ISO9001 Rapid Test Device Nasopharyngeal SARS-CoV-2 Antigen Detection Kit

Rapid Antigen Test Kit SARS-CoV-2 Antigen Rapid Test Kit 20Tests/Kit For Professional Detection Use Rapid Test Kit

Intend Use
This rapid test kit is intended for the qualitative detection of SARS-CoV-2 infection from patients. 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

Main Components

• Test Cassettes
• Sample tubes
• Sample extraction buffer
• Swabs
• Instruction for use

Product Features

• Quick Testing Speed, Read the result in 15 minutes
• Easy for use without extra instrument
• CE Certificated , ISO13485,ISO9001 Certificated

Other Information

• For IN VITRO diagnostic use only.
• Reagents should be used as soon as possible after opened. This reagent cannot be reused for disposable.
• 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.
• All specimens and reagents should be considered potentially hazardous and handled in the same manner as an infectious agent after 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

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.