CENTOGENE´S RESPONSE TO THE PANDEMIC
When the COVID-19 pandemic began to impact our global community, we knew we had to respond – deploying our unsurpassed diagnostic knowledge, medical expertise, and passion for creating solutions for patients around the world.
Combining innovation with state-of-the-art technology, we rethought what an innovative lab is – putting the best result on wheels and certified it with the highest qualifications.
The Mobile Laboratory Optimized for PCR Tests
- A mobile laboratory to carry out COVID-19 analyses efficiently and with the flexibility you need
- The most innovative equipment and automation for stable, efficient, and fast operations
- A ready-to-use solution to immediately deploy large-scale testing programs
- Customizable daily capacities of 5,000 samples a day
- Optimized engineering to support a full-shift system to test 16 – 24 hours a day, 7 days a week
- The highest standards that meet overseas transport requirements
- A unique container setup that can conveniently be stationed where a mobile or cabled network is available
We developed the concept of a mobile laboratory to facilitate field-based testing – whenever, wherever.
CentoTruck™ has the most robust end-to-end process design, including secure delivery of all needed consumables and kits, onsite-support and maintenance, as well as a fully digitized customer workflow from registration, sampling, and payment, to medical results.
THE ALL-IN-ONE SOLUTION TO COMBAT THE COVID-19 PANDEMIC
- Secure registration of test persons
- Several functions, e.g. payment or ordering to support diverse use cases
- Download of results and monitoring of status
- Validated for the detection of SARS-CoV-2 RNA
- Medical device class I – CE labeled
- Easy logistics – can be sent without stabilization buffer
- Ethylene oxide-treated, ready-to-use swabs and collection tubes
- Accordance with FDA Emergency Use guidelines
- External concordance testing by Charité University Clinic
- CAP and EMQN SARS-CoV-2 proficiency testing
- INSTAND e.V. quality assurance for SARS-CoV-2 testing
- Results after 6 – 8 hrs
- Fast track options
In addition to our enhanced safety measures, preventive and easily accessible testing is the key to a stable new normal – not to mention, the health and safety of our global population. This requires a flexible, fully automated, and readily available large-scale testing solution. One that can be customized to specific needs at every site. A solution that can be integrated into existing workflows. A service that is reliable and secure. The answer - CENTOGENE’s market-tested modular solution.
CentoTruck™ can be shipped internationally and customized to serve local needs.
Our mobile lab is uniquely designed to support High Throughput as well as Fast Track testing depending on customer requirements. A hybrid method is also readily available to meet your specific needs.
- The High-Throughput method enables 5,000 samples a day to be processed with a turnaround time of 8 – 12 hours
- The Fast Track approach supports the processing of 600 samples a day with a turnaround time of 3 – 4 hours
For the past 15 years, CENTOGENE has been offering modular, widely market-proven, and comprehensive testing solutions.
CENTOGENE is CAP and ISO 15189 accredited, as well as CLIA certified, and offers complete assurance of the highest data security standards. Our validated SARS-CoV-2 RT-PCR test is a real-time test based on the reverse transcription polymerase chain reaction (RT-PCR) for the qualitative detection of nucleic acid from SARS-CoV-2 in samples of the upper respiratory tract (oropharyngeal swabs). The results are used to identify SARS-CoV-2 RNA, which is usually detectable in oropharyngeal samples during the acute phase of the infection. CENTOGENE’s test is the most sensitive test for early infection.
Furthermore, the SARS-CoV-2 RT-PCR test has been developed under the highest quality standards:
- Conformity with strict FDA Emergency Use Guidelines
- Concordance with analyses of the WHO reference laboratory at Charité Berlin
- Certificate after execution of the INSTAND e.V. interlaboratory test with positive and negative test samples
- CAP and EMQN SARS-CoV-2 professional testing
The CentoSwab™ Advantage
Reliable and proven medical tools are essential for carrying out widespread SARS-CoV-2 testing. Engineered and manufactured in Germany, – consisting of a highly validated oropharyngeal swab and a tube – makes testing that much easier and accessible.
- Medical device validated for the detection of SARS-CoV-2 RNA
- Validated for self-swabbing
- Ethylene oxide-treated, ready-to-use swabs with shippable tubes
- Medical device class I - CE-labeled
- Easy logistics - can be shipped without stabilizing liquids
- Made in Germany - independent from critical and sensitive supply chains
RAPID IMPLEMENTATION OF A COMPLETE TESTING SOLUTION
The setup of our mobile laboratory solution and sampling center can take place after the evaluation of the location (level ground, connections for water and electricity, distance to the sample taking unit) or before testing (connections established, machines like air conditioners started, follow guidelines for setup of lab equipment). A standard implementation can be set up in 1 – 3 weeks – depending on the local situation:
The setup of the container follows a stepwise protocol
- Evaluation of location (level ground, connections for water and electricity, distance to the sample taking unit)
- Setup before testing (connections established, machines like air condition started, follow guidelines for set up of lab equipment)
IMPLEMENTATION IN LESS THAN 4 WEEKS – GUIDED BY CENTOGENE‘S EXPERTS
- Truck- and Lab Architecture
- End-to-end design from sampling to report
- Purchase and assembling of equipment
- Customization and architecture of IT
- Build infrastructure
- Transport and Setup
- Delivery of consumables and kits
Setup & Test
- Onboarding and training of personnel
- Setup and test infrastructure
Customers can incorporate specific branding to make CentoTruck™ an unique instrument for advertisement and brand awareness
Based on chosen technology, very specific demands can be met to deliver the time and througput you need
The CENTOGENE planning team will assist you very step of the way – helping you make the right technology choice and guiding through a hassle-free construction period
On-demand assistance can support you in setting up the lab obsite and carrying out validation
The Workflow Blueprint
Clinical samples are obtained in the form of dry throat swabs. Arriving samples are labeled with a unique barcode for each sample by the sample entry team.
Each sample barcode is scanned directly before processing to prevent sample swaps.
The first step in the analytical workflow is extraction of the viral sample from the throat swab. Viral RNA extraction is performed on the basis of the manufacturer’s instruction manuals from the supplier of choice. The extraction is performed under Laminar-Flow workbenches until the samples have been inactivated.
The viral RNA is transcribed to cDNA and PCR-amplifiedin a one-step reaction. During PCR amplification, fluorescent probes are detected by the instrument in real-time.
The RT-qPCR is performed according to the ‘Instructions For Use’ provided by the suppliers of the kits. Apart from patient samples, at least two negative and two positive samples are included per run as a control. A unique amplification control with an internal human housekeeping gene is performed.
Analytical cut-offs are defined by using positive and negative samples similar to the guidance provided by the assay manufacturer. Reports are categorized by negative (no viral infection detectable), positive (viral infection present), and inconclusive (not sufficient material present to perform analysis).
Your Partner of Choice
For further information and support, please contact our closest representative or our customer support team, easily accessible by phone or email.