Test Catalog

Test Id : HV2QU

HIV-2 RNA Detection and Quantification, Real-Time qRT-PCR, Plasma

Test Catalog

Useful For
Suggests clinical disorders or settings where the test may be helpful

Confirmatory detection of human immunodeficiency virus type 2 (HIV-2) RNA in clinical plasma specimens for the diagnosis of acute or established HIV-2 infection

 

Quantifying plasma HIV-2 RNA levels (viral load) in individuals living with HIV-2:

-Before initiating antiretroviral therapy to obtain baseline viral load

-For monitoring HIV-2 disease progression with or without antiretroviral therapy

Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.

Method Name
A short description of the method used to perform the test

Reverse Transcription Real-time Polymerase Chain Reaction (RT-qPCR)

NY State Available
Indicates the status of NY State approval and if the test is orderable for NY State clients.

Yes

Reporting Name
Lists a shorter or abbreviated version of the Published Name for a test

HIV-2 RNA Detect / Quant, P

Aliases
Lists additional common names for a test, as an aid in searching

Acquired Immune Deficiency Syndrome (AIDS)

AIDS (Acquired Immune Deficiency Syndrome)

HIV (Human Immunodeficiency Virus)

HIV viral load

HIV-2 (Human Immunodeficiency Virus-2) RNA, Viral Load

HIV-2 PCR

HIV-2 Quantitation, PCR

HIV-2 RNA

HIV-2 viral load

Human Immunodeficiency Virus, PCR

PCR, HIV-2 Quantitation

Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.

Specimen Type
Describes the specimen type validated for testing

Plasma EDTA

Ordering Guidance

This test is indicated for either 1) confirmatory qualitative detection of HIV-2 RNA in individuals with indeterminate or positive HIV-2-specific antibody but negative HIV-1-specific antibody test results; or 2) baseline or serial monitoring of HIV-2 viral load in those with confirmed HIV-2 infection with or without antiretroviral therapy.

Shipping Instructions

Ship specimen frozen on dry ice. If shipment will be delayed for more than 24 hours, freeze specimen at -20 to -80 degrees C (up to 35 days) before shipment and then transport on dry ice.

Specimen Required
Defines the optimal specimen required to perform the test and the preferred volume to complete testing

Supplies: Sarstedt Aliquot Tube, 5 mL (T914)

Collection Container/Tube: Lavender top (EDTA)

Submission Container/Tube: Plastic vial

Specimen Volume: 2.1 mL Plasma

Collection Instructions: Centrifuge and aliquot plasma into a plastic vial.

Special Instructions
Library of PDFs including pertinent information and forms related to the test

Specimen Minimum Volume
Defines the amount of sample necessary to provide a clinically relevant result as determined by the testing laboratory. The minimum volume is sufficient for one attempt at testing.

Plasma: 1.1 mL

Reject Due To
Identifies specimen types and conditions that may cause the specimen to be rejected

Gross hemolysis OK
Gross lipemia OK
Gross icterus OK

Specimen Stability Information
Provides a description of the temperatures required to transport a specimen to the performing laboratory, alternate acceptable temperatures are also included

Specimen Type Temperature Time Special Container
Plasma EDTA Frozen (preferred) 60 days ALIQUOT TUBE
Refrigerated 6 days ALIQUOT TUBE

Useful For
Suggests clinical disorders or settings where the test may be helpful

Confirmatory detection of human immunodeficiency virus type 2 (HIV-2) RNA in clinical plasma specimens for the diagnosis of acute or established HIV-2 infection

 

Quantifying plasma HIV-2 RNA levels (viral load) in individuals living with HIV-2:

-Before initiating antiretroviral therapy to obtain baseline viral load

-For monitoring HIV-2 disease progression with or without antiretroviral therapy

Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.

Clinical Information
Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test

Human immunodeficiency virus type 2 (HIV-2) is a lentivirus, a retrovirus in the same genus (Lentiviridae) as HIV-1. It was first isolated in 1986 in West Africa, where it is currently endemic. Most of these cases in the United States have been found in the northeastern United States, and the majority had a West African origin or connection.

