Bioneer AccuPower® COVID-19 Real-Time RT-PCR Kit
Category
Test kits
Subcategory
PCR test
Manufacturer
Bioneer
Company origin
Korea
Certifications & Standards
CE (Europe), ISO 13485, MFDS (Korea)
Brief description
AccuPower® COVID-19 Real-Time RT-PCR Kit is an in vitro diagnostic kit that helps diagnose COVID-19 infections, detects SARS-CoV-2 (E gene and RdRp gene) RNA from a suspected infection patient’s sample (such as sputum, nasopharyngeal swab, oropharyngeal swab) through Real-Time Polymerase chain reaction(PCR) using ExiStation™ Universal MDx system.
Lab COVID-19 Trust Score
Trust score: 90%
Reviewer comment: CE-IVD approved
Photos
Detailed information
Features
SARS-CoV-2 Detection; SARS-CoV-2 (E gene and RdRp gene) RNA can be detected with high sensitivity.
Signature Convenience; All components for the assay are contained within a tube.
Enhanced Sensitivity & Specificity; Bioneer’s proprietary Dual-HotStart technology accomplishes high sensitivity and specificity.
Remarkable Stability; vacuum-dried premix allows stable and reproducible results.
High Quality: all diagnostic kits manufactured by Bioneer are under strict quality control guidelines.
Milestones
- CE-IVD approval
Specifications
Specimen Type
- Sputum
- Nasopharyngeal swab
- Oropharyngeal swab
Kit Contents
- NCV (E gene) Premix 8 well-strip/6 strips
- NCV (RdRp gene) Premix 8 well-strip/6 strips
- Positive Control 8 well-strip/2 strips
- SL Buffer /8 tubesOptical sealing film /1 ea
Instrumentation
- ExiStation™
- ExiStation™ 48
Media coverage
- Genome Web (7 Apr 2020) https://www.genomeweb.com/business-news/bioneer-inks-deal-qatar-petroleum-supply-coronavirus-test-kits-instruments#.Xp5RWlOFPBI
- Genome Web (20 Mar 2020) https://www.genomeweb.com/regulatory-news-fda-approvals/bioneer-receives-ce-mark-coronavirus-kits-inks-supply-agreement#.Xp5RW1OFPBI