Rapid Antigen Test Kit SARS-CoV-2 Antigen Rapid Test Professional Diagnostic Use High Accuracy CE Certificated

Intend Use
The SARS-CoV-2 Antigen Rapid Test Kit is used for the qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in nasopharyngeal (NP), oropharyngeal (OP) and nasl swab specimen.

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

• Reliable, High sensitivity, specificity and total accuracy
• Simple operation, Do not require test equipment, easy to use
• Rapid Test, Test result available within 15 minutes.
• Wide range of applications

Use Steps

1. 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.
2. 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.
3. 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 invald.

Note: When using viral transport medium (VTM), it is important to ensure that the VTM containing the sample is warmed to room temperature. Cold samples will not flow correctly and can lead to erroneous or invalid results. Several minutes will be required to bring a cold sample to room temperature.

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

Precautions

1. For IN VITRO diagnostic use only.

2. Reagents should be used as soon as possible after opened. This reagent cannot be reused for disposable.

3. The test device should remain in the sealed pouches until use. If sealing problem happens, do not test. Don’t use after the expiration date.

4. All specimens and reagents should be considered potentially hazardous and handled in the same manner as an infectious agent after use.

Application

• Families
• Shopping Malls
• Concertes
• Stadiums
• Pharmacies
• Hospitals

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.