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Misidentification of Risk Group 3/Security Sensitive Biological Agents by MALDI-TOF MS in Canada: November
D Pomerleau-Normandin1, M Heisz1, M Su1,2
1Centre for Biosecurity, Public Health Agency of Canada, Ottawa, ON.
Background:
Matrix-Assisted Laser Desorption/Ionization-Time of Flight Mass Spectrometry (MALDI-TOF MS) is a technology increasingly used in diagnostic identification of microorganisms. However, anecdotal evidence suggests that this technology is associated with misidentification of Risk Group 3 (RG3)/Security Sensitive Biological Agents (SSBA) resulting in exposure risks to laboratory personnel.
Objective:
To investigate and characterize incidents related to the use of MALDI-TOF MS in Canada between November 6, 2015, and October 10, 2017.
Methods:
Cases were identified from laboratory incident reports in the national Laboratory Incident Notification Canada (LINC) surveillance system. Eligible cases referred directly to MALDI-TOF MS or one of three RG3/SSBA organisms, Brucella species, Francisella tularensis and Burkholderia pseudomallei. A questionnaire was developed to identify potential risk factors leading to the exposure. Reporters from organizations with selected incidents were interviewed using the questionnaire. Data were entered into an Excel spreadsheet and standard descriptive statistical analysis performed to assess common characteristics and identify possible risk factors.
Results:
There were eight eligible incidents and a total of 39 laboratory workers were exposed to RG3/SSBA organisms. In five (out of eight) of the incidents, the reporters indicated that their device was equipped with both clinical and research reference libraries. For six incidents where reporters knew the type of library used, only the clinical library was employed at the time of the incident even though both libraries were available in five of these incidents. In all eight cases, the exposure occurred during the sample preparation stage with analyses performed on an open bench and directly from the specimen. And in all eight cases, patient specimens were received without information regarding potential risk.
Conclusion:
This first national study characterizing the nature and extent of laboratory incidents involving RG3/SSBA that are related to the use of MALDI-TOF MS identifies risk factors and provides baseline data that can inform mitigation strategies.
Insights
Matrix-Assisted Laser Desorption/Ionization-Time of Flight Mass Spectrometry (MALDI-TOF MS) use led to 39 lab worker exposures to dangerous pathogens. Incidents occurred during sample prep, often with incomplete risk information, highlighting the need for improved safety protocols.
Area of Science:
- Clinical Microbiology
- Laboratory Safety
- Infectious Disease Diagnostics
Background:
- Matrix-Assisted Laser Desorption/Ionization-Time of Flight Mass Spectrometry (MALDI-TOF MS) is widely used for microorganism identification.
- Anecdotal reports suggest MALDI-TOF MS may misidentify Risk Group 3 (RG3)/Security Sensitive Biological Agents (SSBA), posing exposure risks.
Purpose of the Study:
- To investigate and characterize laboratory incidents involving MALDI-TOF MS and RG3/SSBA in Canada.
- To identify risk factors associated with these incidents.
Main Methods:
- Analysis of laboratory incident reports from the Laboratory Incident Notification Canada (LINC) system.
- Interviews with reporters using a questionnaire to gather data on risk factors.
- Descriptive statistical analysis of incident characteristics.
Main Results:
- Eight incidents involving 39 laboratory workers exposed to RG3/SSBA were identified.
- Exposures occurred during sample preparation, often using only clinical libraries despite availability of research libraries.
- Specimens were frequently received without adequate risk information.
Conclusions:
- This study provides the first national characterization of laboratory incidents involving RG3/SSBA and MALDI-TOF MS.
- Identified risk factors can inform the development of mitigation strategies to enhance laboratory safety.
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