| A B C D E F G H I J K L M N O P Q R S T U V W X Y Z # |
HIV DETECTION W/REFLX CONFIRMATION
Test CodeLAB2600
Quest Code
91431
CPT Codes
87389
Includes
If HIV Antigen and Antibody, 4th Generation Screen is Repeatedly Reactive, then HIV-1/2 Antibody Differentiation will be performed at an additional charge (CPT code(s): 86701, 86702).
If HIV-1/2 Antibody Differentiation is Indeterminate or Negative, then HIV-1 and HIV-2 RNA, Qualitative Real-Time PCR will be performed at an additional charge (CPT code(s): 87535, 87538).
If HIV-1/2 Antibody Differentiation is Indeterminate or Negative, then HIV-1 and HIV-2 RNA, Qualitative Real-Time PCR will be performed at an additional charge (CPT code(s): 87535, 87538).
Preferred Specimen
3 mL serum
Minimum Volume
2 mL
Other Acceptable Specimens
Serum collected in: Red-top tube (no gel) • Plasma collected in: EDTA (lavender-top) tube
Instructions
Serum: Collect in a serum separator tube or red-top tube (no gel). The tube should be centrifuged after clotting. Spun serum separator tubes may be submitted at room temperature or refrigerated unopened without transfer to a plastic screw-cap vial. Red-top tube (no gel) serum should be transferred to a plastic screw-cap vial and submitted for testing.
Plasma: Collect in an EDTA (lavender-top) tube and centrifuge tube within 24 hours of collection. Transfer plasma to a plastic screw-cap vial, label as plasma, and submit for testing.
Submitted tubes must be labeled with patient identifier and submitted only for HIV testing.
Plasma: Collect in an EDTA (lavender-top) tube and centrifuge tube within 24 hours of collection. Transfer plasma to a plastic screw-cap vial, label as plasma, and submit for testing.
Submitted tubes must be labeled with patient identifier and submitted only for HIV testing.
Transport Container
Serum separator tube (SST)
Submitted tubes must be labeled with patient identifier and submitted only for HIV testing.
Submitted tubes must be labeled with patient identifier and submitted only for HIV testing.
Transport Temperature
Room temperature
Specimen Stability
Room temperature: 72 hours
Refrigerated: 5 days
Frozen: 30 days
Refrigerated: 5 days
Frozen: 30 days
Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)
Gross hemolysis • Frozen serum separator tube (SST)
Methodology
Immunoassay (IA)
Reference Range
| HIV Final Interpretation | See Laboratory Report |
| HIV Ag/Ab, 4th Gen | Non-Reactive |
Clinical Significance
This algorithm is used to help diagnose HIV-1 and HIV-2 infection, including acute infection, and to differentiate HIV-1 from HIV-2. It is consistent with the HIV diagnostic algorithm recommended by the Centers for Disease Control and Prevention [2]. It can be used in adults, including pregnant women, and in children 2 years or older.
This panel begins with an antigen/antibody assay that allows for detection of acute HIV-1 infection based on the presence of p24 antigen before seroconversion occurs, and HIV-1 and HIV-2 antibodies post-seroconversion. If the HIV-1/HIV-2 antigen/antibody test is positive, an antibody-differentiation test is done (at additional charge) to confirm infection and identify the presence of HIV-1 or HIV-2 specific antibodies. However, the HIV-1/HIV-2 differentiation test can be negative during acute infection (prior to development of specific antibodies). If the antibody-based HIV-1/HIV-2 supplemental test is negative, the specimen will be reflexed to the HIV-1 and HIV-2 RNA, Qualitative, Real-Time PCR test (at additional charge), which can detect the presence of HIV-1 and 2 RNA and identify patients with acute HIV-1 or 2 infection [1].
The United States Preventive Services Task Force (USPSTF) recommends HIV screening for all pregnant women, and for individuals between 15 and 65 years of age who live in regions with an HIV prevalence of >0.1% [2]. In addition, antigen/antibody-based HIV testing is recommended for high-risk individuals who want to begin pre-exposure prophylaxis (PrEP) therapy, because HIV-positive patients who start PrEP without knowing their HIV status face an elevated risk of antiretroviral resistance [3,4].
