OraQuick was originally approved as a moderate complexity test under CLIA. What is different now that the test is waived?
As a moderate complexity test, OraQuick could only be purchased and used by laboratories that were certified to conduct moderate complexity laboratory testing. Laboratories with this level of certification must meet CLIA ’88 requirements for personnel, training, and inspections, among others. In contrast, laboratories performing only waived tests, must meet the following requirements under CLIA ’88: • Enroll in the CLIA ’88 program; • Pay a biennial fee to obtain a Certificate of Waiver; and • Follow manufacturers’ test instructions.
As a moderate complexity test, OraQuick could only be purchased and used by laboratories that were certified to conduct moderate complexity laboratory testing. Laboratories with this level of certification must meet CLIA requirements for personnel, training, and inspections, among others. In contrast, laboratories performing only waived tests, must only meet the following requirements under CLIA: – Enroll in the CLIA program; – Pay a biennial fee to obtain a Certificate of Waiver; and – Follow manufacturers’ test instructions.
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