Florida Bureau of Public Health laboratories
HIV-1 Targeted Next Generation Sequencing
The HIV-1 Targeted Next Generation Sequencing (TNGS) assay is the Florida BPHL’s Laboratory Developed Test (LDT) genotype procedure to accompany HIV-1 viral load testing, as needed. The assay is essential in determining if the HIV virus has mutated against specific antiretrovirals and is a barrier to a patient’s SVR status
Analyte(s)
HIV-1
Test Code
0570
Testing Location
Jacksonville Laboratory
Testing Department
Retrovirology (HIV)
Pre-approval Required?
A documented HIV-1 viral load of at least 2,000 RNA copies within 30 days of the genotype blood draw must be provided or an HIV-1 viral load will be performed by BPHL prior to Genotyping.
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
7-10 business days after receipt at the laboratory.
Minimum Volume
At least 2.5 mL plasma.
Collection Media
“Pearl Top” PPT tube
Specimen Sources
Plasma
Specimen Labeling
Specimen must be labeled with at least two unique patient identifiers, ex: 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
HIV-1 Genotype with Viral load maintain <20°C until shipment
HIV-1 Genotype maintain 2-8°C until shipment
Packaging and Shipping
Genotype and Viral load request – Send plasma on dry ice ≤-20°C, however if dry ice is not available, specimens may be sent on 3 – 4 foam refrigerant packs in a Styrofoam cooler at 2-8°C. Please label cooler on the outside with “Genotyping”. Do not allow specimens to thaw before shipping. Shipment must be sent priority overnight.
Genotype only request – Send plasma on 3 – 4 foam refrigerant packs in a Styrofoam cooler at 2-8°C. Please label cooler on the outside with “Genotyping”. 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
9) Specimen not centrifuged
10) Quantity not sufficient (QNS)
Interferences and Limitations
Hemolysis
Reference Range
HIV-1 RNA Not Detected
Result Indicator
Current anti-retroviral drug resistance report (mutation report optional)
Invalid
Reference lab
3rd party clinical interpretation source
Reflex testing
None