The 14-day turnaround time of current compendial sterility testing is plainly insufficient for a wide range of crucial, life-saving drugs and therapies, including an increasing number of novel cell and gene therapies which are incompatible with membrane filtration. As even slight contamination is unacceptable for parenteral treatments, this necessitates sterility tests that are not only faster than traditional methods, but as sensitive and accurate.
With an ever-increasing demand for faster sterility testing solutions, Alpha Laboratories is pleased to introduce the new RiboNAT™ rapid sterility test by FUJIFILM Wako. This test has been designed with rapid results in mind. It uses the Nucleic Acid Amplification (NAT) method, targeting ribosomal RNA (rRNA) and using RT-rPCR to deliver accurate results in just 7 hours. This test method boasts numerous benefits compared to other sterility tests – ribosomal RNA is present in higher relative quantities in microorganisms than genomic DNA, offering higher sensitivity (9 CFU/mL) while still detecting a broad range of bacteria and fungi. RiboNAT also significantly reduces false positives from dead microorganisms and residual DNA by inactivating and degrading DNA using nucleic acid inactivator and DNase.
The ability of RiboNAT to reliably and accurately detect a wide assortment of microbes in less than a day makes it an invaluable tool for validating and delivering drugs and therapies with short shelf lives, without having to administer at risk. This also seamlessly adds a crucial control point for sterility quality control into your workflow, with a simple and easy-to-learn testing process.
To embrace a faster future for sterility testing please visit www.alphalabs.co.uk/rapid-sterility-testing, or contact us at info@alphalabs.co.uk.
About Alpha Laboratories Ltd
Established in 1975, Alpha Laboratories’ ongoing mission is to continually find new ways to help science improve people’s lives through its evolving specialist diagnostic and laboratory solutions. Through worldwide connections and relationships with leading manufacturers, established and emerging suppliers, the company sources the best products to help solve the problems faced in laboratories or clinics every day. The company is BS EN ISO 9001:2015, 14001:2015 and ISO 13485 accredited.
The top-quality range of laboratory consumables includes Pastettes®, pipette tips, pipettes, general liquid handling, microtubes, racks, PCR consumables and UN3373 compliant sample transport packaging. The research market is supported with an extensive range of antibodies and reagents for numerous disciplines. The diagnostics portfolio offers specialist assays, controls, reagents and instruments used in blood grouping, clinical chemistry, haematology, haemostasis, immunology and rapid test specialities. Specialist areas include bowel cancer screening plus inflammatory bowel disease testing and monitoring.