What needs to be done before a site is permitted to purchase and use the test?
Any site offering the rapid HIV test is considered a laboratory under the Clinical Laboratory Improvements Amendments (CLIA) and must meet certain quality assurance requirements before purchasing OraQuick. Under CLIA, a laboratory is defined as any facility that performs examinations, including the OraQuick rapid test, on humans. A facility can be a clinic or hospital with an on-site lab, a voluntary counseling and testing site, or an outreach setting. Only staff of clinical laboratories may use the test. All customers will receive a letter indicating that their purchase of OraQuick means that they agree to meet these requirements.
