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HIV Infection: Laboratory Testing for Diagnosis and Management

HIV Infection: Laboratory Testing for Diagnosis and Management

Test Guide

HIV Infection

Laboratory Support of Diagnosis and Management

 

Laboratory testing plays a central role in the spectrum of clinical care for patients with human immunodeficiency virus (HIV) infection. This Test Guide provides an overview of the use of laboratory assays in the screening, diagnosis, and management of HIV infection. It also provides an appendix that lists antiretroviral drugs used to treat HIV infection.

The tables (1, 2, 3 and 4) and figure are provided for informational purposes only and are not intended as medical advice. A physician’s test selection and interpretation, diagnosis, and patient management decisions should be based on his/her education, clinical expertise, and assessment of the patient.

Screening and Diagnosis

Voluntary screening for HIV infection is recommended for adolescents and adults 15 to 65 years of age, and beyond this range for individuals at increased risk.1 Screening is also recommended for all pregnant women. Tests offered by Quest Diagnostics for screening and diagnosis can be found in Table 1.

Conventional Testing Algorithm

The conventional testing algorithm for HIV infection begins with a “third-generation” immunoassay that detects IgM and IgG antibodies to HIV-1 and HIV-2. These assays are highly sensitive for HIV antibodies but cannot detect infection during the pre-seroconversion window period, which typically lasts 3 to 4 weeks (or more) after exposure.

Because of the possibility of false-positive screening immunoassay results and their implications, repeatedly reactive results must be confirmed by a supplemental test on the same specimen. Traditionally, the supplemental test that has been most often used to confirm the presence of HIV antibodies is the Western blot. Results are interpreted as positive, indeterminate, or negative based on the banding pattern on the assay strip. Indeterminate Western blot results have been associated with host (patient) factors including recent vaccination, HLA-DR antibodies, rheumatoid factor, hypergammaglobulinemia, and autoimmune diseases.2 An indeterminate Western blot may also represent early seroconversion, HIV-2 infection, or cross-reactivity with viruses such as HTLV.2 Since the timeframe for seroconversion is variable, a negative HIV Western blot result does not rule out infection. Individuals with an initial negative or indeterminate Western blot result should thus be retested >1 month after the initial repeatedly reactive immunoassay result.3 False-negative results can also occur when the patient is immunosuppressed, and, rarely, late in the course of AIDS. HIV-1 RNA assays may be useful for confirmation in these cases (see Alternative Algorithm, “HIV-1 RNA” section below).

Alternative Testing Algorithm

Newer screening tests that can detect HIV infection substantially earlier than Western blots have created a need for an algorithm with supplemental testing that is more sensitive for acute infection.4 The Centers for Disease Control and Prevention (CDC) has proposed an alternative HIV testing algorithm designed to 1) detect acute infections more often; 2) reduce the frequency of indeterminate results on supplemental testing; and 3) differentiate HIV-1 and HIV-2 antibodies.5,6 This algorithm has been reported to have high sensitivity (>99.7%) and specificity (100%)4,5 and has been adopted by the Clinical Laboratory Standards Institute (CLSI).7

HIV Antibodies and p24 Antigen

Like the conventional algorithm, the alternative algorithm begins with a screening test for HIV-1/HIV-2. The screening test of choice is a “fourth-generation” combination assay that detects not only HIV IgM and IgG antibodies, but also HIV p24 antigen. HIV p24 antigen becomes detectable before seroconversion but rapidly disappears thereafter. Thus, the antigen component of fourth-generation assays allows detection of infection during the pre-seroconversion window period, while the antibody component allows detection after seroconversion. Reports suggests that fourth-generation assays can detect acute infection a median of 5 to 7 days before third-generation antibody assays,7-9 although this interval can range from roughly 0 to 20 days. This type of antigen/antibody combination assay has >99.7% sensitivity and >99.3% specificity for HIV infection and identifies most (>80%) acute infections that would otherwise require nucleic acid testing for detection.10,11 As with third-generation assays, reactive screening results require confirmation with a supplemental test.

