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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

AddMedi SARS-CoV-2 RT-qPCR Kit

Manufactured by Addbio Meditek Co., South Korea - www.addbiomeditek.com 

Device identification number
2020
CE Marking
Yes
HSC common list
×No
HSC mutual recognition
×No
Format
Automated
Physical Support
Other, Strip
Target type
Nucleic acid
Specimen
Bronchoalveolar lavage fluid, Nasopharyngeal swab, Oropharyngeal swab
Commercial Status
Commercialised
Last Update
2021-05-10 01:04:00 CET
Comments
The principle of test is based on TaqMan Real-Time qPCR. After open the Kit box, resuspend the 5X RT-qPCR buffer (5X Buffer, 400㎕), 20X Enzyme Solution (ES, 100㎕), 4X Oligo mixture (4X OM, 500㎕), Positive control (PC, 100㎕), and DEPC water for Negative Control (NC, 100㎕). Aliquot the 5X RT-qPCR buffer (4㎕), 20X Enzyme Solution (1㎕), 4X Oligo mixture (5㎕), RNA template (5 or 10㎕), PC (10㎕) and remain volume should be adjusted with DEPC to the reaction volume of 20㎕ into the PCR tube or plate for the chosen PCR platform.
Assay Type
Nucleic acid-PCR
Reader Required
No
Subcategory
Validity test kit
Method
RT-PCR
Measurement
Qualitative
Time
109 minutes
Subclass
Other
LOD
50 copies
Positive control
S gene (FAM): 21 ct; RdRp gene (HEX): 21 ct and IPC (Cy5): 21 ct
Negative control
Only IPC amplify
Analytical Sensitivity
100 %
Analitical Specificity
100 %
Clinical Sensitivity
96 %
Clinical Specificity
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