Because 40% of new HIV infections are transmitted unknowingly by people unaware of their HIV status, early diagnosis is important to reduce HIV transmission [5]. Antigen/antibody-based HIV screening assays have >99.7% sensitivity and >99.3% specificity for HIV infection and can identify most (>80%) acute infections that would otherwise require nucleic acid testing for detection [6,7].
References
1. Moyer V, USPTF. Ann Intern Med. 2013;159:51-60.
2. CDC. Clinical Testing Guidance for HIV. Clinical Testing Guidance for HIV | HIV Nexus | CDC. Published September 10, 2024. Accessed January 27, 2025.
3. CDC. Preventing HIV with PrEP. https://www.cdc.gov/hiv/prevention/prep.html?CDC_AAref_Val=https://www.cdc.gov/hiv/basics/prep.html. Published January 18, 2024. Accessed January 27, 2025.
4. Livant E, et al. J Clin Virol. 2017;94:15-21.
5. CDC. HIV testing. https://www.cdc.gov/hiv/testing/index.html. Published March 2019. Accessed May 20, 2019.
6. Nasrullah M, et al. AIDS. 2013;27:731-737.
7. Chavez P, et al. J Clin Virol. 2011;52(Suppl 1):S51-S55.
This panel begins with an antigen/antibody assay that allows for detection of acute HIV-1 infection based on the presence of p24 antigen before seroconversion occurs, and HIV-1 and HIV-2 antibodies post-seroconversion. If the HIV-1/HIV-2 antigen/antibody test is positive, an antibody-differentiation test is done (at additional charge) to confirm infection and identify the presence of HIV-1 or HIV-2 specific antibodies. However, the HIV-1/HIV-2 differentiation test can be negative during acute infection (prior to development of specific antibodies). If the antibody-based HIV-1/HIV-2 supplemental test is negative, the specimen will be reflexed to the HIV-1 and HIV-2 RNA, Qualitative, Real-Time PCR test (at additional charge), which can detect the presence of HIV-1 and 2 RNA and identify patients with acute HIV-1 or 2 infection [1].
The United States Preventive Services Task Force (USPSTF) recommends HIV screening for all pregnant women, and for individuals between 15 and 65 years of age who live in regions with an HIV prevalence of >0.1% [2]. In addition, antigen/antibody-based HIV testing is recommended for high-risk individuals who want to begin pre-exposure prophylaxis (PrEP) therapy, because HIV-positive patients who start PrEP without knowing their HIV status face an elevated risk of antiretroviral resistance [3,4].
Because 40% of new HIV infections are transmitted unknowingly by people unaware of their HIV status, early diagnosis is important to reduce HIV transmission [5]. Antigen/antibody-based HIV screening assays have >99.7% sensitivity and >99.3% specificity for HIV infection and can identify most (>80%) acute infections that would otherwise require nucleic acid testing for detection [6,7].
References
1. Moyer V, USPTF. Ann Intern Med. 2013;159:51-60.
2. CDC. Clinical Testing Guidance for HIV. Clinical Testing Guidance for HIV | HIV Nexus | CDC. Published September 10, 2024. Accessed January 27, 2025.
3. CDC. Preventing HIV with PrEP. https://www.cdc.gov/hiv/prevention/prep.html?CDC_AAref_Val=https://www.cdc.gov/hiv/basics/prep.html. Published January 18, 2024. Accessed January 27, 2025.
4. Livant E, et al. J Clin Virol. 2017;94:15-21.
5. CDC. HIV testing. https://www.cdc.gov/hiv/testing/index.html. Published March 2019. Accessed May 20, 2019.
6. Nasrullah M, et al. AIDS. 2013;27:731-737.
7. Chavez P, et al. J Clin Virol. 2011;52(Suppl 1):S51-S55.
Performing Laboratory
| Quest Diagnostics-Lenexa |
| 10101 Renner Blvd |
| Lenexa, KS 66219-9752 |
Last Updated: August 13, 2021
