TITLE: Single site, single blind, retrospective and confirmatory clinical trial for the clinical performance of ‘STANDARD F S. pneumoniae Ag FIA’ to calculate clinical sensitivity and specificity and for the comparison with ‘Alere Binax NOW Streptococcus pneumoniae Antigen Card’ in detecting S. pneumoniae antigen in urine”.
Sponsoring agency SD Korea
Project leader Dr. K L Ravi Kumar, Prof. Emeritus Department of Microbiology, KIMSH&RC
Year in which started 2018
Duration in months 6 months
Research Objectives
- To evaluate efficacy with evaluation of clinical sensitivity and specificity of STANDARD F S.pneumoniae Ag FIA for qualitative detection of S. pneumoniae antigen (Ag) for the comparison with Gold standard (Culture method).
- To confirm a clinical performance of investigational device (STANDARD F S.pneumoniae Ag FIA), evaluate a concordance rate in comparison to comparative device (Alere BinaxNOW Streptococcus pneumonia Antigen Card).
Research outcomes
This study observed a significant reduction in the mean number of CFUs in the PureHands group, as compared to the placebo group on days 3, 5 and 7 and a non-significant reduction in the mean number of CFUs in the PureHands groups, as compared to the placebo groups on day 10.
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