TEPAT 1.0 SARS-CoV-2 Multiplex RT-PCR Kit

For detection of the SARS-CoV-2 / COVID-19 RNA

Available formats SKU# Price (SGD)

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