www.fdanews.com/articles/208002-achiko-obtains-ce-mark-for-its-aptamex-rapid-covid-19-test
Achiko Obtains CE Mark for Its AptameX Rapid COVID-19 Test
May 27, 2022
Achiko has received a CE mark certification for its AptameX rapid COVID-19 saliva-based rapid test.
The saliva-based rapid test uses a DNA oligonucleotide instead of an antibody to detect COVID-19, reading the results with an ultraviolet spectrophotometer.
The assay offers more than 97 percent sensitivity in accurately identifying positive samples and and 97 percent specificity for correctly identifying negative samples, the company said.
Switzerland-based Achiko has begun production of the test in Indonesia and has secured contract manufacturing in Taiwan. The company expects to make the test available in Europe in the third quarter of this year.