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Test Id : HIVDI

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HIV-1 and HIV-2 Antibody Confirmation and Differentiation, Serum

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

Confirmation and differentiation of HIV-1 and HIV-2 antibodies in serum specimens that show reactive results with third-(HIV-1/-2 antibody only) and 4th-generation (HIV antigen and antibody) HIV serologic assays

 

Confirmation and differentiation of HIV-1 and HIV-2 antibodies in cadaveric blood or hemolyzed serum specimens that show reactive results with initial HIV serologic screening assays

 

This test is not useful as a screening test for HIV infection in symptomatic or asymptomatic individuals. It is not to be used as a screening or confirmatory test for blood donor specimens.

 

This test is not useful for maternal or newborn HIV screening for specimens originating in New York State.

Reflex Tests
Lists tests that may or may not be performed, at an additional charge, depending on the result and interpretation of the initial tests.

Test Id Reporting Name Available Separately Always Performed
HIS12 HIV-1/HIV-2 RNA Detect, S Yes No

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

This HIV-1 and HIV-2 antibody (Ab) confirmation and differentiation test begins with Geenius HIV-1/2 supplemental assay.

 

This test is for confirmation and differentiation of HIV-1/2 antibodies. If the following result types are obtained, HIV-1/HIV-1 RNA detection will be performed at an additional charge:

-Negative for both HIV-1 Ab and HIV-2 Ab

-Indeterminate for HIV-1 Ab but negative for HIV-2 Ab

-Negative for HIV-1 Ab but indeterminate for HIV-2 Ab

-Indeterminate for both HIV-1 Ab and HIV-2 Ab

-Positive for both HIV-1 Ab and HIV-2 Ab

 

For more information see HIV Testing Algorithm (Fourth Generation Screening Assay), Including Follow-up of Reactive Rapid Serologic Test Results.

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 Ab Confirm / Differentiation, S

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

Acquired Immune Deficiency Syndrome (AIDS)

Anti-HIV

Anti-HIV-1/-2

Anti-HIV-1/-2 Differentiation

HIV Types 1 and 2 Antibodies

HIV-1/-2

HIV-1/-2 Ab

HIV-1/-2 Antibodies

HIV-1/-2 Antibody Differentiation

HIV Antibody Differentiation

Human Immunodeficiency Virus (HIV)

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

This HIV-1 and HIV-2 antibody (Ab) confirmation and differentiation test begins with Geenius HIV-1/2 supplemental assay.

 

This test is for confirmation and differentiation of HIV-1/2 antibodies. If the following result types are obtained, HIV-1/HIV-1 RNA detection will be performed at an additional charge:

-Negative for both HIV-1 Ab and HIV-2 Ab

-Indeterminate for HIV-1 Ab but negative for HIV-2 Ab

-Negative for HIV-1 Ab but indeterminate for HIV-2 Ab

-Indeterminate for both HIV-1 Ab and HIV-2 Ab

-Positive for both HIV-1 Ab and HIV-2 Ab

 

For more information see HIV Testing Algorithm (Fourth Generation Screening Assay), Including Follow-up of Reactive Rapid Serologic Test Results.

Specimen Type
Describes the specimen type validated for testing

Serum

Ordering Guidance

If testing is needed for autopsy or cadaver blood sourced specimens, order the US Food and Drug Administration-licensed assay: HV1CD / HIV-1 and HIV-2 Antibodies for Cadaveric or Hemolyzed Specimens, Serum.

 

This test should not be used to test or screen pregnant individuals. For testing such patients, order HVPPS / HIV-1 and HIV-2 Antibody Confirmation and Differentiation Prenatal, Serum.

 

Screening, supplemental, or confirmatory serologic tests for HIV-1 or HIV-2 antibodies cannot distinguish between active neonatal HIV infection and passive transfer of maternal HIV antibodies in infants during the postnatal period (up to 2 years). Diagnosis of HIV infection in newborns and infants up to 2 years old should be made by virologic tests, such as detection of HIV RNA (HIP12 / HIV-1/HIV-2 RNA Detection, Plasma or HIS12 / HIV-1/HIV-2 RNA Detection, Serum).

