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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

Xpert Xpress CoV-2/Flu/RSV plus

Manufactured by Cepheid, United States - www.cepheid.com/ 

Device identification number
5806
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; Matrix protein (fluA); PB2 (fluA); PA (fluA); Matrix protein (fluB); Non-structural protein (fluB); Gene encoding nucleocapsid of RSV-A and RSV-B)
Specimen
Anterior nasal 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), MERS-CoV, Mumps Virus (MuV), 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; Candida spe.), Parainfluenza Virus Type 1, Parainfluenza Virus Type 2, Parainfluenza Virus Type 3, Parainfluenza Virus Type 4, Rhinovirus
Pathogens detected
Influenza A, Influenza B, Respiratory Syncytial V (RSV), SARS-CoV-2
Commercial Status
Commercialised
Last Update
2022-12-22 08:50:23 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
N.A.
Detection Principle
Other (Molecular probes)
Analytical Sensitivity
100 % (SARS-CoV-2, Influenza A, Influenza B & RSV)
Analytical Specificity
100 % (SARS-CoV-2, Influenza A, Influenza B & RSV)

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