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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

Fluorion nCoV-19 QLP 2.1 Real-Time PCR Kit

Manufactured by Iontek, Turkey - https://iontek.com.tr/ 

Device identification number
1721
CE Marking
Yes
HSC common list (RAT)
×No
Format
Lab-based, Manual, Semi-automated
Physical Support
Microplate, Strip
Target type
Nucleic acid
Specimen
Nasopharyngeal swab, Oropharyngeal swab, Sputum
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
Fluorion nCoV-19 QLP 2.1 Real-Time PCR Kit detects SARS-CoV-2 RNA in oropharyngeal and nasopharyngeal swab samples, and sputum samples. The analytic sensitivity is 10 copies/reaction. N1 and N2 genes are amplified using sequence-specific primers and the detection is done using the FAM filter pair. To control PCR inhibition an endogenous internal control is incorporated into the system. Endogenous internal control is detected with the HEX filter pair during data collection.
Assay Type
Nucleic acid-PCR
Rapid Diagnostic
No
Reader Required
Yes
Method
RT-PCR
Measurement
Qualitative
Time
39 minutes
LOD
8.751 copies/ml
Positive control
x
Positive control
N1 and N2 regions of nucleocapsid gene of SARS-CoV-2 virus and Human RNaseP gene (internal control)
Negative control
x
Analytical Sensitivity
95 %
Analytical Specificity
100 %
Clinical Sensitivity
100 %
Clinical Specificity
100 %
Throughput
single tubes
Notes
http://www.iontek.com.tr/wp-content/uploads/2021/01/iontekkatalog2021.pdf

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