1627
Diagnostic Accuracy of Loop-Mediated Isothermal DNA Amplification (LAMP) Assay for Detection of Clostridium difficile Infection (CDI): a Meta-Analysis

Abstract

Background.  Nucleic acid amplification tests including real-time polymerase chain reaction and loop-mediated isothermal DNA amplification (LAMP) are currently used as standalone diagnostic tests of C. difficileinfection (CDI) in the United States. These assays are reported to have similar sensitivity and specificity to toxigenic culture. The aim of this meta-analysis study is to evaluate the diagnostic accuracy of LAMP in detecting CDI. Methods.  We searched MEDLINE and 4 other databases to identify diagnostic accuracy studies that compared LAMP with cell culture cytotoxicity neutralization assay (CCCNA) or anaerobic toxigenic culture (TC) of C. difficilefrom database inception to 2013. Screening for inclusion, data extraction, and quality assessment were carried out independently by 2 investigators and disagreements resolved. Data in the tables, figures, or text were independently extracted by 2 authors. We used the Mantel-Haenszel (MH) random effects model to calculate summary receiver operating characteristic curves, diagnostic odds ratios and their 95% CIs. Results.  A search of the databases yielded 16 studies (6,798 samples) that met the inclusion criteria. When TC was used as the gold standard (n= 14), the pooled sensitivity was 0.95 (95% CI, 0.93-0.96; I 2 = 37.7); specificity, 0.98 (95% CI, 0.97-0.98; I 2 = 94); and diagnostic odds ratio, 1180 (95% CI, 537-2592; I 2 = 62.2). With CCCNA as a gold standard (n = 3), the pooled sensitivity was 0.90 (95% CI, 0.82-0.95; I 2 = 64.8); specificity, 0.95 (95% CI, 0.92-0.97; I 2 = 94.8); and diagnostic odds ratio, 346 (95% CI, 95-1255; I 2 = 0). Conclusion.  LAMP appears to have high diagnostic accuracy for identifying CDI. Although there was high heterogeneity among the studies, this meta-analysis suggests that LAMP is a useful diagnostic tool with high sensitivity and specificity for detecting CDI. Disclosures.   All authors: No reported disclosures.