Acute respiratory pathogen infections are common causes of acute local and systemic disease with substantial morbidity and mortality in pediatric, adult, and immunocompromised patients. Early and accurate diagnosis of respiratory pathogens diminishes transmission and complications. More efficient laboratory testing enables the physician to determine appropriate and timely patient treatment.1,2
Siemens Healthineers offers solutions for the simultaneous detection of several respiratory pathogens:
- FTD SARS-CoV-2 Assay3 for the specific detection of the coronavirus causing COVID-19
- FTD FLU/HRSV Assay4 for the detection of influenza A, influenza B, and human respiratory syncytial viruses A and B
- FTD Respiratory Pathogens 21 Assay4 for the detection of 20 viruses and 1 bacterium
Características y Beneficios
- Provides simultaneous detection of probable pathogens with one kit using a single sample for increased testing efficiency.
- Compatible with commonly used extraction and thermal cycler platforms. 5,6
- Expanding precision medicine with clinically relevant singleplex and multiplex panels.
- Supports management of respiratory infections throughout the year as well as during seasonal peaks using the same protocol and solution.
- Syndromic panels enable testing of multiple pathogens at the same time, saving time and resources.
- A single sample and test are used to determine all the probable pathogenic causes at the same time, in one run.
FTD SARS-CoV-2 Assay
Specific detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)
FTD FLU/HRSV Assay
respiratory syncytial virus A/B
Other upper respiratory tract pathogens
FTD Respiratory Pathogens 21 Assay
human metapneumovirus A/B
influenza A H1N1
parainfluenza virus 1
parainfluenza virus 2
parainfluenza virus 3
parainfluenza virus 4
respiratory syncytial virus A/B
1) WHO, 2019
2) CDC, 2019
3) FTD SARS-CoV-2 Assay is CE-IVD labelled for diagnostic use in the EU. This test has not been FDA cleared or approved. This test has been authorized by FDA under an EUA for use by authorized laboratories. This test has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens. This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21. U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
4) FTD Resp 21 and FTD FLU/HRSV Assays are CE-IVD for diagnostic use in the EU.
5) The FTD SARS-CoV-2 Assay has been optimized on the Biomerieux EasyMag Extraction System and the Applied Biosystems 7500 Real-time PCR Thermocycler and utilizes the same workflow, including PCR profile, as other FTD Respiratory Disease kits from Siemens Healthineers.
6) Visit fast-trackdiagnostics.com for a list of compatible instruments. Customer is responsible for validating the assay on instruments listed in the compatibility list.
Product availability may vary from country to country and is subject to varying regulatory requirements. Please contact your local representative for availability. All third party trademarks listed in this brochure are the property of their respective owners.