New high-performance air-dryable PCR reagents make simple, cost-effective dried assay development a reality

The new portfolio of reagents offers a simpler, faster, and cheaper alternative to lyophilization

3 Aug 2022
Dora Wells
Clinical Content Editor

PCR Biosystems has launched Air-Dryable Probe 1-Step Mix, a versatile all-in-one, air-dryable 4x RT-qPCR reagent mix for ultra-sensitive detection of RNA and DNA sequences. With this kit, the robust performance of the company’s liquid PCR reagents can be brought to dried assay formats using a standard laboratory oven, offering a simpler, faster, and cheaper alternative to lyophilization (freeze-drying). Now, a larger base of assay kit developers, including smaller organizations with fewer resources, can access the advantages of dried assays — shorter time-to-market, simplified logistics and storage, and significantly reduced costs. Sectors set to realize such benefits include clinical, veterinary, food, environmental, and agricultural testing.

The costly cold-chain shipping and storage demands of traditional ‘wet’ RT-qPCR reagents and tests are increasingly driving assay developers toward dried test formats. But while lyophilized assays have emerged as a powerful option that can reduce test weight, volume, and transport and storage requirements, they can be out of reach for smaller, resource-strapped organizations. This is because lyophilization requires expensive, specialized equipment, deep technical expertise, and extensive drying times. Outsourcing lyophilization alleviates some of this burden, but it entails loss of process control.

With the new air-dryable kits, drying can be done in just 80 minutes with a simple laboratory oven, without extensive training, and at a much lower cost. As a result, organizations unable to build onsite lyophilization capabilities can now create high-performance dried assays in-house, with full control over the drying process and quality control steps. The new kits also do not suffer from the restrictive drying protocol rigidity that can often complicate lyophilization. Further, air-dried assays are less susceptible to moisture and so do not require the strict humidity control during manufacturing that is needed with lyophilized tests. This is particularly useful in high-humidity regions and allows local diagnostic kit developers to more confidently expand their portfolio into dried formats.

As with the company’s lyophilizable mixes, the air-dryable mixes retain performance after reconstitution. Kits also come with the company’s renowned technical support to ensure smooth troubleshooting and optimal results, and free samples are available.

“Dryable reagents are redefining the ease and convenience with which PCR assays are being developed, distributed, and used. Lyophilisation has played a huge part here, but barriers to its adoption have seen smaller companies get left behind,” said Alex Wilson, co-founder of PCR Biosystems. “Our air-dryable mixes erode barriers to drying, so even with minimal resources, developers can get superior-quality dried assays to the point of care, efficiently. This is the latest step in our journey to place simple, cost-effective, and high-performing tests within reach of all.”

The new kits comprise a glycerol-free 4x qPCR mix with hot start Taq polymerase, dNTPs, MgCl2, and a blend of excipients for reliable drying without activity loss. A more stable version of UltraScript Reverse Transcriptase and RiboShield™ RNase inhibitor are blended into the mix, providing a more convenient single-tube format. Kits can be used for both RNA and DNA detection for greater versatility, and dried assays are stable for 3 months at 37 °C.

Critically, PCR Biosystems is certified to conform to Quality Management System standard ISO 13485, ensuring full product traceability, and optimum lot-to-lot consistency. Assay developers can therefore be confident in using the new air-dryable kits to create the highest-quality tests.

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