 

Compared to HIV-1 infection, HIV-2 infection is associated with slower rate of progression, low viral load (which may not be reliably measured with current methods), slower rates of decline in CD4 cell count, and lower rates of transmission (sexually or vertically). Up to 95% of HIV-2-infected individuals are long-term non-progressors, and individuals with undetectable HIV-2 viral load have similar survival rates as that of the uninfected population. However, HIV-2 does cause immunosuppression as well as AIDS with the same signs, symptoms, and opportunistic infections seen in HIV-1. Due to the rarity of HIV-2, there are scant data from controlled trials to inform management decisions.

Reference Values
Describes reference intervals and additional information for interpretation of test results. May include intervals based on age and sex when appropriate. Intervals are Mayo-derived, unless otherwise designated. If an interpretive report is provided, the reference value field will state this.

Undetected

Interpretation
Provides information to assist in interpretation of the test results

The quantification range of this assay is 50 to 3,160,000 IU/mL (1.70 log to 6.50 log IU/mL), with a limit of detection (based on a 95% detection rate) of 18 IU/mL.

 

An "Undetected" result indicates that HIV-2 RNA is not detected in the plasma specimen (see Cautions). The limit of detection for this assay is 18 IU/mL.

 

A result of "<50 IU/mL" indicates that the HIV-2 RNA level present in the plasma specimen is below 50 IU/mL (1.70 log IU/mL), and the assay cannot accurately quantify the HIV-2 RNA present below this level.

 

A quantitative value (reported in IU/mL and log10 IU/mL) indicates the HIV-2 RNA level (i.e., viral load) present in the plasma specimen.

 

A result of ">3,160,000 IU/mL" indicates that the HIV-2 RNA level present in the plasma specimen is above 3,160,000 IU/mL (6.50 log IU/mL), and this assay cannot accurately quantify the HIV-2 RNA present above this level.

 

An "Indeterminate" result suggests the presence of an atypical HIV-2 target sequence. Since the HIV-2 RNA sequence is atypical, repeat testing is unlikely to change this result and therefore is not recommended.

 

An "Equivocal" result indicates that the presence or absence of HIV-2 RNA in the plasma specimen could not be determined with certainty due to atypical real-time reverse transcriptase-polymerase chain reaction (RT-qPCR) probe reactivity. Submission of a new specimen for testing is recommended.

 

An "Inconclusive" result indicates that the presence or absence of HIV-2 RNA in the plasma specimen could not be determined with certainty after repeat testing in the laboratory, possibly due to RT-qPCR inhibition. Submission of a new specimen for testing is recommended.

Cautions
Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances

This assay is optimized for the detection and quantification of HIV-2 groups A, B, and A/B, but due to unexpected mismatches between the polymerase chain reaction primers and unusual or rare HIV-2 target sequences, some plasma specimens may yield "Undetected" or under-quantified results despite the presence of HIV-2 RNA. Results should be interpreted with caution, considering the patient's risk factors for HIV-2 infection, the analytical sensitivity of the assay, and possible source of the infecting HIV-2 strain. Follow-up HIV-2 RNA testing is recommended for patients with initially "Undetected" HIV-2 RNA test results but at high risk for or suspected to have HIV-2 infection.

 

Due to potential differences in assay performance, serial monitoring of HIV-2 viral load in a given patient should be performed with the same quantitative molecular assay.

