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Test Code HIVSS HIV-1 and HIV-2 Antigen and Antibody Routine Screen, Serum


Ordering Guidance


If the specimen is obtained from either autopsy or cadaver blood sources, order HV1CD / HIV-1 and HIV-2 Antibodies for Cadaveric or Hemolyzed Specimens, Serum which is the US Food and Drug Administration-approved assay for these specimen types.

 

This test should not be used to test symptomatic individuals (ie, diagnostic purposes). For testing such patients, order HIVDS / HIV-1 and HIV-2 Antigen and Antibody Diagnostic Evaluation, Serum.

 

This test should not be used to test pregnant individuals. For testing such patients, order HVPRS / HIV Antigen and Antibody Prenatal Routine Screen, 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 children up to 2 years. Diagnosis of HIV infection in newborns and children up to 2 years should be made by virologic tests, such as detection of HIV RNA (HIS12 / HIV-1/HIV-2 RNA Detection, Serum).

 

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


Supplies: Sarstedt Aliquot Tube 5 mL (T914)

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 and aliquot within 2 hours of collection for BD Vacutainer tubes).

2. Aliquot serum into a plastic vial.


Forms

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

Useful For

Screening for HIV-1 and HIV-2 infection in nonsymptomatic, nonpregnant individuals older than 2 years

 

This test should not be used as a screening or confirmatory test for blood donor specimens.

Disease States

  • HIV-2 infection
  • HIV infection

Reflex Tests

Test ID Reporting Name Available Separately Always Performed
HIVDI HIV Ab Confirm / Differentiation, S Yes No
HIS12 HIV-1/HIV-2 RNA Detect, S Yes No

Method Name

Electrochemiluminescence Immunoassay (ECLIA)

Reporting Name

HIV-1/-2 Ag and Ab Screen, S

Specimen Type

Serum SST

Specimen Minimum Volume

1 mL

Specimen Stability Information

Specimen Type Temperature Time Special Container
Serum SST Frozen (preferred) 30 days
  Refrigerated  6 days

Reject Due To

Gross hemolysis Reject
Gross lipemia Reject
Gross icterus Reject
Heat-inactivated specimen Reject

Clinical Information

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, but HIV p24 antigen should be detectable and yield reactive results with the HIV antigen-antibody combination detection assays.

 

Routine serologic screening of patients at risk for HIV-1 or HIV-2 infection usually begins with an 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.

Reference Values

Negative

Day(s) Performed

Monday through Saturday

Report Available

1 to 3 days

Performing Laboratory

Mayo Clinic Laboratories in Rochester

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

87389

G0475 (if appropriate)

86701 (if appropriate)

86702 (if appropriate)

87535 (if appropriate)

87538 (if appropriate)