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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

abTES™ Flu/COVID-19 qPCR I Kit

Manufactured by AITBIOTECH PTE Ltd., Singapore - www.aitbiotech.com 

Device identification number
3129
CE Marking
Yes
HSC common list (RAT)
×No
Format
Automated, Lab-based, Semi-automated
Physical Support
Strip
Target type
Nucleic acid
Targets
nucleocapsid protein/gene, ORF1ab polyprotein/gene
Specimen
Nasopharyngeal swab, Oropharyngeal swab
Cross-reactivity (pathogens tested)
Adenovirus, Alpha Coronavirus 229E (HCoV-229E), Alpha Coronavirus Nl63 (HCoV-Nl63), Beta Coronavirus OC43 (HCoV-OC43), Enterovirus A71 (EV-A71), Hemophilus Influenzae, Parainfluenza Virus Type 1, Parainfluenza Virus Type 2, Parainfluenza Virus Type 3, Parainfluenza Virus Type 4, Respiratory Syncytial V (RSV) Type A, Respiratory Syncytial V (RSV) Type B, Rhinovirus
Pathogens detected
Influenza A, Influenza B, SARS-CoV
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
The abTES™ Flu/COVID-19 qPCR I Kit is a qualitative real-time polymerase chain reaction (qPCR) kit which enables simultaneous detection of SARS-CoV-2 (orf1a), Flu A and Flu B in a single reaction. It also includes detection of human housekeeping gene, GAPDH, as an Internal Control (IC) to monitor RNA extraction efficiency and potential PCR inhibitions from sample processing. The kit contains all the necessary PCR reagents for rapid, sensitive and reproducible real-time detection of four Influenza types using highly specific primer pairs and double-dye hydrolysis probes. The recommended human sample types are nasal and throat swabs.
Assay Type
Nucleic acid-PCR
Rapid Diagnostic
No
Self Test
No
Reader Required
Yes
Subcategory
Other ()
Method
RT-PCR
Measurement
Quantitative
Time
114 minutes
LOD
3.206 cpu (Influenza B)
LOD
2.193 cpu (SARS-CoV-2)
LOD
2.377 cpu (Influenza A)
Positive control
Influenza A, Influenza B, SARS-CoV-2
Negative control
nuclease-free water
Analytical Sensitivity
95 %
Analytical Specificity
100 %
Clinical Sensitivity
100 %
Clinical Specificity
100 %
Throughput
96 samples per run
Notes
performances Delta (100;99.8); Omicron (100;100)

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