SARS-CoV-2 Antigen Saliva Rapid Test Kit Saliva Sample Virus Antigen Rapid Diagnostic Single Packing Self Testing Use

Intend Use

The SARS-CoV-2 Antigen Saliva Rapid Test Kit is used to qualitatively detect SARS-CoV-2 antigen in saliva samples of suspected patients with new coronavirus. The positive result of the antigen test can be used for early classification and rapid management of suspected populations.

Product Details

Product Feature

• Quick Test: get the result in 15 minutes
• High Accuracy, sensitivity and specificity
• Simple to use
• Accurate and reliable
• Store at room temperature

Diagnostic Accuracy

Main Components

• Test Cassette
• Saliva Collector
• Disposable Pipettes
• Sample Extraction Buffer (single dose)
• Instruction Insert

Use Step

• Take sample tube with prefilled sample extraction buffer and remove the sealed film of the sample tube. Then put the tube into tube stand (in the outer box).
• Open the tear hole of the aluminum foil bag, take out the disposable pipette and test cassette, lay them flat.
• Put the saliva collection bag to lips and let
  the saliva flow into the bag.
  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.

• Draw 2/3 dropper range(300ul)of saliva from saliva collection bag with the help of pipette and transfer the entire contents into the extraction buffer of the sample tube. And blow the liquid for 10 times, squeeze bottom of the sample tube to ensure the saliva is thoroughly mixed.
• Close the cap of the sample tube.
  Shake the specimen collection tube at least three times vigorously to mix the saliva sample with extraction buffer. Attention: Please avoid bubbles!
• Add 3 full drops of the treated sample extraction buffer (about 70μL-100μL) vertically into the sample well of the test cassette.
  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).

• INVALID: No colored lines appear, or control line fails to appear, indicating that the operator error or reagent failure.

Virus Sources

Other Information

• Not following the exact instructions can affect the outcome of the test. The final diagnosis must be confirmed by a physician.
• Do not use the test if the packaging is damaged. Do not use broken test components.
• All test components are only intended to be used for this test. Do not reuse the test or test components.
• The test should be carried out immediately or within one hour after opening the foil pouch (18-30°C, humidity <60%).
• Samples be processed as soon as possible after sample collection. If the test cannot be performed immediately, the sample should be stored in a sealed state, stored at 2~8°C for 8 hours. Long-term storage is not recommended.

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.