
1-3 days
86701, 86702
 
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91778
HIV-1/2 Antibody Differentiation with Reflex to HIV-1 RNA, Qualitative TMA - NEW! print

To diagnose HIV infection.

Immunoassay (IA), Reflex: Transcription-Mediated Amplification (TMA)
HIV 1 Antibody: Negative
HIV 2 Antibody: Negative
3 mL serum
Minimum Volume: 2 mL
Plasma collected in an EDTA (lavender-top) tube
Room temperature
1-3 days
86701, 86702
 
91431
HIV-1/2 ANTIGEN AND ANTIBODIES, FOURTH GENERATION, WITH REFLEXES print

This 4th generation HIV Ag/Ab Combo assay is intended to be used as an aid in the diagnosis of HIV1/HIV2 infection, including acute or primary HIV-1 infection.

Immunoassay (IA)
HIV Ag/Ab, 4th Generation: Non-Reactive
3 mL SERUM
Minimum Volume: 2 mL
SERUM COLLECTED IN A RED-TOP TUBE (NO GEL)
PLASMA COLLECTED IN AN EDTA (LAVENDER-TOP) TUBE
ROOM TEMPERATURE
3-5 DAYS
87389
 
49000
HIV-2 DNA/RNA Qualitative Real-Time PCR print

Real-time reverse transcription-PCR is utilized int his assay to detect both the RNA and DNA forms of the HIV-2 genome.

This test is not approved for New York patient testing.

Real-Time RT-PCR
Not detected
1 mL whole blood (ACD or EDTA)
(minimum 0.4 mL)
Room temperature
1 to 2 days
87538
 
-112
HSV (See Herpes Simplex Virus) print

 
31532
HPV DNA, High Risk - NEW! print

HPV is the causative agent of cervical dysplasia and cervical carcinoma. This assay only detects high-risk HPV types, 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59 and 68.

This test is not approved for New York patient testing.

DNA Hybridization
The analytical performance characteristics of this assay, when used to test SurePath™ or vaginal specimens, have been determined by Quest Diagnostics.
Not Detected
Cervical brush or cervical broom on 1 mL Digene® cervical sampler Minimum Volume
Digene® specimen transport medium: 1 mL
ThinPrep® solution: 4.1 mL
SurePathTM: 2 mL
Cervical tissue biopsy 1 mL Digene® specimen collection kit, 2 mL SurePathR, Cell pellet fraction in leak-proof 15 mL conical tube, Cervical/ Endocervical scraping in 8.1 mL liquid cytology (PreservCyt®) preservative (ThinPrep®)
Room temperature (Cervical biopsy: Frozen)
3-6 days
87621
 
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15949
HPV DNA, High Risk, Anal-Rectal - NEW! print

This test is used to detect the presence of HPV DNA in anorectal mucosa.

This test is not approved for New York patient testing.

Hybrid Capture II
Not Detected
1 mL anal-rectal brush or Dacron swab in Digene specimen collection kit
Frozen
2-5 days
87621
 
17185
HPV DNA, Low and High Risk, Anal-Rectal - NEW! print

This test is used to detect the presence of HPV DNA in anorectal mucosa.

This test is not approved for New York patient testing.

Hybrid Capture II
The performance characteristics of this assay have been determined by Quest Diagnostics. Performance characteristics refer to the analytical performance of the test.
 
1 mL anal-rectal brush or Dacron swab in a Digene specimen collection kit
Frozen
3-5 days
87621 (x2)
 
16933
HPV Genotype - NEW! print

Human Papillomavirus (HPV) is one of the most common sexually transmitted diseases worldwide and therefore, routine screenings for the presence of certain types of high-risk HPV DNA is common practice in the United States. Although many types of HPV infections are benign and may resolve on their own, persistent infection with any of the high-risk HPV genotypes increases a woman's risk for progression to dysplasia or cervical cancer. It is therefore essential to be able to determine whether the HPV infection is high or low risk and even more essential to be able to determine the genotype of the HPV infection.

This test is not approved for New York patient testing.

