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Test Code HV1CM HIV-1 and HIV-2 Antibody Screen for Hemolyzed Specimens, Serum

Reporting Name

HIV-1/-2 Ab Screen Hemolyzed, S

Useful For

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.

Reflex Tests

Test ID Reporting Name Available Separately Always Performed
HIVDI HIV Ab Confirm / Differentiation, S No No

Testing Algorithm

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.

Performing Laboratory

Mayo Clinic Laboratories in Rochester

Specimen Type

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


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.


Specimen Minimum Volume

0.2 mL

Specimen Stability Information

Specimen Type Temperature Time Special Container
Serum Frozen (preferred) 30 days
  Ambient  7 days
  Refrigerated  7 days

Reference Values

Negative

Day(s) Performed

Tuesday, Friday

Test Classification

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

86703

G0432

86701 (if appropriate)

86702 (if appropriate)

LOINC Code Information

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
60357 HIV-1/-2 Ab Screen Hemolyzed, S 31201-7

Interpretation

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.

Clinical Reference

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

Report Available

1 to 7 days

Method Name

Enzyme Immunoassay (EIA)-Screening Procedure

Forms

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