A Laboratory Medicine Best Practices Systematic Review and Meta-analysis of Nucleic Acid Amplification Tests (NAATs) and Algorithms Including NAATs for the Diagnosis of Clostridioides (Clostridium) difficile in Adults

Details

• Alternative Title:
  Clin Microbiol Rev
• Personal Author:
  Kraft, Colleen S. ; Parrott, J. Scott ; Cornish, Nancy E. ; Rubinstein, Matthew L. ; Weissfeld, Alice S. ; McNult, Peggy ; Nachamkin, Irving ; Humphries, Romney M. ; Kirn, Thomas J. ; Dien Bard, Jennifer ; Lutgring, Joseph D. ; Gullett, Jonathan C. ; Bittencourt, Cassiana E. ; Benson, Susan ; Bobenchik, April M. ; Sautter, Robert L. ; Baselski, Vickie ; Atlas, Michel C. ; Marlowe, Elizabeth M. ; Miller, Nancy S. ; Fischer, Monika ; Richter, Sandra S. ; Gilligan, Peter ; Snyder, James W.
• Description:
  The evidence base for the optimal laboratory diagnosis of | (|) | in adults is currently unresolved due to the uncertain performance characteristics and various combinations of tests. This systematic review evaluates the diagnostic accuracy of laboratory testing algorithms that include nucleic acid amplification tests (NAATs) to detect the presence of | The systematic review and meta-analysis included eligible studies (those that had PICO [population, intervention, comparison, outcome] elements) that assessed the diagnostic accuracy of NAAT alone or following glutamate dehydrogenase (GDH) enzyme immunoassays (EIAs) or GDH EIAs plus | toxin EIAs (toxin). The diagnostic yield of NAAT for repeat testing after an initial negative result was also assessed. Two hundred thirty-eight studies met inclusion criteria. Seventy-two of these studies had sufficient data for meta-analysis. The strength of evidence ranged from high to insufficient. The uses of NAAT only, GDH-positive EIA followed by NAAT, and GDH-positive/toxin-negative EIA followed by NAAT are all recommended as American Society for Microbiology (ASM) best practices for the detection of the | toxin gene or organism. Meta-analysis of published evidence supports the use of testing algorithms that use NAAT alone or in combination with GDH or GDH plus toxin EIA to detect the presence of | in adults. There is insufficient evidence to recommend against repeat testing of the sample using NAAT after an initial negative result due to a lack of evidence of harm (i.e., financial, length of stay, or delay of treatment) as specified by the Laboratory Medicine Best Practices (LMBP) systematic review method in making such an assessment. Findings from this systematic review provide clarity to diagnostic testing strategies and highlight gaps, such as low numbers of GDH/toxin/PCR studies, in existing evidence on diagnostic performance, which can be used to guide future clinical research studies.
• Subjects:
  Algorithms Benchmarking C. Difficile Infection Clinical Microbiology Best Practices Clostridioides Difficile Clostridium Infections Diagnostic Accuracy Humans Laboratory Diagnosis Meta-analysis Nucleic Acid Amplification Techniques Systematic Review

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• Source:
  Clin Microbiol Rev. 2019; 32(3)
• Pubmed ID:
  31142497
• Pubmed Central ID:
  PMC6589859
• Document Type:
  Journal Article
• Funding:
  U47 OE000055/OE/OSELS CDC HHSUnited States/
• Volume:
  32
• Issue:
  3
• Collection(s):
  CDC Public Access
• Main Document Checksum:
  urn:sha256:4c24d4bb93f191734176cb8086760ebdd87a9cfc0be817e611e9d3e4ff3186c5
• Download URL:
  https://stacks.cdc.gov/view/cdc/121625/cdc_121625_DS1.pdf
• File Type:
  [PDF - 5.39 MB ]