Applications of SARS-CoV-2 serological testing: impact of test performance, sample matrices, and patient characteristics.

IF 6.6 2区 医学 Q1 MEDICAL LABORATORY TECHNOLOGY Critical reviews in clinical laboratory sciences Pub Date : 2024-01-01 Epub Date: 2024-01-05 DOI:10.1080/10408363.2023.2254390
Chun Yiu Jordan Fung, Mackenzie Scott, Jordan Lerner-Ellis, Jennifer Taher
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Abstract

Laboratory testing has been a key tool in managing the SARS-CoV-2 global pandemic. While rapid antigen and PCR testing has proven useful for diagnosing acute SARS-CoV-2 infections, additional testing methods are required to understand the long-term impact of SARS-CoV-2 infections on immune response. Serological testing, a well-documented laboratory practice, measures the presence of antibodies in a sample to uncover information about host immunity. Although proposed applications of serological testing for clinical use have previously been limited, current research into SARS-CoV-2 has shown growing utility for serological methods in these settings. To name a few, serological testing has been used to identify patients with past infections and long-term active disease and to monitor vaccine efficacy. Test utility and result interpretation, however, are often complicated by factors that include poor test sensitivity early in infection, lack of immune response in some individuals, overlying infection and vaccination responses, lack of standardization of antibody titers/levels between instruments, unknown titers that confer immune protection, and large between-individual biological variation following infection or vaccination. Thus, the three major components of this review will examine (1) factors that affect serological test utility: test performance, testing matrices, seroprevalence concerns and viral variants, (2) patient factors that affect serological response: timing of sampling, age, sex, body mass index, immunosuppression and vaccination, and (3) informative applications of serological testing: identifying past infection, immune surveillance to guide health practices, and examination of protective immunity. SARS-CoV-2 serological testing should be beneficial for clinical care if it is implemented appropriately. However, as with other laboratory developed tests, use of SARS-CoV-2 serology as a testing modality warrants careful consideration of testing limitations and evaluation of its clinical utility.

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严重急性呼吸系统综合征冠状病毒2型血清学检测的应用:检测性能、样本矩阵和患者特征的影响。
实验室检测一直是管理严重急性呼吸系统综合征冠状病毒2型全球大流行的关键工具。虽然快速抗原和PCR检测已被证明可用于诊断急性严重急性呼吸系统综合征冠状病毒2型感染,但还需要额外的检测方法来了解严重急性呼吸系综合征病毒2型感染对免疫反应的长期影响。血清学检测是一种有充分记录的实验室实践,它测量样本中抗体的存在,以揭示有关宿主免疫的信息。尽管血清学检测在临床上的应用以前受到限制,但目前对严重急性呼吸系统综合征冠状病毒2型的研究表明,血清学方法在这些环境中的实用性越来越高。仅举几个例子,血清学检测已被用于识别既往感染和长期活动性疾病的患者,并监测疫苗的疗效。然而,测试的实用性和结果解释往往因以下因素而变得复杂:感染早期测试灵敏度低、一些个体缺乏免疫反应、感染和疫苗接种反应重叠、仪器之间抗体滴度/水平缺乏标准化、提供免疫保护的未知滴度、,并且在感染或接种疫苗后个体间的生物变异较大。因此,本综述的三个主要组成部分将研究(1)影响血清学检测实用性的因素:检测性能、检测矩阵、血清流行率问题和病毒变体;(2)影响血清学反应的患者因素:采样时间、年龄、性别、体重指数、免疫抑制和疫苗接种,(3)血清学检测的信息应用:识别既往感染,指导健康实践的免疫监测,以及保护性免疫检查。如果实施得当,严重急性呼吸系统综合征冠状病毒2型血清学检测应该对临床护理有益。然而,与其他实验室开发的检测一样,使用严重急性呼吸系统综合征冠状病毒2型血清学作为检测模式,需要仔细考虑检测的局限性并评估其临床效用。
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来源期刊
CiteScore
20.00
自引率
0.00%
发文量
25
审稿时长
>12 weeks
期刊介绍: Critical Reviews in Clinical Laboratory Sciences publishes comprehensive and high quality review articles in all areas of clinical laboratory science, including clinical biochemistry, hematology, microbiology, pathology, transfusion medicine, genetics, immunology and molecular diagnostics. The reviews critically evaluate the status of current issues in the selected areas, with a focus on clinical laboratory diagnostics and latest advances. The adjective “critical” implies a balanced synthesis of results and conclusions that are frequently contradictory and controversial.
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