Test Catalog

Test Id : HV1CM

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HIV-1 and HIV-2 Antibody Screen for Hemolyzed Specimens, Serum

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Overview

Test Catalog

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

Screening cadaveric or hemolyzed serum specimens for HIV-1 and/or HIV-2 infection in nonsymptomatic patients with or without risk factors for HIV infection

 

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

Highlights

Indicated for testing non-symptomatic individuals (screening purposes) with or without risk factors for HIV infection.

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
HIVDI HIV Ab Confirm / Differentiation, S No No
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 test begins with HIV-1/-2 antibody enzyme immunoassay (EIA). If HIV-1/-2 antibody EIA is reactive, then HIV antibody confirmation/differentiation by immunochromatographic method is performed at an additional charge.

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

Enzyme Immunoassay (EIA)-Screening Procedure

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 Ab Screen Hemolyzed, S

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

Acquired Immune Deficiency Syndrome (AIDS)

AIDS (Acquired Immune Deficiency Syndrome)

Anti-HIV

Anti-HTLV III

HIV (Human Immunodeficiency Virus)

Human Immunodeficiency Virus (HIV)

HV1CM

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 antibody enzyme immunoassay (EIA). If HIV-1/-2 antibody EIA is reactive, then HIV antibody confirmation/differentiation by immunochromatographic method is performed at an additional charge.

Specimen Type
Describes the specimen type validated for testing

Serum

Ordering Guidance

1. This test is not intended for testing symptomatic individuals (ie, diagnostic purposes). For testing hemolyzed specimens from such patients with or without risk factors for HIV infection, order HV1CD / HIV-1 and HIV-2 Antibodies for Cadaveric or Hemolyzed Specimens, Serum.

2. 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.

Additional Testing Requirements

If the initial enzyme immunoassay result is negative and this test was ordered as a follow-up evaluation of a specimen with a reactive rapid HIV antibody test result, clients must call 800-533-1710 or 507-266-5700 to request supplemental testing for HIV antibody confirmation/differentiation by immunochromatography (HIVDI). The HIVDI / HIV-1 and HIV-2 Antibody Confirmation and Differentiation, Serum test is not US Food and Drug Administration approved for testing cadaveric specimens. If performed, test results will be reported with a disclaimer.

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: 1.5 mL

Collection Instructions:

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

2. Aliquot serum into plastic vial.

Forms

If not ordering electronically, complete, print, and send 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

0.2 mL

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

Gross hemolysis OK
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
Serum Frozen (preferred) 30 days
Ambient 7 days
Refrigerated 7 days

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

Screening cadaveric or hemolyzed serum specimens for HIV-1 and/or HIV-2 infection in nonsymptomatic patients with or without risk factors for HIV infection

 

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 antibody enzyme immunoassay (EIA). If HIV-1/-2 antibody EIA is reactive, then HIV antibody confirmation/differentiation by immunochromatographic method is performed at an additional charge.

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

Epidemiological data indicate that AIDS is caused by at least 2 types of HIV. The first virus, HIV-1, has been isolated from patients with AIDS or AIDS-related complex and from asymptomatic infected individuals at high risk for AIDS. HIV-1 is transmitted by sexual contact, exposure to infected blood or blood products, or from an infected mother to her fetus or infant. A second HIV virus, HIV-2, was isolated from patients in West Africa in 1986. HIV-2 appears to be endemic only in West Africa, but it 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 its morphology, overall genomic structure, and its ability to cause AIDS.

 

Antibodies against HIV-1 and HIV-2 are usually not detected until 6 to 12 weeks following exposure and are almost always detected by 12 months. Antibodies may fall into undetectable levels in the terminal stage of AIDS.

 

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

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

A reactive HIV-1/-2 antibody screen result obtained by enzyme immunoassay (EIA) suggests the presence of HIV-1 and/or HIV-2 infection. However, it does not differentiate between HIV-1 and HIV-2 antibody reactivity. 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 presumptive antibody-positive test results should be verified by submitting a second serum specimen for retesting.

 

A negative HIV-1/-2 antibody EIA screen result usually indicates the absence of HIV-1 or HIV-2 infection. However, for specimens reactive by the rapid HIV antibody tests, confirmatory testing is recommended, even if the EIA results are negative.

