KUALA LUMPUR: Medical Innovation Ventures Sdn Bhd (Mediven) has achieved 100 per cent concordance for GenoAmp, its Covid-19 polymerase chain reaction (PCR) test kit in an international third-party evaluation.
External Quality Assessment (EQA)/Proficiency Testing (PT) on the product was done by participating laboratories in the United Kingdom (UK).
According to Mediven, the EQA/PT study was held in the first half of 2020 with at least 51 international brands under 476 participants from 19 countries such as South Korea, Spain, France, China, Germany, the United States, Turkey, Australia and UK.
Only a handful of these brands had a 100 per cent concordance result, it said in a statement today.
Mediven said GenoAmp Real-Time RT-PCR SARS-CoV-2, obtained a detection score of highly satisfactory “0” for all panels tested, suggesting concordant result with the real status of the Quality Control for Molecular Diagnostics panel.
The detection score value ranges from 0 to 3, where 0 is “highly satisfactory”, whereas 3 is “highly unsatisfactory”, it said.
Operations director Dr Lim Li Sze added: “A lot of times it is very difficult to test the presence of the virus when it is at low concentration. This is when our GenoAmp brand has been proven to work well,
“At high concentration of the virus in swab samples, most tests can work, and our test makes a difference by picking out the false negatives, helping to identify patients early, therefore preventing the further spread of the disease.”
Mediven executive director Ariff Ismail said the EQA/PT had proved the reliability of the GenoAmp brand.
“Its real-time PCR test for Covid-19 is accurate and reliable, yet affordable. We want to bring the test to the masses to help fight this disease, with accurate results,” he said.
Real-time PCR test is a test recommended by the World Health Organisation (WHO) and is recognised by the international community as the gold standard for Covid-19 screening. — Bernama
