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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

abTES COVID-19 Variant qPCR I Kit

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

Device identification number
3119
CE Marking
Yes
HSC common list (RAT)
×No
Format
Automated, Lab-based, Semi-automated
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), Influenza A, Influenza B, 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
SARS-CoV
Lineages detected
B.1.1.7 (Alpha), B.1.351 (Beta), B.1.617.1 (Kappa), B.1.617.2 (Delta), P.1 (Gamma)
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
The abTES™ COVID-19 Variant Kit is a real-time polymerase chain reaction (qPCR) kit for the detection of the spike protein (S) of SARS-CoV-2 Variants together with COVID-19 non-structural polypeptide (orf1ab) and nucleocapsid protein (N). It also includes detection of human housekeeping gene, GADPH, as Internal control (IC) to identify the possible for PCR inhibition. The kit contains all the necessary PCR reagents for rapid, sensitive, and reproducible real-time detection of using highly specific primer pairs and double-dye hydrolysis probes. The recommended human sample types of nasopharyngeal and oropharyngeal swabs.
Assay Type
Nucleic acid-PCR
Self Test
No
Reader Required
Yes
Subcategory
Other ()
Method
RT-PCR
Measurement
Quantitative
Time
47 minutes
LOD
550 cpm
Positive control
Orf1ab gene, N gene, S gene and IC (GAPDH)
Negative control
nuclease-free water
Analytical Sensitivity
95 %
Analytical Specificity
100 %
Clinical Sensitivity
100 %
Clinical Specificity
100 %
Throughput
96 samples per run
Notes
lineages_performances Delta(98.24%), Omicron (99.06%)

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