Polymerase Chain Reaction (PCR) • Multi-probe Reverse Hybridization
See Laboratory Report
4 mL liquid cytology (PreservCyt®) preservative (ThinPrep®) residual fluid
Room temperature
2 days
87621
 
19865
HPV Genotypes 16 and 18 - NEW! print

Persistent infection with any of the 14 high-risk HPV types increases a woman's risk for progression to dysplasia or cervical cancer. The rate of progression or degree of risk depends on the HPV type. Of all 14 high-risk types, HPV Types 16 and 18 cause more than 60-65% od cervical cancers. This test will identify the presence or absence of HPV Type 16 DNA and /or Type 18 DNA in PreservCyt ThinPrep reflex specimens originally submitted for Digene High-Risk HPV Hybrid Capture 2. Knowledge of the HPV genotype will help physicians diagnose the type of HPV infection and its risk of delevoping into dysplasia or cervical cancer.

This test is not approved for New York patient testing.

Invader® Signal Amplification
HPV16 DNA, Invader® Not detected
HPV18 DNA, Invader® Not detected
4 mL residual (PreservCyt®) fluid
Minimum Volume: 2 mL
1 mL residual SurePath® fluid in Tripath surepaath vials - post processing of the Pap smear
Room temperature
2-5 days
87621 (x2)
 
91826
HPV Genotypes 16, 18/45 - NEW! print

Assay is used in combination with cervical cytology to assess the presence or absence of high-risk hpv genotypes 16, 18, and/or 45. This information, together with physicians's assessment of cytology history, other risk factors, and professional guidelines, may be used to guide patient management.

This test is not approved for New York patient testing.

Transcription-Mediated Amplification (TMA)
HPV 16 RNA: Not Detected HPV 18/45 RNA: Not Detected
1 mL liquid cytology (PreservCyt®) preservative (Thinprep®) in Aptima® specimen transfer tube(green label) or Aptima® vaginal collection kit (orange label
Room temperature
3-6 days
87621 (x2)
 
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92392
HPV Genotypes 16, 18/45, SurePath® Vial - NEW! print

This test is not approved for New York patient testing.

Transcription-Mediated Amplification (TMA)
Not Detected
SurePath® collection vial or Aptima® transfer tube with 0.5 mL SurePath® fluid
Room temperature
5-8 days
87621 (x2)
 
90887
HPV mRNA E6/E7 - NEW! print

The presence of E6/E7 messenger RNA from 14 high risk HPV types indicates incorporation of HPV DNA into the host cells. Proteins expressed from E6-E7 polycistronic mRNA alter cellular p53 and retinoblastoma protein functions, leading to disruption of cell-cycle check points and cell genome instability. This information, together with the physician’s assessment of cytology history, other risk factors, and professional guidelines, may be used to guide patient management.

This test is not approved for New York patient testing.

Transcription-Mediated Amplification (TMA)
Not detected
3 mL residual (Preservcyt®) fluid in ThinPrep® vial
Room temperature
3-6 days
87621
 
90942
HPV MRNA E6/E7 Reflex to Genotypes 16,18/45 - NEW! print

See individual assays

This test is not approved for New York patient testing.

Transcription-Mediated Amplification (TMA) • Invader® Signal Amplification
Not Detected
5 mL residual (PreservCyt®) fluid in ThinPrep® vial
Room temperature
8 days
87621
 
92203
HPV mRNA E6/E7 SurePath® Vial - NEW! print

This test is not approved for New York patient testing.

Transcription-Mediated Amplification (TMA)
Not Detected
SurePath® collection vial or Aptima® transfer tube with 0.5 mL SurePath® Fluid
Room temperature
2-8 days
87621
 
92211
HPV mRNA E6/E7 SurePath® with Reflex to HPV Genotype 16, 18/45 - NEW! print

This test is not approved for New York patient testing.

Transcription-Mediated Amplification (TMA)
Not Detected
SurePath® collection vial or Aptima® transfer tube with 0.5 mL SurePath® fluid
Room temperature
2-8 days
87621
 
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91932
HPV mRNA E6/E7, Rectal - NEW! print

The HPV mRNA E6/E7 test is used in conjunction with cytology to evaluate anal dysplasia.

This test is not approved for New York patient testing.

