On 2022.10.05, Singclean COVID-19 Antigen Test Kit (Colloidal Gold) Nasal Swab is included in the EU Common List!
HSC Mutual Recognition List is the authoritative list of antigen detection reagents in the European Union.
On 2021.01.21, the European Commission had issued Council Recommendation on a common framework for the use and validation of rapid antigen tests and the mutual recognition of COVID-19 test results in the EU 2021/C 24/0 (refer to as “Common List”).
The common list was issued for making the rapid antigen test results in the EU member countries to get mutual recognition. The HSC specifies that a rapid antigen test from the common list must be validated and used in practice by at least 3 member countries for the results to be mutually recognized.
According to the document, the conditions of being included in the common lists are below:
1, Get certificated by CE
2, Meet the minimum performance requirements: sensitivity >90%, specificity >97%
3, Provide details of the methods and results of these validation studies that have been validated by at least one Member State as applicable to COVID-19, such as the type of sample used for validation, the environment in which the evaluation tests were used, and whether they can be met with respect to the required sensitivity criteria or other performance indicators.
As the clinical data of Singclean COVID-19 Antigen Test Kit (Colloidal Gold) Nasal Swab shows below, Singclean COVID-19 Antigen Test Kit (Colloidal Gold) Nasal Swab is for sure on the list of common list:
1. Lineages detected:
B.1.1.529 (Omicron), B.1.1.7 (Alpha), B.1.351 (Beta), B.1.427 (Epsilon), B.1.429 (Epsilon), B.1.526 (Iota), B.1.617.1 (Kappa), B.1.617.2 (Delta), C.37 (Lambda), P.1 (Gamma)
2. Performance characteristics：
Accuracy 98.63 %
Clinical Sensitivity 97.22 %
Clinical Specificity 99 %
The url below shows the common list certification:
https://covid-19-diagnostics.jrc.ec.europa.eu/devices/detail/1446?fbclid=IwAR14lEozPdnVc0lQI7By0F-Zr0Ud8i-fQ6sVqxGzqfgU4f920XnQFiF8l40
Singclean COVID-19 Test Kit (Colloidal Gold Method) is a solid phase immunochromatographic assay for the rapid, qualitative detection of antigen to 2019 Novel Coronavirus in human nasal cavity. This test provides only a preliminary result. Therefore, any reactive specimen with the COVID-19 Test Kit (Colloidal Gold Method) must be confirmed with alternative testing method(s) and clinical findings.
Singclean COVID-19 Antigen Test
Since the outbreak of COVID-19, Singclean COVID-19 Antigen Test Kit sold well in Germany, Greek, Czech, Latvia and many other countries of Europe.