This year’s coronavirus disease (COVID-19) was challenging to diagnose because its symptoms were similar to the flu. In addition, different tactics for containing and treating the 2 illnesses were required. Thus it was critical that this be done as quickly and accurately as possible. The microfluidic antigen LumiraDx SARS-CoV-2 and Flu A/B Test allows for the simultaneous detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and influenza A/B from a single nose swab; the study examined its sensitivity and specificity in this regard. In the ASPIRE (NCT04557046) and INSPIRE (NCT04288921) investigations, nasal samples were obtained from patients at point-of-care testing sites across the United States. Participants in the ASPIRE research were enrolled if they had recently developed COVID-19 symptoms or if they had a positive SARS-CoV-2 test within the previous 48 hours. Participants in the INSPIRE trial met the inclusion criteria of experiencing influenza symptoms within the previous 4 days. The LumiraDx SARS-CoV-2 and Flu A/B Test were used to analyze the samples after they were extracted into a proprietary buffer. Each person had a reference specimen extracted from them and placed in a universal transport medium before being examined using reference SARS-CoV-2 and influenza RT-PCR kits. Positive and negative percent agreement (PPA and NPA) and their respective 95% (CIs) were used to compare the test and reference samples. The LumiraDx SARS-CoV-2 and Flu A/B Test showed excellent agreement with the reference tests for the detection of SARS-CoV-2 (PPA=95.5% [95% CI 84.9%, 98.7%]; NPA=96.0% [95% CI 90.9%, 98.3%]), influenza A (PPA=83.3% [95% CI 66.4%, 92.7%]; NPA=97.7% While simultaneously detecting and distinguishing between SARS-CoV-2 and influenza A/B, the LumiraDx SARS-CoV-2, and Flu A/B Test demonstrates significant agreement with the reference RT-PCR tests.
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