Analysis of sample-to-cutoff ratios on chemiluminescent immunoassays used for blood donor screening highlights the need for serologic confirmatory testing.
BACKGROUND
High sample-to-cutoff (s/co) ratios on hepatitis C virus antibody (anti-HCV) screening immunoassays (IAs) are indicative of confirmed-positive results and, according to some reports, can be used to determine anti-HCV status without the need for confirmatory testing. The purpose of this study was to determine whether s/co ratios on hepatitis B surface antigen (HBsAg), antibody to human immunodeficiency virus Types 1 and 2 (anti-HIV-1/2), anti-HCV, and antibody to human T-lymphotropic virus Types I and II (anti-HTLV-I/II) chemiluminescent immunoassays (ChLIAs) can be used to discriminate between biologic false-reactive (BFR) and confirmed-positive results.


METHODS
In a blood donor population the s/co ratio distributions for BFR and confirmed-positive results were compared for the Abbott PRISM HBsAg, HIV O Plus, HCV, and HTLV-I/II ChLIAs to determine the extent of overlap between the two distributions for each assay.


RESULTS
The s/co ratio distributions for BFR and confirmed results overlapped in the range of 10.00 to 60.00, 1.00 to 6.00, 3.00 to 15.00, and 1.00 to 100.00 for the PRISM HIV O Plus, HCV, HTLV-I/II, and HBsAg assays, respectively.


CONCLUSIONS
Although high s/co ratios were predictive of confirmed-positive results in all four assays, a number of confirmed-positive samples gave low values while some biologic false-positive samples showed high values. As the s/co ratio distributions for BFR and confirmed-positive results overlapped for all four PRISM assays, this study highlights the importance of serologic confirmatory testing and the need for caution when using screening IA results to assign a final donor status.
Kiely
Philip
P
Infectious Disease Screening Laboratory, Australian Red Cross Blood Service, Melbourne, Brisbane, and Perth, Australia. pkiely@arcbs.redcross.org.au
Walker
Kyall
K
Parker
Susan
S
Cheng
Anthea
A
D000914:Antibodies, Viral / Q000097:blood*; D001315:Australia; D001782:Blood Donors; D046148:Donor Selection / Q000379:methods* / Q000592:standards; D005189:False Positive Reactions; D005260:Female; D006801:Humans; D007118:Immunoassay / Q000379:methods / Q000592:standards; D008163:Luminescent Measurements / Q000379:methods* / Q000592:standards; D008297:Male; D014777:Virus Diseases / Q000097:blood
D000914:Antibodies, Viral