Diagnostic value of loop-mediated isothermal amplification assay for hand, foot, and mouth disease

• Main Authors: Cao, X.-J (Author), Chen, M.-S (Author), Chen, Y.-Z (Author), Guo, X.-G (Author), Li, Y.-P (Author), Zhan, Z.-Q (Author), Zhou, L.-Q (Author)
• Format: Article
• Language: English
• Published: John Wiley and Sons Inc 2021
• Subjects: area under the curve; Article; China; diagnosis; diagnostic accuracy; diagnostic test accuracy study; diagnostic value; Enterovirus A71; false negative result; false positive result; feces analysis; hand foot and mouth disease; Hand, Foot and Mouth Disease; human; Humans; intermethod comparison; loop mediated isothermal amplification; loop-mediated isothermal amplification; medical research; meta analysis; meta-analysis; molecular diagnosis; Molecular Diagnostic Techniques; nucleic acid amplification; Nucleic Acid Amplification Techniques; polymerase chain reaction; Polymerase Chain Reaction; procedures; publication bias; quality control; receiver operating characteristic; reverse transcription polymerase chain reaction; sensitivity and specificity; Sensitivity and Specificity; statistical analysis; systematic review; throat swab
• Online Access: View Fulltext in Publisher
• ISBN: 08878013 (ISSN)
• DOI: 10.1002/jcla.23776

Background: Nowadays, hand, foot, and mouth disease (HFMD) has a significant negative impact on children's health, especially in the Asia-Pacific region. Loop-mediated isothermal amplification assay (LAMP) is a highly efficient and convenient novel tool. However, its diagnostic accuracy for HFMD is still not clear. Therefore, we conducted a meta-analysis in order to evaluate the potential of LAMP assay for the diagnosis of HFMD, in which the reference standard was polymerase chain reaction (PCR). Methods: A protocol was predetermined (CRD42020212882) in PROSPERO. We retrieved seven databases including PubMed for relevant studies published before October 2020. Articles were included if they compared the diagnostic efficiency of LAMP with PCR for HFMD through detecting clinical samples which was more than 15. Statistical analysis was performed by STATA 15.1 software. Risk of bias and applicability were assessed using Quality Assessment of Diagnostic Accuracy Studies. No funding was used for the study. Results: A total of 18 retrospective studies including 2495 samples from China were finally included. Reference standards of them included RT-PCR and non-RT-PCR. The merged sensitivity and specificity with 95% confidence interval (95% CI) were 1.00 (0.97–1.00) and 0.97 (0.88–0.99), respectively. The pooled PLR, NLR, and DOR with 95% CI were 11.17 (5.91–21.11), 0.05 (0.03–0.09), and 538.12 (183.17–1580.83), respectively. The AUC of SROC was 1.00 (95% CI: 0.99–1.00). Conclusion: In conclusion, our research revealed high sensitivity and specificity of LAMP in diagnosing HFMD. However, more high-quality research is required to prove this conclusion. © 2021 The Authors. Journal of Clinical Laboratory Analysis published by Wiley Periodicals LLC