BIO-CARD

BIO-CARD is an analytical microbiology technology based on cell-enzyme profiling sensors. The technology consists of a single-use cell capture and detection cartridge; BIO-CARD and a portable electronic reader which processes cartridges and collects data on specific microorganisms. BIO-CARD device encompasses novel cell-capture membranes integrated with electrode sensors which quantifies electrons derived from assigned cellular enzyme reactions.

Microbiological testing of pharmaceutical and medical device products is critical to ensuring patient safety. While this is particularly the case for sterile products such as parenterals, implants, stents and contact lenses, oral dose pharmaceuticals must also meet strict regulatory microbial standards. Detecting microbial contamination remains a challenge. The initial microbial cell load of the sample is typically low, thereby necessitating the culturing of the microorganisms to enable detection and enumeration by current methodologies. This process is inherently slow, taking several days and delaying the release of products to the market or resulting in equipment down-time. Any analytical solution to this problem must be able to detect microbiological contamination at the levels present during, or shortly after, sampling. To be suitable for a typical quality control laboratory, any test method should have simple sample preparation procedures and should not require complex and expensive equipment.

BIO-CARD meets these challenges and offers the potential for development of rapid and highly sensitive cell detection assays using cell imprinted electrochemical sensors.

The BIO-CARD & HANDHELD READER is under development at MiCRA for the detection of bacteria in water and food samples. In water testing, a water sample is injected through a sampling strip which is then inserted into the BIO-CARD. After a period for on-cartridge culturing, the card is introduced to the handheld reader for processing. Readout follows in minutes identifying the micro-organism and cell count.

Detectable species include:

• Staphylococcus
• Micrococcus
• Salmonella
• Escherichia Coli
• Aspergillus Niger
• Candida Albican

Advantages:

• No user training required
• No sample preparation
• Cost effective (reader €500 and <€1 per analysis)
• Self-contained (no external reagents required)
• Results available within same shift (<8 hrs)
• Sterile and non-obligatory sterile products
• Facilitate rapid go/no-go decisions within manufacturing environment
• Sensitive; 1 cfu/mL
• Multiple, specific organism tests into single card