iPMx Nucleic Acid Analyzer
Manufactured by Industrial Technology Research Institute Medical Device GMP Manufacturer, Taiwan ROC - https://www.itri.org.tw/english/index.aspx
Device identification number
3122
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Lab-based, Manual, Near POC / POC
Target type
Nucleic acid
Targets
nucleocapsid protein/gene
Specimen
Nasal swab, Oropharyngeal swab, Saliva
Cross-reactivity (pathogens tested)
Adenovirus, Adenovirus 7, Alpha Coronavirus 229E (HCoV-229E), Alpha Coronavirus Nl63 (HCoV-Nl63), Beta Coronavirus OC43 (HCoV-OC43), Bordetella Pertussis, Chlamydia Pneumoniae, Coronaviruses (HCoV), Cytomegalovirus (CMV), Epstein-Barr Virus (EBV), Human Metapneumovirus (HMPV), Influenza A H1N1, Influenza B, MERS-CoV, Mumps Virus (MuV), Mycobacterium Tuberculosis, Mycoplasma Pneumoniae, Parainfluenza Virus Type 1, Parainfluenza Virus Type 2, Parainfluenza Virus Type 3, Parainfluenza Virus Type 4, Respiratory Syncytial V (RSV) Type B, Rhinovirus, SARS-CoV
Lineages detected
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
The product is used only with SARS-CoV-2 reagent and control kits (MRPhRI01).
Assay Type
Nucleic acid-PCR
Self Test
No
Reader Required
No
Method
RT-PCR
Measurement
Qualitative
Time
40 minutes
LOD
10 cpu
Positive control
Twist Synthetic SARS-CoV-2 RNA Controls (MN908947.3)
Negative control
Rnase free water
Analytical Sensitivity
100 %
Analytical Specificity
100 %
Clinical Sensitivity
100 %
Clinical Specificity
100 %
Throughput
Lower than 24 samples per run
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