Providing comprehensive data for molecular diagnostics
AusDiagnostics is an Australian in vitro diagnostics (IVD) company offering molecular diagnostic testing platforms that provide pathology laboratories with comprehensive clinical data to improve patient care and laboratory efficiency. The company’s patented, multiplexed-tandem PCR technology is being used for the rapid detection of SARS-CoV-2 (novel coronavirus COVID-19), as well testing to distinguish between the different causes of coronavirus-like infections.
Developing molecular diagnostics systems
AusDiagnostics’ novel PCR multiplexing technique was originally commercialized at the start of the H5N1 (avian) influenza outbreak, and so the company naturally focused on designing test panels for microbiology. Professor Keith Stanley, the company's Managing Director, explained: “Multiplexing offers a complete picture of what is wrong with a patient, without compromising analytical sensitivity and specificity. 10 to 15 percent of patients have more than one infection at a time and, while their symptoms indicate one pathogen, they might actually have a much higher level of something else entirely! It’s therefore much better to test for a complete panel of diseases.”
The company’s automated molecular biology technologies allowed it to respond very quickly to the COVID-19 crisis, positively testing its first clinical sample by the 31st of January – less than three weeks after the first sequence was published – and achieving kit CE marking by the beginning of March. The main screening kit has two targets for SARS-CoV-2 – along with influenza A, influenza B and RSV – making it unlikely that a sample that is positive for both targets could be a false positive. The workflow also has two PCR steps, which has the advantage of making the test very sensitive, and allowing the identification of positives which even a reference lab may miss.
Growing demand requires the right response with the support of the right partner
AusDiagnostics’ screening tests run on the company’s bespoke molecular diagnostic systems, which consist of a sample processor and a real-time PCR analyzer. The Ultra-Plex 96 high throughput screening system was launched in early 2020. The company chose to integrate the Cavro® Air Displacement Pipettor (ADP) as it was ready-made, reducing engineering research and speeding up the development of the full platform. “We wanted to get this platform to market quickly, and decided to use an off-the-shelf pipetting mechanism,” Keith continued. “We turned to Tecan because we were already using 10 Freedom EVO® 150 liquid handling workstations in the production of our kits, and so we trust their technology inherently. Having already developed some of our own pipetting heads, we could admire the cleverness of Tecan’s technology, and see that the component met our precision and reproducibility needs. We were able to easily integrate the ADP into our own robotic platform, and it communicates seamlessly via a USB port.”
The Ultra-Plex 96 can conduct a two-step PCR workflow in parallel, and has a built-in 96-well thermal cycler on the workdeck. The system can run an assay panel with 768 individual PCR results in as little as 3.5 hours, with the ability to reload samples every two hours, making it perfect for the volume of samples that need to be screened during a pandemic. The COVID-19 pandemic has created huge demand for the Ultra-Plex 96 platform from both hospital and private laboratories performing diagnostic SARS-CoV-2 testing. Keith added: “Our platform and kits are really making a difference in this pandemic, and we appreciate the cooperation and collaboration that we have had from Tecan throughout this project. The Tecan team has been very proactive in helping us to find the right solution at each phase, even helping with scheduling parts deliveries.”
ADP product highlights:
- Fully programmable pneumatic pipetting – to meet your unique application needs
- Excellent resolution – of just 25 nl per increment (40,000 increments for 1,000 μl)
- Broad pipetting range – from <5 to 1,000 μl
- Process security – with integrated error handling, tip presence sensor and high resolution pressure sensing
- Maintenance-free design – for reliable long-term operation
- Choice of Tecan disposable tip options – 10, 50, 200 and 1,000 μl tip to match your application
- Tip ejection mechanism – to simplify integration
to find out more about the Cavro ADP.