Test Catalog

Test Id : HIV2L

HIV-2 Antibody Confirmation, Serum

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

Confirmation of the presence of HIV-2 antibodies in patients with repeatedly reactive combined HIV-1 and HIV-2 antibody or HIV-2 antibody-only screening test results

 

Diagnosis of HIV-2 infection

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

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

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

Rapid Immunochromatographic Assay

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 Ab Confirmation, S

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

HIV-2 confirmation

HIV-2 blot

HIV-2 antibody blot

HIV2

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

Serum

Ordering Guidance

This confirmatory assay should be ordered only on specimens that are repeatedly reactive by HIV-2 antibody screening immunoassay.

 

Screening, supplemental, or confirmatory serologic tests for HIV-2 antibodies cannot distinguish between active HIV-2 infection and passive transfer of maternal HIV-2 antibodies in infants during the postnatal period (up to 2 years). Diagnosis of HIV-2 infection in newborns and infants of less than 2 years old should be made by consistently positive nucleic acid test results, such as the presence of HIV-2 DNA/RNA (FHV2Q / HIV-2 DNA/RNA Qualitative Real-Time PCR).

 

New York State clients: This test should not be requested for maternal/newborn HIV screening on specimens originating in New York State, due to state regulatory requirements for expedited result reporting.

Necessary Information

Date of collection is required.

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

Collection Container/Tube:

Preferred: Serum gel

Acceptable: Red top

Submission Container/Tube: Plastic vial

Specimen Volume: 0.5 mL

Collection Instructions:

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

2. Aliquot serum into 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

0.2 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
Serum Frozen (preferred) 30 days
Refrigerated 14 days
Ambient 48 hours

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

Confirmation of the presence of HIV-2 antibodies in patients with repeatedly reactive combined HIV-1 and HIV-2 antibody or HIV-2 antibody-only screening test results

 

Diagnosis of HIV-2 infection

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. As of June 2010, CDC has reported a total of 166 cases that met the CDC case definition of HIV-2 infection in the United States. Most of these cases were 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 nonprogressors, 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.

 

Although there are several FDA-approved screening assays to detect combined HIV-1 and HIV-2 antibodies or HIV-2 antibodies alone, currently there is only one FDA-approved supplemental (confirmatory) HIV-2 serologic assay for clinical use in the United States.

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.

Negative

Interpretation
Provides information to assist in interpretation of the test results

Negative results for HIV-2 antibodies usually indicate the absence of HIV-2 infection. However, in patients with reactive initial combined HIV-1/-2 antigen and antibody test results, such negative results do not rule-out acute or early HIV-2 infection. If acute or early HIV-2 infection is suspected, detection of HIV-2 DNA/RNA (FHV2Q / HIV-2 DNA/RNA Qualitative Real-Time PCR) is recommended, based on the patient's clinical and epidemiologic exposure history.

 

Positive HIV-2 antibody results indicate the presence of HIV-2 infection. Additional testing with a new whole blood specimen for HIV-2 DNA/RNA (FHV2Q / HIV-2 DNA/RNA Qualitative Real-Time PCR) is recommended to verify and confirm the diagnosis of HIV-2 infection prior to initiating antiretroviral treatment.

 

Indeterminate HIV-2 antibody results may be due to acute HIV-1 infection or very early HIV-2 infection (in individuals with risk factors). If acute HIV-1 infection or early HIV-2 infection is suspected, detection of HIV-1 RNA (HIVQN / HIV-1 RNA Detection and Quantification, Plasma) and/or HIV-2 DNA/RNA (FHV2Q / HIV-2 HIV-2 DNA/RNA Qualitative Real-Time PCR) is recommended, depending on the epidemiologic exposure history.

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

A negative HIV-2 antibody supplemental (confirmatory) test result does not exclude the possibility of acute or early (<60 days from time of exposure) HIV-2 infection. Individuals suspected of having acute or early HIV-2 infection should be tested for qualitative HIV-2 DNA/RNA (FHV2Q / HIV-2 DNA/RNA Qualitative Real-Time PCR) or quantitative HIV-2 RNA.

