Synbiosis, a UK manufacturer of automated microbiological systems, and a division of Scientific Digital Imaging (SDI), has added SynStats statistical analysis software to its portfolio.
This software rapidly analyses data from the ProtoCOL 3 automated colony counter and zone measurement system, providing automatic antibiotic efficacy and vaccine potency results from raw data and significantly increasing productivity of testing.
With just one click, microbiologists can export their zone measurement and colony count data from the ProtoCOL 3 directly to SynStats. The software then provides a range of analyses including analysis of assays with single or multiple Latin Squares. It produces a 5 + 1 standard curve and 2 + 2 and 3 + 3 Petri dish assays; highlights outliers and replaces missing values; performs parallel line and slope ratio analysis and produces potencies with confidence limits, as well as providing analysis of variance. Results are provided in graphs and tables, thus saving time with transferring data and presenting the results in a regulatory compliant format.
SynStats is both European Pharmacopoeia- and US Pharmacopeia-compatible and can be supplied with installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) documentation to allow the software to be integrated with the ProtoCOL 3 in a Good Manufacturing Practice (GMP) environment. These features make SynStats suitable for ProtoCOL 3 users developing new antibiotics or vaccines that need to archive and present all their results securely to regulatory authorities such as the US FDA and the EMA.
Kate George of Synbiosis explained: 'Microbiologists producing data to measure antibiotic effectiveness or vaccine potency often have large numbers of Excel spreadsheets containing data to transfer and analyse. This can be a time-consuming and potentially risk-prone activity because the figures do not always transfer across directly into statistical analysis packages and can require additional manual manipulation. What they need is analysis software that is compliant with US and European regulations that they can input raw zone measurement or colony count numbers into and easily obtain vaccine or antibiotic efficacy results out from, without them having to become statistics experts.'
