In February 2022, CLUNGENE® COVID-19 Antigen Rapid Test for self-testing manufactured by Clongene has obtained the CE certification in EU. Our self-testing product can be sold in the European Union and other countries that recognize the CE certification.
CLUNGENE® COVID-19 Antigen Rapid Test can be used by individuals for self-testing at home, and the result can be read at 15-20 minutes after the sample is added. Our product is convenient for individuals and families to detect nasal swab samples rapidly and timely.
n High specificity and sensitivity.
n Instant result at 15-20 minutes.
n Easy to collect samples.
n No equipment required.
n Results are clearly visible.
n Identify early infection.
The CE certification of self-testing product in EU can better meet the requirements of people for self-testing and self-management at home, and further assist the global epidemic prevention and control.
“Clungene COVID-19 Antigen Rapid Test for self-testing” and “Clungene COVID-19 Antigen Rapid Test” manufactured by Clongene have obtained the TGA Certification in Australia on January 7, 2022. The certifications indicate that the Clungene COVID-19 Antigen Rapid Test products are approved to sold in the Australian market by the local government.
Australia is a well-known country with the strict management of drugs and higher requirements of market license. Therapeutic Goods Administration (TGA) is the federal drug regulatory agency under the Australian Department of Health. The products with the TGA certification are all evaluated by strict registration system in Australia.
Clungene COVID-19 Antigen Rapid Test products are easy to use without the equipment, and can read visible results at 15-20 minutes. As a international-renowned brand for rapid test of COVID-19, Clungene COVID-19 Antigen Rapid Test products are effectively qualified to conduct the rapid detection in most markets around the world.
Since the outbreak of the COVID-19, Clungene COVID-19 products have obtained the CE certification in EU, the TGA certification in Australia and some certifications from different countries, which demonstrate the quality of our products are approved by related government institutions. Also, our products have got good reputation from the main markets. Never stop moving forward! Clongene will keep to assist the prevention of the COVID-19 disease around the world and be an important force in the fight against the COVID-19.
Surat Pernyataan Penghentian Kerjasama dengan PT. TAISHAN ALKES INDONESIA
Dari: Hangzhou Clongene Biotech Co., Ltd.
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