abTES™ Qd COVID‐19 qPCR I Kit
Manufactured by AITbiotech, Singapore - www.aitbiotech.com
Device identification number
3131
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Manual
Physical Support
Strip
Target type
Nucleic acid
Specimen
Anterior nasal swab, Nasal swab
Cross-reactivity (pathogens tested)
Adenovirus 3, Adenovirus 7, Alpha Coronavirus 229E (HCoV-229E), Alpha Coronavirus Nl63 (HCoV-Nl63), Beta Coronavirus OC43 (HCoV-OC43), Bordetella Pertussis, Chlamydia Pneumoniae, Cytomegalovirus (CMV), Enterovirus A71 (EV-A71), Epstein-Barr Virus (EBV), Hemophilus Influenzae, Human Metapneumovirus (HMPV), MERS-CoV, Mumps Virus (MuV), Mycoplasma Pneumoniae, Parainfluenza Virus Type 1, Parainfluenza Virus Type 2, Parainfluenza Virus Type 3, Respiratory Syncytial V (RSV) Type A, Respiratory Syncytial V (RSV) Type B, Rhinovirus A, Rhinovirus B, SARS-CoV
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
The abTES™ Qd COVID-19 qPCR Kit is a rapid real-time polymerase chain reaction kit which enables simultaneous detection of two COVID-19-specific signature regions in a single reaction.
Assay Type
Nucleic acid-PCR
Self Test
No
Reader Required
Yes
Method
RT-PCR
Measurement
Qualitative
Time
20 minutes
LOD
1000 cpm
Positive control
Covid-19
Negative control
Nuclease-free Water
Analytical Sensitivity
100 %
Analytical Specificity
100 %
Clinical Sensitivity
100 %
Clinical Specificity
100 %
Throughput
Single tubes
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