SARS-CoV-2/FluA/FluB/RSV detection kit（PCR MALDI-TOF-MS）
Manufactured by Shanghai Conlight Medical Lab Co. Ltd., China - www.kanglijianyan.com
Device identification number
1821
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Lab-based
Physical Support
Chip
Target type
Nucleic acid
Specimen
Nasal swab, Nasopharyngeal swab
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
SARS-CoV-2/FluA/FluB/RSV test is a rapid, multiple Nucleic acid amplification testing.This detection intended for the qualitative detection and differentiation of SARS-CoV-2, influenza A, influenza B, and respiratory syncytial virus (RSV) viral RNA in either nasopharyngeal swab or nasal swab specimens collected from individuals suspected of respiratory viral infection. The product is registered as an in vitro diagnostic under number: SARS-CoV-2/FluA/FluB/RSV detection kit (PCR MALDI-TOF-MS) (no brand name) (NL-CA002-2021-55817)
Assay Type
Nucleic acid-PCR
Subcategory
Other ()
Method
Other ()
Measurement
Qualitative
Time
120 minutes
Subclass
JRC-S
LOD
2750 cpm
Positive control
Able to detect all of SARS-CoV-2, FluA, FluB, RSV, MS2 bacterphage and RNase P.
Negative control
MS2 bacterphage should be detected,and all of SARS-CoV-2, FluA, FluB, RSV should be detected as not
Analytical Sensitivity
100 %
Analytical Specificity
100 %
Clinical Sensitivity
94.3 %
Clinical Specificity
100 %
Notes
resin and Spectro CHIP ( details see instructment of the kit )
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