HIV-1/HIV-2 antibody differentiation assays tend to detect antibodies earlier than Western blot4,12 and are the recommended supplemental test in the alternative algorithm.7 These immunoassays not only detect HIV-1 and HIV-2 antibodies, but can also differentiate between them. This can have important treatment implications, as HIV-2 does not respond to some antiretroviral agents. Results are interpreted as reactive for HIV-1, reactive for HIV-2, reactive for HIV (non-differentiated), or nonreactive. A reactive result confirms the presence of HIV-1 and/or HIV-2 antibodies, whereas nonreactive results prompt confirmation by HIV-1 RNA testing.7

HIV-1 RNA

HIV-1 RNA can be detected earlier than HIV antibodies and p24 antigen: as soon as 6 to 12 days after exposure and 26 days before Western blots become positive.4 Ultrasensitive nucleic acid amplification-based tests such as the HIV-1 qualitative TMA assay (sensitive to 30 copies/mL) are thus useful for detecting suspected infection soon after exposure. Positive HIV-1 RNA results, in the absence of detectable antibodies, indicate acute infection and negative results are consistent with absence of HIV-1 infection. A negative HIV-1 RNA test may be followed with an HIV-2 DNA/RNA test if clinically warranted. When nucleic acid testing is used to diagnose acute infection, subsequent seroconversion should be documented.7

Infection in Newborns

HIV-1 RNA testing is also useful for detecting HIV-1 infection in high-risk infants (eg, those born to mothers with HIV infection).13,14 Antibody-based testing is not appropriate in high-risk infants younger than 18 months, as maternal antibodies can cross the placenta and be detected in the infant for extended periods after birth. The qualitative HIV-1 RNA TMA assay can be used as the initial test. Positive results need to be followed up with a repeat virologic test on a second sample.14

Table 1. Laboratory Tests Used for Screening and Diagnosis of HIV-1 Infection

Test Code Test Name Primary Clinical Use and Differentiating Factors
91431 HIV-1/2 Antigen and Antibodies, Fourth Generation, with Reflexesa Screen for and confirm HIV-1 and HIV-2 infection, including acute infection. Uses “fourth-generation” screening immunoassay; reflexes are consistent with alternative algorithm.
91432 HIV-1/2 Antibody Differentiation Detect and differentiate antibodies to HIV-1 and HIV-2; confirm reactive HIV-1/2 results
19728 HIV Antibodies, HIV-1/-2, EIA, with Reflexesa Screen for and confirm HIV-1 and HIV-2 infection. Uses “third-generation” screening immunoassay; reflexes are consistent with conventional algorithm.
37708 HIV-1 Antibody, HIV-1, Western Blot with Reflex to HIV-2, EIA with Reflex to Immunoblota Confirm reactive result on third-generation HIV-1/2 EIA; negative HIV-1 Western blot result is reflexed to HIV-2 EIA with confirmation
16185 HIV-1 RNA, Qualitative TMA Detect HIV-1 infection, including acute infection; confirm HIV-1 infection in individuals with repeatedly reactive initial results, including those with nonreactive HIV-supplemental test results; detect HIV-1 infection in infants up to 24 months of age
34977(X) HIV-2 DNA/RNA Qualitative Real-Time PCRb Follow-up evaluation of negative results on confirmatory HIV-1 RNA testing, when clinically indicated7

a Reflex tests are performed at an additional charge and are associated with an additional CPT code(s).

b This test was developed and its performance characteristics have been determined by Focus Diagnostics. Performance characteristics refer to the analytical performance of the test.

Management

This section provides a brief overview of tests used in the management of HIV infection (Figure) along

with lists of commonly ordered assays (Tables 2 and 3).

Figure. Tests Used in the Management of Confirmed HIV-1 Infection

Monitoring Immune Status and Viral Load

CD4 (Lymphocyte Subset Testing)

The CD4+ T-cell (CD4) count is the most valuable indicator of immune status in HIV-infected patients and is an important factor in determining when to initiate prophylaxis for opportunistic infections.13 Although antiretroviral therapy is recommended for all patients with HIV-1 infection, CD4 count still provides an indication of the urgency of beginning treatment. For patients who do not immediately begin therapy, CD4 counts should be monitored every 3 to 6 months.13 CD4 measurement also serves as the strongest predictor of disease progression and survival.13 In general, the risk of opportunistic infections and HIV-1-associated malignancies increases as the CD4 count decreases. The trend in counts is more important than any single value; a 30% or greater change in the absolute CD4 count between tests, or a 3-percentage point change in the CD4 percentage, is considered clinically significant.13

After antiretroviral treatment is initiated, the CD4 count should be measured every 3 to 4 months to help assess immunologic response and the need to initiate or discontinue treatment for opportunistic infections. CD4 counts can be measured less frequently (every 6 to 12 months) for stable patients with suppressed viremia unless new treatment with interferon, corticosteroids, or anti-neoplastic agents is initiated.13

CD4 counts exhibit substantial diurnal variation (counts are generally lower in the morning) and may be affected by medications or transiently depressed by an intercurrent illness. Because of the potentially wide biologic variation, obtaining 2 measurements may be advisable if the CD4 count will affect treatment decisions; a third measurement would be required if the results are discordant.

