Safe blood transfusion being the cornerstone of any Blood Transfusion Services requires meticulous testing for Transfusion Transmitted Disease (TTD) markers in donated blood. We performed head-to-head comparison of ELISA and ECLIA for detection of TTD markers for Human Immunodeficiency Virus (HIV), Hepatitis C Virus (HCV) and Hepatitis B Virus (HBV) in 10,164 Indian blood donors. All concordant reactive, discordant reactive and concordant non-reactive samples were re-confirmed using Individual Donor-Nucleic Acid Amplification Test (ID-NAT) as the ‘gold standard’ test. 223 samples were found reactive; out of which 93 (four HIV, 34 HCV and 55 HBV) samples were concordant reactive and tested positive by both methods while 130 discordant reactive samples were reactive either by ELISA or ECLIA. Out of 130 discordant reactive samples ELISA-reactive and ECLIA-non-reactive samples for HIV, HCV and HBV were 15, eight, and 29 respectively while ECLIA-reactive ELISA-non-reactive samples for HIV, HCV and HBV were 39, 36 and three respectively. Sensitivity of ECLIA and ELISA was 100% for all three TTD markers, while specificity was 99.62 % and 99.85 % for HIV; 99.64 % and 99.84 % for HCV and 99.97 % and 99.70 % for HBV respectively. Strength of agreement and Kappa Statistics for ECLIA and ELISA compared to the gold standard test was poor and fair for HIV (k = 0.169 and 0.347), moderate and good for HCV (k = 0.539 and 0.763), and very good and good for HBV (k = 0.973 and 0.783). According to this study, it can be concluded both the testing techniques; ELISA and ECLIA have 100% sensitivity for the detection for HBV, HCV and HIV in blood donors and therefore, either can be used for TTD screening in blood banks in India.

安全输血是任何输血服务的基石，需要对捐献血液中的输血传播疾病（TTD）标记物进行仔细测试。我们对10164名印度献血者中的人类免疫缺陷病毒（HIV），丙型肝炎病毒（HCV）和乙型肝炎病毒（HBV）的TTD标志物的检测进行了ELISA和ECLIA的面对面比较。使用个体供体-核酸扩增测试（ID-NAT）作为“金标准”测试，重新确认所有一致的反应性，不一致的反应性和一致的非反应性样品。发现有223个样品具有反应性；其中93个样本（四个HIV，34个HCV和55个HBV）呈一致反应性，并通过两种方法测试均为阳性，而130个不一致反应性样品通过ELISA或ECLIA呈反应性。在130个不一致的HIV，HCV和HBV ELISA反应样本和ECLIA非反应样本中，分别有15、8和29个ECLIA反应ELISA非反应样本为HIV，HCV和HBV。和三个。所有三种TTD标记的ECLIA和ELISA灵敏度均为100％，而HIV的特异性为99.62％和99.85％。HCV分别为99.64％和99.84％，HBV为99.97％和99.70％。与金标准测试相比，ECLIA和ELISA的一致性强度和Kappa统计数据对HIV较差且尚可（k = 0.169和0.347），对HCV较适中（k = 0.539和0.763），对HBV则非常好（k = 0.973和0.783）。根据这项研究，可以得出两种测试技术的结论。ELISA和ECLIA对HBV的检测灵敏度为100％，