Test Code HIV-1 by PCR HIV-1 Quantitative by PCR
Aliases
HIV Viral Load
Useful For
This test is intended for quantitation of human immunodeficiency virus type 1 (HIV-1) RNA in human plasma from HIV-1 infected individuals. The Aptima HIV-1 Quant assay quantitates HIV-1 RNA groups M, N, and O over the range of 30 to 10,000,000 copies/mL. One international unit is equivalent to 0.35 copies of HIV-1 RNA for the 3rd HIV-1 WHO International Standard (subtype B, NIBSC code: 10/152).
The Aptima HIV-1 Quant assay is intended for use in conjunction with clinical presentation and other laboratory markers for disease prognosis and for use as an aid in monitoring the effects of antiretroviral treatment, as measured by changes in plasma HIV-1 RNA levels. This assay is not intended to be used as a donor screening test for HIV-1 or as a diagnostic test to confirm the presence of HIV-1 infection.
Patient Preparation
No special patient preparation required
Special Collection Instructions
If sample cannot be delivered to the lab within 24 hours, separate and freeze plasma.
Collection Method
Venous collection
Minimum Volume
3 mL
Container
Pink Top EDTA
Preferred Specimen
Froze Plasma from whole blood collected in a Pink Top EDTA tube
Acceptable Specimens
EDTA Whole blood collected within 24 hours
Reference or Target Ranges
Not Detected
Lower Limit of Detection | 30 copies/mL, 1.00 Log10 |
Reportable Units
copies/mL and Log10
Critical Value
Not defined for this assay
Reasons for Rejection
Hemolysis Threshold | N/A |
Icterus Threshold | N/A |
Lipemia Threshold | N/A |
Interfering Subtances/Other |
|
Specimen Stability
Ambient | Whole Blood: 24 Hours |
Refrigerated (4°C to 8°C) | Plasma: 5 Days |
Frozen(-70°C to 0°C) | Plasma: 90 Days |
Performance Information
Days and Time Performed | Once weekly, usually Wednesday |
Expected Turn Around Time | 1 – 7 Days |
Stat Availabilty | No |
Performing Bench | Molecular Pathology |
Methodology/Method Description | Hologic Panther – The Aptima HIV-1 Quant assay involves the steps which all take place in a singe tube on the Panther system: target capture, target amplification by transcription-mediated amplification (TMA), and detection of the amplification products by fluorescent labeled probes. |
CPT Codes
87536
Reflex Testing
Reflex available for HIV-1 genotyping, order HIV-1 Quant w/reflex