Improving Your Infectious Disease Screening

New EasyScreen™ products

EasyScreen™ SARS-CoV-2 Detection Kit

Coronaviruses (CoV) are a family of viruses, transmitted between animals and people, known to cause illnesses ranging in severity from the common cold to more severe diseases such as the Middle East respiratory syndrome (MERS) and severe acute respiratory syndrome (SARS)1. The novel coronavirus SARS-CoV-2 is the seventh known coronavirus to infect humans (others are 229E, NL63, OC43, HKU1, MERS-CoV and SARS-CoV), with the first reported case of the current SAR-CoV-2 (formally known as 2019-nCoV) outbreak originating from Wuhan, China on the 31st December 20192.

The Genetic Signatures’ EasyScreen™ SARS-CoV-2 Detection Kit (RP011/RP011-HT) has been designed to provide rapid and accurate detection of SARS-CoV-2.

 

EasyScreen™ SARS-CoV-2 Detection (RP011/RP011-HT)Targets 

E-gene

EasyScreen™ SARS-CoV-2 Detection (RP012/RP012-HT)Targets 

N-gene

 Regulatory

  • EasyScreenTM SARS-CoV-2 Detection Kits are supplied under the FDA Section IV.c exemption of the Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency (Revised).
  • EasyScreenTM Sample Processing Kits are FDA-listed clinical concentrators.

1Zhu, Na; Zhang, Dingyu; Wang, Wenling; Li, Xinwang; Yang, Bo; Song, Jingdong; Zhao, Xiang; Huang, Baoying; Shi, Weifeng; Lu, Roujian; Niu, Peihua; Zhan, Faxian; Ma, Xuejun; Wang, Dayan; Xu, Wenbo; Wu, Guizhen; Gao, George F.; Tan, Wenjie (24 January 2020). “A Novel Coronavirus from Patients with Pneumonia in China, 2019”. New England Journal of Medicine. United States. doi:10.1056/ NEJMoa2001017. ISSN 0028-4793. PMID 31978945.
2Laboratory testing for 2019 novel coronavirus (2019-nCoV) in suspected human cases. World Health Organization, 17 January 2020. https://www.who.int/publications-detail/laboratory-testing-for- 2019-novel-coronavirus-in-suspected-human-cases-20200117

EasyScreen™ Coronavirus Detection Kit

The EasyScreen™ Coronavirus Detection Kit (RP003) is a rapid in vitro nucleic acid amplification assay for the qualitative detection of Coronavirus nucleic acid, from respiratory specimens. The test, based on real-time PCR, detects multiple Coronavirus targets.

EasyScreen™ Coronavirus Detection (RP003) Targets

Coronavirus OC43
Coronavirus NL63/229E

This product is also available as ASRs.

Regulatory

  • Analyte Specific Reagents (ASRs). Analytical and performance characteristics are not characterized.
  • EasyScreenTM Sample Processing Kits are FDA-listed clinical concentrators.
  • EasyScreenTM Coronavirus Detection Kit is EUA pending April 2020.

Atypical Pathogen Detection Reagents

The Genetic Signatures’ Atypical Respiratory ASRs has been designed to provide rapid and accurate detection of multiple atypical respiratory pathogens. The ASRs uses multiplexed real-time PCR and is compatible with nucleic acid isolated using the EasyScreenTM Sample Processing Kit.

 

Atypical Respiratory Targets

AAR001-3 Bordetella holmesii Primers and Probe
AAR002-1 Legionella longbeachae Primers and Probe
AAR003-3 Pneumocystis jirovecii Primers and Probe
AAR004-4 Chlamydophila psittaci Primers and Probe
AAR005-1 Mycoplasma pneumonia Primers and Probe
AAR006-3 Chlamydophila pneumoniae Primers and Probe
AAR007-4 Legionella pneumophila Primers and Probe

ASRs also include an Extraction and Internal Positive Control for each sample to ensure the quality of the extracted DNA and to detect the presence of any inhibitors, respectively.

The Product Code suffix indicates the detection channel for each real-time PCR probe.

 

Regulatory

  • Analyte Specific Reagents (ASRs). Analytical and performance characteristics are not characterized.
  • EasyScreenTM Sample Processing Kits are FDA-listed clinical concentrators.

ASRs also include an Extraction and Internal Positive Control for each sample to ensure the quality of the extracted DNA and to detect the presence of any inhibitors, respectively.

Regulatory

  • Analyte Specific Reagents (ASRs). Analytical and performance characteristics are not characterized.
  • EasyScreenTM Sample Processing Kits are FDA-listed clinical concentrators.
  • EasyScreenTM Pathogen Detection Kits are for research use only and are not available for in vitro diagnostic use in America. Genetic Signatures also supplies a range of Analyte Specific Reagents for customers in the USA/North America.