Impact of changes in viral marker screening assays.
BACKGROUND
Monitoring the performance of routinely used infectious disease serologic tests is necessary to evaluate their effectiveness in identifying true-positive units and erroneously disqualifying safe blood donors.


METHODS
With two large screening test data sets collected between 1991 and 1998 and between 1997 and 2000, the impact of changes in screening assays for HIV, HCV, and HBsAg was analyzed with regard to the prevalence of confirmed-positive, indeterminate, and confirmed-negative results and the deferral of donors with an indeterminate or negative results (donor loss).


RESULTS
The prevalence of indeterminate results and donors loss increased significantly in the 6 months after introduction of an HIV-1/2 EIA. A second-generation HCV EIA increased the detection of confirmed-positive donations in repeat donors (p < 0.001) and increased the prevalence of indeterminate donations. Implementation of a third-generation HCV EIA resulted in a significant decrease in indeterminate results in first-time donors. Nonspecific test results increased when HBsAg test kits from a different manufacturer were introduced or different lots of HIV antibody screening test kits from the same manufacturer were used.


CONCLUSIONS
Introduction of newly licensed versions of assays, switching kit manufacturers, and lot-to-lot variations have an impact on rates of deferrals of safe donors as well as sensitivity of routine screening. Before considering changes in screening tests, blood centers should be aware of, and evaluate, the potential impact on donor loss.
Sharma
Usha K
UK
Westat, Rockville, Maryland, USA.
Stramer
Susan L
SL
Wright
David J
DJ
Glynn
Simone A
SA
Hermansen
Sigurd
S
Schreiber
George B
GB
Kleinman
Steven H
SH
Busch
Michael P
MP
D000956:Antigens, Viral / Q000097:blood; D015415:Biomarkers / Q000097:blood; D001782:Blood Donors / Q000600:supply & distribution; D003625:Data Collection; D015658:HIV Infections / Q000175:diagnosis; D006509:Hepatitis B / Q000175:diagnosis; D006526:Hepatitis C / Q000175:diagnosis; D006801:Humans; D007124:Immunoenzyme Techniques / Q000592:standards; D008403:Mass Screening / Q000379:methods* / Q000592:standards; D011237:Predictive Value of Tests; D011933:Reagent Kits, Diagnostic / Q000592:standards*
D000956:Antigens, Viral; D015415:Biomarkers; D011933:Reagent Kits, Diagnostic