Accuracy of loop-mediated isothermal amplification for the diagnosis of Clostridium difficile infection: a systematic review

Aaron Lloyd; Vinay Pasupuleti; Priyaleela Thota; Chaitanya Pant; David D K Rolston; Adrian V Hernandez; Vicente A Benites-Zapata; Thomas G Fraser; Curtis J Donskey; Abhishek Deshpande

doi:10.1016/j.diagmicrobio.2015.02.007

Accuracy of loop-mediated isothermal amplification for the diagnosis of Clostridium difficile infection: a systematic review

Diagn Microbiol Infect Dis. 2015 May;82(1):4-10. doi: 10.1016/j.diagmicrobio.2015.02.007. Epub 2015 Feb 23.

Affiliations

¹ Department of Medicine, School of Medicine, Case Western Reserve University, Cleveland, OH, USA.
² Department of Gastroenterology, University of Kansas Medical Center, Kansas City, KS, USA.
³ Department of Internal Medicine, Geisinger Medical Center, Danville, PA, USA.
⁴ Health Outcomes and Clinical Epidemiology Section, Department of Quantitative Health Sciences, Lerner Research Institute, Cleveland Clinic, Cleveland, OH, USA; Postgraduate and Medical Schools, Universidad Peruana de Ciencias Aplicadas (UPC), Lima, Peru.
⁵ Faculty of Human Medicine, Postgraduate Section, Universidad de San Martin de Porres, Lima, Peru.
⁶ Department of Infectious Diseases, Medicine Institute, Cleveland Clinic, Cleveland, OH, USA.
⁷ Department of Medicine, School of Medicine, Case Western Reserve University, Cleveland, OH, USA; Geriatric Research Education and Clinical Center, Cleveland VA Medical Center, Cleveland, OH, USA.
⁸ Department of Infectious Diseases, Medicine Institute, Cleveland Clinic, Cleveland, OH, USA; Medicine Institute Center for Value Based Care Research, Cleveland Clinic, Cleveland, OH, USA. Electronic address: abhishekdp@gmail.com.

PMID: 25752201
DOI: 10.1016/j.diagmicrobio.2015.02.007

Abstract

Loop-mediated isothermal DNA amplification (LAMP) is currently used as standalone diagnostic test for C. difficile infection (CDI). We assessed the diagnostic accuracy of LAMP for the diagnosis of CDI. We searched 5 databases to identify studies that compared LAMP with culture cytotoxicity neutralization assay or anaerobic toxigenic culture (TC) of C. difficile. We used the random-effects model to calculate pooled sensitivities, specificities, diagnostic odds ratios, and their 95% confidence intervals (CIs). The search of the databases yielded 16 studies (6979 samples) that met inclusion criteria. When TC was used as the gold standard (6572 samples), bivariate analysis yielded a mean sensitivity of 0.95 (95% CI, 0.93-0.97; I(2)=67.4) and a mean specificity of 0.99 (95% CI, 0.96-1.00; I(2)=97.0). LAMP is a useful diagnostic tool with high sensitivity and specificity for detecting CDI. The results should, however, be interpreted only in the presence of clinical suspicion and symptoms of CDI.

Keywords: C. difficile; CDI; Diagnostic accuracy; LAMP; Sensitivity; Specificity.

Publication types

Evaluation Study
Review
Systematic Review

MeSH terms

Clostridioides difficile / genetics
Clostridioides difficile / isolation & purification*
Clostridium Infections / diagnosis*
Clostridium Infections / microbiology
Diarrhea / diagnosis*
Diarrhea / microbiology
Humans
Molecular Diagnostic Techniques / methods*
Nucleic Acid Amplification Techniques / methods*
Sensitivity and Specificity