Rapid Test Kit SARS-CoV-2 Antigen Self Tetsing Rapid Test Kit Single Pack High Specificity Antigen Rapid Test Kit

Intend Use

The SARS-CoV-2 Antigen Rapid Test Kit is intended for the qualitative detection of SARS-CoV-2 viral nucleocapsid antigens from human anterior nasal of secretion from individuals suspected of COVID-19. It is for individual self testing use, the test result can be used for early self-screening. It can be used as a basis for judging whether infection or not.

Product Details

Test Principle

This rapid kit is an immunochromatography assay which detects SARS-CoV-2 nucleocapsid antigen in the samples with the help of the double antibody sandwich method. In the testing process if there is virus antigen presence in the sample, it binds with the corresponding colloidal gold antibody. This complex “migrates” across the membrane and binds to the monoclonal antibody at the Test line (T). This creates a visible red line, which indicates a positive result. However, if the sample does not contain any antigen, then the complex cannot be formed and thus no reddish line forms in the Test line (T). Regardless of whether the sample contains antigen or not, a reddish line forms in the Control line (C).

Product Feature

• Reliable: CE Certificated, ISO13485,ISO9001 Certificated
• Accurate: Total accuracy, sensitivity and specificity rate more thhan 95%
• Fast: Fast recation speed, get the result within 15 min
• Simple: One step operation, easy for use

Main Components

• 1 Test Cassette
• 1 Sample Tube
• 1 Extraction Buffer
• 1 Swab
• 1 Instruction for use

Use Step

• Open the sealed pouch and remove the test casstette. Lay it face up on a clean, dry and flat surface.
• Unpack the sample extraction, add all of the sample extraction into the sample tube and then put the tube into tube stand.
• Gently, insert the entire absorbent tip of the swab (around 1.5 cm) into your nostril. Rotate walls of your nostril 5 times or more. Use the same swab to repeat steps in the other nostril.

• Insert the swab into the ssample tube with extraction buffer. Mix well. Mix well and squeeze the swab 10-15 times by compressing the walls of the tube against the swab. Roll the swab head against the inner wall of the tubes as you remove it.
• Close the cape of the sample tube. Add 3 full drops of the mixed solution vertically into the sample well(S) of the test cassette.
• Read the result 15-20minutes after adding the sample. Result got after 20 minutes is invalid.

Result Interpretation

• POSITIVE: Two colored bands appear on the membrane. One band appears in the control region (C) and another band appears in the test region (T).

• NEGATIVE: Only one colored band appears, in the control region (C). No apparent colored band appears in the test region (T).

• INVALID: If there is no Control line (C) or only a Test line (T) in the result window, the test did not run correctly and the results are not valid.

Virus Sources

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.