HIV-1 RNA, Quantitative

HIV-1 viral load is the primary marker of antiretroviral treatment effectiveness. Before treatment initiation, the viral load provides information on the risk of disease progression and establishes a baseline for assessing the effect of antiviral treatment. After treatment is initiated, a primary goal is to decrease the viral load below the limits of detection (LODs) of the available assays within 12 to 24 weeks. Thereafter, viral load measurement is useful in assessing the continuing effectiveness of therapy. A confirmed viral load >200 copies/mL indicates virologic failure.13

The recommended frequency of viral load testing depends on the stage of disease management13:

  • Entry into care/prior to treatment initiation: At the time of diagnosis and every 3 to 6 months thereafter

  • Start of treatment: Immediately prior to initiation of therapy and 2 to 8 weeks after treatment initiation; viral load should decrease by at least 1.0 log10 copies/mL

  • Change in regimen because of suboptimal viral suppression: 2 to 8 weeks after change

  • Change in regimen because of treatment toxicity or regimen simplification: 2 to 8 weeks to assess the effectiveness of the new regimen

  • Continuing therapy/stable antiretroviral regimen: Every 3 to 6 months or when there is a clinical event or significant decline in CD4 count

Several assays are FDA-cleared for quantifying HIV-1 RNA in plasma, including an HIV-1 reverse transcription-polymerase chain reaction (RT-PCR) assay and a signal amplification nucleic acid probe (ie, branched DNA [bDNA]) assay). Ideally, the same assay should be used throughout the patient’s care.

A change in viral load of 3-fold (0.5 log10 copies/mL) or greater is considered statistically significant.13

Table 2. Laboratory Tests Used for Monitoring HIV-1 Infectiona
Test Code Test Name Primary Clinical Use and Differentiating Factors

Lymphocyte Subset Testing

8360(X)

Lymphocyte Subset Panel 5

Includes absolute lymphocyte count, absolute CD4, and percentage CD4.

Monitor urgency of therapy initiation; monitor cellular immunocompetence

HIV-1 Viral Load Testing

40085

HIV-1 RNA, Quantitative, Real-Time PCR

Evaluate prognosis; assess effectiveness of ART and need to switch treatment regimen

Reportable range: 20–10,000,000 HIV-1 RNA copies/mL

29273(X) HIV-1 RNA, Quantitative bDNA (v3.0)

Evaluate prognosis; assess effectiveness of ART and need to switch treatment regimen.

Reportable range: 75–500,000 HIV-1 RNA copies/mL

34471 HIV-1 RNA, Quantitative PCR with Reflex to Genotypeb,c

Evaluate prognosis; assess effectiveness of ART and need to switch treatment regimen.

See Table 3 for clinical use of genotypic and virtual phenotypic assays.

10435 HIV-1 RNA, Quantitative PCR with Reflex to Genotype and Virtual Phenotypeb,c
10596 HIV-1 RNA, Quantitative bDNA with Reflex to HIV-1 Genotypeb,c
10597 HIV-1 RNA, Quantitative bDNA with Reflex to Genotype and Virtual Phenotypeb,c

ART, antiretroviral therapy.

a This test listing is not intended to be comprehensive. For additional testing options, see the Quest Diagnostics Directory of Services (DOS) or consult the Quest Diagnostics online Test Center (http://www.questdiagnostics.com/
testcenter/TestCenterHome.action). Components of panels and reflex tests may be ordered individually.
b Reflex tests are performed at an additional charge and are associated with an additional CPT code(s).
c This test was developed and its performance characteristics have been determined by Quest Diagnostics. Performance characteristics refer to the analytical performance of the test.

