The performance of the Vstrip COVID-19 Antigen Rapid Test for Detection of SARS-CoV-2 was established with 59 individual symptomatic patients who were suspected of COVID-19. Test results were compared to FDA Emergency Use Authorized molecular (RT-PCR) test for detection of SARS-CoV-2. The overall sensitivity and specificity is 83.3% and 98.1%.
The limit of detection (LoD) of this Vstrip® is 1.57×103 TCID50/ml for the CGMH virus strain (conducted at Chang Gung Memorial Hospital, Linkou, Taiwan). The cross-reactivity of this Vstrip® was evaluated with 10 bacteria (at a concentration of over 108 CFU/ml) and 12 viruses (at a concentration of over 104 TCID50 /ml) 1, and none of the microorganisms tested gave a positive result.
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