Donor Eligibility Tests

ANALYTE AND PACKAGE INSERT	METHOD	TEST KIT NAME	MANUFACTURER	TEST TYPE	FDA-LICENSED, APPROVED OR CLEARED FOR DONOR SCREENING	CE Mark
HIV 1/2 Antibody	Automated/Manual	Elecsys HIV Duo	Roche Diagnostics	Screening	Yes	Yes
Hepatitis B Surface Antigen	Automated/Manual	Elecsys HBsAg II and HBsAg II Auto Confirm	Roche Diagnostics	Screening	Yes	Yes
Hepatitis B Core Antibody	Automated/Manual	Elecsys Anti-HBc II	Roche Diagnostics	Screening	Yes	Yes
Hepatitis C Antibody	Automated/Manual	Elecsys Anti-HCV II	Roche Diagnostics	Screening	Yes	Yes
HTLV I/II Antibody	Automated/Manual	Elecsys HTLV-I/II	Roche Diagnostics	Screening	Yes	Yes
Syphilis Non-Treponemal RPR	Automated	ASI Automated RPR	Arlington Scientific, Inc.	Screening	Yes	Yes
Syphilis Treponemal CAPTIA-G	Manual	CAPTIA-G	Trinity BioTech	Screening	Yes	Yes
CMV Antibody	Automated/Manual	Elecsys Anti-CMV	Roche Diagnostics	Screening	Yes	Yes
NAT HIV-1/2, HCV & HBV	Automated	Procleix Ultrio Elite Assay Panther	Grifols	Screening	Yes	Yes
NAT - WNV	Automated	Procleix WNV Assay Panther	Grifols	Screening	Yes	Yes
Chagas	Automated	Elecsys Chagas	Roche Diagnostics	Screening	Yes	Yes
Chlamydia trachomatis (CT) and/or Neisseria gonorrhoeae (GC)	Automated	GEN-PROBE® Aptima Combo 2® Assay	Hologic	Detection	* 510K K180681	No

*Although there are diagnostic tests available, there are currently no FDA-licensed, approved, or cleared tests for donor screening. In the absence of such screening tests, you must use an FDA-licensed, approved, or cleared diagnostic test labeled for the detection of these organisms in an asymptomatic, low-prevalence population (§ 1271.80(c)). The use of Chlamydia trachomatis and Neisseria gonorrhoeae tests utilizing NAT technology adequately and appropriately reduces the risk of transmission of these relevant communicable disease agents (§ 1271.80(c)).