xTAG RPP assay is a PCR-based assay to detect the presence or absence of viral and bacterial DNA / RNA in clinical specimens (nasopharyngeal swabs). The objective of this study is to establish diagnostic accuracy of the xTAG RPP.
Study Type
OBSERVATIONAL
Enrollment
1,500
St. Louis Children's Hospital
St Louis, Missouri, United States
North Shore-LIJ Health System Laboratories
Lake Success, New York, United States
Scott and White Memorial Hospital
Temple, Texas, United States
St. Joseph's Hospital
Hamilton, Ontario, Canada
Diagnostic accuracy will be expressed in terms of clinical sensitivity and specificity for each claimed target.
Accuracy determinations (diagnostic sensitivity and specificity, positive and negative agreement) were based on the fraction of comparator positive (or negative) results which were also positive (or negative) by xTAG RPP.
Time frame: Within the first year after sample extraction
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