Descripción del producto

INTENDED USE
The SARS-CoV*2 Antigen Rapid Test (COVID**9 Ag) is a rapid chromatographic immunoassay for the qualitative detection of novel coronavirus SARS-CoV*2 in human throat and the front of nasal  secretions.
SPECIMEN COLLECTION AND PREPARATION
The SARS-CoV*2 Antigen Rapid Test (COVID- *9 Ag) can be performed using throat secretions and nasal secretions.
· Throat Secretions: Insert the sterile swab into the throat. Gently scrape the secretions around the wall of pharynx.  
· The front of nasal Secretions: The sterile swab was inserted 2.5cm into the nasal cavity.Gently rotate the swab against the wall of the turbinate several times to wet the swab as much as possible.
· Collect 0.5ml of assay buffer and place into a specimen collection tube. Insert the swab into the tube and squeeze the flexible tube to extrude the specimen from the head of the swab. Make the specimen resolved in the assay buffer sufficiently. Add the crystal tip onto the specimen collection tube. If saliva specimen, suck the saliva from the container and place 5 drops (approx.**0ul) of the saliva into the sample collection tube.
The assay should be performed immediately in 2 hours after the specimen preparation. If the assay could not be carried immediately, the prepared specimen should be kept no more than *4 hours at **8°C or 7 days at **0°C.  
Bring specimens to room temperature prior to testing. Frozen specimens must be completely thawed and mixed well prior to testing. Specimens should not be frozen and thawed repeatedly for more than two times.
If specimens are to be shipped, they should be packed in compliance with federal regulations covering the transportation of etiologic agents.
TEST PROCEDURE
Allow the test device, specimen, buffer, and/or controls to equilibrate to room temperature (****0°C) prior to testing.
1. Bring the pouch to room temperature before opening. Remove the test device from the sealed pouch and use it as soon as possible.
2. Place the test device on a clean and horizontal surface. Reverse the specimen collection tube, extrude 3 drops of the prepared specimen into the specimen well (S) of the test cassette and start the timer.
See illustration below.
3. Wait for the colored line(s) to appear. Read results at *0 minutes. Do not interpret the result after *5 minutes.
INTERPRETATION OF RESULTS
- Positive (+): Two colored lines appear. One colored line should always appear in the control line region (C) and another line should be in the T line region.
*NOTE: The intensity of the color in the test line regions may vary depending on the concentration of SARS-CoV*2 present in the specimen. Therefore, any shade of color in the test line region should be considered positive and recorded as such.
- Negative (-): One colored line appears in the control line region (C). No line appears in the T line region.
Invalid: Control line fails to appear. Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the procedure and repeat the test with a new test. If the problem persists, discontinue using the test kit immediately and contact your local distributor.