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

Tianchen Zhang; Yibing Cheng; Yu Li; Junmei Yang; Lu Liang; Jianli Yang; Peng Cui; Chunlan Song; Yonghong Zhou; Di Kang; Qi Qiu; Ninghua Cui; Chun Guo; Yu Jing; Mengyao Zeng; Qianqian Liu; Lu Long; Chongchen Zhou; Hongjie Yu

doi:10.1016/j.jcv.2020.104582

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

J Clin Virol. 2020 Sep:130:104582. doi: 10.1016/j.jcv.2020.104582. Epub 2020 Aug 7.

Authors

Tianchen Zhang¹, Yibing Cheng², Yu Li³, Junmei Yang⁴, Lu Liang⁵, Jianli Yang⁴, Peng Cui⁶, Chunlan Song⁷, Yonghong Zhou⁶, Di Kang⁴, Qi Qiu⁶, Ninghua Cui⁴, Chun Guo⁸, Yu Jing², Mengyao Zeng⁶, Qianqian Liu⁴, Lu Long⁵, Chongchen Zhou⁹, Hongjie Yu¹⁰

Affiliations

¹ Division of Infectious Disease, Key Laboratory of Surveillance and Early-Warning on Infectious Disease, Chinese Center for Disease Control and Prevention, Beijing 102206, China; Emergency Office and Acute Infectious Disease Prevention Institute, Jiangxi Province Center for Disease Control and Prevention, Nanchang 330029, China.
² Zhengzhou Children's Critical Medical Key Laboratory, Children's Hospital Affiliated to Zhengzhou University, Children's Hospital of Henan Province, Zhengzhou 450003, China.
³ Division of Infectious Disease, Key Laboratory of Surveillance and Early-Warning on Infectious Disease, Chinese Center for Disease Control and Prevention, Beijing 102206, China.
⁴ Department of Clinical Laboratory, Children's Hospital Affiliated to Zhengzhou University, Children's Hospital of Henan Province, Zhengzhou 450003, China.
⁵ West China School of Public Health, Sichuan University, Chengdu 610041, China.
⁶ Key Laboratory of Public Health Safety, Ministry of Education, School of Public Health, Fudan University, Shanghai 200032, China.
⁷ Department of Infectious Diseases, Children's Hospital Affiliated to Zhengzhou University, Children's Hospital of Henan Province, Zhengzhou 450003, China.
⁸ Department of Epidemiology and Biostatistics, School of Public Health, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430030, China.
⁹ Zhengzhou Children's Critical Medical Key Laboratory, Children's Hospital Affiliated to Zhengzhou University, Children's Hospital of Henan Province, Zhengzhou 450003, China. Electronic address: [email protected].
¹⁰ Key Laboratory of Public Health Safety, Ministry of Education, School of Public Health, Fudan University, Shanghai 200032, China. Electronic address: [email protected].

PMID: 32795960
DOI: 10.1016/j.jcv.2020.104582

Abstract

Objectives: 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.

Methods: 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.

Results: 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.

Conclusion: 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.

Keywords: Diagnosis; ELISA; EV-A71; Enterovirus; Foot and mouth disease; Hand; IgM.

Publication types

Research Support, Non-U.S. Gov't

MeSH terms

Child
Child, Hospitalized
Enterovirus A, Human*
Enterovirus*
Enzyme-Linked Immunosorbent Assay
Hand, Foot and Mouth Disease* / diagnosis
Humans
Immunoglobulin M
Prospective Studies

Substances

Immunoglobulin M