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Test Code HIS12 HIV-1/HIV-2 RNA Detection, Serum


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 HIVSS / HIV-1 and HIV-2 Antigen and Antibody Routine Screen, Serum; and HIVDS / HIV-1 and HIV-2 Antigen and Antibody Diagnostic Evaluation, 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 a 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.

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 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, S

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

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 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 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 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 specimen tested. Collection of a new specimen for testing is recommended.

Cautions

This test is not licensed by the US Food and Drug Administration as a screening test for HIV-1 infection in donors of blood, human cells, tissues, or tissue products.

 

A single "Undetected" result may not rule out the presence of HIV infection, if the specimen is collected and tested too early after exposure (ie, less than 10 days from exposure) or if patient is infected with a rare HIV variant. Improper storage or processing (ie, incorrect temperature) of the specimen for transport to the testing laboratory may lead to falsely negative viral RNA result.

Clinical Reference

1. Centers for Disease Control and Prevention: 2018 Quick reference guide: Recommended laboratory HIV testing algorithm for serum or plasma specimens. CDC; January 2018. Accessed July 22, 2024. Available at https://stacks.cdc.gov/view/cdc/50872

2. Branson BM, Owen SM, Wesolowski LG, et al: Laboratory testing for the diagnosis of HIV infection: Updated recommendations. Centers for Disease Control and Prevention; June 27, 2014. Accessed July 22, 2024. Available at https://stacks.cdc.gov/view/cdc/23447

3. Duncan D, Duncan J, Kramer B, et al. An HIV diagnostic testing algorithm using the cobas HIV-1/HIV-2 qualitative assay for HIV type differentiation and confirmation. J Clin Microbiol. 2021;59(7):e03030-20. doi:10.1128/JCM.03030-20

4. US Department of Health and Human Services, Panel on Antiretroviral Guidelines for Adults and Adolescents: Guidelines for the use of antiretroviral agents in adults and adolescents with HIV. HHS. Updated February 27, 2024. Accessed July 22, 2024. Available at https://clinicalinfo.hiv.gov/sites/default/files/guidelines/documents/adult-adolescent-arv/guidelines-adult-adolescent-arv.pdf

5. US Department of Health and Human Services, Panel on Antiretroviral Therapy and Medical Management of Children Living with HIV: Guidelines for the use of antiretroviral agents in pediatric HIV infection. HSS. Updated June 27, 2024. Accessed July 22, 2024. Available at https://clinicalinfo.hiv.gov/sites/default/files/guidelines/documents/pediatric-arv/guidelines-pediatric-arv.pdf

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

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
HIS12 HIV-1/HIV-2 RNA Detect, S 96557-4

 

Result ID Test Result Name Result LOINC Value
616342 HIV-1 RNA 25835-0
616343 HIV-2 RNA 69353-1

NY State Approved

Yes