Microbial Identification

Protheragen-ING Lab specializes in providing comprehensive microbiological identification services for medical devices. With a focus on accuracy and efficiency, we offer a range of traditional and rapid microbial identification methods to ensure the safety and quality of medical devices. Our expertise in Gram stain testing, microscopy, selective media, MALDI-ToF mass spectrometry, and genetic sequencing allows us to deliver reliable results to our clients.

Why is microbial identification necessary?

• Accurate identification of microorganisms is essential for effective infection control and prevention as well as for ensuring the safety and efficacy of medical devices.
• ISO 11137-2 states that manufacturers should not only quantify microorganisms on or in products but also characterize the bioburden and identify the different types that may be present.
• Microbial characterization also helps trace the source of infection, investigate outbreaks, and assess the overall cleanliness and sterility of medical devices and healthcare facilities.
• Microbiological characterization provides additional information for investigating potential nonconformities in dosage audits, sterility testing, bioburden testing, bacterial endotoxin testing (LAL), and bioindicator testing.

Our microbiological identification services

Protheragen-ING Lab offers comprehensive microbiological characterization services tailored specifically for medical devices. Our team of highly trained microbiologists and technicians utilize state-of-the-art technology and equipment to provide accurate and timely results.

Our microbial identification methods:

• Morphology (shape, color, etc.)
• Gram strains - Gram positive or Gram negative
• Absence testing (product does not contain specific microorganisms)
• MALDI-ToF - Improves ID accuracy and speed.

The level of identification we offer through microbial identification:

• Type of microorganism (bacteria, yeast, mold).
• Genus, e.g. Staphylococcus.
• Species-level, e.g. Staphylococcus aureus.
• Strain of the same microorganism, e.g. Staphylococcus aureus subsp.

About our test method: MALDI-ToF

MALDI-ToF (Matrix Assisted Light Desorption Ionization Time of Flight) mass spectrometry is a cutting-edge technology for rapid microbial identification. It works by analyzing the ribosomal protein profile of each microorganism. By comparing the obtained mass spectra with an extensive database of known bacterial and fungal species, we can quickly and accurately identify microorganisms present on medical devices. The MALDI-ToF method includes other features, such as identifying antimicrobial drug resistance.

Fig. 1 Workflow for microbial identification using MALDI-TOF MS^[1].

What are the characteristics of MALDI-ToF microbial identification:

• High accuracy of results.
• High speed.
• A large number of IDs.
• Provides genus and species level identification.

Our laboratories are equipped with state-of-the-art MALDI-ToF mass spectrometry instruments, operated by experienced professionals who adhere to strict quality control measures. We ensure reliable, accurate, and reproducible results, giving our customers confidence in the microbiological identification of their medical devices.

Contact us today to learn more about our microbiological identification services and how we can assist you in meeting your specific needs.