SARS-CoV-2 & Flu A/B
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SARS-CoV-2 & Flu A/B Specifications For In Vitro Diagnostic Use. Expanded Clinical Dataset - SARS-CoV-2 The LumiraDx SARS-CoV-2 & Flu A/B test is a rapid microfluidic immunofluorescence assay for use with the LumiraDx Platform intended for the simultaneous detection and differentiation of SARS-CoV-2, Influenza A, and/or Influenza B viral antigens direct from nasal swab specimens from individuals suspected of viral infection consistent with COVID-19 by their healthcare provider. Clinical signs and symptoms of respiratory viral infection due to SARS-CoV-2 and Influenza may be similar. Test description DSSO = DAYS SINCE SYMPTOM ONSET PPA- POSITIVE PERCENT AGREEMENT; NPA – NEGATIVE PERCENT AGREEMENT The LumiraDx SARS-CoV-2 & Flu A/B test is a Point of Care rapid microfluidic immunofluorescence assay. The assay uses SARS-CoV/SARS-CoV-2 specific antibodies, Influenza A specific antibodies and Influenza B specific antibodies in individual channel particle-particle sandwich immunoassays to determine the presence of SARS-CoV-2, Influenza A and/or Influenza B Nucleocapsid Protein (NP) antigen present in the test sample. Built-in Quality Controls LumiraDx Platform is integrated with several control checks when starting the Instrument and for every test run to ensure that the Instrument and Test are functioning correctly, including: • Automatically checking the Test Strip expiration date and that adequate specimen volume is added prior to running a test Electrical component operation, heater operation, battery charge state, mechanical actuators and sensors and optical system performance prospectively collected frozen samples were used in this performance evaluation. Samples were collected from Monitoring of the Test Strip performance and controls during test runtime sequentially enrolled subjects who presented with symptoms of Influenza A/B or COVID-19. Ability to perform Quality Control Tests using LumiraDx Quality Control solutions to meet regulatory compliance requirements. Clinical Performance up to 12 days since symptom onset The performance of the LumiraDx SARS-CoV-2 & Flu A/B test was established with anterior nares swabs prospectively collected from individual subjects. Due to the lack of circulating influenza since the start of the COVID-19 pandemic, SARS-CoV-2 & Flu A/B External Quality Controls Positive and Negative Quality Controls are available from LumiraDx to complete Quality Control assessment of the Instrument and Test Strips. The final LoD of the LumiraDx SARS-CoV-2 & Flu A/B test was determined to be the lowest concentration resulting in positive detection of at least 95% of replicates. Based on this testing the LoD for nasal swab specimens was Analytical Performance; Limit of Detection (LoD) confirmed as: STARTING CONCENTRATION VIRUS MATERIAL

CROSS REACTIVITY SARS-CoV-2 & Flu A/B was found not to cross-react with a panel of organisms and viruses including several human coronaviruses. See LumiraDx SARS-CoV-2 & Flu A/B Product Insert for full details. The LumiraDx SARS-CoV-2 & Flu A/B test does not differentiate between SARS-CoV and SARS-CoV-2. Specifications Sample Type Nasal swabs Result Display Qualitative – Positive or Negative Storage Temperature Operating Temperature Relative Humidity See LumiraDx SARS-CoV-2 & Flu A/B Product Insert for details Onboard Control Onboard Quality Control (OBC) assay and sample processing control...