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28th April 2021  Content supplied by: Jiangsu Bioperfectus Technologies Co., Ltd.

COVID-19 Antigen Test Passes High-Standard Oxford & UK Public Health Validation


The joint PHE Porton Down & University of Oxford SARS-CoV-2 lateral-flow and validation cell has published1 its evaluation of rapid SARS-CoV-2 antigens tests.

It is reported that over 120 lateral flow devices referred by the Department of Health and Social Care (DHSC) have been evaluated by the joint institutions. Approximately 30% of the tests that were referred for validation met the standards for phase 2 validation, and only 19 manufacturers’ lateral flow devices passed phase 3a validation.

As one of the 19 lateral flow devices that passed the 3a validation, Bioperfectus Technologies Novel Corona Virus Ag Rapid Test Kit demonstrated desirable performance characteristics, showing high specificity and sensitivity against viral loads associated with infectiousness.

Bioperfectus Novel Corona Virus (SARS-CoV-2) Ag Rapid Test Kit showed no drop off in sensitivity when compared with the wild-type with respect to the following variants - VOC1 Kent, UK, B.1.1.7 and VOC2 South Africa, B.1.351. Moreover, the same product has also been granted approval by BfArM (The Germany Federal Institute for Drugs and Medical Devices)2 in the same week.

Established in April 2010, Jiangsu Bioperfectus Technologies Co., Ltd. is one of the leading IVD manufacturers worldwide. On December 5th, 2020, Bioperfectus became a public-listed company on the Science and Technology Innovation Board of the Shanghai Exchange.

Bioperfectus is pioneering in the molecular diagnostic market with over 500 products and 8 product lines focused on the infectious disease control area. Bioperfectus products range from real-time PCR kits, nucleic acid extraction systems, rapid tests, and automation laboratory devices.

Bioperfectus in vitro diagnostic products have gained global attention during this COVID-19 pandemic, and the company’s COVID-19 Coronavirus Real-Time PCR Kit formerly gained FDA-EUA, WHO-EUL, Brazil ANVISA as well as Australia TGA.

So far, Bioperfectus products have been distributed to over 50 countries worldwide, and it is actively assisting the world in the fight against the COVID-19 pandemic.

References:

1. Outcome of the evaluation of rapid diagnostic assays for specific SARS-CoV-2 antigens (lateral flow devices) Department of Health & Social Care, 21 April 2021. 

2. Antigen Tests for direct pathogen detection of the coronavirusFederal Institute for Drugs and Medical Devices. 

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Date Published: 28th April 2021

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