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Test Code HIVABAG HIV-1/HIV-2 Antibodies and P24 Antigen Screen with Reflex Confirmation

Important Note

This test is not intended for use in patients less than 2 years of age. For patients less than 2 years of age order HIV-1/HIV-2 RNA Detection, Plasma - Fairbanks Memorial Hospital.

Additional Codes

Cerner

NextGen

HIV-1/HIV-2 ABs and P24 Ag Screen w/Reflex

HIV-1/HIV-2 ABs and P24 Ag Screen w/Reflex

Alternate Name(s)

Human Immunodeficiency Virus (HIV)

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

HIV Rapid

HIV Screen

Methodology

Vitros Immunometric

Patient Preparation

None

Collection Instructions

  • Standard phlebotomy practices.
  • Spin down and remove from cells within 2 hours of collection.

Specimen Requirements

Container

12 x 75 mm tube EDTA-2K or EDTA-3K Lavender

 or 

Stability

Storage

Temperature

Stability

Room Temperature

18-28°C

≤ 24 hours

Refrigerated

 2-8°C

≤ 1 week

Frozen

≤-20 °C

No more than 5 freeze-thaw cycles

Rejection Criteria

Gross Hemolysis

Turbid Specimens

Result Reporting and Reference Values

  • Negative for HIV-1 antigen and HIV-1/HIV-2 antibodies. Negative result does not rule out HIV infection. If acute HIV infection is suspected, consider testing for HIV-1/HIV-2 RNA”.
  • Reactive results:
    • Considered a critical result.
    • Result is not diagnostic (considered preliminary) and diagnosis of HIV infection must be based on supplemental test results. Supplemental HIV antibody differentiation test has been ordered.

Reflex Testing

HIV-1 and HIV-2 Antibody Confirmation and Differentiation, Plasma - Fairbanks Memorial Hospital will be performed on Reactive results.

Limitations

  • This test is not intended for use in patients less than two years of age.
  • Results obtained with this test may not be used interchangeably with different manufacturers’ test methods.
  • Heterophilic antibodies in the sample may cause interference in immunoassays. See IFU for more information.
  • A negative test does not exclude the possibility of exposure or infection with HIV. HIV antibodies and/or P24 antigen may be undetectable in some stages of the infection and in some clinical conditions.

Useful For

Acquired Immunodeficiency Syndrome (AIDS) is caused by two types of human immunodeficiency viruses designated HIV-1 and HIV-2. The VITROS HIV Combo test is a fourth generation HIV test that uses 3 recombinant antigens derived from HIV-1 envelope (env13), HIV-1 group O envelope (env70-3) and HIV-2 envelope (env31). These antigens detect antibodies to HIV-1 and antibodies to HIV-2 in the same test. The use of these recombinant antigens improves test specificity by avoiding non-specific reactions due to cross-reaction with human cell proteins which are present in cell lysates. The VITROS HIV Combo test also uses antibodies to HIV p24 antigen to enable detection of HIV p24 antigen that may be present prior to the onset of antibody response enabling earlier diagnosis of HIV-1 infection.