Covid-19 Antigen Rapid Test Strip Cassette Swab Collection POCT Italian MOH

Covid-19 Antigen Rapid Test Strip Cassette Swab Collection POCT Italian MOH

Fast: 15 Minutes;
Cheap: Lower cost with high efficiency;
Simple: Easy sample collection by one step.

INTENDED USE OF SARS-COV-2 TEST
The product is used for the qualitative detection of SARS-COV-2 infection. The entire detection process takes only 15-20 minutes, and the operation is simple and sensitive. No instrument required. It can be used for the screening of early infected patients and asymptomatic patients. This method is an effective supplement for nucleic acid detection.
 
MAIN CONTENTS OF SARS-COV-2 TEST
• One pouch containing a reaction test Cassette with desiccant.
• Extraction tube.
• Extraction Reagent.
• Instructions for use.
• Flocked Swab.
 
STORAGE AND STABILITY OF RAPID TEST DIAGNOSTIC
• Store at 4 ~ 30 º C in the sealed pouch for 18 months.
 
PRECAUTIONS OF RAPID TEST DIAGNOSTIC
• For in vitro diagnostic use only.
• Do not use after expiration date.
• The test Cassette should remain in the sealed pouch until use.
• The used test Cassette should be discarded according to local regulations.
 
DIRECTION OF USE
1) Insert the test extraction tube into the workstation in this product. Make sure that the tube is standing firm and reaches the bottom of the workstation.
2) Add 0.5 mL (about 12 drops) of the sample extraction buffer into the extraction tube.
3) lnsert the swab into extraction tube which contains 0.5 mL of the extraction buffer.
4) Roll the swab at least 6 times while pressing the head against the bottom and side of the extraction tube.
5) Leave the swab in the extraction tube for 1 minute.
6) Squeeze the tube by fingers from outside of the tube to immerse the swab. Remove the swab. The extracted solution will be used as test sample.
 
LIMITATIONS

• The etiology of respiratory infection caused by microorganisms other than SARS-COV-2 will not be established with this test. The Coronavirus Ag Rapid Test Cassette (Swab) is capable of detecting both viable and non-viable SARS-COV-2. The performance of the Coronavirus Ag Rapid Test Cassette (Swab) depends on antigen load and may not correlate with viral culture results performed on the same specimen.

• Failure to follow the Test Procedure may adversely affect test performance and/or invalidate the test result.

• If the test result is negative and clinical symptoms persist, additional testing using other clinical methods is recommended. A negative result does not at any time rule out the presence of SARS-CoV-2 antigens in specimen, as they may be present below the minimum detection level of the test or if the sample was collected or transported improperly.

• As with all diagnostic tests, a confirmed diagnosis should only be made by a physician after all clinical and laboratory findings have been evaluated.

• Positive test results do not differentiate between SARS-COV and SARS-COV-2.

• Negative results should be treated as presumptive and confirmed with an FDA authorized molecular assay, if necessary, for clinical management, including infection control.