A rapid antibody test that reads in 20 minutes changes what a physician office can do in a single visit. It also creates a short list of obligations: a CLIA certificate, the manufacturer's procedure followed exactly, documentation, and a supply plan that keeps the test in date. Here is what to have on file before the first kit arrives.
The test
OraSure's OraQuick HCV Rapid Antibody Test is FDA approved and CLIA-waived for detecting hepatitis C antibodies in fingerstick and venipuncture whole blood. The manufacturer states results in 20 minutes, read within a 20 to 40 minute window, with accuracy greater than 98 percent for the U.S. formulation. OraSure lists physician offices, community health clinics, laboratories, emergency rooms, and public health settings as intended sites. The same manufacturer's rapid HIV-1/2 antibody test is offered in a CLIA-waived format for point-of-care use.
Two cautions come with any rapid antibody test. A reactive result is preliminary and is confirmed by follow-up testing per the manufacturer's instructions and your clinical protocol. And the regulatory status printed in the package insert governs; if the insert says CLIA-waived for a specimen type, that is the only specimen type your waived site may run.
The certificate
The Clinical Laboratory Improvement Amendments (CLIA) apply to any site that tests a human specimen to diagnose, prevent, or treat disease or assess health. A physician office that runs a waived rapid test needs, at minimum, a CLIA Certificate of Waiver from CMS. CDC describes waived tests as test systems cleared by the FDA for home use and those approved for waiver under the CLIA criteria, and it warns that errors occur when the manufacturer's instructions are not followed or personnel are unfamiliar with the test system. Enrollment is an application through the CMS CLIA program submitted to the state agency.
If your office already holds a Certificate of Waiver for glucose, strep, or urinalysis, adding a new waived test does not require a new certificate. It does require that the new test is on the FDA's waived list and that you run it as the insert says.
The office checklist
- Certificate of Waiver number on file, with the renewal date on the compliance calendar.
- Package insert and procedure for each test, current version, accessible at the testing station.
- Training records for every person who performs or reads the test.
- Quality control as the insert requires, logged with lot numbers.
- Storage at the insert's temperature range, with a thermometer log if kits are refrigerated.
- Result documentation in the chart, including the lot number and the reader's initials.
- Confirmatory pathway written down: where a reactive specimen goes and who follows up.
- Reporting obligations for reportable conditions under your state's rules.
Your clinical lead and compliance officer own the protocol. Purchasing owns items five and nine: the kits arrive in date, stored correctly, and never run out.
Stocking point-of-care tests
- Order by test menu, not by brand. List every waived test you run, the kit count, and the weekly volume. Set a par of four to six weeks for each.
- Lot dating on the quote. Rapid tests are dated. Ask the supplier to state the dating on every quote and to ship the oldest acceptable lot first so stock rotates.
- One professional kit per pathogen. Keep the office on a single kit per test so training and QC stay consistent. Approve one alternate in advance in case of allocation.
- Standing order for the steady lines. HCV, HIV, strep, and glucose volumes are predictable. A monthly standing order with a confirmed ship date removes the weekly purchase order.
- Seasonal buffer for respiratory tests. COVID and flu kits spike from October to February. Order the seasonal par in September, as the respiratory season testing plan describes.
What Keystone supplies
Keystone quotes OraSure OraQuick rapid tests along with professional and self-test kits from Abbott, ACON, Healgen, GenaBio, and Genbody, by the kit or the case, with lot dating stated on the quote. Diagnostic tests are sold to healthcare facilities, employers, public health programs, and other qualified purchasers; the regulatory status of each test is as stated by the manufacturer. Physician offices and clinics can put the whole waived-test menu on one standing order with Net 30 terms for approved accounts.
Browse rapid diagnostic tests or request a point-of-care testing quote.
Sources
- OraSure Technologies, OraQuick HCV Rapid Antibody Test: https://orasure.com/products/OraQuick-HCV.html
- Henry Schein Medical, OraSure Technologies manufacturer showcase (OraQuick HIV and HCV rapid tests): https://www.henryschein.com/us-en/medical/products/manufacturer-showcase/orasure-technologies.aspx
- CDC, Waived Tests: https://www.cdc.gov/lab-quality/php/waived-tests/index.html
- AAFP, CLIA Certification and Waived Tests: https://www.aafp.org/practice-operations/quality-and-compliance/clia