SARS-CoV-2 Antigen Self Test Kit ISO13485 Certificated Rapid Antigen Diagnostic Test Kit

SARS-CoV-2 Antigen Rapid Test Kit ISO13485 Certificated Rapid Antigen Diagnostic Test Kit Self Test Use Easy Operation

Intend Use

• This 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.
• This kit is an immunochromatography assay which detects SARS-CoV-2 nucleocapsid antigen in the samples with the help of the double antibody sandwich method.

Product Details

Diagnostic Accuracy

Product Feature

• Direct detection virus
• Easy operation, fast testing
• High sensitivity and specificity
• Without extra instrument requirement
• Single Packing, convenience and safety

Main Components

• Test Cassette
• Sample tube with prefilled sample extraction buffer
• Swab
• Instruction for use

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.
• Gently, insert the entire absorbent tip of the swab (around 1.5 cm) into your nostril. Slowly, rotate the swab in a circular against the inside walls of your nostril 5 times or more. Be sure to collect any nasal drainage that maybe present on the swab. Gently remove the swab. Use the same swab to repeat steps in the other nostril and slowly, take out the swab.
• 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

WARNINGS AND IMPORTAN INFORMATION

• DISPOSAL The test kit can be disposed of with normal household waste in accordance with applicable local regulations.

• A negative result does not rule out the infection of a SARS-CoV-2 infection. Therefore, the test should not be used as the only reference for the clinical diagnosis. The result must be confirmed by the PCR.

• After use, rinse hands or, in case of contact with the buffer solution, the affected body parts thoroughly with water.

• If symptoms persist: Seek medical advice.

Certificate

• CE cetificated
• Iceland registration
• Philipines certificated
• Germant BfArm List

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.