Evaluation of sensitivity, specificity and positive predictive value in viral screening kits of donors of Iran Blood Transfusion Organization in two high-risk and low-risk groups in 1397 to the first half of 1398

Assessing the sensitivity, specificity and positive predictive value (PPV) of blood-borne infections detection kits are important indicators in the evaluation and use of the kit.

The present study is a descriptive study. The sensitivity of the kit was calculated using the panels of Boston Biomedica Company, definite positive samples of Iranian patients, and the specificity and PPV of the kits in two groups of low-risk )1646371) and high-risk (2525). The results were analyzed with descriptive statistics, SPSS 26, and OR statistical test. (p < 0.05)

In evaluating Monalisa HBs Ag ULTRA, Bio-Rad, and Genscreen ULTRA HIV Ag/Ab kits, Bio-Rad is even more sensitive than reference kits (Enzygnost HBsAg 6.0, Siemens, HIV Ag/Ab Biomerieux) and in the case of Monalisa Anti-HCV kit PLUS Version 3, Bio-Rad sensitivity was equal to 98.6% of the reference kit (Ortho HCV 3.0 Enhanced SAVE). The results of the specificity evaluation in the high-risk group by three kits of HBs Ag, Anti HCV, and HIV Ag/Ab were 99.56%, 100%, and 99.80%, respectively. The results of the evaluation of PPV in the same three kits in the low-risk group were 41.4%, 31.30%, and 6.07% and in the high-risk group they were reported to be 72.5%, 100% and 37.5%, respectively.

Conclusions  :

The results of the present study, in addition to the appropriateness of sensitivity and specificity of the studied kits, showed a significant difference in PPV in communities with different viral prevalence and emphasized the importance of paying attention to prevalence in order to select kits and methods used for viral screening or diagnosis.