TEP@RT Kit

COVID-19 Antigen Self Test (Nasal)

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

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

The Cellbae TEP@RT Kit COVID-19 Antigen Self Test (Nasal) is a single-use, in vitro lateral flow immunochromatographic rapid test kit that utilizes a human nasal swab sample for the qualitative detection of SARS-CoV-2 nucleocapsid antigen. The Cellbae TEP@RT Kit COVID-19 Antigen Self Test (Nasal) is intended to be used manually by untrained lay users as a self-testing kit to aid in detecting active SARS-CoV-2 infection. The result of this test should not be the sole basis for the diagnosis of infection. Confirmatory testing via molecular testing is required.


WORKFLOW


KEY HIGHLIGHTS

  • Highly sensitive

  • Highly specific

  • Rapid detection in 15 minutes


SPECIFICATIONS

Specimen Type

  • Nasal Swabs

Targets

  • SARS-CoV-2 nucleocapsid antigen

Turnaround Time

  • 15 minutes

Limit of Detection

  • 500 (TCID50 mL; SARS-CoV-2 USA-WA1/2020 strain)

Sensitivity / Specificity

  • 100% / 100% (RT-PCR < Ct 30.0)

Storage Temperature

  • 2 to 30 °C

Cross-Reaction and Interference