Covid-19 Rapid Antigen Self Test - FlowFlex
Flowflex Covid-19 Rapid Antigen Self Test
O Test COVID-19 ANTIGEN RAPID TEST is a fast membrane-based lateral flow immunoassay for the qualitative detection of SARS-CoV-2 antigens in a human nasopharyngeal and nasal smear.
Who is it for:
The Covid-19 Rapid Antigen Test is intended to be used as an Autotest, by people, with or without symptoms, as the first approach in the diagnosis of COVID-19.
The COVID-19 Rapid Antigen Test has been validated in different clinical studies, compared to the leading commercial tests of Real-Time PCR (RT-PCR) as reference methods.
A first study, including a total of 204 samples (121 negative and 83 positive), showed a relative sensitivity of 96,4% (95% Cl: 89,8% -99,2%). The study was carried out on individuals suspected of having SARS-CoV-2 infection, 0-7 days after the onset of symptoms.
A second study demonstrated a relative sensitivity of 96,5% (95% Cl: 82,82% - 99,39%) when the values of the threshold cycles (TC) are less than 26, which is associated with the peak of infection . The performance of COVID-19 ANTIGEN RAPID TEST was also assessed for nasal samples, compared to RT-PCR as a reference method. The study included 70 positive samples (collected 0-7 days after the onset of symptoms) and 60 negative samples (asymptomatic), confirmed by RT-PCR.
Used to aid in the diagnosis of infectious coronavirus disease (COVID-19) caused by SARS-CoV-2. Medical Device.
Remove the aluminum foil from the top of the extraction plug tube. Insert the tube into the hole in the kit box (or place the tube into the tube holder). Open the swab wrapper at the end of the toothpick. Caution: Do not touch the absorbent tip of the swab with your hands.
1-Insert the entire absorbent tip of the cotton swab into one of the nostrils. With gentle rotation, push the cotton swab less than 2,5 inch from the edge of the nostril.
2-Turn the cotton swab 5 times, rubbing the inner walls of the nostril. Remove the cotton swab and insert it into the other nostril. Repeat the previous step.
3-Insert the cotton swab into the tube and shake it for 30 seconds.
4-Turn the cotton swab 5 times while pressing the side of the tube.
5-Remove the cotton swab while pressing the tube.
6-Firmly screw the dropper cap onto the extraction buffer tube containing the sample. Mix the sample well by stirring or shaking the bottom of the tube.
7- Gently squeeze the tube and dispense 4 drops of the solution into the sample container.
8-Read the result when the timer reaches 15-30 minutes. DO NOT read the result after 30 minutes.
Then, dispose of the test and all utensils used for the test in the household waste container, following the protocol established by the health authorities, and should not be deposited at the SIGRE post of the pharmacy, or on public roads.