SARS-CoV-2 Antigen Rapid Test Kit CE Certificated Professional Test Virus Antigen Use One Step Use 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.

Product Details

Main Components

• Test Cassettes
• Sample tubes with Prefilled Sample extraction buffer
• Swabs
• Tube Stand
• Instruction for use

Analytical Results

• Sensitivity: 98.04%
• Specificity: 100.00%
• Total accuracy: 99.60%

Product Features

• Rapid testing for Virus antigen within15 minutes
• Simple , time-saving procedure
• All necessary reagents provided
• High sensitivity, specificity and total accuracy, safety and reliable

Use Step

• Take a sample tube (with prefilled sample extraction solution).Remove the aluminum foil sealing of the prefilled sample extraction tube and then put the tube into the tube stand.
• Dip the swab into the sample extraction liquid after sample collection, fully immerse the tip of the swab, rotate and squeeze the swab 10 times, then pull out the swab, and take the stranded liquid as much as possible.
• 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. Read the result 15-20 minutes 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

Sample Preservation
Sample of human nasopharyngeal swabs and oropharyngeal swabs should be processed as soon as possible after sample collection. If the test cannot be performed immediately, the sample should be stored in a sealed state, stored at 2~8℃ for 8 hours, and stored below -20℃ for 1 month. Long-term storage is not recommended.

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.