Clinical Reference
Recommendations for in-depth reading of a clinical nature

1. New York State Department of Health AIDS Institute Clinical Guidelines Program. Diagnosis and management of HIV-2 in adults. June 20, 2023. Available at https://www.hivguidelines.org/wp-content/uploads/2023/01/NYSDOH-AI-Diagnosis-and-Management-of-HIV-2-in-Adults_9-10-2025_HG.pdf

2. U.S. Department of Health and Human Services. HIV-2 infection. December 6, 2023. Available at https://clinicalinfo.hiv.gov/en/guidelines/hiv-clinical-guidelines-adult-and-adolescent-arv/special-populations-hiv-2-infection

3. Spach DH, Budak JZ. National HIV Curriculum: HIV-2 infection. February 3, 2025. Available at https://www.hiv.uw.edu/go/key-populations/hiv-2/core-concept/all#citations

Method Description
Describes how the test is performed and provides a method-specific reference

This assay utilizes real-time polymerase chain reaction (PCR) technology for the qualitative and quantitative detection of human immunodeficiency virus type 2 (HIV-2) RNA in human plasma. Testing involves 3 major processes with the ELITe InGenius integrated system: automated extraction and purification of viral RNA; reverse transcription of viral target RNA sequence to generate complementary DNA (cDNA); and PCR amplification and real-time detection of fluorescent dye-labeled oligonucleotide (Pleiades) probes that allow the specific and simultaneous detection and quantitation of the target sequence as well as an internal MS2 internal control. The assay is calibrated to the Second World Health Organization International Standard for HIV-2 RNA, NIBSC 16/296.(Unpublished Mayo method)

PDF Report
Indicates whether the report includes an additional document with charts, images or other enriched information

No

Day(s) Performed
Outlines the days the test is performed. This field reflects the day that the sample must be in the testing laboratory to begin the testing process and includes any specimen preparation and processing time before the test is performed. Some tests are listed as continuously performed, which means that assays are performed multiple times during the day.

Varies (once per week)

Report Available
The interval of time (receipt of sample at Mayo Clinic Laboratories to results available) taking into account standard setup days and weekends. The first day is the time that it typically takes for a result to be available. The last day is the time it might take, accounting for any necessary repeated testing.

1 to 14 days

Specimen Retention Time
Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded

60 days

Performing Laboratory Location
Indicates the location of the laboratory that performs the test

Mayo Clinic Laboratories - Rochester Superior Drive
CLIA Number: 24D1040592

Fees
Several factors determine the fee charged to perform a test. Contact your U.S. or International Regional Manager for information about establishing a fee schedule or to learn more about resources to optimize test selection.

  • Authorized users can sign in to Test Prices for detailed fee information.
  • Clients without access to Test Prices can contact Customer Service 24 hours a day, seven days a week.
  • Prospective clients should contact their account representative. For assistance, contact Customer Service.

Test Classification
Provides information regarding the medical device classification for laboratory test kits and reagents. Tests may be classified as cleared or approved by the US Food and Drug Administration (FDA) and used per manufacturer instructions, or as products that do not undergo full FDA review and approval, and are then labeled as an Analyte Specific Reagent (ASR) product.

This test was developed and its performance characteristics determined by Mayo Clinic in a manner consistent with CLIA requirements. It has not been cleared or approved by the US Food and Drug Administration.

CPT Code Information
Provides guidance in determining the appropriate Current Procedural Terminology (CPT) code(s) information for each test or profile. The listed CPT codes reflect Mayo Clinic Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.

CPT codes are provided by the performing laboratory.

87539

LOINC® Information
Provides guidance in determining the Logical Observation Identifiers Names and Codes (LOINC) values for the order and results codes of this test. LOINC values are provided by the performing laboratory.

Test Id Test Order Name Order LOINC Value
HV2QU HIV-2 RNA Detect / Quant, P 69354-9
Result Id Test Result Name Result LOINC Value
Applies only to results expressed in units of measure originally reported by the performing laboratory. These values do not apply to results that are converted to other units of measure.
623478 HIV-2 RNA Detect / Quant, P 69354-9

Test Setup Resources

Setup Files
Test setup information contains test file definition details to support order and result interfacing between Mayo Clinic Laboratories and your Laboratory Information System.

Excel | Pdf

Sample Reports
Normal and Abnormal sample reports are provided as references for report appearance.

No Sample Reports Available