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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

Dr Vida pocket for COVID-19

Manufactured by STAB VIDA, Portugal - https://www.stabvida.com/ 

Device identification number
1993
CE Marking
Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Target type
Nucleic acid
Targets
envelope protein/gene, nucleocapsid protein/gene
Specimen
Nasopharyngeal swab
Cross-reactivity (pathogens tested)
Adenovirus 3, Alpha Coronavirus 229E (HCoV-229E), Alpha Coronavirus Nl63 (HCoV-Nl63), Beta Coronavirus HKU1 (HCoV-HKU1), Beta Coronavirus OC43 (HCoV-OC43), Bordetella Pertussis, Chlamydia Pneumoniae, Influenza A, Influenza A H1N1, Influenza A H3N2, Influenza B, Mycoplasma Pneumoniae, Parainfluenza Virus Type, Parainfluenza Virus Type 1, Parainfluenza Virus Type 2, Parainfluenza Virus Type 3, Parainfluenza Virus Type 4, Respiratory Syncytial V (RSV) Type A, Rhinovirus A
Pathogens detected
SARS-CoV
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
The Doctor Vida system is CE-IVD device suitable for molecular amplification and detection of SARS-Cov-2 virus RNA in 40 minutes using a swab nasopharyngeal collected in Viral Preservation Medium. The sample analysis in Doctor Vida pocket and the produced results and report are communicated to the user and the patient through the Doctor VIDA application on the smartphone.
Assay Type
Nucleic acid-Other
Rapid Diagnostic
Yes
Self Test
No
Reader Required
Yes
Subcategory
Other ()
Method
LAMP
Measurement
Qualitative
Time
40 minutes
Subclass
JRC-S
LOD
75 (Particles)
Positive control
SARS-CoV-2 inactivated particles
Negative control
Human Cells
Analytical Sensitivity
95.24 %
Analytical Specificity
100 %
Clinical Sensitivity
95.24 %
Clinical Specificity
100 %
Throughput
Single tubes
Notes
NIID_2019_nCOV_N, isothermal nucleic acid amplification

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