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Test Code LAB5635 HIV-1/HIV-2 Antibodies + p24 Antigen Combination Immunoassay (4th Generation)

Infectious

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