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

Useful For

Diagnosis of HIV-1 and/or HIV-2 infection in cadaveric or hemolyzed serum specimens from asymptomatic patients with or without risk factors for HIV infection (assay kit is FDA-approved for testing cadaveric or hemolyzed blood specimens)

Reflex Tests

Test ID Reporting Name Available Separately Always Performed
HIVDI HIV Ab Confirm / Differentiation, S Yes No
HIV2L HIV-2 Ab Confirmation, S Yes No

Testing Algorithm

This test begins with HIV-1/-2 antibody EIA. If HIV-1/-2 antibody EIA is reactive, then HIV-1/-2 antibody differentiation is performed at an additional charge. HIV-1 and HIV-2 antibody differentiation test begins with the Bio-Rad Multispot HIV-1/HIV-2 Rapid Test, with the following reflex testing. In specimens with indeterminate HIV-1 antibody but negative HIV-2 antibody results, HIV-1 antibody confirmation by Western blot is performed at an additional charge. In specimens with reactive or unreadable results for both HIV-1 and HIV-2 antibodies, HIV-1 antibody confirmation by Western blot and HIV-2 antibody confirmation are performed at additional charges. In specimens with negative HIV-1 antibody but reactive HIV-2 antibody results, HIV-2 antibody confirmation is performed at an additional charge.

 

This is the appropriate test for testing asymptomatic individuals.

 

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

 

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

Method Name

Enzyme Immunoassay (EIA)-Screening Procedure

Reporting Name

HIV-1/-2 Ab Screen Hemolyzed, S

Specimen Type

Serum

Collection Container/Tube: 

Preferred: Serum gel

Acceptable: Red top    

Submission Container/Tube: Plastic vial

Specimen Volume: 1.5 mL

Collection Instructions: Spin down and remove serum from clot within 24 hours.

Additional Information:

1. If the initial EIA 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 Mayo Medical Laboratories at 800-533-1710 or 507-266-5700 to add supplemental testing for HIV-1/-2 antibody differentiation by membrane immunoconcentration (HIVDI).
2. The HV1WB / HIV-1 Antibody Confirmation by Western Blot, Serum test has not been FDA-approved for testing on cadaveric specimens; if performed, testing will be resulted with a disclaimer.

Specimen Minimum Volume

1 mL

Specimen Stability Information

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

Clinical Information

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, AIDS-related complex, and 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. They may fall into undetectable levels in the terminal stage of AIDS.

 

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

Reference Values

Negative

 

See HIV Serologic Interpretive Guide in Special Instructions for further interpretive information.

 

Cautions

Reflex tests have not been FDA-approved for testing on cadaveric specimens.

 

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

 

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

 

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.

 

Negative results should be evaluated cautiously if the patient has clinical symptoms and/or a history of high-risk behavior for HIV infection. The CDC recommends confirmatory testing by Western blot 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 18 months of age). Reactive and confirmed positive antibody test results in infants during this period may indicate passive transfer of maternal HIV antibodies.

 

A reactive screen and confirmed HIV antibody test result should be reported by the health care 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

Day(s) Performed

Monday, Wednesday, Friday; Varies

Report Available

2 days

Performing Laboratory

Mayo Medical Laboratories in Rochester

Test Classification

This test has been cleared or approved by the U.S. 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-HIV-1/-2 antibody hemolyzed screen (if appropriate)

86689-HIV-1 confirmation by Western blot (if appropriate)

86689-HIV-2 line immunoassay (if appropriate)

86701-HIV-1 antibody differentiation (if appropriate)

86702-HIV-2 antibody differentiation (if appropriate)

NY State Approved

Yes