MP Biomedicals Rapid SARS-CoV-2/Influenza A+B Antigen Duo Test Card

Product Code. 30280603

Brand: MP Biomedicals 07AG6020FL

Description

SARS-CoV-2 Ag+Flu A/Flu B Rapid Test is a one-step in vitro test based on immunochromatography.

• Rapid SARS-CoV-2/Influenza A+B Antigen Duo Test Card is an immunochromatographic lateral flow device that employs the principle of double antibody sandwich method.
• Anti-SARS-CoV-2, anti-influenza A and anti-influenza B antibodies are immobilized on the nitrocellulose membrane respectively, as three individual test lines (CoV line, Flu A line and Flu B line) in the test window of the test device.
• When the specimen is added, it migrates by capillary diffusion through the strip to re-hydrate the gold conjugate complexes.
• If present at or above the limit of detection, viral antigens will react with the gold conjugate complexes to form particles, which will continue to migrate along the strip until the Test Zone (T) where they are captured by the immobilized anti-SARS-CoV-2 or anti-influenza A or anti-influenza B antibodies to form a visible red line, which indicates positive test results.
• Absence of this colored band in the test window indicates a negative test result.
• The gold conjugate complexes will continue to migrate alone until being captured by immobilized antibody in the Control Zone (C) to form a red line, which indicates the validity of the test.
• CE marked
• For professional use only
• Accurate Result within 15 to 20 minutes
• One-step procedure
• No equipment needed
• No cross-reaction
• High sensitivity, specificity, and accuracy
• This test is only to be used by professional medical staff, not for home testing. It cannot be used alone as the basis for the diagnosis and exclusion of cases.

Specifications

• CE Marker: Self-declared
• Clia Complexity: Not Applicable
• Detectable Analytes: SARS-CoV-2, Influenza A and Influenza B Nucleoprotein Antigens
• Detection Method: Immunochromatographic lateral flow
• DoA Calibrators: No
• Format: Test card
• Sample Type: Human nasal swabs, Human nasopharyngeal swabs, Human oropharyngeal swabs
• Sensitivity: SARS-CoV-2: 1.3 x 10² TCID{50}/mL, Influenza A: 1.78 x 10² TCID{50}/mL, Influenza B: 1.17 x 10³ TCID{50}/mL
• Type: Rapid Test
• Disposable: Single-use
• For Use With (Application): Rapid and qualitative determination of SARS-CoV-2, Influenza type A and type B viral antigen in nasal swabs, nasopharyngeal swabs or oropharyngeal swabs
• Specificity: SARS-CoV-2: 99.16% (95% CI: 98.49% ~ 99.83%) Influenza A: 98.69% (95% CI: 97.42% ~ 99.97%) Influenza B: 99.37% (95% CI: 98.50% ~ 100%)
• Form: Ready-to-Use (RTU)