Mindray CL-900i assay: An effective assay for hepatitis B surface antigen screening with superior specificity

IF 1.5 Q4 INFECTIOUS DISEASES

IJID regions Pub Date : 2024-12-26 DOI:10.1016/j.ijregi.2024.100561

Gheyath K. Nasrallah , Salma Younes , Nadin Younes , Parveen B. Nizamuddin , Maryam A. Alabdulmalek , Khadija N. Mohammad , Dayana El Chaar , Manal Elshaikh , Mazen Najib Abouassali , Ibrahim Wissam Karimeh , Mohammed Abdelfatah Ibrahim , Mutaz Mohamed Ali , Ibrahim Al Shaar , Zhu Louyin , Palanee Ammaranond , Laith J. Abu-Raddad , Ahmed Ismail

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引用次数: 0

Abstract

Objectives

The chemiluminescence immunoassay automated Abbott ARCHITECT hepatitis B surface antigen (HBsAg) screening assay is globally recognized for its superior sensitivity but notably low specificity. This mandates positive results confirmation by another confirmatory assay, such as the widely used Abbott ARCHITECT HBsAg neutralizing assay. This study aimed to evaluate the performance of the new chemiluminescence immunoassay, Mindray CL-900i HBsAg screening assay in comparison to the ARCHITECT neutralizing/confirmatory assay.

Methods

A total of 200 archived HBsAg-positive and -negative samples by ARCHITECT screening were selected for this study. These samples were classified as follows: true positive (n = 39): positive by ARCHITECT screening and confirmatory assays, true negative (n = 144): negative by ARCHITECT screening and confirmatory assays, and false positive (n = 17): positive by ARCHITECT screening but negative by confirmatory assay. All samples were retested using the Mindray CL-900i HBsAg screening assay.

Results

Compared with ARCHITECT confirmatory assay, the Mindray HBsAg CL-900i demonstrated perfect agreement with the confirmatory assay, as indicated by a Cohen κ value of 0.98 (0.95-1.02). Mindray CL-900i exhibited a sensitivity of 97%, positive predictive value of 100%, and negative predictive value of 99%. The specificity was 100% because none of the true-negative and false-positive results were identified as positive.

Conclusions

Mindray CL-900i could offer a cost-effective alternative for HBsAg screening, boasting perfect specificity and overcoming the limitations of current automated assays.

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迈瑞CL-900i试验：一种有效的乙型肝炎表面抗原筛选试验，具有优越的特异性。

目的：化学发光免疫测定自动化Abbott ARCHITECT乙型肝炎表面抗原（HBsAg）筛选试验因其高灵敏度而获得全球认可，但特异性明显较低。这就要求通过另一种验证性试验来确认阳性结果，例如广泛使用的雅培ARCHITECT HBsAg中和试验。本研究旨在评估新的化学发光免疫分析法，迈瑞CL-900i HBsAg筛选试验与ARCHITECT中和/验证试验的性能。方法：选取经ARCHITECT筛选的归档hbsag阳性和阴性样本200份。这些样本分类如下：真阳性（n = 39）：通过ARCHITECT筛选和验证试验为阳性，真阴性（n = 144）：通过ARCHITECT筛选和验证试验为阴性，假阳性（n = 17）：通过ARCHITECT筛选为阳性，但通过验证试验为阴性。所有样本使用迈瑞CL-900i HBsAg筛选法重新检测。结果：与ARCHITECT验证性试验比较，迈瑞HBsAg CL-900i与验证性试验完全吻合，Cohen κ值为0.98（0.95-1.02）。迈瑞CL-900i的敏感性为97%，阳性预测值为100%，阴性预测值为99%。特异性为100%，因为没有真阴性和假阳性结果被确定为阳性。结论：迈瑞CL-900i可提供一种低成本的HBsAg筛查替代方法，具有完美的特异性，克服了当前自动化检测方法的局限性。

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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