99% Specificity Self Collection Saliva Test Home Kit ISO13485

SARS-CoV-2 Antigen Saliva Rapid Test Kit Self-test For Home Use (Immunochromatography)

Intended Use

This rapid test kit is intended for the qualitative detection of SARS-CoV-2 antigen in human saliva samples from novel coronavirus suspected person with symptoms within 9 days from onset. Further nucleic acid detection should be carried out for suspected population whose antigen test result is positive or negative.

Product Details

Product Feature

• Fast: Result in 15 minutes
• Simple: Easy to use, no extra operation
• Reliable: High accuracy and safety
• Variety: Detection of mutations

Main Components

• 1 Test Cassette
• 1 Saliva Collectors With Collection Tube
• 1 Sample Extraction Buffer
• 1 Package Insert

Use Step

• Open the cap of the collection tube and istall saliva collector.
• Put the collection tube with saliva collector close to lips and let the saliva flow into the collection tube. Tje volum of saliva needs to be half of 0.5 scal mark(0.25).
• Screw the sample extraction buffer carefully.

• Add all sample extration buffer to the collection tube. Discard the saliva collector, tighten the cap onto the specimen collection tube.
• Shake the specimen collection tube at least three time vigorously to mix the saliva and the extraction buffer. Squeeze bottom of the collection tube ensure the saliva is thoroughly mixed.
• Add 3 full drops of the solution to the sample well(S). Read the result at 15 minutes. Do not interpret the result after 20 minutes.

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). The negative result does not indicate the absence of analytes in the sample, it only indicates the level of tested analytes in the sample is less than the minimum detection limit.

• INVALID: No colored lines appear, or control line fails to appear, indicating that the operator error or reagent failure. Verify the test procedure and repeat the test with a new testing device.

Virus Sources

Advantage

• One-step Operation without extra step
• Fast Reaction, test speed within 15 minutes
• Individual Specimen buffer
• Detection of mutations, such as: Delta, Gemma, Alpha
• Self-testing At Home Use
• Testing process is comfortable

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.