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HIV-1 and HIV-2 Antigen and Antibodies (Fourth Generation), Reflex to Confirmation

Message

Important Note


If a secondary SST and Lavender sample are not provided, complete confirmation testing may not be performed.


Test Code
HIV4


Alias/See Also
Epic: LAB11729


Includes
This test begins with HIV-1/-2 antigen and antibody screen by chemiluminescence immunoassay. If the screen result is reactive, then HIV-1/-2 antibody differentiation (HIVD) test by immunochromatographic method is performed at an additional charge.

If the HIV-1/-2 antibody differentiation test is negative for both HIV-1 antibody and HIV-2 antibody, then HIV-1 RNA (HIV1P) and HIV-2 RNA (HIV2P) detection  is performed at an additional charge.


Preferred Specimen

Specimen Type: Serum & Whole blood EDTA
Collection Container: Serum gel AND Lavender top (EDTA)
Specimen Volume: 2x 3 mL serum AND 1x 3 mL whole blood




Minimum Volume

0.5 mL serum




Instructions
Collection Instructions
  1. Centrifuge Serm gel tubes and separate cells after clot formation and within 4 hours of collection. 
Additional Information
  1. Secondary Serum gel and lavender tubes are used for confirmation testing.  If tubes are not collected, additional conformation testing may not be performed.


Specimen Stability

Room temperature: 3 days
Refrigerated: 7 days
Frozen: >7 days




Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)

Unlabeled, mislabeled, wrong tube type, hemolyzed, QNS, exceeds specimen/stability requirements.




Methodology

Chemiluminescent microparticle immunoassay (CMIA)



Setup Schedule

Daily




Report Available

Same day / 1 day




Limitations

For diagnostic purposes, results should be used in conjunction with other data: symptoms, results of other tests, clinical impressions, etc.
Potentially interfering substances include : Hemoglobin  500 mg/dL; Bilirubin 20 mg/dL; Triglycerides  1250 mg/dL; Total Protein 12 g/dL 
Patients receiving mouse monoclonal antibodies for diagnosis or treatment may develop Human anti-mouse antibodies (HAMA).  HAMA may cause falsely elevated or decreased values when tested with assay kits which employ mouse monoclonal antibodies. Additional information may be required for diagnosis.
Heterophilic antibodies in human serum can react with reagent immunoglobulins, interfering with in vitro immunoassays.
The performance of this assay has not been established for individuals younger than 2 years of age.
An ARCHITECT HIV Ag/Ab Combo reactive result does not distinguish between the detection of HIV-1p24 Ag, HIV-1 Ab, or HIV-2 Ab.
The ARCHITECT HIV Ag/Ab Combo is not intended for use in screening blood or plasma donors




Reference Range
Non-reactive


Clinical Significance
The ARCHITECT HIV Ag/Ab Combo is an assay for the simultaneous qualitative detection of human immunodeficiency virus (HIV) p24 antigen and antibodies to HIV type1 (HIV-1 group M and group O) and/or type 2(HIV-2) in human serum or plasma. Early infection with HIV-1, but prior to seroconversion, HIV-1 core protein p24 antigen, may be detected in HIV-1 individuals.  ARCHITECT HIV Ag/Ab Combo uses anti-HIV-1p24 reagents to detect HIV-1p24 antigen, thereby decreasing the window period and improving early detection of HIV infection.


Performing Laboratory

Inova Laboratories

2832 Juniper Street

Fairfax, VA 22031




Last Updated: April 11, 2023
Last Review: N. Wolford, April 11, 2023


The CPT Codes provided in this document are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payor being billed. Any Profile/panel component may be ordered separately. Reflex tests are performed at an additional charge.