CE ISO13485 COVID-19 RTK Saliva Self Test Kit For IN VITRO Diagnostic

Rapid Test Kit COVID-19 Antigen Saliva Rapid Test Kit Self Test 1 Test Single Pack Protable Test Kit

Intend Use
This rapid test kit is intended for the qualitative detection of SARS-CoV-2 antigen in human saliva sample from novel coronavirus suspected person with symptoms within 9 days from onset. The test result can be used for early detection and triage of people suspected of being infected.

Product Details

Product Feature

• Protable and convenient
• High Accuracy, Sensitivity and Specificity
• Excellent Performance, Strong test line and control line
• Easy for use, sample collected is very easy

Main Components

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

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

Storage And Expiry

Store as packaged in the sealed pouch at 2-30℃, avoid heat and sunshine, dry place, valid for 24 months. Do not freeze. Do not open the inner packaging until ready, it must be used within one hour if opened (Humidity≤60%, Temp: 20℃-30℃). Please use immediately when the humidity＞60%.
Precaution

• For IN VITRO diagnostic use only.
• Waste should be treated in accordance with infectious substances and should be discarded properly.
• The extraction reagent contains preservative agent which may be toxic if ingested. When disposed of through a sink, flush with a large volume of water.
• Do not use samples that have been placed for longer than one hour or contaminated.
• If the saliva is not well mixed in the sample extraction tube, false negative results may occur.

FAQ

• Production quantity?

It depends on the specification of the products. For big orders, we can produce 100k-250k per day.

• Have after-sale service?

Yes we support technical services. And if the goods are missing due to our fault, we promise to compensate.

• Register your products in our country?

Yes. We can offer full files for you to register.

• Lead time?

Stock 3-7 days in general. Or please contact us by email for specific lead time base on your order quantities.

• Support ODM or OEM?

Yes we support both. If needed,welcome to discuss details with us.

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.