 

The US Association of Public Health Laboratories recommends verification of all first-time positive supplemental test results for the definitive diagnosis of HIV infection. A second serum specimen should be obtained from the patient and submitted for repeat testing to verify all first-time positive test results.

 

Although a positive HIV-2 antibody supplemental test result indicates HIV-2 infection, a diagnosis of AIDS can only be made based on the case definition established by the CDC. In many US states, positive HIV-2 antibody supplemental test results are required to be reported to the state department of health.

 

Individuals at risk for HIV-2 infection with indeterminate or negative HIV-2 antibody supplemental test results should be retested in 2 to 4 weeks or have qualitative HIV-2 DNA/RNA (FHV2Q) testing performed.

 

Assay performance characteristics have not been established for the following specimen characteristics:

-Heat-inactivated specimens

-Cadaveric specimens

-Presence of particulate matter

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

1. Campbell-Yesufu OT, Gandhi RT: Update on human immunodeficiency virus (HIV)-2 infection. 2011 Mar 15;52(6):780-787

2. Centers for Disease Control and Prevention and Association of Public Health Laboratories. Laboratory testing for the diagnosis of HIV infection: Updated recommendations. June 27, 2014. Accessed June 15, 2020. Available at https://stacks.cdc.gov/view/cdc/23447

3. Malloch L, Kadivar K, Putz J, et al: Comparative evaluation of the Bio-Rad Geenius HIV-1/2 confirmatory assay and the Bio-Rad Multispot HIV-1/2 rapid test as an alternative differentiation assay for CLSI M53 algorithm-I. J Clin Virol. 2013 Dec;58(Suppl. 1):e85-e91

4. Montesinos I, Eykmans J, Delforge ML: Evaluation of the Bio-Rad Geenius HIV-1/2 test as confirmatory assay. J Clin Virol. 2014 Aug;60(4):399-401

5. Mor O, Milequir F, Michaeli M, Levy I, Mendelson E: Evaluation of the Bio-Rad Geenius HIV 1/2 assay as an alternative to the INNO-LIA HIV 1/2 assay for confirmation of HIV infection. J Clin Microbiol. 2014 Jul;52(7):2677-2679

6. Abbate I, Pergola C, Pisciotta M, et al: Evaluation in a clinical setting of the performances of a new rapid confirmatory assay for HIV-1/2 serodiagnosis. J Clin Virol. 2014 Sep;61(1):166-169

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

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

The Geenius HIV 1/2 Supplemental Assay cassette contains antibody-binding protein A, which is conjugated to colloidal gold dye particles, and HIV-1 and HIV-2 antigens, which are bound to the membrane solid phase. The sample is applied to the sample and buffer well. After the sample and buffer have migrated onto the test strip, additional buffer is added to the buffer well. The buffer causes the specimens and reagents to flow laterally and facilitates the binding of antibodies to the antigens. In a reactive sample, the antibodies are captured by the antigens immobilized in the test area.

 

The protein A-colloidal gold binds to the captured antibodies, causing development of pink/purple lines. When there are no HIV antibodies, there are no pink/purple lines in the test area. The sample continues to migrate through the membrane and a pink/purple line develops in the control (C) area, which contains Protein A. This built-in procedural control provides evidence that the test was performed properly and that the sample and reagents have migrated through the cassette.(Package insert: Geenius HIV 1/2 Supplemental Assay; Bio-Rad Laboratories; 07/2019)

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.

Monday through Friday

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 3 days

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

14 days

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

Rochester

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 Regional Manager. 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 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
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.

86689

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
HIV2L HIV-2 Ab Confirmation, S 81641-3
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.
61785 HIV-2 Ab Confirmation, S 81641-3

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.

Normal Reports | Abnormal Reports

SI Sample Reports
International System (SI) of Unit reports are provided for a limited number of tests. These reports are intended for international account use and are only available through MayoLINK accounts that have been defined to receive them.

SI Normal Reports | SI Abnormal Reports