Test Code LAB5635 HIV-1/HIV-2 Antibodies + p24 Antigen Combination Immunoassay (4th Generation)
Performing Laboratory
Barnes-Jewish Hospital Laboratory
Methodology
Electrochemiluminescence Immunoassay (ECLIA)
Testing Algorithm:
If reactive, antibody differentiation testing is performed. If the differentiation test is reactive for HIV-1 antibodies only, or reactive for HIV-1 and HIV-2 antibodies, or is not reactive for HIV-1 and HIV-2 antibodies, HIV-1 RNA (viral load) test is recommended on a separately collected sample.
Literature Reference:
Package insert: Roche Diagnostics, Elecsys HIV DUO. 2022-08, V1.0
Specimen Requirements
Specimen Type: Serum
Container/Tube: Red/grey separator tube or gold separator tube
Specimen Volume: 10mL, Full tube
Day(s) Test Set Up
Performed upon receipt
Turnaround Time:
STAT: not available
Routine: results available 2-4 hours from receipt in the laboratory
Test Classification and CPT Coding
87389- (G0475) HIV-1 antigen, with HIV-1 and HIV-2 antibodies
86701-(G0432) HIV-1 (if appropriate)
86702-(G0432) HIV-2 (if appropriate)
Specimen Transport Temperature
Ambient
Additional Information
For BJH Laboratory Use Only
Alternate Tube(s):
7 mL pink top (K2EDTA) tube
7 mL mint green or dark green (lithium or sodium heparin), with or without gel
7mL pearl/white (K2EDTA) with gel is acceptable for HIV differentiation test.
Analyte Stability:
Ambient temperature stability at 20° C to 25° C: 48 hours
Separated from cells refrigerated stability at 2° C to 8° C: 7 days
Frozen at </= -20° C stability: 90 days. Avoid more than 5 freeze/thaw cycles. Repeated freeze/thaw cycles can cause analyte deterioration.
Laboratory Processing Instructions:
1. Specimens that repeat reactive on the Cobas method will have HIV Ab differentiation testing performed on Biorad Geenius.
2. If the differentiation test is reactive for HIV-1 antibodies only, or reactive for HIV-1 and HIV-2 antibodies, or is not reactive for HIV-1 and HIV-2 antibodies, HIV-1 RNA (viral load) test is recommended to be performed with a separate specimen at BJH Molecular Diagnostics Laboratory. If the differentiation test is reactive for HIV-2 antibodies, HIV-2 PCR may be considered. HIV-2 infection is rare in the United States. The patient's history and clinical condition can be considered if HIV-2 PCR testing is required.
3. Confirmed HIV-1 positives are reported to the state within 3 days.
Test performed in BJH Core lab. Processed by Cobas 8100 automated line for delivery to the Roche Cobas e801. Completed specimens are stored refrigerated for 5 days.
Reference Intervals
Non-reactive
See HIV Clinical Interpretive Guide in special Instructions for further interpretive information.
Literature Reference: Package insert: Roche Diagnostics, Elecsys HIV DUO. 2022-08, V1.0
LOINC Code Information
Name | LOINC Code |
Roche Cobas e801 | 56888-1 |
Geenius | 80203-3 |