Lyo-Ready PCR Reagents Make Ultra-Sensitive Diagnostics Development Painless

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 lyophilized test formats to circumvent these challenges and develop more compact, lighter, and shelf-stable assays. However, developing lyophilized diagnostics is complex — traditional reagent mixes contain lyophilization-incompatible components such as glycerol, and concerns can often arise around test sensitivity after reagents are resuspended. Now, newly-launched reagents come already optimized for freeze-drying, meaning diagnostic developers only need to add their desired probes and primers prior to lyophilization, 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.

PCR Biosystems Ltd. (London, UK) has launched the Lyo-Ready Probe 1-Step Kit, a lyophilizable 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.

Image: The new reagents are designed for ultra-sensitive high-throughput detection of RNA sequences (Photo courtesy of PCR Biosystems Ltd.)

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. 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.

“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 customization options.”

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PCR Biosystems Ltd.