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

The predictive value of a reactive (or positive) test 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 of the test.

 

A person who has participated in an HIV vaccine study may develop antibodies to the vaccine and may or may not be infected with HIV. Clinical correlation is indicated with appropriate counseling, medical evaluation, and, possibly, additional testing to decide whether a diagnosis of HIV infection is accurate.

 

Negative results should be evaluated cautiously if the patient has clinical symptoms and/or a history of high-risk behavior for HIV infection. The Centers for Disease Control and Prevention recommends confirmatory testing on serum specimens that are reactive by the rapid HIV antibody tests, even if the initial EIA results are negative.

 

Screening and confirmatory tests for HIV-1/-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 of age). Reactive and confirmed positive antibody test results in infants during this period may indicate passive transfer of maternal HIV antibodies. Diagnosis of HIV infection in newborns and infants up to 2 years should be made by virologic tests, such as detection of HIV-1 DNA or RNA (HIVP / HIV-1 DNA and RNA Qualitative Detection by PCR, Plasma) or HIV-1 RNA (HIVQN / HIV-1 RNA Detection and Quantification, Plasma).

 

A reactive screen and confirmed HIV antibody test result should be reported by the healthcare provider to the State Department of Health in accordance with the legislation in some states.

 

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

-Lipemic

-Icteric

-Containing particulate matter

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

1. Constantine N: HIV antibody assays. In: HIV InSite Knowledge Base. Regents of the University of California; May 2006. Available at http://hivinsite.ucsf.edu/InSite?page=kb-00&doc=kb-02-02-01

2. Centers for Disease Control and Prevention (CDC), Association of Public Health Laboratories: Laboratory testing for the diagnosis of HIV infection. CDC; Updated June 27, 2014. Available at: stacks.cdc.gov/view/cdc/23447

3. Centers for Disease Control and Prevention (CDC), Association of Public Health Laboratories: 2018 Quick reference guide: Recommended laboratory HIV testing algorithm for serum or plasma specimens. CDC; January 2018. Available at https://stacks.cdc.gov/view/cdc/50872

4. Hariri S, McKenna MT: Epidemiology of human immunodeficiency virus in the United States. Clin Microbiol Rev. 2007 Jul;20(3):478-4884

5. Owen SM, Yang C, Spira T, et al: Alternative algorithms for human immunodeficiency virus infection diagnosis using tests that are licensed in the United States. J Clin Microbiol. 2008 May;46(5):1588-1595

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

The Genetic Systems HIV-1/HIV-2 PLUS O enzyme immunoassay is based on the principle of direct antibody sandwich technique. Microwell-strip plates (solid-phase) are coated with purified HIV antigens: gp160 and p24 recombinant proteins derived from HIV-1, gp36 peptide representing the immunodominant region of the HIV-2 transmembrane glycoprotein, and a synthetic polypeptide mimicking an artificial (not encoded by any existing virus) HIV-1 group O-specific epitope.

 

Serum samples and assay controls are added to the antigen-coated wells of the microwell-strip plate along with specimen diluent. The specimen diluent contains a dye which changes color from purple to blue when combined with a specimen or control. The wells are incubated and then washed. The next step is the addition of a colored conjugate solution (green) which contains the peroxidase-conjugated antigens. The wells are then incubated. If HIV-1 and/or HIV-2 antibody is present, it will bind to the antigen coated on the well and to the peroxidase-conjugated antigens in the conjugate solution. The antigen-antibody-antigen complexes remain bound to the well during the subsequent wash step, which will remove any unbound materials. Working chromogen solution is added to the plate wells and allowed to incubate. A blue or blue-green color develops in proportion to the amount of HIV antibody present in the sample. Color development is stopped by the addition of acid, which changes the blue-green color to yellow. The optical absorbance of specimens and controls is determined spectrophotometrically at a wavelength of 450 nm.(Package insert: Genetics Systems HIV-1/HIV-2 PLUS O EIA. Bio-Rad Laboratories; 02/2019)

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.

Tuesday, 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 7 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.

86703

G0432

86701 (if appropriate)

86702 (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
HV1CM HIV-1/-2 Ab Screen Hemolyzed, S 31201-7
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.
60357 HIV-1/-2 Ab Screen Hemolyzed, S 31201-7

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 | PHP Pdf | CMS 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