Used in conjunction with clinical presentation and other laboratory markers as an indicator of disease prognosis and as an aid in assessing viral response to antiretroviral treatment as measured by changes in plasma HIV-1 RNA levels.

This test should be used for patients with documented HIV-1 infection as a monitor of response to antiretroviral therapy.

Viral RNA levels detected below the AMR of this method are not quantitated and are therefore reported as “Detected at less than 1.3 log10 (less than 20) copies/mL”.

HIV-1 RNA DETECTED at quantity expressed as Log 10 converted copies/mL 

ANALYTICAL MEASUREMENT RANGE: 1.3 to 7.0 log10 (20 TO 10 MILLION) copies/mL.

This test should only be used for patients with documented HIV infection.

Results below the limit of detection are reported as “HIV-1 RNA Not Detected”.

Real-Time Polymerase Chain Reaction (PCR)

The performance of this PCR test was verified in the Clinical Microbiology Laboratory at Duke University Medical Center.

COLLECTION REQUIREMENTS:   
•	4 mL EDTA (Lavender) tube for adult and pediatric.   
•	If 4 mL cannot be collected, submit a single 2 mL Lavender PEDS tube or four Lavender Microtainers. Please note that any volume less than 4 mL may result in insufficient separated plasma for testing and the order will be cancelled for Quantity Not Sufficient (QNS). 

SHIPPING/HANDLING INSTRUCTIONS:   
•	Specimen must be received into the Clinical Microbiology Laboratory within 24 hours of collection.  
•	If transport delay is expected, separate the plasma into a sterile, plastic screw top vial, and store in refrigeration (if transporting within 2 days) or freeze (if > 2 days). Must send the original EDTA collection tube with the separated plasma vial. 

CAUSE FOR REJECTION:  
•	Insufficient volume after plasma separation. Whole blood collection < 4mL may not yield sufficient plasma for testing.  
•	Grossly hemolyzed  
•	> 24 hours from time of collection  
•	Specimen leakage  
•	Incorrect specimen label  
•	Incorrect collection tube