Clinical Validation of the LumiraDx SARS-CoV-2 & Flu A/B Test in Detecting and Differentiating Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), Influenza A (Flu A), and/or Influenza B (Flu B)

Overview

This is a prospective multicenter study conducted to evaluate the performance of the LumiraDx SARS-CoV-2 \& Flu A/B tests at point of care sites. Subjects presenting with symptoms suggestive of coronavirus disease 2019 (COVID-19) and Influenza at the time of the study visit will be enrolled and asked to donate swab sample(s) for testing on the device under evaluation.

This will be a prospective study at point of care sites in the United States for the clinical validation of the LumiraDx SARS-CoV-2 \& Flu A/B test for the differential detection of the SARS-CoV-2, and influenza A \& B using anterior nasal samples. Up to 1,500 or more symptomatic subjects who are currently experiencing symptoms associated with COVID-19 and Influenza A \& B may be enrolled. The samples are obtained from each subject using standard collection methods and are processed and tested by untrained operators without laboratory training and with no prior experience using the candidate test. The primary objective of this study is to evaluate the performance (positive percent agreement, negative percent agreement and 95% confidence intervals for upper and lower bounds) of the LumiraDx SARS-CoV-2 \& Flu A/B test for the qualitative and differential detection of SARS-CoV-2, Influenza A \& B virus antigen using anterior nares samples collected by a healthcare professional, compared to a 510(k) cleared or Emergency Use Authorized (EUA) high-sensitivity reverse transcription-polymerase chain reaction (RT-PCR) test for COVID-19 and a 510(k) cleared Influenza A/B test. The secondary objective is to assess the usability and user accuracy/performance around limit of detection (LoD) of the investigational test using a questionnaire and accuracy study.

Conditions