IVD SARS-CoV-2 20 Tests Professional ART Self Test Kit ISO9001

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

Intend Use

This rapid test kit is qualitative detection of SARS-CoV-2 antigen in saliva sample which can be used to detection of SARS-CoV-2 antigen in human saliva samples from novel coronavirus suspected person with symptoms within 9 days from onset. The test result can be used for early triage and rapid management of suspected populations, but it cannot be used as diagnosis basis of SARS-CoV-2 infection. 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 as soon as 10-15 minutes
• Simple, time-saving procedure
• Little specimen, only few saliva sample
• All necessary reagents provided, no extra equipment needed
• High sensitivity and specificity

Test Principle

This kit is an immunochromatography assay. According to the gold immunochromatographic test principle, double antibody sandwich method was used to detect SARS-CoV-2 nucleocapsid antigen in the samples.

• Main Components
• 20 Test Cassettes
• 20 Saliva Collectors With Collection Tubes
• 20 Sample Extraction Buffer
• 1 Tube stand
• 1 Package Insert

Sample Collection

• 30 minutes before sampling, please do not eat, smoke, drinking alcohol or drinks.
• Place the tip of tongue against the upper or lower tooth root to enrich saliva, and then swallow saliva to the throat without ingesting saliva to esophagus, followed by returning saliva to the mouth. Repeat the process for 5 times.
• The sample should not be inactivated.

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

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.