Rapid Test Kit SARS-CoV-2 Antigen Rapid Test Kit One Test For Self-test For In Vitro Diagnostic 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

• Rapid testing for virus antigen within 15 minutes
• Simple, time-saving procedure
• All necessary material provoded, no extra equipment requirement
• High sensitivity and specificity
• One step operated, simple for use

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

• DISPOSAL The test kit can be disposed of with normal household waste in accordance with applicable local regulations.
• A negative result does not rule out the infection of a SARS-CoV-2 infection. Therefore, the test should not be used as the only reference for the clinical diagnosis. The result must be confirmed by the PCR.
• After use, rinse hands or, in case of contact with the buffer solution, the affected body parts thoroughly with water.
• If symptoms persist: Seek medical advice.