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

PCR Biosystems has introduced the Lyo-Ready Probe 1-Step Kit, a lyophilisable 4x RT-qPCR reagent mix for ultra-sensitive high-throughput detection of RNA sequences. The new reagents bring the exceptional sensitivity of their 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 is possible, and logistical and storage infrastructure required to deliver tests to the point of use will be streamlined. Diagnostics developers can accelerate time to market, and clinical, veterinary, food and environmental testing end-users can 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 arise around test sensitivity after reagents are resuspended.

The new reagents come optimised for freeze-drying, meaning diagnostic developers only need to add their desired probes and primers prior to lyophilisation, unlocking smoother, faster test development. 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 and capable of retaining exceptionally low limits of detection. Customers also benefit from the PCR Biosystems edge - free evaluation samples, agile technical support, and tailored product customisation options.”

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. The mixes include 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 lyo-ready mixes to carry those benefits into freeze-dried tests. We’re closer than ever to delivering critical HIV testing to regions without cold chain infrastructure.”

PCR Biosystems is Quality Management System standard ISO 13485 certified, ensuring full product traceability, and optimum lot-to-lot consistency.

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

For more information, visit the Lyo-Ready Probe 1-Step Kit product page. Free evaluation samples can be requested here.

More information about Dr Kibirige’s research can be found here.