Florida Bureau of Public Health laboratories
The HIV-1/2 Ag/Ab combo test is an FDA-approved chemiluminescent immunoassay for the simultaneous qualitative detection of HIV-1 p24 antigen and antibodies to HIV-1 (groups M and O) and HIV-2 in human serum or plasma.
Analyte(s)
HIV-1 and HIV-2
Test Code
0500 or 0590
Testing Location
Testing Department
Retrovirology (HIV)
Pre-approval Required?
No
Required Forms
BPHL Test Requisition, DH1847
(not needed if orders are placed via electronic order)
Supply Ordering
Supplies may be requested from your servicing laboratory. Supplies ordered from the BPHL should only be used for specimen sent to the BPHL for testing.
Turn Around time
2-3 business days after receipt at the laboratory.
Minimum Volume
At least 2.5 mL of plasma or serum
Collection Media
• Pearl top plasma preparation tube (PPT), preferred
• Red/tiger top serum separator tube (SST), acceptable
Specimen Sources
Plasma or serum
Specimen Labeling
Specimen must be labeled with at least two unique patient identifiers, e.g. name and DOB, and the date of collection.
Information on the specimen must match the requisition and/or test order.
Special SPecimen Preparation
Centrifuge PPT or SST specimens within 8 hours of collection and refrigerate at 2-8° C until shipment
Storage Conditions
Centrifuge PPT or SST specimens within 8 hours of collection and refrigerate at 2-8° C until shipment
If a blood sample may not be delivered to the laboratory within 7 days of collection, it must be frozen prior to and shipped on dry ice at ≤-20° C
Packaging and Shipping
Specimens should be shipped overnight at 2-37° C, or frozen on dry ice to be shipped at ≤-20° C. Select Saturday delivery on packages shipped on Friday.
Specimens shipped at 2-8° C must be received at the laboratory within 7 days post-collection.
Specimens shipped at 8-37° C must be received at the laboratory within 72 hours post-collection.
Multiple specimen shipments should be sent during a week to ensure an acceptable reporting turnaround time.
unsatisfactory specimen
1. Quantity not sufficient (QNS)
2. No ID on specimen
3. Information on specimen does not match requisition/test order
4. Grossly hemolyzed
5. Leaked in transit
7. No specimen received with test order
8. Bloods received 2-8° C greater than 7 days post-collection
9. Bloods received 8-37° C greater than 72 hours post-collection
10. Expired collection device used for specimen collection
11. Patient age is not appropriate for testing
Interferences and Limitations
Not recommended for use for patients under 2 years of age.
Reference Range
• HIV-1 negative
• HIV-2 negative
Result Indicator
HIV antibody negative
HIV-1 antibody positive
HIV-1 antibody indeterminate (resubmit a plasma PPT)
HIV-2 antibody positive
HIV-2 antibody indeterminate (resubmit a plasma PPT)
HIV antibody positive Untypable
HIV antibody indeterminate (resubmit a plasma PPT)
Invalid (resubmit a plasma PPT)
Reference lab
None
Reflex testing
Discordant cases reflex to HIV-1 RNA testing