HIV-1 Antigen & HIV-1/HIV-2 Antibody

A-Z Navigation

A - Z Index:   A   B   C   D   E   F   G   H   I   K   L   M   N   O   P   Q   R   S   T   V   W   X   Y

HIV-1 Antigen and HIV-1 / HIV-2 Antibody (Human Immunodeficiency Virus) with Reflex to HIV-1/HIV-2 Antibody Differentiation

 

Brief Description

Specimens will be screened by a fourth generation CMIA test for the qualitative detection of HIV-1 p24 antigen, and IgM and IgG antibodies to HIV-1 and/or HIV-2. Any repeatedly reactive CMIA specimen will be tested with the Multispot test that differentiates antibodies to Human Immunodeficiency Virus Types 1 and 2 (HIV-1/HIV-2). If the Multispot is Non-Reactive or HIV-1 Indeterminate, the specimen will be sent out for an HIV nucleic acid test (NAT) if specimen requirements are met. This multi-test algorithm is recommended by the Centers for Disease Control and Prevention (CDC) and has been adopted by the Clinical Laboratory Standards Institute (CLSI) for the diagnosis of HIV. This test is not intended for use in screening blood or plasma donors. This test has not been FDA approved for children less than 2 years of age or for cadaveric specimens.

Laboratory Unit

Immunology

Methodology

Chemiluminescent Microparticle Immunoassay (CMIA) / ImmunoConcentration

Specimen Collection

One 6 mL red top vacutainer tube or EDTA, heparin, serum separator (SST)

Storage/Transport

6 mL of whole blood or 1.5 mL of serum or plasma
Store specimens at 2-8° C for 7 days.
After 7 days, the serum/plasma must be removed from clot, red blood cells, or separator gel and stored frozen at -20° C or colder
Specimens should be sent daily or next working day
Transport in SPHL shipping containers at room temperature or with coolant (if available)

Acceptable Specimen
Type(s)

Serum, plasma



Possible Results

CMIA:  Reactive, Non-Reactive, Unsatisfactory
Multispot: HIV-1 Positive, Non-Reactive, HIV-1 Indeterminate, HIV Positive (Undifferentiated), HIV-2 Positive, Invalid, Unsatisfactory

Reference Range

HIV Ag/Ab Combo:  Non-Reactive
Multispot: Non-Reactive

Unacceptable Conditions

No Name on Specimen
Name on Specimen Does Not Match Name on Request Form
Quantity Not Sufficient
Grossly Hemolyzed
In Transit for More Than 10 Days

Interfering Substances

Hemolysis and bacterial contamination

Result Reported

1-3 days after receipt of specimen

Fees

For private entities, there is a $10 handling fee.

CPT Codes

87389 HIV-1 Ag/HIV-1 and HIV-2 Ab; if reflexed, add HIV-1 and HIV-2 Antibody Differentiation 86701 and 86702

LOINC/SNOMED Codes

HIV Ag/Ab: 56888-1, Multispot: 69668-2

Additional Information

Testing alone cannot be used to diagnose AIDS, which is a clinical syndrome. The diagnosis of AIDS must be established clinically. A nonreactive result does not exclude the possibility of exposure to or infection with HIV-1 and/or HIV-2. Nonreactive results may be because antigen and antibody levels are below the limit of detection of this assay.

Effective April 1, 2012, the HIV Blue Card, officially known as the Provider's Confidential Report of HIV/AIDs Infection report form (MO 580-1641), will no longer be provided with the positive HIV Western Blot laboratory results. Click here to view letter.