HIV-1 Proviral DNA PCR
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| WSLH Department: | CDD - Communicable Disease Division |
| WSLH Test Code: | SS00091 |
| Day(s) Performed: | Daily, Monday - Friday |
| Turn-around Time: | 1 Day |
| Recommended Uses: | PCR is a process of DNA amplification not dependent on an antibody response. It allows identification of HIV infection before symptoms of disease and seroconversion occur. PCR should be selected in only a few distinct situations: neonates whose mothers are HIV antibody positive or considered to be at high risk for HIV infection; patients with HIV Ag/Ab Combo positive and with negative or indeterminate Geenius results for HIV; patients suspected of acute HIV infection prior to seroconversion. |
| Pre-approval: | N |
| Contraindications: | Testing will not be performed as a screening test. |
| Additional Tests Performed: |
| Preparation for Collection: | Routine blood draw |
| Specimen Requirements: | One 7 ml EDTA (lavender top) vacutainer of whole blood for adults. Greater than or equal to 400 ul EDTA (lavender top) vacutainer of whole blood for pediatrics. Store refrigerated at 2-8 C. Patient specimen must be received within 5 days of collection. |
| Collection Instructions: | Comply with Wisconsin informed opt-out statutes. |
| Collection Kit/Container: |
HIV-1 Proviral DNA PCR (Kit 22P)
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| Requisition Form: |
CDD Requisition Form B
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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: | Specimen collected in container other than EDTA or ACD vacutainer tube. Specimens received >5 days after collection. |
| Specimen Handling: | Patient specimen must be received within 5 days of collection. |
| 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 proviral DNA detected, No HIV-1 proviral DNA detected, or Indeterminate |
| Limitations: | This test is not FDA cleared, but has been validated at WSLH. Does not detect HIV-2 virus. Patients undergoing CAR-T cell therapy may test positive with this assay in the absence of HIV infection. |
| Additional Tests Recommended: | Individuals testing positive should have HIV viral load testing, available at reference laboratories. |
| Additional Comments: | Additional testing is recommended for all patients testing positive for the first time. |
| Methodology: | Real-time PCR |
| Includes: | Real-time PCR assay for the detection of HIV-1 proviral DNA |
| Regulatory Compliance: |
| CPT Code: | 87535 |
| Price: | $276.00 Price Effective 1/1/25 |
| Fee Exempt Eligible: | N |
| Billing and Revenue Office: | 1-800-862-1065 arbill@slh.wisc.edu |