Processes and Software Building 30: Donor HCV Screening Tests

The testing algorithms may trigger additional testing, repeat of current testing at some future date, or permanent deferral.  One of the most complex processes is for HCV testing.  The following criteria are based on US FDA CBER guidelines, but are modified for the availability of test methodologies not licensed in the USA.

For HCV, we use the following testing in all donors:

  1. HCV antibody EIA
  2. HCV NAT
  3. If any of the tests are non-negative, then we do the HCV LIA immunoblot assay. 

HCV LIA is more sensitive than RIBA-3 (now no longer performed in the USA) but is not available in the USA.  This test has been incorporated into the testing algorithm from CBER:

  1. Hepatitis C:
    1. HCV-RNA positive confirmed, regardless of other HCV results:  permanent deferral, refer to Infectious Disease clinic
    2. HCV-RNA borderline:  repeat all HCV testing after 6 months
    3. HCV-InnoLIA positive, regardless of other HCV results:  permanent deferral, refer to Infectious Disease clinic
    4. HCV-InnoLIA indeterminate:  repeat all HCV testing after 6 months
    5. HCV-Ab positive, HCV-RNA negative, do HCV-InnoLIA:
      1. If HCV-InnoLIA positive, permanent deferral, refer to Infectious Disease clinic
      2. If HCV-InnoLIA indeterminate or negative, repeat all HCV testing after 6 months
    6. Repeat Hepatitis C Testing After 6 months:
      1. HCV-RNA or HCV-InnoLIA positive:  permanent deferral, refer to Infectious Disease clinic
      2. HCV-RNA or HCV-InnoLIA borderline:  permanent deferral, HCV infection not confirmed
      3. HCV-Ab positive or borderline without positive HCV-RNA or positive HCV-InnoLIA:  permanent deferral, HCV infection not confirmed
      4. HCV-Ab negative, HCV-RNA negative, HCV-InnoLIA negative:  reenter donor into donor pool

Note that indeterminate HCV results may be carried forward repeatedly by CBER rules but I decided to permanently defer the donor after 2 cycles of indeterminate results.  The donor must wait SIX MONTHS before the next round of testing.  Should he/she return before that time, those results may not be used for determining donor eligibility (unless the results have become clearly positive).

To Be Continued:

10/8/20