Lyophilised test formats may help circumvent transport and storage challenges
PCR Biosystems has expanded its range of diagnostic reagents with the launch of the Lyo-Ready Probe 1-Step Kit, a lyophilisable 4x RT-qPCR reagent mix for detection of RNA sequences. The reagents bring the sensitivity of the company’s liquid format 1-step RT-qPCR reagents to a freeze-dryable format. As a result, it says, 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.
Diagnostics developers are increasingly looking to use lyophilised test formats to circumvent transport and storage 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 Lyo-Ready kit comes optimised for freeze-drying, the company claims, meaning diagnostic developers only need to add their desired probes and primers prior to lyophilisation. The reagents are pre-blended with a mix of excipients designed to ensure sensitivity after resuspension, making the reagents suitable for high-performance multiplex tests.
Alex Wilson, co-founder of PCR Biosystems said: "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."
The kits contain a glycerol-free 4x qPCR mix UltraScript Reverse Transcriptase and a blend of excipients that maintain performance pre- and post-drying. As with PCR Biosystems’ other 1-step RT-qPCR kits, the 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."