Rapid Test Kit CoV-2 Antigen Saliva Rapid Test Individual Self Testing Simple Operation Antigen Rapid Test Kit

Intended Use

This rapid test kit is intended for the qualitative detection of SARS-CoV-2 antigen in human saliva samples from novel coronavirus suspected person with symptoms within 9 days from onset. Positive result of the antigen test 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. Negative results do not rule out SARS-CoV-2 infection and should not be used as the sole basis for treatment or patient management decisions. Further nucleic acid detection should be carried out for suspected population whose antigen test result is positive or negative.

Product Details

Product Feature

• One-step Operation, Simple, fast and convenient
• Protable tets kit, testing in anywehere
• Easy to collect specimen
• Fast test speed, easy to read the result
• Single pack, safety and reliability

Main Components

• Test Cassette
• Saliva Collectors With Collection Tube
• Sample Extraction Buffer
• Instruction for use

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

Other Information

• This kit is a qualitative detection, which cannot determine the exact content of antigen.
• For IN VITRO diagnostic use only.
• False negative results may be caused by unreasonable sample collection, transport and treatment, and low viral load in samples.
• Waste should be treated in accordance with infectious substances and should be discarded properly
• 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.
• Keep away from children. Any child under age 13 shouldn’t perform the test without parental guidance, or professional aid.