Description
EC Certificate No. 1434-IVDD-426/2021
JUSCHEK AUTODIAGNOSTIC Rapid Test for COVID-19 Antigen (Salivary Oral Fluid)
INTENDED USE:
Self test/Quick disposable test to detect COVID-19 antigen in human oral fluid. It is designed for home use with self-collection of oral fluid samples from symptomatic individuals suspected to be infected with COVID-19 virus.
REAGENTS:
The test device contains anti-SARS-Cov-2 antibodies.
MATERIALS PROVIDED:
- Testing device
- Sample collection device (funnel, tube and tube tip)
- Buffer solution
- Package leaflet
- Bio-safety bags
BEFORE TAKING THE TEST:
- Do not put anything in your mouth (food, drinks, gum, smoke) for at least the 10 minutes before the test
- Washing the mandi with soap and water
SELF-TESTING INSTRUCTIONS:
- Insert the funnel into the tube
- Cough deeply 3-5 times
- Gently spit the oral fluid into the funnel.
- The oral fluid should reach the height indicated by the baseline
- Place the pipe in the pipe holder in the plastic holder
- Pull to open the buffer solution
- Pour all the solution into the tube with the oral fluid
- Insert the cap on the tube
- Gently compress the tube 15 times to mix well
- Remove the test device from the sealed case and use it within one hour
- Place the test cassette of the test on a flat surface
- Turn the tube upside down and pour 2 drops of solution into the well of the test device
- Read the results after 15 minutes, beware that after 20 minutes they will no longer be valid
- If 2 colored lines appear the result will be POSITIVE at Codid-19, if one appears the result is NEGATIVE, if the control line does not appear the result will be INVALID
PERFORMANCE CHARACTERISTICS:
A clinical evaluation was conducted by comparing the results obtained by the COVID-19 Rapid Antigen Test with the results of the molecular test. The clinical trial included 406 oral fluid samples. The results demonstrated a specificity of 99.3% and a sensitivity of 90.1% with an overall accuracy of 97.0%.
Manufactured by: Hangzhou AllTest Biotech Co, Ltd. 550 Yinhai Street. Hangzhou Economic & Technological Development Area, Hengzhou 310018 P.R. China
