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Molecular Techniques for Diagnosis of Clostridium difficile Infection: Systematic Review and Meta-analysis

      Abstract

      Objective

      To assess the usefulness of 2 rapid molecular diagnostic techniques, polymerase chain reaction (PCR) and loop-mediated isothermal amplification (LAMP), in Clostridium difficile infection (CDI).

      Methods

      We conducted a systematic review and meta-analysis to evaluate the accuracy of PCR and LAMP in diagnosis of CDI, including studies that used toxigenic culture or cytotoxicity assay as reference standard.

      Results

      A search of PubMed and CinAHL medical databases yielded 25 PCR studies, including 11,801 samples that met inclusion criteria and 6 heterogeneous studies that evaluated LAMP. With toxigenic culture as a standard, pooled sensitivity was 0.92 (95% confidence interval [CI], 0.91-0.94); specificity, 0.94 (95% CI, 0.94-0.95); and diagnostic odds ratio, 378 (95% CI, 260-547). With cytotoxicity as a standard, pooled sensitivity was 0.87 (95% CI, 0.84-0.90); specificity, 0.97 (95% CI, 0.97-0.98); and diagnostic odds ratio, 370 (95% CI, 226-606).

      Conclusion

      Polymerase chain reaction is a highly accurate test for identifying CDI. Heterogeneity in LAMP studies did not allow meta-analysis; however, further research into this promising method is warranted.

      Abbreviations and Acronyms:

      CDI (Clostridium difficile infection), CI (confidence interval), DOR (diagnostic odds ratio), FN (false-negative), FP (false-positive), LAMP (loop-mediated isothermal amplification), LR+ (positive likelihood ratio), LR− (negative likelihood ratio), NPV (negative predictive value), PCR (polymerase chain reaction), PPV (positive predictive value), PRISMA (preferred reporting items for systematic meta-analysis), SROC (summary receiver operating curve), TN (true-negative), TP (true-positive)
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