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HelpTest Code HVDSP HIV-1 and HIV-2 Antibody Confirmation and Differentiation, Prenatal, Plasma
Ordering Guidance
This test is not suitable for follow-up testing of patients with reactive results from any rapid HIV tests, except for pregnant patients who were reactive by the Determine HIV-1/-2 Ag/Ab Combo rapid point-of-care test on serum or plasma (but not whole blood). Per the latest CDC recommended HIV testing algorithm patients with reactive results from any rapid HIV tests should be tested subsequently with laboratory-based HIV antigen and antibody combination immunoassays, such as HIVSP / HIV Antigen and Antibody Prenatal Routine Screen, Plasma.
If specimens are autopsy or cadaver blood sources, the proper US Food and Drug Administration licensed assay is HV1CD / HIV-1 and HIV-2 Antibodies for Cadaveric or Hemolyzed Specimens, Serum.
New York State clients: This test should not be requested for maternal/newborn HIV screening on specimens originating in New York State, due to state regulatory requirements for expedited result reporting.
Necessary Information
Date of collection is required.
Specimen Required
Supplies: Sarstedt Aliquot Tube, 5 mL (T914)
Collection Container/Tube: Lavender top (EDTA)
Submission Container/Tube: Plastic vial
Specimen Volume: 1 mL
Collection Instructions:
1. Centrifuge blood collection tube per collection tube manufacturer's instructions (eg, centrifuge and aliquot within 2 hours of collection for BD Vacutainer tubes).
2. Aliquot plasma into plastic vial.
Useful For
Confirmation and differentiation of HIV-1 and HIV-2 antibodies in plasma specimens from prenatal patients who show reactive results with 3rd- (HIV-1/-2 antibody only) and 4th-generation (HIV antigen and antibody) HIV serologic assays
This test is not useful as a screening test for HIV infection in symptomatic or asymptomatic individuals.
This test should not be used as a screening or confirmatory test for blood donor specimens.
Testing Algorithm
This test is for confirmation and differentiation of HIV-1/2 antibodies (Ab). If the following result types are obtained, HIV-1/HIV-2 RNA detection will be performed at an additional charge:
-Negative for both HIV-1 Ab and HIV-2 Ab
-Indeterminate for HIV-1 Ab but negative for HIV-2 Ab
-Negative for HIV-1 Ab but indeterminate for HIV-2 Ab
-Indeterminate for both HIV-1 Ab and HIV-2 Ab
-Positive for both HIV-1 Ab and HIV-2 Ab
If the following result types are obtained, HIV-1 RNA detection and quantification will be performed at an additional charge:
-Positive for HIV-1 Ab and negative for HIV-2 Ab
-Positive for HIV-1 Ab and indeterminate for HIV-2 Ab
The following algorithms are available:
-HIV Prenatal Testing Algorithm, Including Follow-up of Reactive Rapid Serologic Test Results
Special Instructions
Method Name
Rapid Immunochromatographic Assay
Reporting Name
HIV Ab Differentiation Prenatal, PSpecimen Type
PlasmaSpecimen Minimum Volume
0.8 mL
Specimen Stability Information
| Specimen Type | Temperature | Time | Special Container |
|---|---|---|---|
| Plasma | Frozen (preferred) | 30 days | |
| Refrigerated | 6 days |
Reference Values
Negative
Interpretation
Negative results for both HIV-1 and HIV-2 antibodies usually indicate the absence of HIV-1 and HIV-2 infection. However, in patients with reactive initial combined HIV-1/-2 antigen and antibody test results, such negative results do not rule-out acute or early HIV infection. HPP12 / HIV-1/HIV-2 RNA Detection, Prenatal, Plasma will be performed automatically per testing algorithm.
Positive HIV-1 antibody but negative HIV-2 antibody results indicate the presence of HIV-1 infection. Together with reactive initial combined HIV-1/-2 antigen and antibody test results, individuals with such results are presumed to have HIV-1 infection. HIQNP / HIV-1 RNA Detection and Quantification, Prenatal, Plasma will be performed automatically per testing algorithm.
Positive HIV-1 antibody but indeterminate HIV-2 antibody results indicate the presence of HIV-1 infection with probable cross-reactivity of HIV-1 antibodies with HIV-2 antigens on the assay strip. HIQNP will be performed automatically per testing algorithm.
Indeterminate HIV-1 antibody but negative HIV-2 antibody results suggest either very early HIV-1 infection (in individuals with risk factors) or the presence of nonspecific cross-reactivity between the patients' specimens and HIV-1 antigens on the assay strip. HPP12 will be performed automatically per testing algorithm.
Negative HIV-1 antibody but indeterminate HIV-2 antibody results may be due to acute HIV-1 infection, very early HIV-2 infection (in individuals with risk factors), or the presence of nonspecific cross-reactivity between the patients' specimens and HIV-2 antigens on the assay strip. HPP12 will be performed automatically per testing algorithm.
