SARS-CoV-2 Lateral Flow Flu Rapid Antigen Test Kit ISO9001

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

Intended Use

• It is a lateral flow chromatography immunoassay
• It is 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
• Specimen is nasopharyngeal Swabs or oropharyngeal Swabs
• 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
• It is for professional use only

Specification

Main Components

• 20 Test cassettes
• 2 Sample extraction Buffers
• 20 Sample tubes
• 20 Swabs
• 1 Tube Stand
• 1 Instruction Manual

Feature

• Result read in15 minutes
• Accurate diagnostic tool active infection
• Easy to administer 
• Affordable, no need for instrument, highly portable
• Enable testing on a massive scale
• For healthcare workers use only

Sample Collection
 

• Nasopharyngeal swab: Holding 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 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

• 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.

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.
• False negative results may be caused by unreasonable sample collection, transport and treatment, and low viral load in samples.
• 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.