Clinical significance of viral markers testing by ELISA and Individual Donation Nucleic Acid Testing (ID-NAT) for blood screening in blood bank: Single center study in Egypt.

The Egyptian journal of immunology Pub Date : 2024-04-01 DOI:10.55133/eji.310206

Fadia M. Attia, A. M. Farouk, S. A. Abdelhady

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Abstract

Prevention of transfusion-transmitted viral infections and insurance of safe blood transfusion are the main goals of all blood banks worldwide. Despite the high sensitivity and specificity of currently used enzyme linked immunosorbent assay (ELISA) for hepatitis B virus (HBV), hepatitis C virus (HCV) and human immunodeficiency virus (HIV) testing, viral transmission could still occur during the window period. Introducing viral individual donation nucleic acid testing (ID-NAT) can greatly decrease such risk providing an additional layer in securing blood transfusion. We aimed to assess the clinical significance of viral markers testing by ELISA and ID-NAT for blood screening in the Blood Bank of Suez Canal University Hospital. We studied all donations (2132) collected during a two-months period. Blood donor samples were screened by ELISA and ID-NAT tests for HBV, HCV, and HIV. Serological testing results for HCV by ELISA revealed 2,122 (99.5 %) negative donations compared to 2,131 (99.95 %) negative donations by ID-NAT testing. Of the positive ELISA samples, only one was NAT positive. For HBV ELISA testing, 2,115 (99.2 %) donations were negative, also by ID-NAT testing 2,115 (99.2 %) donations were HBV DNA negative. Out of the negative ELISA samples, two samples were ID-NAT reactive donors which were missed by serology assay being in the window period. HIV ELISA testing revealed negative 2,130 (99.9 %) donations while ID-NAT testing showed 2,131 (99.95 %) negative donations and one positive donation. In conclusion, this is the first study carried out in the Suez Canal and Sinai region, Egypt to assess the importance of ID-NAT implementation. The introduction of ID-NAT in blood banks is an effective method for increasing safety of the blood transfusion.

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通过酶联免疫吸附试验（ELISA）和个人献血核酸检测（ID-NAT）对血库血液筛查进行病毒标记物检测的临床意义：埃及单中心研究。

预防输血传播病毒感染和确保输血安全是全球所有血库的主要目标。尽管目前使用的酶联免疫吸附试验（ELISA）对乙型肝炎病毒（HBV）、丙型肝炎病毒（HCV）和人类免疫缺陷病毒（HIV）的检测具有很高的灵敏度和特异性，但在窗口期仍有可能发生病毒传播。引入病毒个体捐献核酸检测（ID-NAT）可大大降低这种风险，为确保输血安全提供多一层保障。我们的目的是评估通过 ELISA 和 ID-NAT 对苏伊士运河大学医院血库的血液筛查进行病毒标记物检测的临床意义。我们对两个月内收集的所有献血样本（2132 份）进行了研究。通过 ELISA 和 ID-NAT 测试对献血者样本进行了 HBV、HCV 和 HIV 筛查。通过 ELISA 检测 HCV 的血清检测结果显示，2122 份（99.5%）捐献样本呈阴性，而通过 ID-NAT 检测的 2131 份（99.95%）捐献样本呈阴性。在 ELISA 检测呈阳性的样本中，只有一个样本的 NAT 检测呈阳性。在乙型肝炎病毒 ELISA 检测中，2,115 份（99.2 %）捐献样本呈阴性，而在 ID-NAT 检测中，2,115 份（99.2 %）捐献样本的乙型肝炎病毒 DNA 呈阴性。在 ELISA 检测呈阴性的样本中，有两个样本是 ID-NAT 反应性捐献者，由于血清学检测处于窗口期而被漏检。艾滋病毒 ELISA 检测显示 2130 例（99.9%）捐献者为阴性，而 ID-NAT 检测显示 2131 例（99.95%）捐献者为阴性，1 例捐献者为阳性。总之，这是在埃及苏伊士运河和西奈半岛地区开展的第一项评估 ID-NAT 实施重要性的研究。在血库中引入 ID-NAT 是提高输血安全性的有效方法。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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The Egyptian journal of immunology

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