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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail



abCyclerQd Real‐time PCR System

Manufactured by abCyclerQd Real‐time PCR System, Singapore - www.aitbiotech.com 

Device identification number
3132
CE Marking
Yes
HSC common list (RAT)
×No
Format
Automated
Physical Support
Other, 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), Influenza A H1N1, Influenza A H3N2, Influenza B Victoria, Influenza B Yamagata, 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
2022-06-14 05:01:17 CET
Comments
The abCyclerQd is a small, fast, easy-to-use point-of-care-testing (PoCT) system, suitable for on-site rapid nucleic acid detection and testing. It is highly sensitive and can achieve a rapid thermal cycle by moving the consumables tube between two high precision temperature zones, greatly reducing the detection time. A test on the abCyclerQd can be completed within 20 minutes.
Assay Type
Nucleic acid-PCR
Self Test
Yes
Reader Required
Yes
Method
RT-PCR
Measurement
Qualitative
Time
20 minutes
Subclass
N.A.
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