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FTD Respiratory Assays

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

New analysis confirms Siemens Healthineers PCR influenza assays detect new H3N2 influenza strain exhibiting genetic drifts.†

The influenza A assay included in the FTD SARS-CoV-2/FluA/FluB/HRSV Assay4, FTD Respiratory pathogens 21 Assay4, and FTD FLU/HRSV Assay4, detects the new H3N2 strain exhibiting genetic drifts.

Read the full statement

†Data on file at Fast Track Diagnostics Luxembourg S.à r.l., a Siemens Healthineers Company. Data is current as of date 30th November 2022.

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:

Features & Benefits

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Greater Efficiency

  • Provides simultaneous detection of probable pathogens with one kit using a single sample for increased testing efficiency.
  • Uses the same protocol, enabling operators to more easily switch during the peak season without additional training.
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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.
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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.

Assays

SARS-CoV-2

FTD SARS-CoV-2 Assay 

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

FTD SARS-CoV-2/FluA/FluB/HRSV Assay

Detection and differentiation of SARS-CoV-2, influenza A, influenza B, and human respiratory syncytial viruses A/B

SARS-CoV-2
influenza A
influenza B
respiratory syncytial virus A/B

Seasonal Flu

FTD SARS-CoV-2/FluA/FluB/HRSV Assay

Detection and differentiation of SARS-CoV-2, influenza A, influenza B, and human respiratory syncytial viruses A/B

SARS-CoV-2
influenza A
influenza B
respiratory syncytial virus A/B

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, 2022

2

CDC, 2022

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 SARS-CoV-2/FluA/FluB/HRSV, FTD Resp 21, and FTD FLU/HRSV Assays are CE-IVD for diagnostic use in the EU.