The Novel Coronavirus (2019-nCoV) Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing) is an U.S. Food and Drug Administration (FDA) emergency use authorized, all-in-one in vitro diagnostic kit that enables specimen storage/transport, specimen preparation, as well as real-time RT-PCR-based COVID-19 detection.

Features

Specific

Multi-target assay. Targets ORF1ab and N genes. Does not exhibit cross-reactivity with common pathogens found in the respiratory systems.

Sensitive

Limit of detection of 200 copies/ml.

Accurate

Covers 100% of known SARS-CoV-2 sequences published on NCBI, GISAID, and NGDC1.

Convenient

Enables SARS-CoV-2 detection without prior viral nucleic acid isolation or other specimen preparation procedures2.

Cross-Reactivity

Does not exhibit cross-reactivity with pathogens commonly found in upper and lower respiratory specimens such as:

  • Human coronavirus 229E
  • Human coronavirus OC43
  • Human coronavirus HKU1
  • Human coronavirus NL63
  • SARS (RNA)
  • MERS (Pseudovirus)
  • Adenovirus 1
  • Human Metapneumovirus (hMPV)
  • Parainfluenza virus 1-4
  • Influenza A (viral standard)
  • Influenza B
  • Enterovirus (EV-C95)
  • Respiratory syncytial virus
  • Rhinovirus
  • Chlamydia pneumonia
  • Haemophilus influenzae (viral standard)
  • Legionella pneumophila (viral standard)
  • Mycobacterium tuberculosis
  • Streptococus pneumoniae (viral standard)
  • Streptococcus pyogenes
  • Bordetella pertussis
  • Mycoplasma pneumoniae
  • Pneumocystis jirovecii (PJP)

Intended Use

TERMS AND CONDITIONS

  • 1. Includes all sequences posted by March 25, 2020.
  • 2. Applicable only when using the Sample Storage Reagent included in kit.
  • 3. This product is only available to clinical laboratories conducting testing for COVID-19. Regulations prohibit us from providing this product to individual customers.