STAT-NAT® SARS-CoV-2 SN200 - 1N045S
Manufactured by SENTINEL CH. SpA, Italy - www.sentineldiagnostics.com
Device identification number
2981
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Automated
Target type
Nucleic acid
Specimen
Nasopharyngeal swab
Cross-reactivity (pathogens tested)
Adenovirus, Alpha Coronavirus Nl63 (HCoV-Nl63), Beta Coronavirus HKU1 (HCoV-HKU1), Beta Coronavirus OC43 (HCoV-OC43), Bordetella Pertussis, Chlamydia Pneumoniae, Enterovirus A71 (EV-A71), Hemophilus Influenzae, Human Metapneumovirus (HMPV), Influenza A H1N1, Influenza B, MERS-CoV, 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 A, Respiratory Syncytial V (RSV) Type B, Rhinovirus, SARS-CoV
Pathogens detected
SARS-CoV
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
The STAT-NAT® SARS-CoV-2 SN200 kit is an automated, lyophilized Real-Time RT-PCR multiplex assay based on nucleic acid amplification for the in vitro qualitative detection of RNA from the SARS-CoV-2, in human nasopharyngeal swab specimens on SENTiNAT® 200 instrument. This assay is an aid in the diagnosis of SARS-CoV-2 infection. For laboratory professional use only. Positive control kit: STAT-NAT® SARS-CoV-2 SN200 Positive Control – Sentinel REF. 1N046S. Consumables/Accessories: SENTiNAT®200 extraction kit consumable set – Sentinel REF.1N1004, STAT-NAT® SARS-CoV-2 consumable set – Sentinel REF. 1N1007, Elution plates – Sentinel REF. 1N1008 Extraction Kit: Sentinel Diagnostics STAT-NAT® Pathomag SN200 extractionkit – Sentinel REF. 1N1001S Validated automated system: SENTiNAT® 200, and the dedicated instrument consumables. Software platform and Analysis Software: FastFinder (UgenTec), the assay-specific STAT-NAT®SARS-CoV-2 SN200 Plugin REF. PLSN20001.
Assay Type
Nucleic acid-PCR
Self Test
No
Subcategory
Other ()
Method
RT-PCR
LOD
5 cpr
Positive control
STAT-NAT® SARS-CoV-2 SN200 Positive Control – Sentinel REF. 1N046S
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