Sign in →

Test Code HPS12 HIV-1/HIV-2 RNA Detection Prenatal, Serum


Ordering Guidance


This test is indicated for qualitative detection and differentiation of HIV-1 and HIV-2 infection in pregnant individuals with indeterminate or inconclusive HIV serologic test results or who are 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 HVPRS / HIV Antigen and Antibody Prenatal Routine Screen, Serum or HVPPS / HIV-1 and HIV-2 Antibody Confirmation and Differentiation Prenatal, Serum, 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 serum specimen at -20 to -80° C until shipment on dry ice.



Specimen Required


Supplies: Sarstedt Aliquot Tube, 5 mL (T914)

Collection Container/Tube: Serum gel

Submission Container/Tube: Plastic vial

Specimen Volume: 1.5 mL

Collection Instructions:

1. Within 2 hours of collection, centrifuge and aliquot serum into plastic vial.  .

2. Freeze aliquoted serum for shipment.


Forms

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

Secondary ID

615818

Useful For

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

 

Diagnosis of HIV-1 and/or HIV-2 infection in pregnant individuals in the acute or early phase of HIV-1 and/or HIV-2 infection

Method Name

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

Specimen Type

Serum SST

Specimen Minimum Volume

0.8 mL

Specimen Stability Information

Specimen Type Temperature Time Special Container
Serum SST Frozen (preferred) 40 days
  Refrigerated  6 days

Reject Due To

Gross hemolysis OK
Gross lipemia OK
Gross icterus OK

Reference Values

Undetected

Interpretation

A "Detected" result indicates that the presence of RNA of the specific virus in the plasma specimen tested, consistent with the presence of this viral infection. For example, a "Detected" result for HIV-1 RNA by this assay is indicative of HIV-1 infection in the tested individual. A follow-up plasma specimen should be collected from this individual to both verify the diagnosis and quantify the HIV RNA prior to initiation of antiviral therapy.

 

An "Undetected" result indicates that the assay was unable to detect RNA of the specific virus in the plasma specimen tested.

 

An "Inconclusive" result indicates that the presence or absence of viral RNA could not be determined with certainty after repeat testing in the laboratory, possibly due to presence of inhibitory substances in the plasma specimen tested. Collection of a new plasma for testing is recommended.

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:  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

Report Available

1 to 3 days

Specimen Retention Time

30 days

Performing Laboratory

Mayo Clinic Laboratories in Rochester

CPT Code Information

87535

87538

LOINC Code Information

Test ID Test Order Name Order LOINC Value
HPS12 HIV-1/HIV-2 RNA Detect Prenatal, S 96557-4

 

Result ID Test Result Name Result LOINC Value
616346 HIV-1 RNA 25835-0
616347 HIV-2 RNA 69353-1