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: |
Positive specimens will be automatically repeated in duplicate and reflexed to the HIV 1/2 Supplemental Assay SS00030 (additional charge). If the supplemental assay is negative or indeterminate, specimens will automatically reflex to HIV-1 DNA PCR SS00091 (additional charge). PCR will only be performed on Plasma. |
| Preparation for Collection: | |
| 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: | Routine blood draw Comply with Wisconsin informed opt-out statutes. |
| Collection Kit/Container: |
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| Requisition Form: |
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| 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 2-8 °C; heat-inactivated serum or plasma; grossly hemolyzed specimens; specimens with obvious microbial contamination, or received >8 °C. |
| Specimen Handling: | Prompt shipment is recommended. Specimens may be stored refrigerated (2-8 °C) for up to 7 days and shipped with frozen cold packs. If longer storage or transport is required, serum specimens may be frozen (-20 to -80 °C) and shipped with dry ice. |
| Packaging Requirements: | |
| Courier Information: | This test is not eligible for fee-exempt courier service. |
| 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, such as acute infection. This assay does not distinguish between positivity due to the individual components. |
| Additional Tests Recommended: | |
| Additional Comments: |
| Methodology: | Chemiluminescent microparticle immunoassay (CMIA) |
| Includes: | Qualitative assay for the detection of HIV-1 p24 antigen and antibodies to HIV-1 and HIV-2. The HIV-1/HIV-2 Antibody Supplemental Assay (Geenius) and HIV-1 DNA RT-PCR assays will be performed, if indicated, and additional charge(s) will be incurred. |
| Regulatory Compliance: | FDA Approved – CMIA & Geenius Lab Developed Test (LDT) – HIV-1 DNA PCR |
| CPT Code: | 87389 |
| Price: | $28.00, additional charges may incur based on the algorithm |
| Fee Exempt Eligible: | Yes, with DHS approval only, 608-267-9003 |
| Billing and Revenue Office: | 1-800-862-1065 arbill@slh.wisc.edu |