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The Thermo Fisher Scientific Amplitude Solution has received Emergency Use Authorization from the US FDA for COVID-19 testing for use with the TaqPath COVID-19 High-Throughput Combo Kit, the highly automated molecular diagnostic testing solution that can analyze from 1,000 to 8,000 COVID-19 specimens in 24 hours. The Amplitude Solution can help laboratories quickly scale COVID-19 testing to volumes needed to help reduce the spread of disease and restore economies and communities. This solution offers maximum throughput with minimal hands-on time, equipment, and staffing.

As COVID-19 testing needs fluctuate, the Amplitude Solution has the ability to flex to your lab’s needs. The Amplitude Solution will provide a means to address the testing needed for companies, schools, universities, communities and others to begin returning back pre-pandemic life.

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Mark Stevenson EUA Announcement

Chief Operating Officer and Executive Vice President of Thermo Fisher Scientific, Mark Stevenson, is excited to share with you how this achievement will help in the next phase of the ongoing fight against COVID‑19.

Elliot Shelton EUA Achievement

Senior Director and General Manager of the Amplitude Solution, Elliot Shelton, shares the excitement of achieving Emergency Use Authorization from the US FDA.

Amplitude Solution Workflow

Take a look through the highly automated workflow of the Amplitude Solution.


Sample and swab
1,000 to 8,000 test results per day
Support Tools
24/7 priority support
User
4-employee operation
support-center-snippet-icon
1 trusted source for secured supply

As the world leader in serving science, Thermo Fisher Scientific has brought together industry-leading products into a high-throughput diagnostic solution with the convenience of purchasing a secured supply of assays and consumables directly from a single-source supplier. Your initial purchase comes with an up-front monthly delivery of reagents for your laboratory’s needs over the first year. Our all-inclusive service partnership will handle every detail of the process to help ensure a seamless installation and offers 24/7, 365-day priority access to reliable scientists or specialists you can count on for any issues that arise now and into the future.

 
Amplitude workflow

Module 1

After each tube is uncapped, inactivated, and barcoded, the tube rack is placed into the Tecan Fluent™ 1080 liquid handler. This instrument automates the process for your lab by adding a negative control, beads/binding solution, proteinase K, and MS2 and by preparing four 96-deep-well plates for transfer into the next step.

amplitude-8

Module 2

  • Extracts and purifies RNA from specimens
  • Combines 4 x 96-well RNA plates into 384-well TaqPath reaction plates
  • Performs real-time PCR workflow for TaqPath assay
  • Seperates liquid and plastic waste for easy disposal

 

Sample analysis

  • End-to-end sample tracking and data management within the Amplitude Solution
  • The qPCR run data is automatically analyzed and the COVID-19 test results are generated
  • COVID-19 test results are available to be submitted to your laboratory's LIMS

Module 1

After each tube is uncapped, inactivated, and barcoded, the tube rack is placed into the Tecan Fluent™ 1080 liquid handler. This instrument automates the process for your lab by adding a negative control, beads/binding solution, proteinase K, and MS2 and by preparing four 96-deep-well plates for transfer into the next step.

amplitude-8

Module 2

  • Extracts and purifies RNA from specimens
  • Combines 4 x 96-well RNA plates into 384-well TaqPath reaction plates
  • Performs real-time PCR workflow for TaqPath assay
  • Seperates liquid and plastic waste for easy disposal

 

Sample analysis

  • End-to-end sample tracking and data management within the Amplitude Solution
  • The qPCR run data is automatically analyzed and the COVID-19 test results are generated
  • COVID-19 test results are available to be submitted to your laboratory's LIMS
 

 

At the core of the Amplitude Solution is the Applied Biosystems TaqPath COVID-19 High-Throughput Combo Kit, which consistently delivers superior sensitivity and specificity to detection of the SARS-CoV-2 virus

  • Three assays targeting SARS-CoV-2 regions with low genetic mutation risk (orf-1ab, S and N protein target)
  • Highly sensitive and specific for the SARS-CoV-2 virus; offering increased accuracy and confidence in test results
  • Targeted specificity to 100% of currently available complete genomes for SARS-CoV-2
  • Multiplex kit available with 20,000 reactions per kit for nasal and nasopharyngeal samples to help maximize specimen throughput
COVID-19-box-alt-view
Service and support
All-inclusive service partnership

Our service team will be the single point of contact you can rely on to handle everything from installation, which includes performance checks, and training to optimizing workflow applications, software, and all instrument components to help ensure your lab is quickly performing at its peak.

Get answers and keep moving

We offer a rapid response 24/7, 365 days a year for both in-person and remote troubleshooting depending on your specific needs. Our service partnership includes planned maintenance visits to solve problems before they arise and on-hand locally stocked parts for those unavoidable repairs to minimize downtime and keep your lab moving forward in the fight against COVID-19.

For Emergency Use Authorization (EUA) only. For prescription use only. For in vitro diagnostic use.