Test results in 15 minutes

Fast diagnosis with results in 15 minutes in various locations such as clinical laboratories, hospitals etc.

Sensitivity  93%

specificity  100%

Frozen Nasopharyngeal Swab

The clinical performance of MARK-B™ COVID-19 Ag was evaluated with frozen nasopharyngeal swab specimens, which have been collected from multiple sites in the United States between September 2020 and April 2021, against a commercial RT-PCR molecular assay as a reference method. To be enrolled in the study, patients had to be presenting at the sites with COVID-19 like symptoms within 8 days of symptom onset. the RT-PCR assay and a total of 207 samples including 72 positive and 135 negative specimens were selected for the study. MARK-B™ COVID-19 Ag test was performed by minimally trained operators who are representative of the intended users. The clinical performance of MARK-B™ COVID-19 Ag was concluded as a sensitivity of 93% (67/72) and a specificity of 100% (135/135).

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*Molecular assay: Allplex™ 2019-nCoV Assay

Nasopharyngeal Swab in Viral Transport Medium

The clinical performance of MARK-B™ COVID-19 Ag was evaluated with nasopharyngeal swab specimens in viral transport medium, which have been collected from multiple sites in the United States between September 2020 and February 2021, against a commercial RT-PCR molecular assay as a reference method. To be enrolled in the study, patients had to be presenting at the sites with COVID-19 like symptoms within 22 days of symptom onset. the RT-PCR assay and a total of 170 samples including 60 positive and 110 negative specimens were selected for the study. The specimens were tested based on the Instruction For Use of the MARK-B™ COVID-19 Ag test cartridge. The clinical performance of MARK-B™ COVID-19 Ag was concluded as a sensitivity of 90% (54/60) and a specificity of 99% (109/110).

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*Molecular assay: Real-Q 2019-nCoV detection Kit

Limit of Detection

Specification