HIV 1/2 Supplemental Assay
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| WSLH Department: | CDD - Communicable Disease Division |
| WSLH Test Code: | SS00030 |
| Day(s) Performed: | Daily, Monday - Friday |
| Turn-around Time: | 1-3 Days |
| Recommended Uses: | Confirmation and differentiation of the presence of HIV antibodies in a specimen repeatedly reactive in a 4th or 5th generation HIV-1/HIV-2 antigen/antibody assay (e.g. WSLH Test SS00095, HIV-1/HIV-2 Antigen/Antibody). |
| Pre-approval: | N |
| Contraindications: | Testing will not be performed as a screening test or a stand-alone test. Must have a reactive screening test result. Not approved for testing deceased individuals. Not approved for screening blood products. |
| Additional Tests Performed: |
Negative or indeterminate specimens will be automatically reflexed (plasma only) to HIV-1 RT-PCR (test code SS00091) for an additional fee. |
| Preparation for Collection: | |
| Specimen Requirements: | Minimum of 0.5 ml serum or plasma (EDTA) |
| 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 stored longer than 7 days at 2-8 °C are unacceptable for testing. The Geenius HIV 1/2 Supplemental Assay is not to be used for primary screening purposes; therefore, specimens for which 4th or 5th generation HIV antigen/antibody testing has not been performed are unacceptable. Grossly hemolyzed specimens will be rejected. |
| Specimen Handling: | Store at 2-8 °C and transport with frozen cold packs. If specimens will not be tested within 7 days of collection, serum specimens may be frozen at -20 °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: | HIV-1 Positive, HIV-1 Indeterminate, HIV-2 Positive, HIV-2 Indeterminate, HIV Positive (Undifferentiated), HIV Negative |
| Limitations: | Results should not be interpreted alone. They must be used in conjunction with other HIV testing and clinical assessment. A negative result does not rule out infection with HIV. Individuals with recent exposure to HIV may not test positive for 2-4 weeks post exposure. |
| Additional Tests Recommended: | |
| Additional Comments: | The following anticoagulants have been found to be acceptable for use with this test: EDTA, sodium citrate and sodium heparin. Use of other anticoagulants has not been evaluated and may give inaccurate results. Testing individual specimens of body fluids other than fresh or frozen serum or plasma is not acceptable. In addition, pooled blood or processed plasma, and products made from such pools is not acceptable. |
| Methodology: | Geenius HIV 1/2 Supplemental Assay |
| Includes: | Immunochromatographic test for the confirmation and differentiation of individual antibodies to Human Immunodeficiency Virus Types 1 and 2 (HIV-1 and HIV-2). |
| Regulatory Compliance: |
| CPT Code: | 86689 |
| Price: | $122.00 |
| Fee Exempt Eligible: | Yes, with DHS approval only, 608-267-9003 |
| Billing and Revenue Office: | 1-800-862-1065 arbill@slh.wisc.edu |