Florida Bureau of Public Health laboratories
HIV-1 RNA QuantDX
The FDA approved HIV-1 RNA QuantDx transcription mediated amplification (TMA) assay has a dual intended use claim for plasma, i.e. quantitative viral load and diagnostic application. The assay is essential in monitoring antiretroviral therapy and a Sustained Virologic Response (SVR).
Analyte(s)
HIV-1
Test Code
0560 (viral load – quantitative) Plasma only
0530 (diagnostic – qualitative) Plasma or Serum
Testing Location
Jacksonville Laboratory
Miami Laboratory
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
1-3 business days after receipt at the laboratory.
Minimum Volume
At least 2.5 mL plasma or serum.
Collection Media
“Pearl Top” PPT tube (preferred) or “purple top” EDTA tube (Purple tops will require decanting of plasma from cells, into a sterile screw-top plastic tube) or
“Tiger top” SST tube
Specimen Sources
Plasma (diagnostic and viral load)
Serum (diagnostic only)
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 the PPT or purple top within 8 hours of collection for 10-15 minutes at 1000 x g. PPT is now ready to freeze until shipment is prepared (decanting plasma is not required).
Purple tops will require decanting of plasma from cells, into a sterile screw-top plastic tube.
Storage Conditions
Centrifuge PPT within 8 hours of collection and freeze until shipment. Specimen must arrive at the lab within 6 days of collection.
Packaging and Shipping
Send plasma overnight on dry ice at ≤-20° C, however if dry ice is not available, specimens may be sent on 3 – 4 frozen ice packs in a styrofoam cooler at 2-8° C. Please label cooler on the outside with “Viral Load”.
Do not allow specimens to thaw before shipping. Shipment must be sent priority overnight.
unsatisfactory specimen
1) Incorrect collection device was used
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) Quantity not sufficient (QNS)
Interferences and Limitations
Hemolysis
Reference Range
HIV-1 RNA Not Detected
Result Indicator
RNA Detected
RNA Not Detected (serum or plasma)
RNA copies/ml blood (plasma only)
Invalid
Reference lab
None
Reflex testing
None