The Biopanda COVID-19/Influenza A+B/RSV Antigen Combo Rapid Test is a qualitative lateral flow immunoassay designed to detect SARS-CoV-2 (COVID-19), Influenza A, Influenza B and Respiratory Syncytial Virus (RSV) antigens in human nasopharyngeal swab samples. It is intended to assist in the diagnosis of these respiratory infections in conjunction with other tests. 

The test uses a nasopharyngeal swab specimen. The kit includes sterile swabs as well as the extraction tubes and extraction buffer required to process the specimen. 

Results should be read at 15 minutes. Results should not be interpreted after 20 minutes, as a false-positive line may appear. 

Yes. The combination test is designed to detect antigens associated with all 3 respiratory infections from a single processed nasopharyngeal swab specimen. Each result window should be interpreted independently. 

A positive result is indicated when a control line appears together with a coloured test line in the relevant test region. Any shade of colour in a test region should be considered positive. The test uses separate regions to distinguish the targets, with T1 corresponding to RSV/Influenza B and T2 corresponding to COVID-19/Influenza A in their respective result windows. 

No. A negative result does not rule out infection. The viral load may be too low at the time of testing, or specimen quality may affect the result. Results should therefore be considered alongside clinical information, including symptoms, exposure history and other test results. If symptoms persist following a negative result, the IFU recommends retesting after a few days or using a molecular diagnostic test to rule out infection. 

Clinical evaluation against RT-PCR reported relative sensitivity/specificity of 96.4%/99.0% for COVID-19, 93.2%/96.2% for RSV, 99.1%/98.9% for Influenza A, and 97.5%/99.0% for Influenza B. The respective reported accuracies were 98.2%, 96.1%, 99.0% and 98.6%. 

Store the kit at 2–30°C in a cool, dry place away from direct sunlight. The kit should not be frozen, and refrigeration is not required. Unopened test cassettes are stable until the expiry date printed on the foil pouch. 

No. The test is for in vitro diagnostic use by trained healthcare professionals. 

Each kit contains 20 individually foil-wrapped test cassettes, 20 extraction tubes and tips, 20 sterile swabs, an extraction buffer bottle, a workstation and a package insert.