Influenza A+B Test Kit Performance Study

Authors
Category Primary study
Registry of Trialsclinicaltrials.gov
Year 2022
Prospective clinical study on the performance of an Influenza A+B rapid test kit. The main goal is to establish the sensitivity and specificity (i.e. how accurate the test is) when compared to a gold standard. Option of participating in this clinical study will be presented to patients displaying influenza-like illness. Informed consent will be collected from patients or patient\'s next of kin/guardian before samples (nasopharyngeal swab) are taken from the patient. Nasopharyngeal swabs are tested using both the investigational test kit and a predicate fluorescence immunoassay test kit. All samples will be tested using a molecular-based PCR test kit as a confirmatory test. The results will be analysed statistically and the performance of the Influenza A+B test kit can be evaluated.
Epistemonikos ID: 0cc83752b47f09a23db4654d58136b5ad2a22f34
First added on: May 22, 2024