Meril COVID-19 One-step RT-PCR Kit
Manufactured by Meril Diagnostics Pvt Ltd., India - www.merillife.com
Device identification number
792
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Automated, Manual
Target type
Nucleic acid
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Assay Type
Nucleic acid-PCR
Method
RT-PCR
Time
120 minutes
LOD
0.5 cpu ( )
Positive control
Positive control is provided with the kit.
Negative control
No template control is provided with the kit. The test utilizes external controls (positive control and a negative control(DEPC-treated H2O)
Analytical Sensitivity
100
Analytical Specificity
100
Clinical Sensitivity
100
Clinical Specificity
100
Throughput
96 samples/run
Notes
Information provided by the manufacturer: Meril COVID-19 One step RT-PCR Kit is intended for qualitative detection of nucleic acid from SARS-CoV-2 using real time PCR from Human nasal, nasopharyngeal, oropharyngeal swab specimens, and bronchoalveolar lavage samples. The results can be used to assist diagnosis of patients with COVID-19 infection. The Meril COVID-19 One step RT-PCR Kit is intended for use by qualified and trained clinical laboratory personnel specifically instructed and trained in the techniques of real-time PCR and in vitro diagnostic procedures. Summary and explanation of the test: The Meril COVID-19 One-step RT-PCR Kit is a qualitative test uses nucleic acid amplification technology and the standard hydrolysis probe system .The Human RNase P Internal Control is used to monitor the entire sample preparation and PCR amplification process. In addition, the test utilizes external controls (positive control and a negative control(DEPC-treated H2O).Principle:The primer and probe mix for this kit adopts the dual-target gene design, which targets the specific conserved sequence encoding the ORF 1ab gene and the nucleoprotein N gene. With the PCR reaction mix provided, the amplification of template can be quantitatively monitored by the increasing fluorescence signal detected by a real time PCR instrument.The PCR detection system includes an endogenous internal control primer and probe mix. The result of internal control provides the accuracy of sampling and extraction process, in order to avoid false negative results.Instrument Compatibility:This kit is compatible with real time PCR instruments with FAM, HEX/VIC, RED/ROX channels.
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