Transcription-Mediated Amplification (TMA)
Not detected
Dacron swab in 3 mL liquid cytology (PreservCYT®) preservative (Thin Prep®) vial
Dacron swab in 3 mL liquid cytology (PreservCYT®) preservative (Thin Prep®) vial
Room temperature
3-6 days
87621
 
19863
HPV, High Risk, Hybrid Capture II with Reflex to Genotypes 16,18 - NEW! print

HPV is the causative agent of cervical dysplasia and cervical carcinoma. The hybrid capture assay detectd high- risk HPV types 6, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, and 68 and low-risk types of HPV 6, 11, 42, 43, and 44. The reflex test only identifies whether the high risk types detected are genotypes 16 or 18.

This test is not approved for New York patient testing.

DNA Hybridization Invader®
Not Detected
8 mL residual (PreservCyt®) fluid Liquid cytology (PreservCyt®) preservativeThinPrep®) • SurePath® cytorich cell pellet in 2 mL SurePath® fluid plus 2 mL residual SurePath® fluid in 15 mL conical centrifuge tube
2 mL cervical broom in tripath SurePath® vials (post processing of the pap smear) • 2 mL residual SurePath® fluid in tripath SurePath® vials (post processing of the pap smear)
Room temperature
4-7 days
87621
 
36453
HPV, High/Low Risk - NEW! print

HPV is the causative agent of cervical dysplasia and cervical carcinoma. This assay detects high-risk HPV types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59 and 68, and low-risk types of HPV 6, 11, 42, 43 and 44.

This test is not approved for New York patient testing.

DNA Hybridization, Hybrid Capture® (Digene®)
 
Cervical brush or cervical broom in 1 mL Digene® cervical sampler
Minimum Volume
Digene® specimen transport medium: 1 mL
ThinPrep® Solution: 4.1 mL
SurePathTM: 2 mL
Cervical tissue biopsy in 1 mL Digene® specimen collection kit, 2 mL SurePathTM cell pellet fraction in leak-proof 15 mL conical tube, Cervical/Endocervical Scraping in 8.1 mL liquid cytology ((PreservCyt®) preservative (ThinPrep®))
Room temperature (Cervical biopsy: Frozen)
4-7 days
87621 (x2)
 
19864
HPV, Low/High Risk, Hybrid Capture II with Reflex to Genotypes 16,18 - NEW! print

HPV is the causative agent of cervical dysplasia and cervical carcinoma. The hybrid capture assay detects high-risk HPV types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, and 68 and low-risk types of HPV 6, 11, 42, 43, and 44. The reflex test only identifies whether the high risk types detected are genotypes 16 or 18.

This test is not approved for New York patient testing.

DNA Hybridization Invader®
Not Detected
8 mL residual ( PreservCyt ®) fluid Liquid cytology (PreservCyt®) preservative ThinPrep ®) • SurePath® cytorich cell pellet in 2 mL SurePath® fluid plus 2 mL residual SurePath® fluid in 15 mL conical centrifuge tube
2 mL cervical broom in tripath SurePath® vials (post processing of the pap smear) • 2 mL residual SurePath® fluid in tripath SurePath® vials (post processing of the pap smear)
Room temperature
4-7 days
87621 (x2)
 
36175
HTLV I/II Antibody with Reflex to Confirmatory Assay print

HTLV-I causes adult T cell leukemia (ATL) or HTLV-associated myelopathy (HAM) in approximately 10%of infected individuals. HTLV-II is closely related to HTLV-I, but disease associations are less clear. If the HTLV-I/II Antibody is reactive the Western Blot will be performed at an additional charge.

Test performed at Quest Diagnostics Nichols Institute, Chantilly, VA.

This test is approved for New York patient testing.

Chemiluminescence
Nonreactive
1 mL serum
(minimum 0.7 mL)
Refrigerated
1 to 4 days
86790 (add 86689* if reflexed)
 
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4220
HTLV I/II DNA, Qualitative Real-Time PCR print

HTLV-I/II DNA PCR is a highly specific and sensitive method used to detect HTLV-I/II proviral DNA in clinical specimens. In addition, the assay can also differentiate between HTLV-I and HTLV-II infected individuals.

This test is not approved for New York patient testing.