Antiretroviral Drug Selection

HIV-1 Drug Resistance Testing

The development of drug-resistant HIV-1 variants is an important cause of virologic failure (ie, persistent viremia in the presence of drug treatment). Resistance assays are useful for selecting active drugs when changing regimens because of virologic failure or suboptimal reduction in viral load. Genotypic testing is recommended for patients on their first or second regimen, with the addition of phenotypic resistance testing for patients with complex drug resistance patterns.13 Ideally, testing should be performed on samples obtained while the patient is still receiving the failing regimen. If samples are taken beyond 4 weeks after a drug is withdrawn, resistant variants may not be detected but may re-emerge if the drug is reinstated. Because drug-resistant HIV-1 variants can be transmitted and may affect response to the initial drug regimen, resistance testing (preferably genotypic) is recommended upon entry into care; if therapy is not begun soon after entry into care, resistance testing may be repeated before treatment initiation to guide selection of the starting regimen.13

Quest Diagnostics offers genotypic resistance testing with a rules-based resistance prediction or with a virtual phenotypic interpretation (Virco®TYPE).

HIV-1 Genotype

HIV-1 genotyping identifies mutations that may confer drug resistance. Quest Diagnostics employs a rules-based algorithm developed by experts to interpret the results of this mutation analysis. Thus, predicted drug resistance patterns are reported in addition to the actual mutations. The Quest Diagnostics “HIV-1 Genotype” assay tests for mutations associated with resistance to currently available protease inhibitors and reverse transcriptase inhibitors and also reports the HIV-1 subtype. Additional genotypic tests are available for evaluating resistance to integrase strand-displacement inhibitors (HIV-1 Integrase Genotype assay) and to the HIV fusion inhibitor enfuvirtide (HIV-1 gp41 Envelope Genotype assay).

The absence of resistance-associated mutations does not necessarily imply drug susceptibility; mutations in minor viral populations may not be detected but may become predominant in the future.

VircoTYPE (Virtual Phenotype)

The virtual phenotype uses gene sequence data to predict phenotypic resistance to protease and reverse transcriptase inhibitors. Phenotypic susceptibility is derived from the sequence data of the patient’s HIV-1 protease and reverse-transcriptase genes using a linear model that correlates matched genotype and phenotype data from tens of thousands of patient samples. The predicted, or virtual, phenotype is expressed as the average fold change in IC50 for each available drug. HIV-1 susceptibility is determined by comparing this fold change to clinically relevant cut-off values. Fold changes below a drug’s lower clinical cutoff suggest maximal virologic response, whereas changes between the lower and upper cutoff suggest partial or reduced virologic response. Fold change values above the upper cutoff suggest minimal virologic response.

HIV-1 Coreceptor Tropism Testing

HIV-1 coreceptor tropism testing helps determine eligibility for treatment with CCR5 antagonists, a class of entry inhibitor. HIV-1 utilizes the CD4 cell surface receptor and 1 of 2 chemokine receptors, CCR5 (R5) or CXCR4 (X4), to infect cells. R5 antagonists such as maraviroc inhibit HIV-1 by binding to R5 and are only effective against virus that exclusively utilizes the R5 coreceptor; they do not effectively inhibit either X4-tropic viruses or dual/mixed (D/M)-tropic viruses, which can utilize both X4 and R5. About 15% to 20% of treatment-naïve and 50% of treatment-experienced patients harbor X4 and D/M viruses. Thus, tropism testing is required before initiating an R5 antagonist, to exclude patients with X4 or D/M tropic virus.

Phenotypic tropism testing is generally preferred because of a greater weight of supporting evidence, but genotypic tropism testing is considered an alternative because of its lower cost and faster analytical times.13 The Quest Diagnostics genotypic tropism test is comparable to a high-sensitivity phenotypic test in distinguishing between virologic responders and nonresponders.15 It utilizes triplicate RT-PCR and DNA sequencing to detect HIV-1 envelope V3 variants associated with X4 and R5 utilization. If only R5 virus is detected, next-generation sequencing is performed (at additional charge) to more sensitively detect minority X4 virus.

Standard genotypic coreceptor tropism testing requires a viral load of at least 1,000 HIV-1 RNA copies/mL. For patients with lower viral loads, the sequencing assay can be performed on proviral HIV-1 DNA rather than HIV-1 RNA.

