The Hygiene Screening System (HSS) allows rapid and robust identification of the most common bacteria from hygiene monitoring samples, Corynebacterium, Staphylococcus, Micrococcus, Kocuria, and Kytococcus, with a simple procedure starting from a single bacterial colony. The system minimizes the use of other expensive and time consuming identification procedures and is the optimal extension to these systems.

The system was developed to meet the need for a fast and specific method for environmental monitoring in the pharmaceutical industry. A validation study with several pharmaceutical companies revealed that up to 80% of the microorganisms isolated from samples derived from the pharmaceutical environment (personnel, air and surface) belong to the genera Staphylococcus, Micrococcus or Corynebacterium.

The method is based on a fast real-time PCR technology using the Lightcycler^® 2.0 Carousel-Based System. Highly specific HybProbes allow the simultaneous detection of the mentioned genera within a single PCR reaction in less than 90 minutes. A subsequent melting curve analysis can be used to identify the most important species and species groups within these genera.

Bacterial colonies, even micro-colonies, growing on solid agar media used for environmental monitoring like air sampling, surface testing or sedimentation  are suspended in the provided Suspension Buffer. A part of this lysate is added to the ready-to-use master mix containing primers and hybridization probes. After addition of the recommended Enzyme Mix containing Taq DNA Polymerase and Uracil-N-Glycosylase (UNG) for carry-over-prevention the complete reaction is amplified and analyzed in the Lightcycler System. The simple set-up of only a few steps minimizes errors, guaranteeing highly accurate and precise results.

Since 2004, the usage of more sensitive and specific tests has been recommended by the European Pharmacopoeia (E.P., Chapters 5.1.6 and 2.6.1) and by the FDA Aseptic Guideline with reference to molecular biological methods. There is a need for new methods because most of the conventional methods are time-consuming and sometimes show insufficient accuracy. The Hygiene Screening System meets these recommendations by providing an innovative method which allows rapid and robust identification.