JusChek 1 Kit Self-diagnostic Quick Test

JusChek Self-diagnostic Rapid Test - Antgene Covid-19

JUSCHEK SELF-DIAGNOSTIC Rapid Test for COVID-19 Antigen (Salivary Oral Fluid)

INTENDED USE

Self test / Single use rapid 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 of being infected with the COVID-19 virus.

REAGENTS

The test device contains antibodies to SARS-Cov-2

MATERIALS PROVIDED

Test device

Sample collection device (funnel, tube and tube tip)

Buffer solution

Package leaflet

Bags of bio-security

BEFORE TAKING THE TEST

Do not put anything in your mouth (food, drink, gum, smoke) for at least 10 minutes before the test

Wash them with soap and water

SELF TEST 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 reference line

Place the tube in the tube 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 squeeze the tube 15 times to mix well

Remove the test device from the sealed pouch and use it within one hour

Place the test cassette on a flat surface

Invert the tube and pour 2 drops of solution into the well of the test device

Read the results after 15 minutes, attention 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 with the COVID-19 Rapid Antigen Test with the results of the molecular test. The clinical trial included 406 oral fluid samples. Results demonstrated 99.3% specificity and 90.1% sensitivity with an overall accuracy of 97.0%.

Format

Pack of one kit.