On May 24th, COVID-19 Ag rapid self-test kit (Colloidal Gold) developed by Huachenyang (Shenzhen) Tech Co., Ltd. was awarded the EU CE 2934 certifi...View details
The European Health Security Committee (HSC) has created a whitelist of COVID-19 rapid antigen test products to prevent the inconsistent quality that are acknowledged by member states known as the “HSC Common List,” and its test results will be acknowledged in the 27 member states of the EU. Before a product is included to the Common list, manufacturers must offer more clinical verification evidence to demonstrate the product’s effectiveness.
HCY COVID-19 Ag Rapid Test Kit is included in the latest EU Common List. Previously, the product also obtained EU CE2934 certification and Thailand TFDA certification.
HSC Common List
From June 1, 2022,The EU common list of COVID-19 antigen tests has been split up in two categories.
Category A: Antigen tests for which their performance has been evaluated through prospective clinical field studies and that meet the criteria agreed.
Category B: Antigen tests for which their performance has been evaluated through retrospective in vitro studies and that meet the criteria agreed.
EU Member States are strongly encouraged to use, in particular, antigen tests included under
Category A of the EU common list for the issuance of EU Digital COVID certificates.
HCY COVID-19 Ag Rapid Test Kit has passed prospective clinical field studies in German and Greek laboratories and is therefore classified as Category A.
Huachenyang COVID-19 Ag Rapid Test Kit
Huachenyang COVID-19 Ag Rapid Test Kit have great reputation in EU for its fast, convenient and accurate advantages.It is recognized as quick and reliable detection techniques.
- Rapid test: Results are available in 15 minutes
- Convenient: No need for instrumentation and cumbersome operation
- Accuracy: Clinical sensitivity against Omicron variant 91% (Ct<25: 100%, 25<Ct<30:81.1%, Ct>30: 40%), specificity 100%
Winter is coming, the pandemic is not going away, and the several varieties are raging outside. One of the keys to halting the pandemic from spreading is swift and efficient testing.
We have developed COVID-19 Ag Rapid Test Kit Professional Version and the Self-Test Version, each version could be customized in order to satisfy diverse usage scenarios.
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The COVID-19 antigen rapid test kit is designed to identify the SARS-CoV-2 nucleocapsid antigen.View details
The COVID-19 Ag Rapid Test Kit uses the double antibody sandwich method to legally detect the novel coronavirus antigen in nasopharyngeal swabs.View details