 

This test is not useful for follow-up testing of patients with reactive results from any rapid HIV tests. Per the latest Centers for Disease Control and Prevention recommended HIV testing algorithm, these patients should be tested subsequently with laboratory-based HIV antigen and antibody combination immunoassays, such as HIVDX / HIV-1 and HIV-2 Antigen and Antibody Diagnostic Evaluation, Plasma or HIVDS / HIV-1 and HIV-2 Antigen and Antibody Diagnostic Evaluation, Serum.

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: Serum gel

Submission Container/Tube: Plastic vial

Specimen Volume: 1.5 mL

Collection Instructions:

1. Centrifuge blood collection tube per manufacturer's instructions (eg, centrifuge 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

Forms

If not ordering electronically, complete, print, and send an Infectious Disease Serology Test Request (T916) with the specimen.

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.

0.8 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 6 days

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

Confirmation and differentiation of HIV-1 and HIV-2 antibodies in serum specimens that show reactive results with third-(HIV-1/-2 antibody only) and 4th-generation (HIV antigen and antibody) HIV serologic assays

 

Confirmation and differentiation of HIV-1 and HIV-2 antibodies in cadaveric blood or hemolyzed serum specimens that show reactive results with initial HIV serologic screening assays

 

This test is not useful as a screening test for HIV infection in symptomatic or asymptomatic individuals. It is not to be used as a screening or confirmatory test for blood donor specimens.

 

This test is not useful for maternal or newborn HIV screening for specimens originating in New York State.

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

This HIV-1 and HIV-2 antibody (Ab) confirmation and differentiation test begins with Geenius HIV-1/2 supplemental assay.

 

This test is for confirmation and differentiation of HIV-1/2 antibodies. If the following result types are obtained, HIV-1/HIV-1 RNA detection will be performed at an additional charge:

-Negative for both HIV-1 Ab and HIV-2 Ab

-Indeterminate for HIV-1 Ab but negative for HIV-2 Ab

-Negative for HIV-1 Ab but indeterminate for HIV-2 Ab

-Indeterminate for both HIV-1 Ab and HIV-2 Ab

-Positive for both HIV-1 Ab and HIV-2 Ab

 

For more information see HIV Testing Algorithm (Fourth Generation Screening Assay), Including Follow-up of Reactive Rapid Serologic Test Results.

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

AIDS is caused by 2 known types of HIV. HIV type 1 (HIV-1) is found in patients with AIDS or AIDS-related complex and in asymptomatic infected individuals at high risk for AIDS. The virus is transmitted by sexual contact, by exposure to infected blood or blood products, or from an infected mother to her fetus or infant. HIV type 2 (HIV-2) infection is endemic only in West Africa, and it has been identified in individuals who had sexual relations with individuals from that geographic region. HIV-2 is similar to HIV-1 in viral morphology, overall genomic structure, and its ability to cause AIDS.

 

Antibodies against HIV-1 and HIV-2 are usually not detectable until 6 to 12 weeks following exposure and are almost always detectable by 12 months. They may fall to undetectable levels (ie, seroreversion) in the terminal stage of AIDS when the patient's immune system is severely depressed.

 

Routine serologic screening of patients at risk for HIV-1 or HIV-2 infection usually begins with a HIV-1/-2 antigen and/or antibody screening test, which may be performed by various US Food and Drug Administration-approved assay methods, including rapid HIV antibody tests, enzyme immunoassays, and chemiluminescent immunoassays. In testing algorithms that begin with these methods, supplemental or confirmatory testing should be requested only for specimens that are repeatedly reactive by these methods according to assay manufacturers' instructions for use.

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 both HIV-1 and HIV-2 antibodies usually indicate the absence of HIV-1 and HIV-2 infection. However, negative results do not rule-out acute or early HIV infection in patients with reactive initial combined HIV-1/-2 antigen and antibody test results. HIS12 / HIV-1/HIV-2 RNA Detection, Serum will be performed automatically per testing algorithm.

 

Positive HIV-1 antibody but negative HIV-2 antibody results indicate the presence of HIV-1 infection. Together with reactive initial combined HIV-1/-2 antigen and antibody test results, individuals with these results are presumed to have HIV-1 infection. Verification of a first-time positive test result is recommended for the diagnosis of HIV-1 infection. Additional testing with a newly submitted plasma specimen for HIVQN / HIV-1 RNA Detection and Quantification, Plasma. HIV-1 RNA quantification in plasma is recommended to determine the baseline HIV-1 viral load prior to initiating antiretroviral treatment.

