Test Catalog

Test Id : HIVDX

HIV-1 and HIV-2 Antigen and Antibody Diagnostic Evaluation, Plasma

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

Diagnosing HIV-1 and/or HIV-2 infection in symptomatic patients more than 2 years old

 

Follow-up testing of individuals with reactive rapid HIV test results

 

This test is not offered as a screening or confirmatory test for blood donor specimens.

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
HVDIP HIV Ab Confirm / Differentiation, P Yes No
HIVQN HIV-1 RNA Detect/Quant, P Yes No

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

This test begins with HIV-1/-2 antigen and antibody screen by chemiluminescence immunoassay. If the screen result is reactive, then HIV-1/-2 antibody confirmation/differentiation test by immunochromatographic method is performed at an additional charge.

 

If HIV-1/-2 antibody confirmation/differentiation is negative for both HIV-1 antibody and HIV-2 antibody, or indeterminate/negative for HIV-1/HIV-2 antibody, or indeterminate/indeterminate for HIV-1/ HIV-2 antibody, then HIV-1 RNA detection and quantification is performed at an additional charge.

 

The following algorithms are available in Special Instructions:

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

-Meningitis/Encephalitis Panel Algorithm

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

Chemiluminescent Microparticle Immunoassay

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-1/-2 Ag and Ab Diagnostic, P

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

Acquired Immune Deficiency Syndrome (AIDS)

Anti-HIV

Anti-HIV-1/-2

HIV Types 1 and 2 Antibodies

HIV-1/-2

HIV-1/-2 Ab

HIV-1/-2 Ag/Ab

HIV-1/-2 Antibodies

HIV-1/-2 Antigen

HIV combo

Human Immunodeficiency Virus (HIV)

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

This test begins with HIV-1/-2 antigen and antibody screen by chemiluminescence immunoassay. If the screen result is reactive, then HIV-1/-2 antibody confirmation/differentiation test by immunochromatographic method is performed at an additional charge.

 

If HIV-1/-2 antibody confirmation/differentiation is negative for both HIV-1 antibody and HIV-2 antibody, or indeterminate/negative for HIV-1/HIV-2 antibody, or indeterminate/indeterminate for HIV-1/ HIV-2 antibody, then HIV-1 RNA detection and quantification is performed at an additional charge.

 

The following algorithms are available in Special Instructions:

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

-Meningitis/Encephalitis Panel Algorithm

Specimen Type
Describes the specimen type validated for testing

Plasma

Ordering Guidance

If specimen is from either autopsy or cadaver blood sources, the proper FDA-licensed assay is HV1CD / HIV-1 and HIV-2 Antibodies for Cadaveric or Hemolyzed Specimens, 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 old). Diagnosis of HIV infection in newborns and infants up to 2 years old should be made by virologic tests, such as detection of HIV-1 DNA and RNA (HIVP / HIV-1 DNA and RNA Qualitative Detection by PCR, Plasma) or HIV-1 RNA (HIVQN / HIV-1 RNA Detection and Quantification, Plasma).

 

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.

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

Collection Container/Tube: Lavender top (EDTA)

Submission Container/Tube: Plastic vial

Specimen Volume: 4 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 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

1.2 mL

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

Gross hemolysis Reject
Gross lipemia Reject
Gross icterus Reject

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 Refrigerated (preferred) 6 days
Frozen 30 days

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

Diagnosing HIV-1 and/or HIV-2 infection in symptomatic patients more than 2 years old

 

Follow-up testing of individuals with reactive rapid HIV test results

 

This test is not offered as a screening or confirmatory test for blood donor specimens.

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

This test begins with HIV-1/-2 antigen and antibody screen by chemiluminescence immunoassay. If the screen result is reactive, then HIV-1/-2 antibody confirmation/differentiation test by immunochromatographic method is performed at an additional charge.

 

If HIV-1/-2 antibody confirmation/differentiation is negative for both HIV-1 antibody and HIV-2 antibody, or indeterminate/negative for HIV-1/HIV-2 antibody, or indeterminate/indeterminate for HIV-1/ HIV-2 antibody, then HIV-1 RNA detection and quantification is performed at an additional charge.

 

The following algorithms are available in Special Instructions:

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

-Meningitis/Encephalitis Panel Algorithm

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, AIDS-related complex, and 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 FDA-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.

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 HIV-1/-2 antigen and antibody screening test results usually indicate the absence of HIV-1 and HIV-2 infection. However, such negative results do not rule-out acute HIV infection. If acute HIV-1 infection is suspected, detection of HIV-1 RNA (HIVQN / HIV-1 RNA Detection and Quantification, Plasma) or HIV-1 DNA and RNA (HIVP / HIV-1 DNA and RNA Qualitative Detection by PCR, Plasma) is recommended.

 

Reactive HIV-1/-2 antigen and antibody screening test results suggest the presence of HIV-1 and/or HIV-2 infection, but it is not diagnostic for HIV infection and should be considered preliminary. A reactive result does not differentiate among reactivity with HIV-1 p24 antigen, HIV-1 antibody, and HIV-2 antibody. Diagnosis of HIV infection must be based on results of supplemental tests, such as HIV antibody confirmation/differentiation test (automatically reflexed on all samples with reactive screen test results at an additional charge).

