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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
 
Riyahi S.¹, Amini-Kafiabad S.², Minai Tehrani D.¹, Maghsudlu M.², Alavian S.M.^3
 
 
1Life Sciences and Biotechnology Faculty, Shahid Beheshti University, Tehran, Iran
²Blood Transfusion Research Center, High Institute for Research and Education in Transfusion Medicine, Tehran, Iran
³Baqiyatallah University of Medical Sciences, Tehran, Iran
 
Abstract
Background and Objectives
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.
 
Materials and Methods
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)
 
Results
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.
 
Key words: Predictive Value of Tests, Sensitivity, Specificity
 
Received:   2  Jun 2021
Accepted: 14 Jul  2021
 
 

Correspondence: Amini Kafi-Abad S., MD. Pathologist. Professor of Blood Transfusion Research Center, High Institute for Research and Education in Transfusion Medicine.
P.O.Box: 14665-1157, Tehran, Iran. Tel: (+9821) 88601558; Fax: (+9821) 88601542
E-mail: s.amini@ibto.ir