Skip to main content
COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

VZV DNA QUANTITATION (QT)

Manufactured by DIA.PRO Diagnostic Bioprobes Srl, Italy - www.diapro.it 

Device identification number
2466
CE Marking
Yes
HSC common list (RAT)
×No
Format
Lab-based, Semi-automated
Physical Support
Microplate, Strip
Target type
Nucleic acid
Specimen
Plasma
Cross-reactivity (pathogens tested)
Varicella Zoster Virus (VZV)
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
ORF31 gene, CEREBROSPINAL FLUID
Assay Type
Unknown
Reader Required
Yes
Subcategory
Other ()
Method
RT-PCR
Measurement
Quantitative
Time
75 minutes
LOD
0.5 copies/μl
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
SPECIFICITY PERCENT 100%
False negatives
SENSITIVITY PERCENT 100%
Precision
Evaluated
Accuracy
100 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
100 %
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