Real-Time PCR
Not detected
1 mL whole blood (EDTA or ACD)
(minimum 0.4 mL)
Room temperature
1 to 2 days
87798 x 2
 
8511
HTLV I/II, Confirmatory Assay print

HTLV-I causes adult T cell leukemia (ATL) or HTLV-associated myelopathy (HAM) in approximately 10%of infected individuals. HTLV-II is closely related to HTLV-I, but disease associations are less clear. This assay may be used to further characterize specimens repeatedly reactive for HTLV I/II Antibody ELISA.

Test performed at Quest Diagnostics Nichols Institute, Chantilly, VA

*This test was performed using a kit that has not been cleared or approved by the FDA. The analytical performance characteristics of this test have been determined by Focus Diagnostics. This test should not be used for diagnosis without confirmation by other medically established means.

This test is approved for New York patient testing.

Line Immunoassay (LIA)
Negative
1 mL serum
(minimum 0.6 mL)
Potassium Oxalate (gray-top) and ACD-B (yellow-top) plasma are no longer acceptable
Refrigerated
2 to 4 days
86689*
 
37053
Hu Antibody Screen with Reflex to Titer and Western Blot print

Paraneoplastic Syndrome involves non-metastatic systemic effects that accompany malignant disease. Antineuronal Nuclear Antibody (Anti-Hu) is found in 5-10% of patients with small cell carcinoma of the lung. Anti-Hu is associated with subacute syndrome of encephalomyeloradiculopathy, sensory neuropathy, and autoimmune neuropathy, predominantly affecting the gastrointestinal tract.

If the Hu Ab, IFA, Serum result is positive, then Hu Ab, Western Blot, Serum will be performed at an additional charge (CPT code(s): 84181).

If the Hu Ab, Western Blot, Serum result is positive, then Hu Ab Titer, Serum will be performed at an additional charge (CPT code(s): 86256)

Immunofluorescence Assay
Negative
0.5 mL serum
(0.2 mL min)
Room temperature
 
86255
 
-113
Hu Antibodies (See Anti-Neuronal Nuclear Antibody)
-114
Hughes Syndrome (See Phospholipid) print

 
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37710
Hu Antibody Screen with Reflex to Titer and Western Blot, CSF print

If the Hu Ab, IFA, CSF result is positive, then Hu Ab, Western Blot, CSF will be performed at an additional charge (CPT code(s): 84181)

If the Hu Ab, Western Blot, CSF result is positive, then Hu Ab Titer, CSF will be performed at an additional charge (CPT code(s): 86256)

Immunofluorescence Assay
Negative
0.8 mL CSF
(0.5 mL min)
Refrigerated (2-8° C)
 
86255
 
90138
Hu, Yo, and Ri Antibodies with Reflex to Titers and Western Blot print

Hu anti-neuronal nuclear antibody (anti-Hu) is found in 5-10% of patients with small cell carcinoma of the lung. Purkinje cell (Yo) antibody is found in patients with paraneoplastic cerebellar degeneration and is associated with breast, ovarian, and other gynecologic cancers. Some patients with ovarian cancer have low titers of Yo antibodies in the absence of cerebellar degeneration. Anti-Hu antibodies are associated with paraneoplastic encephalomyelitis and sensory neuropathy. Anti-Ri antibody can be detected in patients with paraneoplastic opsoclonus/myoclonus syndrome. Neoplasms most often associated with anti-Ri include breast cancer, small cell lung cancer, and gynecological cancers.

If the Hu Ab, IFA, Serum result is positive, then Hu Ab, Western Blot, Serum will be performed at an additional charge (CPT code(s): 84181)
If the Hu Ab, Western Blot, Serum result is positive, then Hu Ab Titer, Serum will be performed at an additional charge (CPT code(s): 86256)
If the Yo Ab, IFA, Serum result is positive, then Yo Ab, Western Blot, Serum will be performed at an additional charge (CPT code(s): 84181)
If the Yo Ab, Western Blot, Serum result is positive, then Yo Ab Titer, Serum will be performed at an additional charge (CPT code(s): 86256)
If the Ri Ab, IFA, Serum result is positive, then Ri Ab, Western Blot, Serum will be performed at an additional charge (CPT code(s): 84181)
If the Ri Ab, Western Blot, Serum result is positive, then Ri Ab Titer, Serum will be performed at an additional charge (CPT code(s): 86256)

Immunofluorescence Assay
Negative
1.5 mL (0.6 mL min) serum
Room temperature
 
86255 (x3)
 
90122
Hu, Yo, Ri Antibodies with Reflex to Titers and Western Blot, CSF print

See individual assay for description.