HLA-B*5701 Typing

The nucleoside reverse transcriptase inhibitor abacavir is associated with a 2% to 9% risk of a hypersensitivity reaction.16 Susceptibility to this serious and sometimes fatal reaction has been associated with a specific human genetic variation known as HLA-B*5701. Pharmacogenetic screening for HLA-B*5701 is recommended for abacavir-naïve patients and before reinitiation of abacavir in previously treated patients.16 A negative result indicates that the patient is unlikely to have a hypersensitivity reaction to abacavir, but does not rule out this possibility. A positive result indicates that alternatives to abacavir should be used for treatment. This test uses PCR amplification followed by hybridization with sequence-specific oligonucleotide probes to detect the HLA-B*5701 allele.

Table 3. Laboratory Tests Used for Selection of Antiretroviral Drugsa
Test Code Test Name Primary Clinical Use and/or Differentiating Factors
34949

HIV-1 Genotypeb

Detect mutations associated with resistance to RTI and PI
90955 HIV-1 Genotype and Coreceptor Tropism w/ reflex to Ultradeep Sequencingb,c Detect mutations associated with resistance to RTI, PI and CCR5 antagonists
10469 HIV-1 Genotype with Reflex to Virtual Phenotypeb,c Assess virtual phenotypic drug resistance based on mutation patterns in reverse transcriptase and protease genes
11367(X)

HIV-1 gp41 Envelope Genotypeb

Detect gp41 mutations associated with resistance to the fusion inhibitor enfuvirtide
16868

HIV-1 Integrase Genotypeb

Assess mutations associated with resistance to integrase inhibitors (raltegravir and elvitegravir)
90666 HIV-1 Coreceptor Tropism with
Reflex to Ultradeep Sequencingb,c
Evaluate eligibility for therapy with CCR5 antagonist (genotypic assay)
91299

HIV-1 Coreceptor Tropism, Proviral DNAb

Evaluate eligibility for therapy with CCR5 antagonist (genotypic assay) in patients with low viral load (<1,000 HIV-RNA copies/mL)
19774 HLA-B*5701 Typing Assess risk of abacavir hypersensitivity reaction
RTI, reverse transcriptase inhibitors; PI [or PRI], protease inhibitors.

a This test listing is not intended to be comprehensive. For additional testing options, see the Quest Diagnostics Directory of Services (DOS) or consult the Quest Diagnostics online Test Center (http://www.questdiagnostics.com
/testcenter/TestCenterHome.action). Components of panels and reflex tests may be ordered individually.
b This test was developed and its performance characteristics have been determined by Quest Diagnostics. Performance characteristics refer to the analytical performance of the test.
c Reflex tests are performed at an additional charge and are associated with an additional CPT code(s).

Therapeutic Drug Monitoring (TDM)

The use of TDM to optimize antiretroviral therapy has been widely studied but is not currently recommended for routine care of HIV-infected individuals.13 However, TDM may be helpful in certain clinical settings when variations in drug disposition might be expected (eg, pregnant women, children, individuals with liver or kidney failure) or when other factors indicate the need to verify expected drug levels. Refer to treatment guidelines for a more detailed overview.13 For TDM test ordering information, please consult the Focus Diagnostics website at http://www.focusdx.com/focus/1-reference_
laboratory/index.asp.

Monitoring Patient Health

Blood Count, Basic Chemistry, Glucose, and Lipid Testing

Both HIV infection and the drugs used to treat it can have adverse effects on various organ systems. Periodic monitoring of patient health after entry into care typically includes complete blood count, basic chemistry tests, markers of liver and kidney function, and evaluation of fasting glucose and lipid profile (Figure). Please see the Quest Diagnostics Directory of Services or online Test Center for testing options.

Testing for Comorbid Conditions

Table 4 describes tests used to evaluate conditions that are often associated with HIV infection. Current guidelines address testing for several comorbid infectious diseases, including tuberculosis, viral hepatitis (A, B, and C), trichomoniasis, cytomegalovirus, varicella zoster virus, chlamydia, gonorrhea, syphilis, and Toxoplasma gondii infection.3 HPV screening and Pap testing for cervical and anal neoplasia should also be considered in the context of a patient’s clinical history.3

