COVID-19 rapid test BELTEST-IT

IgGIgMSARS-COV-2

The BELTEST-IT COV-2 Rapid Test is an in-vitro diagnostic test for the qualitative detection of IgG and IgM antibodies to the SARS-CoV-2 virus in human serum and whole blood (venipuncture and/or fingerstick) samples collected in CLIA certified laboratories and/or by healthcare professionals at the point-of-care. It provides healthcare professionals with a fast, convenient, and qualitative aid in the diagnosis of SARS-CoV-2 infection.* PRODUCT INFORMATION Specimen Type - Human whole blood (venipuncture and/or fingerstick) or serum Storage Conditions - 2°C to 30°C (35°F to 86°F) Shelf Life - 12 months KIT CONTENTS Pipette for transferring blood from the fingertip to the test cassette Desiccant packet Lancet Vial containing buffer solution Plastic bag for disposal of used test materials Pouch with label Instructions for use TEST PERFORMANCE As of June 20, 2020; a total of 1,809 tests were carried out for validation, with 643 measurements evaluated to determine the test sensitivity and 1,166 for specificity. CROSS REACTIVITY Pharmact tested serum samples from five HCV patients, five ANA patients, five RSV (respiratory syncytial virus) patients and six influenza (no fever) patients. All results were negative, suggesting that infection with these four diseases does not affect the specificity of the test.