Tepat 1.0 COVID-19 Test Kit
1.5 hours from RNA to results
100% coverage with 100% identity of all SARS-CoV-2 genomes in the world
Detects 6 copies of viral RNA (0.24 copies/uL)
Multiplex RdRp and M viral genes detection enhances sensitivity and specificity
Whole process control: human RNase P
1.5 hours from RNA to results
100% coverage with 100% identity of all SARS-CoV-2 genomes in the world
Detects 6 copies of viral RNA (0.24 copies/uL)
Multiplex RdRp and M viral genes detection enhances sensitivity and specificity
Whole process control: human RNase P
The Cellbae Multiplex RT-PCR kit provides for high-throughput, sensitive and specific detection of SARS-CoV-2 RNA extracted from nasopharyngeal swabs*. It can detect 6 copies of viral RNA per reaction with > 95% confidence. Clinical validation shows 100% sensitivity, with no cross-reaction with non-SARS-CoV-2 species.
Workflow
Sampling
RNA Extraction
RT-PCR
Data Analysis
Kit Components
100 Tests/Kit
Multiplexed Detection
Kit Specification
Targets
RdRp, M and RNase P genes
Inclusivity
100% coverage of all SARS-CoV-2 genomes (as of Aug. 10, 2020)
Turnaround Time
1.5 hours
Limit of Detection
6 copies per reaction
Storage / Shelf life
-25 to -15oC / 6 months
Validated Machines
Bio-Rad CFX96, LightCycler 480 II
Sensitivity / Specificity
100% / 100% (CV: < 4%)
Certification
Singapore Health Sciences Authority (HSA) MDPA2020-127 received Sept. 15, 2020
CE Certification (OEARC – GZ 0286-2020) received 3 Dec 2020
*A positive result from the test may indicate the presence of SARS-CoV-2-specific RNA in the test sample. If the test result is negative and clinical symptoms persist, additional testing using other clinical methods is recommended. A negative result does not at any time preclude the possibility of SARS-COV-2 infection.
