Respiratory Pathogen Detection
The rapid and accurate detection of respiratory pathogens is important. Potential advantages of specific pathogen detection include obtaining prognostic information, limiting additional testing, instituting appropriate infection control precautions and limiting unnecessary antibiotic usage1.
Molecular methods offer the advantages of rapidity and the ability to detect pathogens regardless of growth requirements or the availability of reagents for rapid diagnostic testing1.
The Respiratory Reagents are based on real-time PCR and is a qualitative in vitro diagnostic test for the detection of selected target nucleic acids, in respiratory specimens treated using an EasyScreen™ Sample Processing Kit. The device specifically detects nucleic acid sequences from viral and bacterial pathogens of the respiratory system. Compatible specimens include swabs (dry, or in UTM), sputum, bronchial washings, and Nasopharyngeal Aspirates.
The Respiratory Pathogen ASRs are rapid in vitro nucleic acid amplification tests for the qualitative detection of respiratory pathogen nucleic acid from respiratory specimens.
Molecular methods offer the advantages of rapidity and the ability to detect pathogens regardless of growth requirements or the availability of reagents for rapid diagnostic testing. The reagents use multiplexed real-time PCR assays and is compatible with nucleic acids isolated using an appropriate EasyScreen™ Sample Processing Kit.
Respiratory Pathogen Targets
| Rhinovirus | Parainfluenza 2 |
| Influenza B | Adenovirus |
| Respiratory syncytial virus- A/B | Mycoplasma pneumoniae |
| Human Metapneumovirus | Parainfluenza 4 |
| Parainfluenza 1 | Bordetella pertussis |
| Parainfluenza 3 | Bordetella parapertussis |
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.
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 |
|---|
| Chlamydia pneumoniae |
| Streptococcus pneumoniae |
| Legionella pneumophila |
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.
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 (RP012/RP012-HT) has been designed to provide rapid and accurate detection of SARS-CoV-2.
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
1 Arens M, Buller R, Rankin A, et al 2010.Comparison of the Eragen Multi-Code Respiratory Virus Panel with Conventional Viral Testing and Real-Time Multiplex PCR Assays for Detection of Respiratory Viruses. Journal of Clinical Microbiology 48(7):2387.
Regulatory:
- 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.
- Analyte Specific Reagents (ASRs). Analytical and performance characteristics are not characterized.
- EasyScreenTM Sample Processing Kits are FDA-listed clinical concentrators.
