Sensitivity and Specificity of Gram's stain for the detection of Campylobacter spp. in stool
Not Applicable
- Conditions
- Gastrointestinal infection/Campylobacter spp.
- Registration Number
- JPRN-UMIN000038341
- Lead Sponsor
- Tsukuba Medical Center Hospital
- Brief Summary
For the microscopic examination, the sensitivity and specificity were 53.5% and 98.1% for physician A, 46.7% and 96.2% for physician B, 63.0% and 100% for the clinical laboratory technician, and 67.4% and 100% for microbiologists, respectively. The antigen testing was evaluated in 131 of the 205 samples and showed a sensitivity of 93.3% and specificity of 99.0%. Microscopic examination of the stool samples showed high specificity.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 205
Inclusion Criteria
Not provided
Exclusion Criteria
None
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Evaluation of the sensitivity and specificity of stool Gram's stain for the detection of Campylobacter spp.
- Secondary Outcome Measures
Name Time Method 1) To investigate variance between examiners, regarding the diagnostic accuray of Gram's stain for the detection of Campylobacter spp. 2) To assess whether the diagnostic accuracy of Gram's stain improves over time, regarding the detection of Campylobacter spp. 3) To compare the sensitivity and specificity of an antigen testing (Quicknavi-Campylo) with those of stool Gram's stain, regarding the detection of Campylobacter spp. 4) To measure the turn around time of the antigen testing (Quicknavi-Campylo) and to investigate its clinical utility for the the detection of Campylobacter spp. 5) To compare between the physician-estimated disease probabilities (pretest probabilities) of Campylobacter gastroenteritis and the positive rate of stool cultures/nucleic acid amplification test