ODM Oropharyngeal Swab Influenza Antigen Test Kit ISO13485

Rapid Antigen And Influenza Test Kit SARS-CoV-2 Antigen & Influenza A/B Rapid Test Kit

Intended Use

The SARS-CoV-2 Antigen & Influenza A/B Rapid Test Kit is a lateral flow chromatography immunoassay intended for the qualitative detection and differentiation of nucleocapsid protein antigens from SARS-CoV-2, influenza type A and influenza type B in the same time directly from nasal/nasopharyngeal (NS/NP) swab, oropharyngeal (OP) swab and saliva specimens from patients with signs and symptoms of respiratory viral infection. It is for professional use only. It is an aid in the diagnosis of the patients with suspected SARS-CoV-2 or influenza infection in conjunction with clinical presentation and results of other laboratory tests. Results from this test kit should not be used as the sole basis for diagnosis.

Specification

Main Components

• Test cassettes
• Sample extraction Buffer
• Sample tubes
• Swabs
• Tube Stand
• Instruction Manual

Feature

• High Specificity and Sensitivity
• Safety and Reliability, individual package keep clean
• Simple operation step, one step to do the test
• Fast reacton read the result within15 min

Use  Step

• Take out the test cassette from the sealed pouch, place it on a clean and level surface with the sample port well up.

• Apply 2 full drops of the treated sample (60μl-70μl) vertically into each of the two sample wells of the test cassette.

• Observe the test results immediately within 15~20 minutes, the result is invalid over 20 minutes.

Interpretation Of Result

• POSITIVE: The presence of T (T on nCoV /A or B on Flu) and C lines within the reaction window indicate a positive result on SARS-CoV-2 or Flu A and/or B infection or co-infection.

• NEGATIVE: One colored line appears in the control region(C). No apparent colored line appears in the test region (T on nCoV /A or B on Flu). The negative result does not indicate the absence of analytes in the sample, it only indicates the level of tested analytes in the sample is less than the minimum detection limit

• INVALID: No colored lines appear, or control line fails to appear, indicating that the operator error or reagent failure. Verify the test procedure and repeat the test with a new testing device.

PRINCIPLE

The SARS-CoV-2 Antigen & Influenza A/B Rapid Test Kit employs a lateral flow chromatographic technology to detect the presence of the nucleocapsid protein antigen directly from influenza A, influenza B, and SARS-CoV-2.