ForaCare Suisse has released its FORA COVID-19 Antigen Rapid Test, which can deliver quick, precise, and easy-to-interpret test results in 15 minutes.
The lateral flow immunoassay for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 does not require laboratory processing and can be carried out by trained professionals.
Using a nasopharyngeal swab, the sample material needed for the test is obtained during the acute infection phase.
For conducting the test, ten drops of the extradition buffer are dispensed to the extradition tube. Then, the nasal swab sample is inserted to the tube and mixed for 30 seconds.
The extradition tube is closed with a nozzle cap and three to five drops of the processed sample are dispensed into the sample well of the cassette. The result is delivered in 15 minutes.
The FORA COVID-19 Antigen Rapid Test is a Swissmedic-approved diagnostic test for detecting an acute infection of SARS-CoV-2, the virus that causes Covid-19.
It is authorised for distribution in Switzerland and non-restricted sale in its treaty countries. In addition, the antigen test is reimbursable in Germany and is listed by the Federal Institute for Drugs and Medical Devices (BfArM).
The test was developed in partnership with Taiwan Academia Sinica.
Data from the latest clinical studies showed that the test was accurate and reliable with a 95.8% sensitivity and a 98.6% specificity.
The clinical study analysed 57 PCR-positive and 80 PCR-negative specimens.
ForaCare Suisse CEO Ty-Minh Tan said: “We are proud to offer trained testing professionals an alternative that allows them to make fast, accurate, and reliable tests without waiting on outside laboratories to determine active virus.”
In April last year, ForaCare Suisse launched Fora Autonomous Temperature Measuring Station to assist healthcare system in fighting the Covid-19 pandemic.