Evaluation of the diagnostic performance and its associated factors of a commercial anti-EV-A71 IgM-capture ELISA kit in hospitalized children with clinical diagnostic HFMD

• Published in: Journal of clinical virology Vol. 130; p. 104582
• Main Authors: Zhang, Tianchen, Cheng, Yibing, Li, Yu, Yang, Junmei, Liang, Lu, Yang, Jianli, Cui, Peng, Song, Chunlan, Zhou, Yonghong, Kang, Di, Qiu, Qi, Cui, Ninghua, Guo, Chun, Jing, Yu, Zeng, Mengyao, Liu, Qianqian, Long, Lu, Zhou, Chongchen, Yu, Hongjie
• Format: Journal Article
• Language: English
• Published: Netherlands Elsevier B.V 01.09.2020
• Subjects: Diagnosis; ELISA; Enterovirus; EV-A71; Foot and mouth disease; Hand; IgM; EV-A71; Foot and mouth disease; Enterovirus; Diagnosis; Hand; IgM; ELISA
• ISSN: 1386-6532; 1873-5967
• DOI: 10.1016/j.jcv.2020.104582

•The detection yield of a commercial EV-A71 IgM-capture ELISA kit increased with increasing time between symptom onset and sample collection.•The overall sensitivity, specificity, PPV and NPV of this commercial EV-A71 IgM-capture ELISA kit were 0.61, 0.94, 0.62 and 0.94, respectively.•First time found previous vaccination against EV-A71 was significantly associated with the diagnostic performance of anti EV-A71 IgM-capture ELISA Enterovirus A71 (EV-A71) is the main pathogen of severe hand, foot, and mouth disease (HFMD). Commercial enzyme-linked immunosorbent assays (ELISAs) are widely used in Chinese hospitals for the rapid diagnosis of acute EV-A71 infections. We present an evaluation of the diagnostic performance of a commercial anti-EV-A71 IgM-capture ELISA kit. A prospective, hospital-based HFMD cohort was established in Henan Children's Hospital (February 2017 - February 2018). Stool and blood specimens were collected from 1413 participants for diagnosing EVA71 by quantitative Real-Time Reverse Transcription-Polymerase Chain Reaction (qRT-PCR) and anti-EV-A71 ELISA. Detection yields of EV-A71 IgM increased from 6.5 % (95 % CI:3.3 %–11.4 %) at 0∼24 h, to 42 % (95 % CI:28.3 %–57.8) at 120∼144 h from onset to sampling, and stabilized at ∼40 % after 144 h. With increased time from onset to sampling, the sensitivity of the commercial ELISA increased from 0.54 (95 % CI:0.25−0.81) to 0.74 (95 % CI:0.43−0.66), while specificity decreased from 0.97 (95 % CI:0.93−0.99) to 0.80 (95 % CI:0.69−0.89), and PPV decreased from 0.96 (95 % CI:0.92−0.99) to 0.84 (95 % CI:0.73−0.92). Multivariate analysis found age, EV-A71 vaccination, previous HFMD/Herpangina infection, disease severity, infection during peak EV-A71 season, and sampling time after symptom onset were significantly associated with the diagnostic performance of this anti-EV-A71 IgM-capture ELISA. Achieving satisfactory specificity and sensitivity scores, this commercial anti-EV-A71 IgM-capture ELISA kit is suitable for clinical EV-A71 diagnosis, particularly in resource-poor areas. However, clinicians should interpret results in the context of patient history and epidemiological setting.