Nasrallah Gheyath K, Younes Salma, Younes Nadin, Nizamuddin Parveen B, Alabdulmalek Maryam A, Mohammad Khadija N, Chaar Dayana El, Elshaikh Manal, Abouassali Mazen Najib, Karimeh Ibrahim Wissam, Ibrahim Mohammed Abdelfatah, Ali Mutaz Mohamed, Shaar Ibrahim Al, Louyin Zhu, Ammaranond Palanee, Abu-Raddad Laith J, Ismail Ahmed
Department of Biomedical Sciences, College of Health Sciences, Q.U. health, Qatar University, Doha, Qatar.
Biomedical Research Center, Qatar University, Doha, Qatar.
IJID Reg. 2024 Dec 26;14:100561. doi: 10.1016/j.ijregi.2024.100561. eCollection 2025 Mar.
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.
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.
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.
Mindray CL-900i could offer a cost-effective alternative for HBsAg screening, boasting perfect specificity and overcoming the limitations of current automated assays.
化学发光免疫分析法自动化雅培ARCHITECT乙肝表面抗原（HBsAg）筛查检测因其卓越的灵敏度而在全球得到认可，但特异性显著较低。这就要求通过另一种确证检测来确认阳性结果，比如广泛使用的雅培ARCHITECT HBsAg中和检测。本研究旨在评估新型化学发光免疫分析法迈瑞CL-900i HBsAg筛查检测与ARCHITECT中和/确证检测相比的性能。
本研究选取了总共200份经ARCHITECT筛查的HBsAg阳性和阴性存档样本。这些样本分类如下：真阳性（n = 39）：经ARCHITECT筛查和确证检测均为阳性；真阴性（n = 144）：经ARCHITECT筛查和确证检测均为阴性；假阳性（n = 17）：经ARCHITECT筛查为阳性但经确证检测为阴性。所有样本均使用迈瑞CL-900i HBsAg筛查检测进行重新检测。
与ARCHITECT确证检测相比，迈瑞HBsAg CL-900i与确证检测显示出完美一致性，科恩κ值为0.98（0.95 - 1.02）。迈瑞CL-900i的灵敏度为97%，阳性预测值为100%，阴性预测值为99%。特异性为100%，因为没有一个真阴性和假阳性结果被判定为阳性。
迈瑞CL-900i可为HBsAg筛查提供一种经济高效的替代方法，具有完美的特异性，克服了当前自动化检测的局限性。
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