Panel Includes:

  • Neuronal Nuclear Antibody (Hu) Screen, CSF
  • Neuronal Nuclear Antibody, Western Blot, CSF
  • Neuronal Nuclear Antibody Titer, CSF
  • Yo Antibody Screen, IFA, CSF
  • Yo Antibody Western Blot, CSF
  • Yo Antibody Titer, CSF
  • Ri Antibody Screen, IFA, CSF
  • Ri Ab, Western Blot, CSF
  • Ri Antibody Titer, CSF


If the Hu Ab, IFA, CSF result is positive, then Hu Ab, Western Blot, CSF will be performed at an additional charge (CPT code(s): 84181)
If the Hu Ab, Western Blot, CSF result is positive, then Hu Ab Titer, CSF will be performed at an additional charge (CPT code(s): 86256)
If the Yo Ab, IFA, CSF result is positive, then Yo Ab, Western Blot, CSF will be performed at an additional charge (CPT code(s): 84181)
If the Yo Ab, Western Blot, CSF result is positive, then Yo Ab Titer, CSF will be performed at an additional charge (CPT code(s): 86256)
If the Ri Ab, IFA, CSF result is positive, then Ri Ab, Western Blot, CSF will be performed at an additional charge (CPT code(s): 84181)
If the Ri Ab, Western Blot, CSF result is positive, then Ri Ab Titer, CSF will be performed at an additional charge (CPT code(s): 86256)

Immunofluorescence Assay
Negative
2.4 mL (1.5 mL min) CSF
in sterile screw cap container
Refrigerated (2-8° C)
 
86255 (x3)
 
1468
Human Anti-mouse Antibody (HAMA) print

The presence of human anti-mouse antibody (HAMA) has been associated with patients receiving injections of murine monoclonal antibody (MAb) for diagnostics and/or therapeutic purposes. HAMA produced in response to monoclonal antibody therapy may interfere with therapeutic efficacy. Therefore, it is recommended that baseline HAMA levels are determined prior to the initiation of therapy with murine-derived proteins.

Test performed at Quest Diagnostics Nichols Institute.

This test is not approved for New York patient testing.

Enzyme Linked Immunosorbent Assay
<75 ng/mL
1 mL (0.5 mL minimum) serum collected in red-top tube (no gel)
FROZEN
7-14 days
83520
 
-115
Human Babesiosis (See Parasite Examination, Blood and Tissue)
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4355
Human Ehrlichiosis DNA Panel print

See individual assay for description.

Panel includes:

  • Anaplasma Phagocytophilum DNA, Qualitative Real-Time PCR
  • Ehrlichia chaffeensis DNA, Real-Time PCR
  • Ehrlichia ewingii DNA, Real-Time PCR

This test is not approved for New York patient testing.

Real-Time PCR
By report
0.7 mL whole blood (ACD or EDTA)
(minimum 0.3 mL)
OR
tick (in ethanol or live)
(minimum 1 tick)
2-8° C
1 to 3 days
87798 x 3
 
-116
Human Granulocytic Ehrlichiosis (See Anaplasma phagocytophilum) print

 
-117
Human Herpesvirus (See Herpesvirus) print

 
-118
Human Immunodeficiency Virus (See HIV) print

 
49200
Human Metapneumovirus RNA, Qualitative Real-Time PCR print

Human metapneumovirus is a recently identified human pathogen that is becoming widely recognized as a cause of respiratory infection, particularly in children. Symptoms range from asymptomatic infection to severe bronchitis and bronchiolitis; infection is clinically indistinguishable from RSV (respiratory syncytial virus). The detection of human metapneumovirus (hMPV) RNA is based upon reverse transcription of specific conserved hMPV genomic RNA sequences followed by real-time PCR amplification.

This test is approved for New York patient testing.

