The FTD™ SARS-CoV-2/FluA/FluB/HRSV Assay*, for use on the VERSANT® kPCR Molecular System, is a semi-automated reverse-transcription real-time PCR assay for in-vitro qualitative detection and differentiation of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2; ORF1ab and N genes), influenza A virus (IAV), influenza B virus (IBV), and human respiratory syncytial virus A and B (HRSV A/B) RNA in nasopharyngeal swab specimens in a viral transport medium obtained from individuals with signs and symptoms of respiratory infections. The test is intended as an aid in the differential diagnosis of SARS-CoV-2, IAV, IBV, and HRSV A/B in humans.
FTD SARS-CoV-2/
FluA/FluB/HRSV Assay
For the detection of five respiratory viruses from one sample eluate: SARS-CoV-2, Influenza A virus, Influenza B virus, and human Respiratory Syncytial Viruses A/B.
FluA/FluB/HRSV Assay
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 Assay*, FTD Respiratory pathogens 21 Assay*, and FTD FLU/HRSV Assay*, detects the new H3N2 strain exhibiting genetic drifts.
†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.
Clinical Use
Respiratory Testing
During the COVID-19 pandemic, circulation of respiratory viruses changed dramatically, and recent flu seasons have shown atypical patterns compared to pre-pandemic times. It is expected that upcoming seasons will return to normal with the co-circulation of respiratory viruses.
SARS-CoV-2 targets the epithelial cells of the respiratory tract and causes infection that can lead to Coronavirus disease 2019 (COVID-19). Influenza A and B are major causes of seasonal epidemics of respiratory infections in children and adults with rapid onset of fever. HRSV is an important cause of severe lower respiratory tract infections in children, immuno-compromised patients, and the elderly. It is also the leading viral cause of death in infants less than 1 year of age.
Siemens Healthineers’ new RT-PCR FTD SARS-CoV-2/FluA/FluB/HRSV Assay detects these five relevant pathogens to meet your laboratory’s clinical and epidemiological (surveillance) needs.
Emergent SARS-CoV-2 Variants
As part of our Global Surveillance Program, the FTD SARS-CoV-2 Assay and FTD SARS-CoV-2/FluA/FluB/HRSV Assay have been shown to detect emergent SARS-CoV-2 variants.
Features & Benefits
- Detection of SARS-CoV-2, Influenza A virus, Influenza B virus, and human Respiratory Syncytial Viruses A and B from the same sample eluate
- Designed with the same high SARS-CoV-2 sensitivity as the FTD SARS-CoV-2 Assay (targets conserved regions withing ORF1ab and N gene)
- Differentiation between SARS-CoV-2, FluA, FluB, and HRSV A/B
- Mid- to high-throughput semi-automated solution to manage seasonal respiratory testing in the context of COVID-19 pandemic and beyond
* CE-IVD labeled for diagnostic use in the EU.
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