Who is permitted to purchase and use the test?
Only clinical laboratories that meet certain quality assurance requirements may purchase OraQuick. In addition, only agents of clinical laboratories may use the test. An agent of the clinical laboratory is someone who works for the laboratory whether it is high complexity, moderate complexity, or waived. All customers will receive a letter indicating that through their purchase, they agree to meet these requirements. Quality assurance requirements include: • planned systematic activities to assure that requirements for quality will be met, and • assurance that operators will receive and use the instructional materials.