Real-Time RT-PCR
Not detected
Nasopharyngeal swab in 3.0 mL
M4 media, V-C-M medium (green-cap) tube, or equivalent (UTM)
(minimum 2.0 mL)
OR
0.7 mL nasopharyngeal aspirate or (BAL)
(minimum 0.3 mL)
2-8° C
1 to 2 days
87798
 
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81247
Human Metapneumovirus, DFA print

Human metapneumovirus (hMPV) is a recently described respiratory virus that accounts for approximately 10% of previously uncharacterized viral respiratory illnesses. The hMPV seasonal distribution is comparable to that of influenza and RSV. Most infections are mild; however, severe disease may occur among young children less than 2 years old, the immunocompromised, and the elderly. This test detects the presence of hMPV in direct clinical specimens.

This test is approved for New York patient testing.

DFA (Direct Fluorescent Antibody)
Not detected
Nasal wash or aspirate,
2 mL in VCM, UTM, or M4
(minimum 1 mL)
Nasal wash/aspirate
in sterile container;
BAL, broncial wash, sputum
in VCM, UTM, M4
or sterile container and NP swab
in VCM, UTM, or M4
2-8° C
1 to 2 days
87299†
 
-120
Human Monocytic Ehrlichiosis (See Ehrlichia chaffeensis) print

 
-121
Human Parvovirus (See Parvovirus) print

 
2070
Humoral Immunity Evaluation print

See individual assay for description.

Panel Includes:

  • Diphtheria Antitoxoid
  • Haemophilus influenzae Type b Antibody (IgG)
  • Streptococcus pneumoniae IgG Antibody (6 Serotypes), MAID
  • Tetanus Antitoxoid

To request testing for 12 or 14 serotypes of Streptococcus pneumoniae IgG Antibody, contact Client Services.

Please see the following technical sheet for more information:
 Vaccine Response Testing

ELISA (Enzyme Linked Immunosorbent Assay) and MAID (Multi-Analyte Immunodetection)
By report
4 mL serum
(minimum 2 mL)
2-8° C
1 to 5 days
86317 x 6; 86648; 86684; 86774
 
2071
Humoral Immunity Evaluation II print

See individual assay for description.

Panel Includes:

  • Diphtheria Antitoxoid
  • Streptococcus pneumoniae IgG Antibody (6 Serotypes), MAID
  • Tetanus Antitoxoid, ELISA

To request testing for 12 or 14 serotypes of Streptococcus pneumoniae IgG Antibody, contact Client Services.

Please see the following technical sheet for more information:
 Vaccine Response Testing

ELISA (Enzyme Linked Immunosorbent Assay) and MAID (Multi-Analyte Immunodetection)
By report
4 mL serum
(minimum 2 mL)
2-8° C
1 to 5 days
86317 x 6; 86648; 86774
 
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20775
21-Hydroxylase Antibody print

The microsomal enzyme 21-hydroxylase is the major autoantigen recognized by adrenal cortex autoantibodies, found in chronic primary adrenal insufficiency (Addison’s disease). Autoantibodies to 21-hydroxylase are found in approximately 70% of patients with isolated Addison’s disease, >90% of patients with Addison’s disease as part of autoimmune poyglandular syndrome, and 1 to 5% of patients with other autoimmune endocrine diseases.

*This test was performed using a kit that has not been cleared or approved by the FDA. The analytical performance characteristics of this test have been determined by Focus Diagnostics. This test should not be used for diagnosis without confirmation by other medically established means.

Test performed at Quest Diagnostics Nichols Institute.

RIA (Radioimmunoassay)
Negative
1 mL (0.5 mL minimum) serum
Room temperature
3 to 29 days
83519*
 
91921
Hypersensitivity Evaluation II print

Hypersensitivity Pneumonitis (an inflammatory lung disease) may be demonstrated by detection of precipitating antibodies to a variety of inhaled antigens from organic dusts or molds. A positive test does not always indicate active disease and should be supported by historical and clinical evidence, since some asymptomatic individuals may develop precipitins to one or more antigen types. A negative test does not preclude a diagnosis of hypersensitivity and should be evaluated along with other clinical findings.

Disk Diffusion
Not Detected
1 mL (0.8 mL minimum) serum
Refrigerated (2-8° C)
4 to 7 days
86606, 86609 (x4)
 
 
 
   
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