Skip to main content
COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

qSanger-COVID-19 Assay

Manufactured by BillionToOne Inc., United States - billiontoone.com/ 

Device identification number
1401
CE Marking
×No
HSC common list (RAT)
×No
Format
Lab-based
Target type
Nucleic acid
Specimen
Nasal swab, Nasopharyngeal swab, Oropharyngeal swab
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
https://billiontoone.com/wp-content/uploads/2020/09/BillionToOne-IFU-1.pdf
Assay Type
Nucleic acid-PCR
Method
RT-PCR
LOD
3200 copies/ml
Analytical Specificity
100 %
Clinical Sensitivity
90 %
Notes
Website: upper respiratory swab specimens (such as nasal swab, mid-turbinateswab, nasopharyngeal swab, and oropharyngeal swab specimens); Sanger sequencing-based test for detection of SARS-CoV-2 RNA

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