Donor testing is performed to screen potential donors for infectious diseases prior to donation. For many RCDADs, donor testing requires testing the donor specimens by both an antibody test and a nucleic acid amplification test (NAAT or NAT).1
Donor testing must be performed with appropriate FDA-licensed, approved, or cleared donor screening tests, in accordance with the manufacturer’s instructions. Until such time as appropriate FDA-licensed, approved, or cleared donor screening tests for Chlamydia trachomatis and for Neisseria gonorrhea are available, donor testing must be performed with FDA-licensed, approved, or cleared diagnostic tests labeled for the detection of those organisms in an asymptomatic, low-prevalence population.2
Consistent with FDA guidelines, Quest Diagnostics does not make any alteration to tests used for donor testing.2 Laboratory-developed tests or modifications to an FDA-approved test are prohibited for use in donor testing.