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Test 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.

Secondary ID

615815

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

Highlights

This test is to be used 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").

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 Special Container
Plasma EDTA Frozen (preferred) 40 days
  Refrigerated  6 days

Reject Due To

Gross hemolysis OK
Gross lipemia OK
Gross icterus OK

Clinical Information

Currently, 2 types of HIV, HIV type 1 (HIV-1) and HIV type 2 (HIV-2), are known to infect humans. HIV-1 has been isolated from patients with AIDS or AIDS-related complex, and from asymptomatic infected individuals at high-risk for AIDS. Accounting for more than 99% of HIV infection in the world, HIV-1 is transmitted by sexual contact, by exposure to infected blood or blood products, from an infected pregnant woman to fetus in utero or during birth, or from an infected mother to infant via breast-feeding. HIV-2 has been isolated from infected patients in West Africa, and it appears to be endemic only in that region. However, HIV-2 also has been identified in individuals who have lived in West Africa or had sexual relations with individuals from that geographic region. HIV-2 is similar to HIV-1 in overall genomic structure and ability to cause AIDS, but viral load tends to lower in HIV-2 than HIV-1 infection.

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: 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

Test Classification

This test has been cleared, approved, or is exempt by the US Food and Drug Administration and is used per manufacturer's instructions. Performance characteristics were verified by Mayo Clinic in a manner consistent with CLIA requirements.

CPT Code Information

87535

87538

LOINC Code Information

Test ID Test Order Name Order LOINC Value
HIP12 HIV-1/HIV-2 RNA Detect, P 96557-4

 

Result ID Test Result Name Result LOINC Value
616340 HIV-1 RNA 25835-0
616341 HIV-2 RNA 69353-1