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

Labnovation Technologies, Inc. is an original manufacturer established in Shenzhen, China since 2001. We are dedicated in developing and manufacturing IVD instruments and reagents including HbA1c analyzer and reagents, rapid test reader & reagents, hematology reagents, clinical chemistry reagents, electrolyte reagents, wash solution and urine test reagents.
 

Labnovation products are developed in house, tested extensively in clinics and passed strict quality controls. All of our products are CE marked and approved by SFDA. In the past 15 years, our products have been exported to 110 different countries and used in 8000 hospitals worldwide. We provide both ready-to-use final products and bulk OEM reagents, including ready-to-use reagents, concentrated, and powder.

With an investment of 10% of our annual sales into R&D, we release new products every years. We win more and more domestic and international cooperation by company reputation and products quality while we actively take part in fairs like MEDICA,AACC, ARBA HEALTH and so on through which we are well-known by the companies in this field.