Assay Sheet

Test ID

1800 HIV-1 RT-qPCR by Abbott RealTime™

CPT Code

87536

Clinical Utility

Human Immunodeficiency Virus (HIV) is the etiologic agent of Acquired Immunodeficiency Syndrome (AIDS). Quantitative measurement of HIV levels in peripheral blood has been shown to be an essential parameter in prognosis and management of HIV infected individuals. Decisions regarding initiation or changes in antiretroviral therapy are guided by monitoring plasma HIV RNA levels (viral load), CD4+ T cell count, and the patient's clinical condition. The goal of antiretroviral therapy is to reduce the HIV virus in plasma to below detectable levels of available viral load tests.

The Abbott RealTime™ HIV-1 assay is intended for use in conjunction with clinical presentation and other laboratory markers for disease prognosis and for use as an aid in assessing viral response to antiretroviral treatment as measured by changes in plasma HIV type 1 (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.

Procedure

Extraction of HIV-1 RNA from plasma followed by amplification and detection using quantitative, real-time RT-PCR.  An internal control is added to ensure the extraction was performed correctly and the RT-PCR reaction was not inhibited.

Specimen type & specimen handling

Plasma: 2 to 4 ml of plasma isolated from whole blood (PPT, EDTA or ACD-A)Freshly collected whole blood (PPT, EDTA, or ACD A) must be promptly centrifuged (within 6 hrs from blood draw) to isolate the plasma.  After centrifugation, the plasma should be transferred into a screw-cap tube prior to shipment.  If whole blood was collected in a PPT tube, the entire tube can be shipped following centrifugation.

Plasma must be received at ViraCor Laboratories within the following time-frames depending on the storage and shipping conditions:

1. Within 24 hrs from plasma isolation if stored and shipped at ambient temperature (15-30C)

2. Within 5 days from plasma isolation if stored at 4-8C and shipped on frozen gel packs or dry ice

3. Indefinitely if plasma frozen at -70C or lower and shipped on frozen gel packs or dry ice

CSF: 2 mls collected in a sterile, screw top tube. Freeze and ship on dry ice Monday thru Friday.  Specimen must be received within 96 hrs of collection.

Causes for Rejection

Specimens that have been stored or shipped at temperatures other than requirements specified above.

If storage longer than 5 days is needed, samples should be frozen at -70°C. Unless indicated as stored frozen, the specimen will be rejected if the draw date is >5 days from receipt at ViraCor.

Specimen types other than those listed above.

Specificity

Detects and quantitates all known HIV-1 groups M, N, and O, as well as non-B subtypes. Rebaselining not required with current HIV-1 viral load tests (correlation coefficient, 0.936).

The specificity of the RealTime HIV-1 assay was evaluated at three external sites by testing 514 HIV-1 seronegative plasma specimens from volunteer blood donors.  HIV-1 RNA was not detected for all 514 specimens and the RealTime HIV-1 assay specificity was estimated to be 100% (514/514), 95% CI 99.28 to 100%.

Assay Range

Plasma: 40 to 1x10⁷ copies/ml

CSF: 60 to 1x10⁷ copies/ml

Turnaround Time

1 to 4 days from receipt of specimen; assay performed twice weekly on Mondays and Wednesdays with results reported on Tuesdays and Thursdays. 

Shipping

Ship Monday through Friday. Friday shipments must be labeled for Saturday delivery. All specimens must be labeled with patient's name and collection date.

Ship specimens Fed Ex Priority Overnight® to:

ViraCor Laboratories, 1001 NW Technology Dr, Lee's Summit, MO 64086 

Information derived from the Abbott RealTime HIV-1 package insert REF 6L18 #15-602146/R2 (Abbott Molecular, Inc.). RealTime is a trademark of Abbott Molecular, Inc.

The CPT codes provided are based on ViraCor's interpretation of the American Medical Association's Current Procedural Terminology (CPT) codes and are provided for informational purposes only. CPT coding is the sole responsibility of the billing party. Questions regarding coding should be addressed to your local Medicare carrier. ViraCor assumes no responsibility for billing errors due to reliance on the CPT codes illustrated in this material.