Positive results for both HIV-1 and HIV-2 antibodies suggest probable presence of HIV-1 and HIV-2 coinfection. However, such results may be rarely due to either an HIV-1 infection with HIV-2 antibody cross-reactivity or an HIV-2 infection with HIV-1 antibody cross-reactivity (eg, absence of HIV-1 p24 and p31 bands). Verification of a first-time positive test result is recommended for the diagnosis of HIV infection. HPP12 will be performed automatically per testing algorithm.
Indeterminate results for both HIV-1 and HIV-2 antibodies indicate either very early HIV infection (in individuals with risk factors) or the presence of nonspecific cross-reactivity between the patients' specimens and HIV antigens on the assay strip. Nonspecific cross-reactivity may be due to recent non-HIV infections, hypergammaglobulinemic states, connective tissue disorders, or pregnancy (alloantibodies). HPP12 will be performed automatically per testing algorithm.
Negative HIV-1 antibody but positive HIV-2 antibody results indicate the presence of HIV-2 infection. Together with a reactive initial HIV-1/-2 antigen and antibody screening test results, individuals with such results are presumed to have HIV-2 infection. Additional testing with a newly submitted whole blood specimen for FHV2Q / HIV-2 DNA/RNA Qualitative Real-Time PCR is recommended to verify and confirm the diagnosis of HIV-2 infection prior to initiating antiretroviral treatment.
Reactive HIV-1 antibody but positive HIV-2 antibody results usually indicate the presence of HIV-2 infection with HIV-1 antibody cross-reactivity (eg, presence of only HIV-1 gp41 and/or gp160 band). However, such results may be rarely due to HIV-1 and HIV-2 coinfection. Verification of a first-time positive test result is recommended for the diagnosis of HIV-2 infection by submitting a whole blood specimen for FHV2Q.
Indeterminate HIV-1 antibody but positive HIV-2 antibody results indicate the presence of HIV-2 infection, with probable cross-reactivity of HIV-2 antibodies with HIV-1 antigens on the assay strip. Verification of a first-time positive test result is recommended for the diagnosis of HIV-2 infection by submitting a whole blood specimen for FHV2Q.
The following algorithms are available:
-HIV Prenatal Testing Algorithm, Including Follow-up of Reactive Rapid Serologic Test Results
Clinical Reference
1. Branson BM, Owen SM, Wesolowski LG, et al. Laboratory testing for the diagnosis of HIV infection: Updated recommendations. Centers for Disease Control and Prevention; June 27, 2014. Accessed December 20, 2023. Available at https://stacks.cdc.gov/view/cdc/23447
2. Malloch L, Kadivar K, Putz J, et al. Comparative evaluation of the Bio-Rad Geenius HIV-1/2 confirmatory assay and the Bio-Rad Multispot HIV-1/2 rapid test as an alternative differentiation assay for CLSI M53 algorithm-I. J Clin Virol. 2013;58(Suppl. 1):e85-e91
3. Montesinos I, Eykmans J, Delforge ML. Evaluation of the Bio-Rad Geenius HIV-1/2 test as confirmatory assay. J Clin Virol. 2014;60(4):399-401
4. Abbate I, Pergola C, Pisciotta M, et al. Evaluation in a clinical setting of the performances of a new rapid confirmatory assay for HIV-1/2 serodiagnosis. J Clin Virol. 2014;61(1):166-169
5. Centers for Disease Control and Prevention and Association of Public Health Laboratories. 2018 Quick Reference Guide: Recommended laboratory HIV testing algorithm for serum or plasma specimens. January 2018. Accessed December 20, 2023. Available at https://stacks.cdc.gov/view/cdc/50872
6. Duncan D, Duncan J, Kramer B, et al. An HIV diagnostic testing algorithm using the cobas HIV-1/HIV-2 Qualitative Assay for HIV type differentiation and confirmation. J Clin Microbiol. 2021; 59(7):e03030-20. doi:10.1128/JCM.03030-20
Day(s) Performed
Monday through Friday
Report Available
1 to 3 daysPerforming Laboratory
Mayo Clinic Laboratories in Rochester
Test Classification
This test has been cleared, approved, or is exempt by the US Food and Drug Administration and is used per manufacturer's instructions. Performance characteristics were verified by Mayo Clinic in a manner consistent with CLIA requirements.CPT Code Information
86701
86702
87535 (if appropriate)
87538 (if appropriate)
87536 (if appropriate)
LOINC Code Information
| Test ID | Test Order Name | Order LOINC Value |
|---|---|---|
| HVDSP | HIV Ab Differentiation Prenatal, P | 89365-1 |
| Result ID | Test Result Name | Result LOINC Value |
|---|---|---|
| 91952 | HIV-1 Ab Differentiation Prenatal, P | 68961-2 |
| 91953 | HIV-2 Ab Differentiation Prenatal, P | 81641-3 |
Reflex Tests
| Test ID | Reporting Name | Available Separately | Always Performed |
|---|---|---|---|
| HPP12 | HIV-1/HIV-2 RNA Detect Prenatal, P | Yes | No |
| HIQNP | HIV-1 RNA Detect/Quant Prenatal, P | Yes | No |