 

Positive HIV-1 antibody but indeterminate HIV-2 antibody results indicate the presence of HIV-1 infection with probable cross-reactivity of HIV-1 antibodies with HIV-2 antigens on the assay strip. Verification of a first-time positive test result is recommended for the diagnosis of HIV-1 infection by submitting a plasma specimen for HIV-1 RNA quantification (HIVQN).

 

Indeterminate HIV-1 antibody but negative HIV-2 antibody results suggest either very early HIV-1 infection (in individuals with risk factors) or the presence of nonspecific cross-reactivity between the patient serum specimen and HIV-1 antigens on the assay strip. HIS12 will be performed automatically per testing algorithm.

 

Negative HIV-1 antibody but indeterminate HIV-2 antibody results may be due to acute HIV-1 infection, very early HIV-2 infection (in individuals with risk factors), or the presence of nonspecific cross-reactivity between the patient serum specimen and HIV-2 antigens on the assay strip. HIS12 will be performed automatically per testing algorithm.

 

Positive results for both HIV-1 and HIV-2 antibodies suggest the probable presence of HIV-1 and HIV-2 coinfection. However, such results may rarely be due to either HIV-1 infection with HIV-2 antibody cross-reactivity or HIV-2 infection with HIV-1 antibody cross-reactivity (eg, absence of HIV-1 p24 and p31 bands). Verification of a first-time positive test result is recommended for the diagnosis of HIV infection. HIS12 will be performed automatically per testing algorithm.

 

Indeterminate results for both HIV-1 and HIV-2 antibodies indicate either very early HIV infection (in individuals with risk factors) or the presence of nonspecific cross-reactivity between the patients' specimens and HIV antigens on the assay strip. Nonspecific cross-reactivity may be due to recent non-HIV infections, hypergammaglobulinemic states, connective tissue disorders, or pregnancy (alloantibodies). HIS12 will be performed automatically per testing algorithm.

 

Negative HIV-1 antibody but positive HIV-2 antibody results indicate the presence of HIV-2 infection. Together with a reactive initial HIV-1/-2 antigen and antibody screening test results, individuals with such results are presumed to have HIV-2 infection. Verification of a first-time positive test result is recommended for the diagnosis of HIV-2 infection by submitting a new whole blood specimen for FHV2Q / HIV-2 DNA/RNA Qualitative Real-Time PCR.

 

Reactive HIV-1 antibody but positive HIV-2 antibody results usually indicate the presence of HIV-2 infection with HIV-1 antibody cross-reactivity (eg, presence of only HIV-1 gp41 and/or gp160 band). However, such results may rarely be due to HIV-1 and HIV-2 coinfection. Verification of a first-time positive test result is recommended for the diagnosis of HIV-2 infection by submitting a new whole blood specimen for FHV2Q.

 

Indeterminate HIV-1 antibody but positive HIV-2 antibody results indicate the presence of HIV-2 infection with probable cross-reactivity of HIV-2 antibodies with HIV-1 antigens on the assay strip. Verification of a first-time positive test result is recommended for the diagnosis of HIV-2 infection by submitting a new whole blood specimen for FHV2Q.

 

For more information see HIV Testing Algorithm (Fourth Generation Screening Assay), Including Follow-up of Reactive Rapid Serologic Test Results

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

A negative result for both HIV-1 and HIV-2 antibodies does not rule-out acute HIV infection.

 

All initially positive supplemental or confirmatory HIV test results should be verified by submitting a second specimen for repeat testing. Such positive HIV test results are required under laws in many states in the United States to be reported to the departments of health of the respective states where the patients reside.

 

Recipients of HIV-1 vaccine (eg, participants in HIV-1 vaccine study trials) may develop vaccine-specific antibodies that may cross-react with this test and yield to a positive, indeterminate, or unreadable HIV-1 antibody result. However, the patient may or may not be infected with HIV-1.

 

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. 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 May 12, 2023. Available at https://stacks.cdc.gov/view/cdc/23447

2. 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;58(Suppl 1):e85-e91

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

4. 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;61(1):166-169

5. 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

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 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 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 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.

86701

86702

87535 (if appropriate)

87538 (if appropriate)

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
HIVDI HIV Ab Confirm / Differentiation, S 89365-1
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.
36112 HIV-1 Ab Differentiation, S 68961-2
36113 HIV-2 Ab Differentiation, 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

Test Update Resources

Change Type Effective Date
New Test 2023-05-09