Donor Eligibility Tests
| ANALYTE AND PACKAGE INSERT | METHOD | TEST KIT NAME | MANUFACTURER | TEST TYPE | FDA-LICENSED, APPROVED OR CLEARED FOR DONOR SCREENING | CE Mark Affixed to Test Kit |
| HIV 1/2 Antibody | Automated/Manual | GS HIV-1/2 Plus O EIA | Bio-Rad | Screening | Yes BL125030 | Yes |
| Hepatitis B Surface Antigen | Automated/Manual | GS HBsAg 3.0 EIA | Bio-Rad | Screening | Yes BL103590 | No |
| Hepatitis B Core Antibody | Automated/Manual | Anti-HBcore Total ELISA | Ortho | Screening | Yes BL103062 | No |
| Hepatitis C Antibody | Automated/Manual | Anti-HCV 3.0 ELISA | Ortho | Screening | Yes BL103065 | No |
| HTLV I/II Antibody | Automated/Manual | Hanti-HTLV I/II ELISA | Avioq | Screening | Yes BL125394 | No |
| Syphilis Non-Treponemal RPR | Automated | ASI Automated RPR | Arlington Scientific, Inc. | Screening | Yes BK200488 | Yes |
| Syphilis Treponemal CAPTIA-G | Manual | CAPTIA-G | Trinity BioTech | Screening | Yes K014233 | Yes |
| CMV Antibody 1 / CMV Antibody 2 | Automated/Manual | Capture-CMV AB (Total) | Immucor | Screening | Yes BK180247 | Yes |
| NAT HIV-1/2, HCV & HBV | Automated | Procleix Ultrio Elite Assay Panther | Grifols | Screening | Yes BL125652 | Yes |
| NAT - WNV | Automated | Procleix WNV Assay Panther | Grifols | Screening | Yes BL125121 | Yes |
| Chagas | Automated | Ortho T. cruzi ELISA Test System | Ortho | Screening | Yes BL125161 | 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)).