Views: 0 Author: Site Editor Publish Time: 2021-12-20 Origin: Site
UDXBIO COVID-19 Antigen Rapid Test is and colloidal gold immunochromatography assay based rapid test to detect SARS-
CoV-2 nucleocapsid antigens in the specimens. External controls may be used to QC the kit before testing.
When you intended to use external controls to QC UDXBIO COVID-19 Antigen Rapid Test please contact UDX for UDXBIO COVID-19 Antigen External controls. UDX can provide the external controls on demands.
We do not recommend use external controls from other suppliers since they may not apply to UDXBIO COVID-19 Antigen Rapid Test according to the following reasons:
1) They may not apply to antigen tests: Some controls may be used for PCR tests and they are nuclear acid of SARS-CoV-2 which does not apply to antigen test.
2) They may not apply to nucleocapsid antigen tests: Some controls may be used for antigen test which specified to proteins rather than nucleocapsid protein of SARS-CoV-2(e.g. spike protein). They will not apply to nucleocapsid antigen tests.
3) They may not apply to UDXBIO COVID-19 Antigen Rapid Test since they use different antigen with different epitope to make the controls, which may not react with UDXBIO COVID-19 Antigen Rapid Test since UDX BIO COVID-19 Antigen Rapid were designed to binding a specific epitope of SARS-CoV-2 nucleocapsid antigens.
4) They may not apply to UDXBIO COVID-19 Antigen Rapid Test since their matrix is not compatible with UDX BIO COVID-19 Antigen Rapid Test: The matrix of external controls need compatible with test device in order to provide accurate results. However, external controls form other suppliers are neither verified nor validated by UDX, which may cause inaccurate results.
5) They may not apply to UDXBIO COVID-19 Antigen Rapid Test since the sampling method is different and may results in inaccuracy: The sampling method (along with the extraction buffer) of UDXBIO COVID-19 Antigen Rapid Test is unequally design and optimized for the test device. We do not recommend use external controls from other suppliers since their sampling method may not work well with the UDX test device.
If you independent to use external controls from other suppliers to QC UDXBIO COVID-19 Antigen Rapid Test, we strongly recommend you to ship those external controls back to UDX to verify and validate before use. Only the controls that are verified and validated by UDX can be used to QC UDXBIO COVID-19 Antigen Rapid Test.
