NxTAG® Respiratory Pathogen Panel + SARS-CoV-2
Manufactured by Luminex Molecular Diagnostics Inc., Canada - www.luminexcorp.com
Device identification number
2518
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Automated
Physical Support
Microplate, Microtiter plate
Target type
Nucleic acid
Specimen
Anterior nasal swab, Mid-turbinates swab, Nasal aspirate, Nasal swab, Nasopharyngeal swab, Oropharyngeal swab, Wash aspirate
Cross-reactivity (pathogens tested)
Adenovirus, Alpha Coronavirus 229E (HCoV-229E), Alpha Coronavirus Nl63 (HCoV-Nl63), Beta Coronavirus HKU1 (HCoV-HKU1), Beta Coronavirus OC43 (HCoV-OC43), Chlamydia Pneumoniae, Enterovirus A71 (EV-A71), Human Metapneumovirus (HMPV), Influenza A, Influenza A H1N1, Influenza A H3N2, Influenza B, Mycoplasma Pneumoniae, Parainfluenza Virus Type 1, Parainfluenza Virus Type 2, Parainfluenza Virus Type 3, Parainfluenza Virus Type 4, Respiratory Syncytial V (RSV) Type A, Respiratory Syncytial V (RSV) Type B, Rhinovirus, SARS-CoV
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
The NxTAG® Respiratory Pathogen Panel + SARS-CoV-2 is a qualitative test intended for the simultaneous detection and identification of nucleic acids from multiple respiratory viruses and bacteria extracted from upper respiratory tract specimens collected from individuals with clinical signs and symptoms of a respiratory tract infection.
Assay Type
Unknown
Reader Required
Yes
Method
RT-PCR
Measurement
Qualitative
Time
59 minutes
Subclass
JRC-S
LOD
SARS-CoV-2: 5.00E+02 Copies/mL
Positive control
External
Negative control
Negative Amplification Control: RNasefree water
Analytical Sensitivity
100 %
Analytical Specificity
100 %
Clinical Sensitivity
100 %
Clinical Specificity
99.7 %
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