Yijun Li, Fangfang Jin, Yunhui Li, Yan Li, Yajie Wang, Ximing Yang
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Screening-reactive results were confirmed by Western blotting and nucleic acid testing.</p><p><strong>Results: </strong>Total imprecision was within 2.49%-6.56%. The C<sub>5</sub>-C<sub>95</sub> interval was within -10.20%-7.67% away from C<sub>50</sub>. The limit of detection for p24 antigen was <1.00 IU/mL. Using national reference panels and banked sample pools, LiCA<sup>®</sup> successfully detected all negative and positive controls in line with the criteria, and all HIV-positive specimens containing different viral subtypes. In 13 seroconversion panels, LiCA<sup>®</sup> detected reactive results on average 5.73 days (95% CI: 3.42-8.04) after the initial RNA test results were confirmed positive, which was 1.27 days earlier (-3.75 to 1.21) compared to Architect<sup>®</sup>. Paired comparisons in 21,042 clinical patient samples demonstrated that LiCA<sup>®</sup> detected HIV Ag/Ab with a slightly better performance in sensitivity (100.00% vs. 99.65%), specificity (99.85% vs. 99.81%), negative predictive value (NPV, 100.00% vs. 99.99%), and positive predictive value (PPV, 89.84% vs. 87.85%) than Architect<sup>®</sup>. Total agreement between two assays was 99.67% with a kappa value of 0.89.</p><p><strong>Conclusion: </strong>LiCA<sup>®</sup> HIV Ag/Ab is a precise and highly sensitive assay for measuring HIV-1 p24 antigen and HIV-1/2 antibodies with differentiated S/Co values of Ag/Ab. 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引用次数: 0
摘要
目的：本研究的目的是利用光激发化学发光法（LiCA®）评估一种新的人类免疫缺陷病毒抗原和抗体（HIV Ag/Ab）检测的分析和临床性能，并将其与临床环境中完善的Architect®HIV Ag/Ab组合检测进行比较。方法：我们使用银行样本和国家对照来鉴定检测HIV Ag/Ab和不同病毒亚型的能力。测试了13个血清转换组，以评估早期发现艾滋病毒。共收集了21042例患者样本，比较LiCA®和Architect®的诊断性能。筛选反应结果经Western blotting和核酸检测证实。结果：总不精密度在2.49% ~ 6.56%之间。C5-C95区间与C50的距离在-10.20% ~ 7.67%之间。p24抗原的检出限®成功检测出所有符合标准的阴性和阳性对照，以及所有含有不同病毒亚型的hiv阳性标本。在13个血清转化组中，LiCA®在初始RNA检测结果确认为阳性后平均5.73天（95% CI: 3.42-8.04）检测到反应性结果，比Architect®早1.27天（-3.75至1.21）。在21,042例临床患者样本中进行的配对比较表明，LiCA®检测HIV Ag/Ab的灵敏度（100.00% vs. 99.65%）、特异性（99.85% vs. 99.81%）、阴性预测值（NPV, 100.00% vs. 99.99%）和阳性预测值（PPV, 89.84% vs. 87.85%）略优于Architect®。两种检测方法的一致性为99.67%，kappa值为0.89。结论：LiCA®HIV Ag/Ab是一种精确、高灵敏度的检测HIV-1 p24抗原和HIV-1/2抗体的方法，具有不同的Ag/Ab S/Co值。该检测方法适用于早期检测HIV的临床常规检测。
Evaluation of a new human immunodeficiency virus antigen and antibody test using light-initiated chemiluminescent assay.
Objectives: The goal of this study is to evaluate the analytical and clinical performance of a new human immunodeficiency virus antigen and antibody (HIV Ag/Ab) test using light-initiated chemiluminescent assay (LiCA®) and compare it with the well-established Architect® HIV Ag/Ab combo assay in a clinical setting.
Methods: We used banked samples and national reference controls to identify the ability to detect HIV Ag/Ab and different viral subtypes. Thirteen seroconversion panels were tested to evaluate early detection of HIV. A total of 21,042 patient samples were collected to compare the diagnostic performance of LiCA® with Architect®. Screening-reactive results were confirmed by Western blotting and nucleic acid testing.
Results: Total imprecision was within 2.49%-6.56%. The C5-C95 interval was within -10.20%-7.67% away from C50. The limit of detection for p24 antigen was <1.00 IU/mL. Using national reference panels and banked sample pools, LiCA® successfully detected all negative and positive controls in line with the criteria, and all HIV-positive specimens containing different viral subtypes. In 13 seroconversion panels, LiCA® detected reactive results on average 5.73 days (95% CI: 3.42-8.04) after the initial RNA test results were confirmed positive, which was 1.27 days earlier (-3.75 to 1.21) compared to Architect®. Paired comparisons in 21,042 clinical patient samples demonstrated that LiCA® detected HIV Ag/Ab with a slightly better performance in sensitivity (100.00% vs. 99.65%), specificity (99.85% vs. 99.81%), negative predictive value (NPV, 100.00% vs. 99.99%), and positive predictive value (PPV, 89.84% vs. 87.85%) than Architect®. Total agreement between two assays was 99.67% with a kappa value of 0.89.
Conclusion: LiCA® HIV Ag/Ab is a precise and highly sensitive assay for measuring HIV-1 p24 antigen and HIV-1/2 antibodies with differentiated S/Co values of Ag/Ab. The assay is appropriate for use in the clinical routine test for the early detection of HIV.
期刊介绍：
Frontiers in Cellular and Infection Microbiology is a leading specialty journal, publishing rigorously peer-reviewed research across all pathogenic microorganisms and their interaction with their hosts. Chief Editor Yousef Abu Kwaik, University of Louisville is supported by an outstanding Editorial Board of international experts. This multidisciplinary open-access journal is at the forefront of disseminating and communicating scientific knowledge and impactful discoveries to researchers, academics, clinicians and the public worldwide.
Frontiers in Cellular and Infection Microbiology includes research on bacteria, fungi, parasites, viruses, endosymbionts, prions and all microbial pathogens as well as the microbiota and its effect on health and disease in various hosts. The research approaches include molecular microbiology, cellular microbiology, gene regulation, proteomics, signal transduction, pathogenic evolution, genomics, structural biology, and virulence factors as well as model hosts. Areas of research to counteract infectious agents by the host include the host innate and adaptive immune responses as well as metabolic restrictions to various pathogenic microorganisms, vaccine design and development against various pathogenic microorganisms, and the mechanisms of antibiotic resistance and its countermeasures.
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