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

Intended Use

The 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

• 20 Test cassettes
• 2 Sample extraction Buffer
• 20 Sample tubes
• 20 Swabs
• 1 Tube Stand
• 1 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

Sample Collection

Nasopharyngeal swab:The sampler gently holds the head of the person to be collected with one hand, holds the swab with the other hand, sticks the swab to the nostril to enter, and slowly penetrates backwards along the bottom of the lower nasal passage, so as not to exert too much force to avoid traumatic hemorrhage. When the tip of the swab reaches the posterior wall of the nasopharynx cavity, gently rotate it for one week and then slowly take out the swab.

Oropharyngeal swab: The head of the person to be collected is slightly tilted and his mouth is wide open, exposing the pharyngeal tonsils on both sides. Wipe the swab across the root of the tongue. Wipe the pharyngeal tonsils on both sides of the person to be collected back and forth with a little force for at least 3 times, and then wipe up and down the posterior pharyngeal wall for at least 3 times.

Use Step

Note: When using viral transport medium (VTM), it is important to ensure that the VTM containing the sample is warmed to room temperature. Cold samples will not flow correctly and can lead to erroneous or invalid results. Several minutes will be required to bring a cold sample to room temperature.

• 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.

Other Information

• This reagent is a qualitative detection reagent, which cannot determine the exact content of antigen.
• The test results of this reagent are only for the reference of clinicians and should not be taken as the sole basis for clinical diagnosis and treatment. Clinical management of patients should be considered in the light of their symptoms/signs, medical history, other laboratory tests and treatment responses.
• Restricted by antigen detection reagent method, the lowest detection limit (sensitivity analysis) is generally lower than that of nucleic acid detection, so the researchers deal with negative result to give more attention, should be combined with other test results comprehensive judgment, advice to doubt the negative result of nucleic acid detection or virus isolation culture identification method for review.