Florida Bureau of Public Health laboratories
HIV-1 Pre-Exposure Prophylaxis (PrEP) Monitoring
The HIV-1 PrEP (pre-exposure prophylaxis) monitoring algorithm consists of two parallel FDA approved tests (HIV-1/HIV-2 Ag/Ab CMIA and HIV-1 RNA QuantDx TMA) routinely used to monitor an at-risk person’s HIV seronegative status.
Analyte(s)
HIV-1
Test Code
0580
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 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
Collection Media
“Pearl top” Plasma Preparation Tube (PPT) or
“Purple top” EDTA tube.
Specimen Sources
Plasma
Specimen Labeling
Specimen must be labeled with at least two unique patient identifiers, e.g., name and DOB, and date of collection.
Information on the specimen must match the requisition and/or test order.
Special SPecimen Preparation
This service is limited to HIV seronegative persons actively enrolled in an oral or long-acting injectable PrEP care regimen.
Centrifuge (10-15 minutes at 1000 x g) the PPT or purple top within 8 hours of collection. PPT is now ready to freeze until shipment is prepared (decanting plasma is not required).
Purple top EDTA tubes will require decanting of plasma from cells, into a sterile screw-top plastic tube.
Storage Conditions
Centrifuge PPT specimens within 8 hours of collection and freeze the PPT tube or decanted plasma at -20° 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 frozen on dry ice at ≤-20°C. Select Saturday delivery on packages shipped on Friday. Follow appropriate packaging and transporting guidelines. Send these specimens as “UN 3373 Biological Substance Category B”. Do not transport dry ice in an airtight container.
or 3-4 frozen refrigerant packs in Styrofoam cooler at 2-8°C.
Please label outside of cooler with “PrEP Monitoring”
Multiple specimen shipments should be sent during a week to ensure an acceptable reporting turn-around time (TAT).
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 greater than 6 days post-collection
9) Specimen not centrifuged
10) Expired collection device used for specimen collection
Interferences and Limitations
For use only in monitoring individuals actively enrolled with HIV PrEP.
Reference Range
HIV-1 Negative
Result Indicator
HIV-1 Positive
HIV-1 Negative
Quantitative values expressed in RNA copies/mL blood
Inconclusive
Reference lab
None
Reflex testing
None