CE SARS-CoV-2 Professional Antigen Rapid Test Kit IVD Reagent Type

Rapid Test Kit Antigen Rapid Test SARS-CoV-2 Antigen Rapid Test Kit High Accuracy For Professional Use Antigen Rapid Test Kit

Intend Use

• This rapid test kit is intended for the qualitative detection of SARS-CoV-2 infection from patients. It is for professional use only. It is an aid in the diagnosis of the patients with suspected SARS-CoV-2 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.
• The test provides preliminary test results. Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for treatment or other management decision.

Product Details

 
Product  Feature

• ​High Accuracy, Sensitivity and Specificity, Accuracy rate more than 95%
• Fast recation speed, read the result within 15 minutes
• CE certificated,Stric quality control
• Easy for use, One step operation process

 
PRINCIPLE

• This kit is an immunochromatography assay. According to the gold immunochromatographic test principle, double antibody sandwich method was used to detect SARS-CoV-2 nucleocapsid antigen in the samples. When there is virus antigen presence in the sample, the antigen binds with the corresponding colloidal gold monoclonal antibody and the coated monoclonal antibody at the detection line to form a compound and then condenses into a red band, indicating a positive result. If there is no antigen in the sample, complex cannot be formed at the detection line, and no red band is shown, indicating negative result.
• Whether the sample contains antigen or not, the gold monoclonal antibody will bind to the enveloped antibody at the quality control line, form a compound and condense into a red band.

Main Components

• 20 Test Cassettes
• 20 Sample tubes 
• 2 Sample extraction
• 20 Swabs
• 1 Instruction for use

 
Use Step

• Add 550μL sample extraction (about 22-24 drops) into the sample tube.
• Insert the swab into the sample tube prefilled with extraction buffer. Mix well and squeeze the swab 10-15 times by compressing the wall s of the tube against the swab.
• Roll the swab head against the inner wall of the tubes as you remove it. Try to release as much liquid as possibe. Dispose of the used swab in accordance with your biohazard waste disposal protocol.
• Close the cap of the sample tube.
• Add 3 full drops of the mixed solution vertically into the sample well (S) of the test cassette.

 
Result Interpretation

• POSITIVE: Two (2) distinct colored lines appear. One line should be in the control region (C) and the other line should be in the test region (T).

• NEGATIVE: One (1) colored line appears in the control region(C). No apparent colored line appears in the test region (T). 

• INVALID: No colored lines appear, or control line fails to appear, indicating that the operator error or reagent failure.

 

 
Virus Sources

 
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.

Certificate