SARS CoV-2 IgG/IgM Rapid Test
Manufactured by Tersaco AG, Switzerland - tersaco.ch/
Device identification number
1030
CE Marking
×No
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Lateral flow
Target type
Antibody
Targets
envelope protein, non-structural protein NSP3, nucleocapsid protein, ORF1a polyprotein, ORF1ab polyprotein, spike protein
Specimen
Whole blood
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
https://www.testlinecd.com/file/1580/COVID-19_AN_NEW%20(002).pdf?version=202008131535 I could not find CE-IVD proof
Assay Type
Immuno-Antibody
Rapid Diagnostic
Yes
Reader Required
No
Method
Immunoassay
Measurement
Qualitative
Time
10 minutes
Clinical Sensitivity
95.9 % IgM
Clinical Sensitivity
96.5 % IgG
Clinical Specificity
97.7 % IgM
Clinical Specificity
98 % IgG
Type of antigen
combination of selected parts of the specific antigens of SARS-CoV-2 (NCP, RBD, Spike S2, E, ACE2, PLPro protein) and antigens for exclusion cross-reactivity with other endemic coronaviruses (MERS-CoV, SARS-CoV, HCoV 229E Np, HCoV NL63 Np).
The database contains publicly available In Vitro Diagnostic Medical Devices for COVID-19 and it is being updated periodically. Please note that additional performance (as retrieved from manufacturers web pages) is provided only for devices commercially available with CE-IVD mark. Acknowledgements