HIV 1/2 4th Gen, Rflx Conf

Test Code: TD_3540

CPT Code(s): 87389

$45

Test Details

Alternative Name(s)

HIV 1/2 AB/AG Rflx Conf
HIV 1/2 AG/AB Combo
Human Immunodeficiency Virus

Test Includes

HIV 1/2 4th Gen, Rflx Conf

Methodology

Roche COBAS Electrochemiluminescence Immunoassay (ECLIA). HIV-1 AG standardized to WHO p24 ag, NIBSC code 90/636.
Note: the performance of this assay has not been established for individuals younger than 2 years of age.

Rejection Criteria

Heat-inactivated specimens
Heparin specimens

Reference Range(s)

Non-Reactive
Will reflex to HIV-1/HIV-2 Confirmation when result is reactive

Specimen Requirements

Preferred Specimen

Serum Separator Tube

Minimum Volume

2 mL Serum

Sample Stability

2 days room temperature
7 days refrigerated
6 weeks frozen

Transport Temperature

Refrigerated

Collection Instructions

Allow SST to clot in an upright position for at least 30 minutes, then centrifuge sample within 2 hours of collection. Refrigerate.
Note: performance characteristics of this assay have not been assessed in children less than 2 years of age.
Consider nucleic acid testing for definitive classification in early infancy.
Note: Do not collect samples from patients receiving therapy with high biotin doses (>5 mg/day) until at least 8 hours following the last biotin administration.

Alternative Specimen

3 mL serum from a plain red top tube. Allow sample to clot in an upright position for at least 60 minutes, then centrifuge sample and transfer serum to a plastic transport tube within 2 hours of collection. Clearly label tube as serum from a plain red top tube. Refrigerate.
Note: performance characteristics of this assay have not been assessed in children less than 2 years of age.
Consider nucleic acid testing for definitive classification in early infancy.
Note: Do not collect samples from patients receiving therapy with high biotin doses (>5 mg/day) until at least 8 hours following the last biotin administration.