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Order Code HIP12 HIV-1/HIV-2 RNA Detection, Plasma


Ordering Guidance


This test is indicated for qualitative detection and differentiation of HIV-1 and HIV-2 infection in a person with indeterminate or inconclusive HIV serologic test results or who is suspected to be in the acute / early HIV infection stage (ie, "window period"). If serologic testing has not yet been performed on the patient, order either HVCOP / HIV-1 and HIV-2 Antigen and Antibody Routine Screen, Plasma or HIVDX / HIV-1 and HIV-2 Antigen and Antibody Diagnostic Evaluation, Plasma, where this test will automatically be added on depending on the results of the serologic test.



Shipping Instructions


1. Ship specimen frozen on dry ice.

2. If shipment will be delayed for more than 24 hours, freeze plasma specimen at -20 to -80° C until shipment on dry ice.



Specimen Required


Supplies: Sarstedt Aliquot Tube, 5 mL (T914)

Collection Container/Tube: Lavender top (EDTA)

Submission Container/Tube: Plastic vial

Specimen Volume: 1.5 mL

Collection Instructions:

1. Centrifuge blood collection tube and aliquot plasma into plastic vial per collection tube manufacturer's instructions (eg, centrifuge and aliquot within 2 hours of collection for BD Vacutainer tubes).

2. Freeze aliquoted plasma for shipment.


Forms

If not ordering electronically, complete, print, and send a Microbiology Test Request (T244) with the specimen.

Useful For

Diagnosis of HIV-1 and/or HIV-2 infection in individuals with indeterminate or inconclusive HIV serologic test results

 

Diagnosis of HIV-1 and/or HIV-2 infection in individuals with acute or early HIV-1 and/or HIV-2 infection

 

Diagnosis of HIV-1 and/or HIV-2 infection in infants under 18 months of age who are born to HIV-infected mothers

Method Name

Real-Time Reverse Transcription-Polymerase Chain Reaction (RT-PCR)

Reporting Name

HIV-1/HIV-2 RNA Detect, P

Specimen Type

Plasma EDTA

Specimen Minimum Volume

0.8 mL

Specimen Stability Information

Specimen Type Temperature Time
Plasma EDTA Frozen (preferred) 40 days
  Refrigerated  6 days

Reject Due To

Gross hemolysis Reject
Gross lipemia Reject
Gross icterus OK

Reference Values

Undetected

Method Description

This test is a US Food and Drug Administration approved, real-time polymerase chain reaction (PCR) assay performed on the cobas 5800/6800/8800 Systems for fully automated sample preparation (including extraction and purification of viral nucleic acid), amplification, detection, and differentiation of HIV-1 and HIV-2 RNA. It utilizes a multi-target approach to amplify 2 highly conserved gag and long terminal repeat (LTR) regions of the HIV-1 genome and the LTR region of the HIV-2 genome for detection by target sequence-specific TaqMan probes. A non-HIV, RNA internal control is introduced into each specimen during sample preparation to assess substantial failures during the sample preparation and PCR amplification processes, while HIV-1 and HIV-2 positive controls and a negative control are used as assay run controls. The assay generates individual results for the presence or absence of HIV-1 RNA and HIV-2 RNA.(Package insert: cobas HIV-1/HIV-2 Qualitative - nucleic acid test for use on the cobas 5800/6800/8800 Systems. Roche Molecular Systems, Inc; Doc rev. 5.0, 05/2023)

Day(s) Performed

Monday through Saturday

Performing Laboratory

Mayo Clinic Laboratories in Rochester

CPT Code Information

87535

87538