U-TOP™ COVID-19 TEST KITS FREQUENTLY ASKED QUESTIONS

Who is Seasun Biomaterials?

Seasun Biomaterials is an in vitro diagnostic company that develops molecular diagnostic platforms of infection diseases, cancer and genetic and epigenetic disorders.  Seasun develops and commercializes innovative real-time PCR-based diagnostic platforms through the development of proprietary technologies to provide more advanced molecular diagnostic services.  

 

Seasun Biomaterials reliable products are used in hundreds of hospitals and laboratories throughout the world.

http://www.seasunbio.com/english/etc.html

 

What is the U-TOP COVID-19 Detection Kit?

The U-TOP COVID-19 Detection Kit is a real-time, PCR-based, in-vitro diagnostic product intended for detection of the novel coronavirus SARS-CoV-2 (COVID-19) RNA in sputum, bronchoalveolar lavage, oropharyngeal or nasopharyngeal smears collected from patients with suspected viral infection.

The kit is composed of:

  • 2x Reaction Buffer

  • Enzyme Mix

  • Reaction Mix

  • Positive Control

  • Negative Control

Can the U-TOP COVID-19 Detection Kit be used in the United States?

U-TOP COVID-19 Detection Kit was authorized by the FDA under the Emergency Use Authorization, as of April 27, 2020. For more information see the Emergency Use Authorization FDA website: https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations

 

What are the specifications of the U-TOP COVID-19 Detection Kit?

Detection Target: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).

  • Target Region:                      ORF1ab, N gene.

  • Detection Technology:       Real-Time One step RT-qPCR.

  • Specimen Type:                   Sputum, Bronchoalveolar lavage, Oropharyngeal, Nasopharyngeal smears.

  • Compatible Instruments:   CFX96TM Real-Time PCR System (Bio-Rad),

                                                         ABI7500 Real-Time PCR System (Thermo Fisher Scientific) .

  • PCR Running Time:               ≤ 2.5h.

 

What are the advantages of using the U-TOP COVID-19 Detection Kit?

  • Working Method:       PNA probe (hybridization), High sensitivity and accuracy.

  • Analysis program:      U-TOP COVID-19 Detection Analyzer.

  • Reagent:                      All made in Korea. Reduces chances of supply issues.

  • Clinical Experience:   Abundant.

  • Accuracy:                     ~99%.