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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
  • Plasma not separated and frozen within 24 hours of collection
  • Leakage or contamination of specimen, improper collection, container or transport, questionable patient or specimen identification, insufficient quantity

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.

Reflex Testing

Reflex available for HIV-1 genotyping, order HIV-1 Quant w/reflex

CPT Codes

87536