Table 4. Laboratory Tests for Comorbid Conditions in Individuals with HIV-1 Infection Entering Carea
Test Code Test Name Primary Clinical Use
Chlamydia and Gonorrhea Testing
17303 Chlamydia trachomatis DNA, SDA (urine or swab) Detect infection with C trachomatis
11361 Chlamydia trachomatis RNA, TMA (urine or swab)
16505 Chlamydia trachomatis RNA, TMA, Rectalb
70048 Chlamydia trachomatis RNA, TMA, Throatb
17304 Neisseria gonorrhoeae DNA, SDA (urine or swab) Detect infection with N gonorrhoeae
11362(X) Neisseria gonorrhoeae RNA, TMA (urine or swab)
16504 Neisseria gonorrhoeae RNA, TMA, Rectalb
70049 Neisseria gonorrhoeae RNA, TMA, Throatb
17305 Chlamydia/Neisseria gonorrhoeae DNA, SDA (urine or swab) Detect infection with C trachomatis or N gonorrhoeae
16506 Chlamydia trachomatis/Neisseria gonorrhoeae RNA, TMA, Rectalb
70051 Chlamydia trachomatis/Neisseria gonorrhoeae RNA, TMA, Throatb
11363

SureSwab® Chlamydia trachomatis/Neisseria gonorrhoeae RNA, TMA

91448 Chlamydia/N gonorrhoeae and T vaginalis RNA, Qualitative TMA, Pap Vialb

Detect infection with C trachomatis,
N gonorrhoeae, or Trichomonas vaginalis

16492

SureSwab®, CT/NG, T vaginalisb

Detect infection with C trachomatis,
N gonorrhoeae, or T vaginalis

Hepatitis (Viral) Testing

10306

Hepatitis Panel, Acute with Reflex to Confirmationc

Includes hepatitis A IgM (acute), hepatitis B surface antigen, hepatitis B core IgM, and hepatitis C antibody. If hepatitis B surface antigen is positive, confirmation by neutralization will be performed.

Screen for and confirm acute viral hepatitis
512 Hepatitis A IgM First-line diagnostic test for acute hepatitis A
4848 Hepatitis B Core Antibody (IgM) First-line diagnostic test for acute hepatitis B; indicates recent infection (within preceding 4-6 months)
498 Hepatitis B Surface Antigen with Reflex to Confirmationd First-line diagnostic test for acute hepatitis B; indicates chronic hepatitis when still positive 6 months after diagnosis of acute HBV infection
556 Hepatitis Be Antibody Indicator of resolution or carrier state when interpreted along with the other hepatitis B markers
555 Hepatitis Be Antigen Indicator of active viral replication and high infectivity
34181 Hepatitis B Virus DNA, Qualitative, Real-Time PCRb Indicator of chronic hepatitis when still positive 6 months after diagnosis of acute HBV infection; indicator of viral replication in patients with mutant HBV (eg, HBeAg- and HBeAb+ individuals)
91438 Hepatitis C Antibody with Reflex to Hepatitis C Virus RNA, Quantitative Real-Time PCRb,d Screen for and confirm presence of HCV infection; establish viral load at baseline
35645 Hepatitis C Viral RNA, Quantitative Real-Time PCRb Confirm HCV infection; establish viral load at baseline; determine duration of treatment
37273 Hepatitis C Viral RNA, Qualitative TMA Confirm presence of HCV infection in patients with HCV antibodies; differentiate between resolved and active infection
Syphilis Testing
36126 RPR (Diagnosis) with Reflex to Titer and Confirmatory Testingd Detect non-treponemal (reagin) antibodies associated with syphilis; confirmation of titer and antibodies to T pallidum performed if RPR is reactive
4112 FTA-ABS Confirm presence of antibodies to T pallidum
653 Treponema pallidum Ab, Particle Agglutination Confirm presence of antibody to T pallidum
Toxoplasma Testing
8636 Toxoplasma Antibodies (IgG, IgM) Screen for past or present T gondii infection
91633 Toxoplasma Antibodies (IgG, IgM), Pregnancy with Reflex to Confirmationd Screen for past or present T gondii infection
Trichomoniasis Testing
19550

SureSwab® Trichomonas vaginalis RNA, Qualitative TMA

Detect infection with T vaginalis
90521 Trichomonas vaginalis RNA, Qualitative TMA, Pap Vialb
91448 Chlamydia/N gonorrhoeae and T vaginalis RNA, Qualitative TMA, Pap Vialb Detect infection with C trachomatis,
N gonorrh
oeae, or Trichomonas vaginalis
16492 SureSwab®, CT/NG, T vaginalisb
Tuberculosis Testing
16603

