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
; 130: 104582, 2020 09.
Article
em En
| MEDLINE
| ID: mdl-32795960
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 % CI3.3 %-11.4 %) at 0â¼24â¯h, to 42 % (95 % CI28.3 %-57.8) at 120â¼144â¯h from onset to sampling, and stabilized at â¼40 % after 144â¯h. With increased time from onset to sampling, the sensitivity of the commercial ELISA increased from 0.54 (95 % CI0.25-0.81) to 0.74 (95 % CI0.43-0.66), while specificity decreased from 0.97 (95 % CI0.93-0.99) to 0.80 (95 % CI0.69-0.89), and PPV decreased from 0.96 (95 % CI0.92-0.99) to 0.84 (95 % CI0.73-0.92). 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.Palavras-chave
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Base de dados:
MEDLINE
Assunto principal:
Enterovirus
/
Enterovirus Humano A
/
Doença de Mão, Pé e Boca
Tipo de estudo:
Diagnostic_studies
/
Observational_studies
/
Risk_factors_studies
Limite:
Child
/
Humans
Idioma:
En
Ano de publicação:
2020
Tipo de documento:
Article