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
| Autor: | Yu Li, Peng Cui, Yibing Cheng, Mengyao Zeng, Yu Jing, Tianchen Zhang, Junmei Yang, Di Kang, Hongjie Yu, Lu Long, Jianli Yang, Yonghong Zhou, Lu Liang, Ninghua Cui, Chongchen Zhou, Qi Qiu, Chunlan Song, Qianqian Liu, Chun Guo |
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| Rok vydání: | 2020 |
| Předmět: |
0301 basic medicine
medicine.medical_specialty 030106 microbiology Context (language use) Enzyme-Linked Immunosorbent Assay medicine.disease_cause Herpangina 03 medical and health sciences 0302 clinical medicine Virology Internal medicine Epidemiology medicine Humans Medical history 030212 general & internal medicine Prospective Studies Child Enterovirus Foot-and-mouth disease business.industry medicine.disease Enterovirus A Human Vaccination Infectious Diseases Immunoglobulin M Cohort business Hand Foot and Mouth Disease Child Hospitalized |
| Zdroj: | Journal of clinical virology : the official publication of the Pan American Society for Clinical Virology. 130 |
| ISSN: | 1873-5967 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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