HIV-1 Antigen and HIV-1 / HIV-2 Antibody

Specimens will be screened by using a 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 Geenius assay that differentiates antibodies to Human Immunodeficiency Virus Types 1 and 2 (HIV-1/HIV-2).
If the Geenius Interpretation is Negative, HIV-1 Indeterminate, HIV-2 Indeterminate, or HIV 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.

Immunology

Chemiluminescent Microparticle Immunoassay (CMIA) / Immunochromatographic

Collect blood sample in a serum tube (red top) or a serum separator tube (SST) (yellow or marble top)
Centrifuge sample, if possible. If using a red top vacutainer tube, transfer serum into a labeled pour over tube
Minimum of 2 mL of whole blood or 1 mL of serum

Store freezer pillows in freezer for at least 24 hours prior to shipping with specimens.
Store specimens in refrigerator (2–8°C) after collection.
Specimens should be sent daily or next working day.
Transport in provided MSPHL shipping containers with freezer pillow(s).
Specimens must be received in the laboratory within 7 days after collection.

Serum

Immunology Test Request Form
Instructions for completing the Test Request Form

CMIA:  Reactive, Non-Reactive, Test Cancelled/Unsatisfactory
Geenius Interpretation: HIV-1 Positive, Negative, HIV-1 Indeterminate, HIV Positive (Untypable), HIV-2 Positive, HIV-2 Indeterminate, HIV Indeterminate, HIV-2 Positive with HIV-1 cross reactivity, Test Cancelled/Unsatisfactory

Specimen is not labeled with the patient’s name or 2 unique identifiers
Quantity Not Sufficient
Grossly Hemolyzed
Not received within 7 Days of collection
Sample transport conditions failed to meet acceptability criteria during accessioning

Hemolysis and bacterial contamination

1-3 days after receipt of specimen

N/A

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

HIV Ag/Ab Combo: 56888-1, Geenius: 80203-3 (HIV-1 Ab: 68961-2, HIV-2 Ab: 81641-3)

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.