CareStart COVID-19 MDx RT-PCR
Manufactured by Access Bio Inc., United States - www.accessbio.net/
Device identification number
760
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Manual
Target type
Nucleic acid
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
samples: upper respiratory specimens (such as and nasopharyngeal wash/aspirate or nasal aspirate) and bronchoalveolar lavage https://accessbiodiagnostics.net/covid-19-mdx-rt-pcr/
Assay Type
Nucleic acid-PCR
Method
RT-PCR
Time
83 minutes
Subclass
2019-nCoV_N1
LOD
10 copies/reaction
Positive control
N gene, RdRP gene, and MS2
Negative control
nuclease free water
Clinical Sensitivity
100 %
Clinical Specificity
100 %
Throughput
100 tests
Notes
https://accessbiodiagnostics.net/wp-content/uploads/2020/07/EUA-access-carestart-ifu.pdf
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