Quantiferon® TB Gold (Client Incubated)

Detect infection with Mycobacterium tuberculosis
Cancer Screening
3526 Cytology, Conventional Pap Smeare Detect abnormal cervical cytology including cervical cancer
14471

SurePath® Pape

35455

ThinPrep® Pape

15095

SurePath® Pap and HR HPV DNAe

Detect abnormal cervical cytology including cervical cancer; assess presence or absence of high risk HPV types
15003

ThinPrep® Pap and HR HPV DNAe

15949(X)

HPV DNA, High Risk, Anal-Rectalb

Detect anorectal infection with HPV types associated with high risk of cancer
31532 HPV (Human Papillomavirus) High Risk DNA, Hybrid Capture II Detect infection with HPV types associated with high risk of cervical cancer
90887 HPV RNA, High Risk, E6/E7, TMA Detect infection with HPV types associated with high risk of cervical cancer
90942 HPV RNA, High Risk, E6/E7, TMA with Reflex to Genotypes 16,18 Detect infection with HPV types associated with high risk of cervical cancer

a This test listing is not intended to be comprehensive. For additional testing options, including cervical cytology and sexually transmitted infection (STI) testing using liquid-based cytology samples, see the Quest Diagnostics Directory of Services (DOS) or consult the Quest Diagnostics online Test Center (http://www.questdiagnostics.com
/testcenter/TestCenterHome.action). Components of panels and reflex tests may be ordered individually.

b The performance characteristics of this assay have been determined by Quest Diagnostics Nichols Institute. Performance characteristics refer to the analytical performance of the test.
c This test was developed and its performance characteristics have been determined by Quest Diagnostics Nichols Institute. Performance characteristics refer to the analytical performance of the test.
d Reflex tests are performed at an additional charge and are associated with an additional CPT code(s).
e Pap results requiring physician interpretation will be performed at an additional charge and associated with an additional CPT code(s).

References

  1. Moyer VA, U.S.Preventive Services Task Force. Screening for HIV: U.S. Preventive Services Task Force Recommendation Statement. Ann Intern Med. 2013;Epub ahead of print: April 30, 2013.

  2. Guan M. Frequency, causes, and new challenges of indeterminate results in Western blot confirmatory testing for antibodies to human immunodeficiency virus. Clin Vaccine Immunol. 2007;14:649-659.

  3. Aberg JA, Kaplan JE, Libman H, et al. Primary care guidelines for the management of persons infected with human immunodeficiency virus: 2009 update by the HIV Medicine Association of the Infectious Diseases Society of America. Clin Infect Dis. 2009;49:651-681.

  4. Masciotra S, McDougal JS, Feldman J, et al. Evaluation of an alternative HIV diagnostic algorithm using specimens from seroconversion panels and persons with established HIV infections. J Clin Virol. 2011;52 Suppl 1:S17-S22.

  5. Wesolowski LG, Delaney KP, Hart C, et al. Performance of an alternative laboratory-based algorithm for diagnosis of HIV infection utilizing a third generation immunoassay, a rapid HIV-1/HIV-2 differentiation test and a DNA or RNA-based nucleic acid amplification test in persons with established HIV-1 infection and blood donors. J Clin Virol. 2011;52 Suppl 1:S45-S49.

  6. Branson BM. The future of HIV testing. J Acquir Immune Defic Syndr. 2010;55 Suppl 2:S102-S105.

  7. CLSI. Criteria for laboratory Testing and Diagnosis of Human Immunodeficiency Virus Infection; Approved Guideline. M53-A ed. Wayne, PA: Clinical and Laboratory Standards Institute, 2011.

  8. Fiebig EW, Wright DJ, Rawal BD, et al. Dynamics of HIV viremia and antibody seroconversion in plasma donors: implications for diagnosis and staging of primary HIV infection. AIDS. 2003;17:1871-1879.

  9. ARCHITECT HIV Ag/Ab Combo [package insert]. 2009. Wiesbaden, Germany, Abbot Laboratories.

  10. Nasrullah M, Wesolowski LG, Meyer WA, III, et al. Performance of a fourth-generation HIV screening assay and an alternative HIV diagnostic testing algorithm. AIDS. 2013;27:731-737.

