A rapid microbial detection kit presented as the only genetic-based test on the market to quantify yeast and mould has been launched by Switzerland's Lonza.
The microCompass TYMC (Total Yeast and Mould Count) Detection Kit is a supplement to the microCompass system introduced by the company last September. According to Lonza, it was the first bioscience company to offer a molecular testing method that could attain a viable count of microorganisms in as little as four hours.
The same claim is made for the microCompass TYMC kit. Standard methods for detecting yeast and mould can take 3-14 days to produce results, Lonza says.
The microCompass system is suitable for detecting bacteria, yeast and mould in pharmaceutical raw materials, over-the-counter drugs, nutraceuticals, personal care products, cell cultures, compressed gases, pasteurised and UHT products, water and beverages.
In pharmaceutical manufacturing, microbial detection can be a cumbersome, time-consuming and labour-intensive part of the quality control process - an expensive consideration for a high-value sector in which productivity and production costs are in serious need of attention.
Using a Real-Time Reverse Transcriptase PCR (polymerase chain reaction) assay and MGB Eclipse Probe technology to detect universal RNA sequences in bacteria and spores, the microCompass system offers improved sensitivity and detection of viable organisms without the need for pre-enrichment, Lonza says. Expected sensitivity is 100cfu per sample or 1 cfu/ml with a 100ml sample.
With a high throughput level of up to 96 samples at a time, the system promises significant labour and cost savings. "And by taking days and even weeks off your time to results, you can get production ramped up faster and products released sooner," Lonza adds.
The microCompass system also reduces the margin for error, it notes. Specifically targeting ribosomal RNA means the system detects only viable organisms, so users "can virtually eliminate false or presumptive results". Moreover, since microCompass is an automated molecular method, is not liable to the errors that can occur in preparing samples and waiting for microorganisms to grow at their own pace, Lonza points out.
The microCompass procedure involves a mechanical lysis system, an RNA extraction robot, microbial detection kits and a R.A.P.I.D. LT thermal cycler. Microorganisms are isolated from filterable samples by centrifuging them in a 0.2 micron spin filtration unit. RNA booster is then added to equilibrate the ribosomal RNA pool.
A combination of mechanical lysis and lysis buffer is used to break down the cells and spores and to liberate nucleic acid from the samples. These are transferred to a 96-well plate and loaded onto the RNA extraction robot, where the RNA binds to the surface of coated paramagnetic beads.
Once they have been purified through a series of wash steps, the extracted RNA samples are added to capillary tubes with PCR reagents. The final step is placing the closed capillary tubes in a carousel and loading them into the thermal cycler, which produces a real-time PCR report.
The microCompass detection kits contain all the reagents needed for universal detection of bacteria or yeast and mould RNA, Lonza says. Each kit is used with Tth DNA polymerase (this is supplied separately), a thermo stable enzyme with RNA-dependent reverse transcriptase activity and DNA-dependent polymerase activity, enabling reverse transcriptase and PCR to be combined in a single tube reaction.
Amplicons (pieces of DNA formed via PCR or other means of amplification) are detected using the MGB Eclipse specific probe and by monitoring the resulting fluorescent signal.
According to Shawn Cavanagh, president of Lonza Bioscience, the early indications are that customers "appreciate the speed and accuracy microCompass TYMC provides".