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Bioperfectus SARS-CoV-2 Rapid Antigen Test Kit Passes 3A Validation Among Over 120 Devices Referred by DHSC

By LabMedica International staff writers
Posted on 23 Apr 2021
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Image: Novel Corona Virus (SARS-CoV-2) Ag Rapid Test Kit (Photo courtesy of Jiangsu Bioperfectus Technologies Co., Ltd.)
Image: Novel Corona Virus (SARS-CoV-2) Ag Rapid Test Kit (Photo courtesy of Jiangsu Bioperfectus Technologies Co., Ltd.)
Jiangsu Bioperfectus Technologies Co., Ltd.’s (Shanghai, China) Novel Corona Virus (SARS-CoV-2) Ag Rapid Test Kit has been proved to have very high specificity and sensitivity against viral loads associated with infectiousness in an evaluation of more than 4,000 kits done by the joint PHE Porton Down and University of Oxford SARS-CoV-2 test development and validation cell.

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

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 test has also been granted approval by BfArM (The Germany Federal Institute for Drugs and Medical Devices).



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