TEPAT 1.0 SARS-CoV-2 Multiplex RT-PCR Kit *Not Available
For detection of the SARS-CoV-2 / COVID-19 RNA
Available formats SKU# Price (SGD)
100 tests/kit TP-001-01 *Not Available
Manufactured at Cellbae’s Singapore facilities, which are certified to ISO 13485:2016 Medical Devices ‒ Quality Management Systems
INTENDED USE
TEPAT 1.0 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
KEY HIGHLIGHTS
1.5 hours from RNA to results
Multiplex RdRp and M viral genes detection enhances sensitivity and specificity
100% coverage of all SARS-CoV-2 genomes in the world
Detects 6 copies of viral RNA
Whole process control: human RNase P
SPECIFICATIONS
Specimen Type
Nasopharyngeal Swabs
Targets
RdRP gene
M gene
RNase P gene
Inclusivity
100% coverage of all SARS-CoV-2 genomes (as of Aug 10, 2020)
Turnaround Time
1.5 hours
Limit of Detection
6 copies /reaction
Sensitivity / Specificity
100% / 100% (CV < 4%)
Storage Temperature
-25 to -15 °C
Certification
Singapore Health Sciences Authority (HSA), MDPA2020-127, received on 15 Sep 2020
CE IVD Certified