On 21 January 2021, Member States unanimously agreed on a Council recommendation setting a common framework for the use of rapid antigen tests and the mutual recognition of COVID-19 test results across the EU.
The products need to meet the following requirements:
(a) Carry CE marking;
(b) Meet the minimum performance requirements of ≥ 90% sensitivity and ≥ 97% specificity; and
(c) Have been validated by at least one Member State as being appropriate for their use in the context of COVID-19, providing details on the methodology and results of such studies, such as the sample type used for validation, the setting in which the use of the test was assessed, and whether any difficulties occurred as regards the required sensitivity criteria or other performance elements.
The Health Security Committee agrees that, for rapid antigen test results to be mutually recognized, at least three Member States should be using a rapid antigen tests in practice.
Clongene COVID-19 Antigen Rapid Test Kit with CE approved has become the main force of the anti-virus war in the EU, which also highlights the advantages of the product itself:
l easy to perform, but only for professional use.
l quick tests, enabling rapid implementation of infection control measures, including contact tracing.
l results are clearly visible.
l suitable for large-scale rapid screening.
l no equipment required.
CLUNGENE® COVID-19 Antigen Rapid Test Cassette has passed the test of PEI in Germany. PEI (Paul-Ehrlich-Institut) is affiliated to the Federal Ministry of Health. It is the Cooperation Centre of WHO for Quality Assurance of blood products and IVD equipment. The approval of PEI indicates the quality of the product has reachedthe international standard, and also indicates that our company has reached a new level in production technology, quality control, quality management and other aspects.
We are glad to announce that Technical validation report CLUNGENE ® COVID-19 Antigen Rapid Test Cassette is received and the Test Kit has passed the validation criteria as described by the Swiss Society of Microbiology. It has been recommended by the Swiss authorities Bundesamt für Gesundheit as an antigen reagent for use outside the laboratory environment.
Hangzhou Clongene Biotech Co., Ltd is a hightech enterprise specialized in biological raw materials and in vitro diagnostic products. As well known biological raw materials supplier, which also specialized in producing products such as antigens, antibodies and enzymes, Clongene is facing the new coronavirus epidemic spreading situation. Clongene has a high degree of social responsibility, actively respond to the call of the party, fulfill the mission, developing rapidly to produce “The novel coronavirus antigen NCP” raw materials for all diagnostic test products.
The antigen and antibody is available from now on!
We sincerely invite you and your company to visit our booth H3J92-9 for MEDICA 2019, November 18th - 21st, at Dusseldorf in Germany.View detailed