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FTD Respiratory Assays

FTD Respiratory AssaysSyndromic testing for emerging, routine, and seasonal outbreaks of respiratory infections using multiplex RT-PCR

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

Greater Efficiency

  • 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

Better Outcomes

  • 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.

Lower Costs

  • 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.

ensayos

SARS-CoV-2

FTD SARS-CoV-2 Assay

Specific detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)

Seasonal Flu

FTD FLU/HRSV Assay

Detection of influenza A, influenza B, and human respiratory syncytial viruses A and B


influenza A
influenza B
respiratory syncytial virus A/B

Other upper respiratory tract pathogens

FTD Respiratory Pathogens 21 Assay
Detection of 20 viruses and 1 bacterium

adenovirus
bocavirus
coronavirus
coronavirus 229E
coronavirus HKU1
coronavirus NL63
coronavirus OC43
enterovirus
human metapneumovirus A/B
parechovirus
influenza A
influenza A H1N1
influenza B
Mycoplasma pneumoniae
parainfluenza virus 1
parainfluenza virus 2
parainfluenza virus 3
parainfluenza virus 4
respiratory syncytial virus A/B
rhinovirus

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.