PCR Biosystems launches freeze-dryable reagents for ultra-sensitive PCR diagnostic tests

08 April 2022 | Friday | News

New ultra-sensitive lyo-ready PCR reagents unlock lower detection limits in lyophilised multiplex diagnostic assays

PCR Biosystems has expanded its comprehensive range of diagnostic reagents with the launch of the Lyo-Ready Probe 1-Step Kit, a lyophilisable 4x RT-qPCR reagent mix designed for ultra-sensitive high-throughput detection of RNA sequences. The new reagents will bring the exceptional sensitivity of the company’s liquid format 1-step RT-qPCR reagents to a freeze-dryable format. As a result, simplified creation of freeze-dried multiplex assays with lower limits of detection will be possible, and the logistical and storage infrastructure required to deliver tests to the point of use will be streamlined. Diagnostic developers can thus accelerate their time to market, and a broader swathe of clinical, veterinary, food and environmental testing end-users will be able to benefit from superior nucleic acid detection.

Molecular diagnostics have traditionally relied on ‘wet’ reagents, necessitating costly temperature-controlled transport and on-site cold storage at the point of test use. Diagnostics developers are increasingly looking to use lyophilised test formats to circumvent these challenges and develop more compact, lighter, and shelf-stable assays. However, developing lyophilised diagnostics is complex — traditional reagent mixes contain lyophilisation-incompatible components such as glycerol, and concerns can often arise around test sensitivity after reagents are resuspended.

The new reagents from PCR Biosystems come already optimised for freeze-drying, meaning diagnostic developers only need to add their desired probes and primers prior to lyophilisation, unlocking smoother, faster test development. Importantly, the new reagents are pre-blended with a unique mix of excipients to ensure uncompromised sensitivity after resuspension — even for multiple RNA targets — making the reagents ideal for high-performance multiplex tests.

"With all our PCR reagents, we’ve done the hard work to make ultra-sensitive diagnostics development as painless as possible." said Alex Wilson, co-founder of PCR Biosystems. "For lyophilised multiplex assays, that means creating a reagent mix that’s ready for freeze-drying right out of the packet, and capable of retaining exceptionally low limits of detection. On top of this, customers also benefit from the PCR Biosystems edge — free evaluation samples, agile technical support, and tailored product customisation options."

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The lyo-ready kits contain a glycerol-free 4x qPCR mix, high-concentration thermostable UltraScript Reverse Transcriptase for superior sensitivity and accuracy, and a blend of excipients that confer identical performance pre- and post-drying. As with PCR Biosystems’ other 1-step RT-qPCR kits, the new mixes include the company’s proprietary hot start Taq polymerase for specific template amplification, and advanced buffer chemistry including magnesium and dNTPs.

Dr Catherine Kibirige, Research Scientist, IAVI Human Immunology Laboratory, Imperial College London, added, "My work developing an affordable and sensitive HIV test to support treatment monitoring across Africa has benefitted immensely from PCR Biosystems’ offerings. Having achieved unmatched sensitivity and protocol simplicity with their liquid format reagents, I’m now using the new lyo-ready mixes to carry those benefits into a freeze-dried test. We’re closer than ever to delivering critical HIV testing to regions without cold chain infrastructure or highly trained staff."

PCR Biosystems has been certified to conform to Quality Management System standard ISO 13485, ensuring full product traceability, and optimum lot-to-lot consistency. Diagnostic developers can therefore be confident in using the new kits to create the highest-quality assays.

Furthermore, the reagent mixes have been validated for the qualitative detection of SARS-CoV-2 as well as the most common respiratory viruses, including influenza and respiratory syncytial virus. As such, the new reagent formulations are perfectly suited for the creation of multiplex winter panel diagnostic kits.

PCR Biosystems launches freeze-dryable reagents for ultra-sensitive PCR diagnostic tests

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