 

All initially positive supplemental or confirmatory HIV test results (by serologic or molecular test methods) should be verified by submitting a second plasma 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.

 

See HIV Testing Algorithm (Fourth-Generation Screening Assay), Including Follow-up of Reactive Rapid Serologic Test Results in Special Instructions.

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

Reactive result of this assay does not differentiate among reactivity with HIV-1 p24 antigen, HIV-1 antibody, and HIV-2 antibody.

 

A reactive screening test result is not diagnostic for HIV infection and should be considered preliminary.

 

The positive predictive value of a reactive screening test result is highly dependent on the prevalence of HIV infection in the population tested. The lower the prevalence of HIV infection, the lower the positive predictive value and higher the false-positive rate of the test. Diagnosis of HIV infection must be based on positive results of the supplemental or confirmatory serologic or molecular tests.

 

Recipients of experimental HIV-1 vaccines may have false-reactive HIV antibody test results due to the presence of vaccine-induced, HIV-1-specific antibodies without actual HIV infection.

 

Negative serologic or molecular HIV screening test results should be evaluated with caution in patients with clinical symptoms and/or a history of high-risk behavior for HIV infection. Repeat testing in 1 to 2 months is recommended in these at-risk individuals.

 

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

-Grossly hemolyzed (hemoglobin level of >500 mg/dL)

-Grossly lipemic (triolein level of >1250 mg/dL)

-Grossly icteric (total bilirubin level of >20 mg/dL)

-Heat-inactivated specimens

-Cadaveric specimens

-Presence of particulate matter

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

1. Bennett B, Branson B, Delaney K, et al: HIV testing algorithms: a status report. A publication from the Association of Public Health Laboratories and the Centers for Disease Control and Prevention. APHL; April 2009. Accessed June 15, 2020. Available at https://stacks.cdc.gov/view/cdc/5696/cdc_5696_DS1.pdf

2. Chavez P, Wesolowski L, Patel P, Delaney K, Owen SM: Evaluation of the performance of the Abbott ARCHITECT HIV Ag/Ab Combo assay. J Clin Virol. 2011 Dec;52(Suppl 1):S51-S55. doi: 10.1016/j.jcv.2011.09.010

3. 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 May 3, 2021. Available at http://stacks.cdc.gov/view/cdc/23447

4. Centers for Disease Control and Prevention: 2018 Quick reference guide: Recommended laboratory HIV testing algorithm for serum or plasma specimens. CDC; January 2018. Accessed May 3, 2021. Available at https://stacks.cdc.gov/view/cdc/50872

5. Centers for Disease Control and Prevention. Technical update: Use of the Determine HIV 1/2 Ag/Ab combo test with serum or plasma in the laboratory algorithm for HIV diagnosis. CDC; October 4, 2017. Accessed May 3, 2021. Available at https://stacks.cdc.gov/view/cdc/48472

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 Abbott Architect HIV Ag/Ab Combo assay for use on the Architect i System is a 2-step immunoassay to determine the presence of HIV-1 p24 antigen, antibodies to HIV-1 (groups M and O), and antibodies to HIV-2 in human serum or plasma using chemiluminescent microparticle immunoassay technology. First, patient's specimen, Architect i wash buffer, assay diluent, and paramagnetic microparticles are combined in a single reaction well. HIV-1 p24 antigen and HIV-1/HIV-2 antibodies present in the patient's specimen bind to the HIV-1 antigen-, HIV-2 antigen-, and HIV-1 p24 monoclonal (mouse) antibody-coated microparticles. After washing, the bound HIV-1 p24 antigen and HIV-1/HIV-2 antibodies bind to the acridinium-labeled conjugates. Following another wash cycle, pretrigger and trigger solutions are added to the reaction mixture. The resulting chemiluminescent reaction is measured as relative light units (RLU). The amount of HIV antigen and antibodies present in the patient's specimen is directly proportionate to the RLU detected by the Architect i System optics. The presence or absence of HIV-1 p24 antigen or HIV-1/HIV-2 antibodies in the specimen is determined by comparing the chemiluminescent signal in the reaction to the cutoff signal determined periodically by assay calibration. Patients' specimens with signal-to-cutoff (S/CO) values greater than or equal to 1.00 are considered reactive for HIV-1 p24 antigen or HIV-1/HIV-2 antibodies. Specimens with S/CO values under 1.00 are considered nonreactive or negative.(Package insert: HIV Ag/Ab Combo. Abbott Laboratories; 10/2017)

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 Saturday

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 2 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.

87389

LOINC® Information

Test Id Test Order Name Order LOINC Value
HIVDX HIV-1/-2 Ag and Ab Diagnostic, P 56888-1
Result Id Test Result Name Result LOINC Value
Result LOINC Value Tooltip
HIVC4 HIV-1/-2 Ag and Ab Diagnostic, P 56888-1

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