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 antibody in a specimen repeatedly reactive in a 4th or 5th generation HIV-1/HIV-2 antigen/antibody assay (e.g. WSLH Test SS00099, 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. |
| Additional Tests Performed: |
| Preparation for Collection: | Routine blood draw |
| Specimen Requirements: | Minimum of 0.5 ml serum or plasma. |
| Collection Instructions: | Comply with Wisconsin informed opt-out statutes. |
| Collection Kit/Container: |
EDTA
Serology Specimens Sodium Citrate Sodium Heparin 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 stored longer than 7 days at 2-8 degrees are unacceptable for testing. The Geenius HIV1/2 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. |
| Specimen Handling: | Store at 2-8 degrees Celsius and transport with cool packs. If specimens will not be tested within 3 days of collection, freeze at -20 degrees Celsius and transport with cool packs. |
| Packaging Requirements: | |
| Courier Information: | |
| 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: | |
| 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 incorrect 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 HIV1/2 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: | 86689x1 |
| Price: | $122.00 Price Effective 1/1/25 |
| Fee Exempt Eligible: | N |
| Billing and Revenue Office: | 1-800-862-1065 arbill@slh.wisc.edu |