Vstrip® COVID-19 Antigen Rapid Test is a rapid immunochromatographic assay that utilizes specific monoclonal antibodies to detect the nucelocapsid protein (NP) of SARS-CoV-2 virus in nasopharyngeal swab specimens, producing results in 10 minutes and at approximately 10% the cost of a PCR.
This product comes from the AEP alliance of three biotech companies in Taiwan: AnTaimmu BioMed; EirGenix; Panion & BF Biotech. AnTaimmu BioMed discovered and developed novel monoclonal antibodies against SARS-CoV-2 NP, EirGenix mass-produced GMP certificated antibodies, and Panion & BF Biotech developed and produced the rapid test through their GMP facility.
Taiwan FDA announced its approval of Vstrip® COVID-19 Antigen Rapid Test under Emergency Use Authorization (EUA) on August 27th and this is the FIRST antigen rapid test product approved by Taiwan FDA. Furthermore, the Indian Council for Medical Research (ICMR) announced that it has validated and approved Vstrip® COVID-19 Antigen Rapid Test as satisfactory on September 25th (https://www.icmr.gov.in/ckitevaluation.html). Only 5 antigen rapid tests are approved by ICMR so far and Vstrip® is the first Taiwanese-made antigen rapid test.
CLINICAL PERFORMANCE and LIMIT OF DETECTION
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.