HIV-1/HIV-2 Diagnostic Algorithm
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| WSLH Department: | CDD - Communicable Disease Division |
| WSLH Test Code: | SS00095 |
| Day(s) Performed: | Daily, Monday - Friday |
| Turn-around Time: | 1-4 days |
| Recommended Uses: | Screening test to aid in the diagnosis of HIV-1/HIV-2 infection, including acute or primary HIV-1 infection |
| Pre-approval: | N |
| Contraindications: | Not intended for use in screening blood or plasma donors. Test has not been FDA approved for children less than 2 years of age or for cadaveric specimens. |
| Additional Tests Performed: |
HIV-1/HIV-2 Confirmation
|
| Preparation for Collection: | Routine blood draw |
| Specimen Requirements: | 3 ml (1 ml minimum) of serum or plasma (EDTA) or 7-10 ml vacutainer, no additives. EDTA Plasma is preferred. |
| Collection Instructions: | Comply with Wisconsin informed opt-out statutes. |
| Collection Kit/Container: |
Serology Specimens
Sterile Transfer Tube |
| Requisition Form: |
CDD Requisition Form B
|
| Required Information: | Laboratory regulations require the following minimum information to be provided on the requisition form for a specimen to be accepted for testing: Patient name or unique identifier; date and time of collection, patient date of birth and sex, specimen type/site of collection, test request(s), clinician name and UPIN, and address for reporting results. Please be certain that name/identifier on the form matches that on the specimen label. |
| Rejection Criteria: | Specimens received after more than 7 days storage at 2-8C; heat-inactivated serum or plasma; grossly hemolyzed specimens; specimens with obvious microbial contamination, or received >8C. |
| Specimen Handling: | Prompt shipment is recommended. Specimens may be stored refrigerated (2-8C) for up to 7 days and shipped with frozen cool packs. If longer storage or transport is required, specimens may be frozen (-20 to -80C) and shipped with dry ice. |
| Packaging Requirements: | |
| Courier Information: | |
| Specimen Receiving Hours: | Monday-Friday 7:45 AM - 4:30 PM, Saturday 7:45 AM - 12:00 PM |
| Results Include: | Reactive or Non-reactive (screening CMIA); HIV-1, HIV-2, Indeterminate or Negative (HIV-1/HIV-2 antibody confirmatory assay); Detected or Not Detected (RT-PCR) and final interpretation. |
| Limitations: | A test result that is nonreactive does not exclude the possibility of exposure to or infection with HIV-1 and/or HIV-2. Nonreactive results may be due to antigen and antibody levels that are below the limit of detection of this assay. This assay does not distinguish between positivity due to the individual components. |
| Additional Tests Recommended: | HIV-1 DNA PCR if indicated (see Additional Comments) |
| Additional Comments: | Repeatedly reactive specimens are automatically reflexed to the HIV-1/HIV-2 antibody confirmatory assay. Additional reflex testing may include HIV-1 DNA PCR if the HIV-1/HIV-2 antibody confirmatory assay is negative or indeterminate and plasma is submitted. If serum is submitted, plasma or whole blood must be collected for HIV PCR to complete the testing algorithm. |
| Methodology: | Chemiluminescent microparticle immunoassay (CMIA) |
| Includes: | Qualitative assay for the detection of antibodies to HIV-1 and HIV-2 and HIV-1 p24 antigen. The HIV-1/HIV-2 Antibody confirmatory assay and HIV-1 DNA RT-PCR will be performed, if indicated, and additional charge(s) will be incurred. |
| Regulatory Compliance: |
| CPT Code: | 87389 |
| Price: | $28.00 Price Effective 1/1/25 |
| Fee Exempt Eligible: | N |
| Billing and Revenue Office: | 1-800-862-1065 arbill@slh.wisc.edu |