98.02 Percent Accuracy Labnovation Saliva Test Device Immunochromatography

Rapid Test Kit SARS-CoV-2 Antigen Saliva Rapid Test Kit Saliva Specimen Sample Professional Use Rapid Test Kit

Intend Use

The SARS-CoV-2 Antigen Rapid Test Kit is intended for qualitative detection of SARS-CoV-2 Antigen in human saliva sample. The test result can be used for early triage and rapid management of suspected populations but it should not be used as the sole basis for treatment or patient management decisions. Nucleic acid detection should be carried out for suspected population whose antigen test result is positive or negative.

Product Details

Product Feature

• Protable and convenience
• Simple operation one step to use
• High accuracy, sensitivity and specificity, total accuracy rate more than 95%
• Reliable, CE approved and ISO13485 certificated
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  Main Components

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

SAMPLE PRESERVATION

After the samples of human saliva are collected, the saliva should be processed as soon as possible and tested within 1 hour. If it cannot be tested immediately, it can be stored at 2-8℃ for 4 hours and long-term storage is not recommended.

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

PRECAUTION

• The Rapid Test Kit 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.
• If the saliva is not well mixed in the sample extraction tube, false negative results may occur.
• False negative results may be caused by unreasonable sample collection, transport and treatment, and low viral load in samples.

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.