  11. Chavez P, Wesolowski L, Patel P, et al. Evaluation of the performance of the Abbott ARCHITECT HIV Ag/Ab Combo Assay. J Clin Virol. 2011;52 Suppl 1:S51-S55.

  12. Owen SM, Yang C, Spira T, et al. Alternative algorithms for human immunodeficiency virus infection diagnosis using tests that are licensed in the United States. J Clin Microbiol. 2008;46:1588-1595.

  13. Panel on Antiretroviral Guidelines for Adults and Adolescents.Guidelines for the use of antiretroviral agents in HIV-1-infected adults and adolescents. Department of Health and Human Services. February 12, 2013. http://aidsinfo.nih.gov/contentfiles/lvguidelines/adultandadolescentgl.pdf. Accessed May 1, 2013.

  14. Panel on Antiretroviral Therapy and Medical Management of HIV-Infected Children.Guidelines for the Use of Antiretroviral Agents in Pediatric HIV Infection. Department of Health and Human Services. November 5, 2012. http://aidsinfo.nih.gov/contentfiles/lvguidelines/pediatricguidelines.pdf. Accessed May 1, 2013.

  15. Kagan RM, Johnson EP, Siaw M, et al. A genotypic test for HIV-1 tropism combining Sanger sequencing with ultradeep sequencing predicts virologic response in treatment-experienced patients. PLoS One. 2012;7:e46334.

  16. FDA Alert [7/24/2008]. Abacavir (marketed as Ziagen) and abacavir-containing medications. July 24, 2008. http://www.drugs.com/fda/abacavir-marketed-ziagen-abacavir-containing-12406.html. Accessed October 12, 2011.

Appendix. Antiretroviral Drugs Commonly Used in the Treatment of HIV Infection
Drug or Drug Combination Abbreviation Brand Name
Nucleoside/Nucleotide Reverse Transcriptase Inhibitors (NRTIs)
Abacavir ABC

Ziagen®

Abacavir/lamivudine ABC/3TC

Epzicom®

Abacavir/zidovudine/lamivudine ABC/ZDV/3TC

Trizivir®

Didanosine ddI

Videx®; Videx® EC

Emtricitabine FTC

Emtriva®

Lamivudine 3TC

Epivir®

Lamivudine/zidovudine ZDV/3TC

Combivir®

Stavudine d4T

Zerit®

Tenofovir disoproxil fumarate TDF

Viread®

Tenofovir/emtricitabine TDF/FTC

Truvada®

Zidovudine ZDV (AZT)

Retrovir®

Non-nucleoside Reverse Transcriptase Inhibitors (NNRTIs)

Efavirenz EFV

Sustiva®

Etravirin ETR

Intelence®

Nevirapine NVP

Viramune®

Rilpivirine RPV

Edurant®

Protease Inhibitors (PIs)
Atazanavir/ritonavir ATV/r

Reyataz®/Norvir®

Darunavir/ritonavir DRV/r

Prezista®/Norvir®

Fosamprenavir/ritonavir FPV/r

Lexiva®/Norvir®

Indinavir/ritonavir IDV/r

Crixivan®/Norvir®

Lopinavir/ritonavir LPV/r

Kaletra®

Nelfinavir NFV

Viracept®

Saquinavir/ritonavir SQV/r

Fortovase® or Invirase®/Norvir®

Tipranavir/ritonavir TPV/r

Aptivus®/Norvir®

Fusion Inhibitors (FIs)

Enfuvirtide ENF (T-20)

Fuzeon®

Entry Inhibitor (CCR5 co-receptor antagonist)

Maraviroc MVC

Selzentry®

Integrase Strand Transfer Inhibitor
Raltegravir RAL

Isentress®

Multiclass Combination Therapy
Efavirenz, emtricitabine, tenofovir EFV/FTC/TDF

Atripla®

Emtricitabine, rilpivirine, tenofovir FTC/RPV/TDF

Complera®

Elvitegravir/cobicistat/emtricitabine/tenofovir EVG/COBI/FTC/TDF

Stribild®

   


 

   

Polymerase chain reaction (PCR) is performed pursuant to a license agreement with Roche Molecular Systems, Inc.

Content reviewed 06/2013

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* The tests listed by specialist are a select group of tests offered. For a complete list of Quest Diagnostics tests, please refer to our Directory of Services.