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Comparison Between Screening and Confirmatory Serological Assays in Blood Donors in a Region of South Italy

Linda Sommese · Carmela Iannone · Francesco Cacciatore · Gustavo De Iorio · Claudio Napoli A

21 citations0/0 files storedJournal of Clinical Laboratory Analysis

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Blood donation and transfusion practices Clinical Laboratory Practices and Quality Control Blood transfusion and management

Abstract

BACKGROUND: Screening assays are needed in order to guarantee safety of donated blood, but a significant number of safe donations are removed from blood supply because of reactive screening results. It is important to evaluate the positive predictive value (PPV) of screening assays in order to modulate confirmatory algorithm and implement an adequate counseling. METHODS: An analysis of 17,912 blood donations has been conducted at Transfusion Medicine at Second University Naples, Italy, in 2009-2012. Serological screening for syphilis, hepatitis B virus (HBV), hepatitis C virus (HCV), and human immunodeficiency virus (HIV) was performed by ARCHITECT (Abbott Diagnostics, Wiesbaden, Germany); repeatedly reactive (RR) samples were checked by respective confirmatory tests. The relationship between sample/cutoff and confirmed seropositivity were analyzed. RESULTS: RR rates were low as expected in blood donors: 0.47% for syphilis, 0.42% for HBV, 0.50% for HCV, and 0.15% for HIV. The specificity on RR + gray zone (GZ) was 99.67%, 99.79%, 99.77%, and 99.88%, respectively; due to the low prevalence, PPV value was 30.6% for syphilis, 50.7% for HBV, 42.2% for HCV, and 18.5% for HIV. These values increased substantially reaching a plateau of 89.3% for syphilis, 94.6% for HBV, 85.7% for HCV, and 100% for HIV at the threshold established by receiver operating characteristics curve analysis. CONCLUSIONS: Supplemental testing on samples with high signal by screening assays seems to add little information. GZ settings and confirmatory testing for positive screening results should be designed taking in account several factors, including difference in the natural history among blood-borne infections, the characteristics of first- and second-level tests, and, when available, the results of nucleic acid amplification testing.

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References

2009Infectivity of human immunodeficiency virus‐1, hepatitis C virus, and hepatitis B virus and risk of transmission by transfusion 2011International survey on NAT testing of blood donations: expanding implementation and yield from 1999 to 2009 2012Expert Consensus Statement on achieving self‐sufficiency in safe blood and blood products, based on voluntary non‐remunerated blood donation (VNRBD)*2008Impact of nucleic acid testing for hepatitis B virus, hepatitis C virus, and human immunodeficiency virus on the safety of blood supply in Italy: a 6‐year survey 2002An estimate of the current risk of transmitting blood‐borne infections through blood transfusion in Italy 2010Nucleic acid testing (NAT) in high prevalence–low resource settings 2003Analysis of voluntary blood donors with biologic false reactivity on chemiluminescent immunoassays and implications for donor management 2010The significance of repeat testing in Turkish blood donors screened with HBV, HCV and HIV immunoassays and the importance of S/CO ratios in the interpretation of HCV/HIV screening test results and as a determinant for further confirmatory testing

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