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Bioperfectus Obtains CE Mark for SARS-CoV-2 Antigen Rapid Self-Test

By LabMedica International staff writers
Posted on 05 Jan 2022

Image: Novel Corona Virus (SARS-CoV-2) Ag Rapid Test Kit (Self-test) (Photo courtesy of Jiangsu Bioperfectus Technologies Co., Ltd.)

Image: Novel Corona Virus (SARS-CoV-2) Ag Rapid Test Kit (Self-test) (Photo courtesy of Jiangsu Bioperfectus Technologies Co., Ltd.)

Jiangsu Bioperfectus Technologies Co., Ltd. (Shanghai, China) has obtained CE Mark for its Novel Corona Virus (SARS-CoV-2) Ag Rapid Test Kit (Self-test).

The lateral flow test is intended for non-prescription home use with self-collected nasal swab specimens. It is used to detect symptomatic individuals who are suspected of COVID-19 or asymptomatic individuals who have had contact with confirmed COVID-19 patients but do not show any symptoms. It delivers fast results within 15 minutes and is able to detect asymptomatic cases as well as remain effective in the case of variants.

The Novel Corona Virus (SARS-CoV-2) Ag Rapid Test Kit was previously available as a home test in the German and Austrian markets since May 20th, 2021. With the CE Mark, the test has received official approval following the traditional registration pathway and can now also be used in markets that have not established regulatory exemption pathways.

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