![]() The principle of the TC test is to detect strains of C. Currently, two tests, TC and the CCNA, serve as reference methods for the diagnosis of C. ![]() These include toxigenic culture (TC) the cell cytotoxicity neutralization assay (CCNA) enzyme immunoassays (EIAs) and immunochromatographic assays for the detection of glutamate dehydrogenase (GDH), toxin A or B, or both toxins and, within the last 10 years, nucleic acid amplification tests (NAATs). Several laboratory assays are available to support CDI diagnosis in combination with clinical presentation. Current laboratory practice is not standardized, with wide variation in test methods and diagnostic algorithms. difficileīest practices for laboratory diagnosis of CDI remain controversial ( 14). Quality Gap: Factors Associated with the Laboratory Diagnosis of C. Consequently, among patients presenting with diarrhea, there is significant potential for underdiagnosis or overdiagnosis as can arise from incorrect diagnostic workups ( 13). Accurate diagnosis of CDI is critical for appropriate patient management and reduction of harms that may arise from diagnostic error ( 12) and is critical for implementation of infection control measures to prevent transmission ( 11). The diagnosis of CDI requires the combination of appropriate test ordering and accurate laboratory testing to differentiate CDI from non-CDI diarrheal cases, including non-CDI diarrhea in a C. The cost of hospital-associated CDI ranges from $10,000 to $20,000 per case ( 4, – 7) and $500 million to $1.5 billion per year nationally ( 1, 4, 5, 8, – 10).Īccurate diagnosis of CDI is critical for effective patient management and implementation of infection control measures to prevent transmission ( 11). This adds a significant burden to the health care system by increasing the length of hospital stay and readmission rates, with significant financial implications. difficile as a health care-associated infection (HAI) is associated with increased morbidity and mortality. It accounts for 15% to 25% of health care-associated diarrhea cases in all health care settings, with 453,000 documented cases of CDI and 29,000 deaths in the United States in 2015 ( 3). 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.Ĭlostridioides ( Clostridium) difficile infection (CDI) is the leading cause of health care-associated infections in the United States ( 1, 2). 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. ![]() 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 C. 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 C. The strength of evidence ranged from high to insufficient. Seventy-two of these studies had sufficient data for meta-analysis. Two hundred thirty-eight studies met inclusion criteria. The diagnostic yield of NAAT for repeat testing after an initial negative result was also assessed. The systematic review and meta-analysis included eligible studies (those that had PICO elements) that assessed the diagnostic accuracy of NAAT alone or following glutamate dehydrogenase (GDH) enzyme immunoassays (EIAs) or GDH EIAs plus C. This systematic review evaluates the diagnostic accuracy of laboratory testing algorithms that include nucleic acid amplification tests (NAATs) to detect the presence of C. The evidence base for the optimal laboratory diagnosis of Clostridioides ( Clostridium) difficile in adults is currently unresolved due to the uncertain performance characteristics and various combinations of tests. ![]()
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