Xpert SARS-CoV-2 Plus
Manufactured by Cepheid, United States - www.cepheid.com/
Device identification number
5805
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Automated, Lab-based
Physical Support
Cartridge
Target type
Nucleic acid
Targets
envelope protein/gene, nucleocapsid protein/gene, Other (RdRP: RNA dependent RNA polymerase gene)
Specimen
Anterior nasal swab, Mid-turbinates swab, Nasopharyngeal swab
Cross-reactivity (pathogens tested)
Adenovirus, Adenovirus 7, Alpha Coronavirus 229E (HCoV-229E), Alpha Coronavirus Nl63 (HCoV-Nl63), Beta Coronavirus HKU1 (HCoV-HKU1), Beta Coronavirus OC43 (HCoV-OC43), Bordetella Pertussis, Chlamydia Pneumoniae, Cytomegalovirus (CMV), Epstein-Barr Virus (EBV), Hemophilus Influenzae, Herpes Simplex (HSV), Human Metapneumovirus (HMPV), Influenza A H1N1, Influenza B Victoria, MERS-CoV, Mycobacterium Tuberculosis, Mycoplasma Pneumoniae, Other (SARS-coronavirus, Urbani; Neisseria mucosa; Propionibacterium anes; Pseudomonas aeruginosa; diverse Stephylococcus spp.; Influenza C; Pneumocystis jivecii; Lactobacillus reuterii; Neusseria meninitides; Echovirus; ), Parainfluenza Virus Type 1, Parainfluenza Virus Type 2, Parainfluenza Virus Type 3, Parainfluenza Virus Type 4, Respiratory Syncytial V (RSV) Type A, Rhinovirus
Pathogens detected
SARS-CoV-2
Lineages detected
Commercial Status
Commercialised
Last Update
2022-12-22 08:49:46 CET
Assay Type
Nucleic acid-PCR
Rapid Diagnostic
Yes
Self Test
No
Reader Required
N.A.
Subcategory
N.A.
Method
RT-PCR
Measurement
Qualitative
Subclass
Multiple
Detection Principle
Other (Molecular probes)
Analytical Sensitivity
100 % (Nasal specimens)
Analytical Specificity
100 % (Nasal specimens)
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