U-TOP™ COVID-19 Detection Kit

SEASUN BIOMATERIALS INC.

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The Gold Standard PCR Diagnostic Test

Highly sensitive and highly accurate, this Gold Standard PCR test demonstrated 100.0% positive and negative agreement in clinical trials. U-TOP™ was used to help successfully contain COVID-19 in Korea before receiving its U.S. FDA EUA authorization on April 27, 2020.

Order
 

Test Type

Diagnostic
RT-qPCR

Delivery

7-14 days
Shipped from Korea

FDA Status

EUA Authorized
April 27, 2020

Manufacturer

Seasun Biomaterials Inc. is a Korean company founded in 2012 with ISO 13485, GMP, and CE certifications. It is also certified as a DNA Testing Institution by the Korean CDC. An expert developer of PCR kits, Seasun has developed and sold numerous PCR kits worldwide..

Clinical Studies

  • 100% PPA, 100% NPA (N=120)

  • Inclusivity analysis: 100% identity for known SARS-CoV-2 strains

  • In-silico and wet specificity testing: No cross-reactivity

See Instructions for Use for clinical data.

Specifications

Intended Use
Real-time RT-PCR test intended for the qualitative detection of nucleic acid from SARS-CoV-2 in individuals suspected of COVID-19 infection.

Who Can Perform Testing
CLIA-certified laboratories qualified to perform high complexity tests.

Time to Result
Approximately 2.5 hours

Sample Types
Oropharyngeal and nasopharyngeal swab specimens, anterior nasal and mid-turbinate nasal swabs, nasopharyngeal wash/aspirate or nasal aspirate specimens, and sputum.

Probe Targets
Two SARS-CoV-2 genome targets in Orf1ab, one target in N.

Limit of Detection
1,000 copies per mL

Controls
Internal Control — Human RNase P gene
Positive Control — Orf1ab and N targets; human RNase P gene
Negative Control — RNase/DNase free distilled water

Components
2X Reaction Buffer — PCR buffer
750µL (2 tubes) Enzyme Mix — Reverse transcriptase, Taq polymerase
100µL Reaction Mix — Primer/Probe mix
400µL (with Internal Control) Positive Control — SARS-CoV-2 target templates
RNase P, 200µL Negative Control — RNase/DNase free distilled water, 200µL

Storage & Handling
Store at –20°C; Use within 3 months of opening; Thaw reagents except Enzyme Mix at room temperature before use; Place all reagents on ice once thawed during entire test procedure; Place Enzyme Mix on ice during entire test procedure; Avoid excessive freeze/thaw cycles; Vortex and spin down reagents before each use.

Sample Collection Kit (Recommended)

  • Viral Sample Collection Kit by Noble Bio (Cat. No. UTNFS-3B-1)

  • BDTM Universal Viral Transport System by BD (Cat. No. 220531) for collection and transport of upper respiratory tract samples.

  • Sputum Collection Container: Sterile Container with Screw Cap by BD (Cat. No. 90004-118) for collection of sputum samples.

RNA Extraction Kit (Required)

  • QIAamp DSP Virus Kit by Qiagen (Cat. No. 60704)

PCR Instruments (Required)

  • Applied Biosystems 7500 Real-Time PCR Systems with software v2.0.6, or

  • Bio-Rad CFX96 Real-Time PCR Detection Systems with software CFX manager v3.1

Manuals and Instructions

 

*Pricing, shipping, and delivery times subject to change without notice. Generally, shipping adds an additional 3% cost. TEST Cordx-covid-flu-patient-facts Cordx-covid-flu-eua-letter cordx-covid-flu-ifu cordx-covid-flu-quick-ref