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Diagnostic value of loop-mediated isothermal amplification assay for hand, foot, and mouth disease
Ying-Zhou Chen1,2, Zhi-Qing Zhan1,3, Li-Quan Zhou1,2
1Department of Clinical Laboratory Medicine, The Third Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.
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.
Insights
Loop-mediated isothermal amplification (LAMP) assay shows high accuracy in diagnosing hand, foot, and mouth disease (HFMD) in children. This meta-analysis confirms LAMP
Area of Science:
- Medical Diagnostics
- Molecular Biology
- Infectious Diseases
Background:
- Hand, foot, and mouth disease (HFMD) significantly impacts child health, particularly in the Asia-Pacific region.
- Loop-mediated isothermal amplification (LAMP) assay is a novel, efficient diagnostic tool.
- The diagnostic accuracy of LAMP for HFMD requires clarification.
Purpose of the Study:
- To evaluate the diagnostic potential of LAMP assay for HFMD.
- To compare LAMP diagnostic efficiency against the reference standard, polymerase chain reaction (PCR).
Main Methods:
- A systematic meta-analysis was conducted following a predetermined protocol (CRD42020212882).
- Seven databases, including PubMed, were searched for studies published before October 2020.
- Included studies compared LAMP and PCR for HFMD diagnosis using clinical samples (n>15).
- Quality assessment and statistical analysis were performed using established tools and software (STATA 15.1).
Main Results:
- Eighteen retrospective studies with 2495 samples were analyzed.
- Pooled sensitivity and specificity for LAMP were 1.00 (95% CI: 0.97-1.00) and 0.97 (95% CI: 0.88-0.99), respectively.
- High diagnostic accuracy was indicated by pooled positive likelihood ratio (PLR), negative likelihood ratio (NLR), diagnostic odds ratio (DOR), and area under the summary receiver operating characteristic curve (AUC of SROC).
Conclusions:
- LAMP assay demonstrates high sensitivity and specificity for diagnosing HFMD.
- Further high-quality research is recommended to validate these findings.
- LAMP shows promise as a reliable diagnostic tool for HFMD.
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