CTK Biotech’s Single-Use COVID-19 Antigen Self-Test Receives CE Mark

By LabMedica International staff writers
Posted on 04 Nov 2021

Image: OnSite COVID-19 Ag Self Test (Photo courtesy of CTK Biotech, Inc.)

CTK Biotech, Inc. (Poway, CA, USA) has obtained the CE mark for its OnSite COVID-19 Ag Self Test and will begin shipping the new test to the countries that accept the CE mark this month.

The OnSite COVID-19 Ag Self Test is a single-use lateral flow immunoassay for the qualitative detection of SARS-CoV-2 nucleocapsid antigens in nasal swab specimens from individuals suspected of COVID-19. The test is designed for use with self-collected samples within the first seven days post-onset of symptoms, as an aid in identifying SARS-CoV-2 infection. The easy-to-use test screens for COVID-19 in 15 to 20 minutes and uses nasal swab for ease of use and minimizing discomfort. The OnSite COVID-19 Ag Self-Test comes with two individually sealed test kits.

With over 20 years in infectious disease diagnostics, CTK has manufactured a line-up of professional use COVID-19 diagnostic tools. In addition to the OnSite COVID-19 Ag Self Test, the company also offers the OnSite COVID-19 Ag Rapid Test that detects the presence of antigens from the SARS-CoV-2 virus, namely the viral Nucleocapsid Protein (NP). The OnSite COVID-19 Ag Rapid Test can detect the NP mutants with mutations from the UK, South Africa, and Brazil variants.

In August this year, the company had launched the Aridia COVID-19 Real-Time PCR Test for the specific and qualitative detection of the novel coronavirus SARS-CoV-2, responsible for COVID-19, in respiratory specimens. The test targets the conserved regions of the SARS-CoV-2 ORF1ab and N genes using specific primers and fluorescently labeled probes. The test can detect the SARS-CoV-2 UK, South Africa, Brazil, California, Nigeria, and India (Delta) variants. Furthermore, as the Aridia COVID-19 Real-Time PCR Test detects two SARS-CoV-2 targets, its performance is less susceptible to the effects of variants than tests designed to detect a single target.

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