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Environmental Analysis

Sporometrics receives Drug Establishment Licence

Published: January 30th, 2019

Revised: January 30th, 2019

In 2017, Sporometrics was issued a Drug Establishment License (DEL) by Health Canada, in accordance to the Food and Drugs Act and Regulations (Division 1). The license enables us to conduct testing on pharmaceutical products. As a license holder, Health Canada conducts periodic inspections of our facility and operations to ensure our adherence with Good Manufacturing Practices (GMP).

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Accreditation for qPCR

Published: June 2nd, 2017

Revised: January 28th, 2019

Sporometrics is now accredited for Molecular methods!

We are pleased to announce accreditation for two new qPCR methods: Legionella pneumophila by qPCR and Mycobacterium chimaera by qPCR. Molecular methods represent the state of the art in microbiological forensic analysis and can provide results much faster than traditional methods.

This accreditation represents the single most comprehensive and widely recognized international credential in the performance of environmental microbiological laboratory analyses of a range of matrices from the built environment.

Our Technical Manager, Michael Saleh, played a key role in developing the EMLAP PCR Accreditation Field of Testing at AIHA-LAP and conducted training for volunteers and site assessors.  Check out the August 2017 issue of the Synergist for more information about this new field of molecular testing.

Our dedication to the ongoing and rigorous quality assurance practices mandated by this accreditation represents our continued commitment to you and your clients. We thank you for your business and value your suggestions as we continue to improve the quality of our services.

Agritech Trade Mission to Brazil

Published: March 28th, 2017

Revised: January 30th, 2019

Sporometrics was selected to participate in the Canadian AgriTech Mission to Brazil led by Global Affairs Canada and NRC-IRAP. The Mission has been organized by Global Affairs Canada (GAC) through the Consulate General of Canada in São Paulo and the National Research Council Industrial Research Assistance Program (NRC-IRAP). The goals are to establish industrial R&D collaboration and co-development opportunities in the AgriTech sector between Canadian and Brazilian companies leading to future commercial benefits for Canada and Brazil. The Mission will take place on the margins of the “AgriShow Ribeirão” (www.agrishow.com.br), the largest trade event in Latin America for farm equipment and technologies.

Target contacts will include senior executives, managers, investors, government representatives, service providers, research centres/universities and commercial partners. The Mission will focus on establishing strategic contacts, generating business through meetings and promoting networking tackling priority areas such as Automation of the agriculture value-chain; precision agriculture technologies; management (of the farm & production); traceability (livestock, grains, fruits); grains handling and storage management technologies; pest control; crop monitoring, soil analysis.

The mission will comprise briefings, networking events with the local AgriTech and agriculture community, and partnership development one-on-one meeting sessions with Brazilian counterparts.  This mission will provide Canadian companies with a unique opportunity to establish a personal relationship with key Brazilian business counterparts, which is required for doing business in Brazil and will enable further collaboration, co-development and business in the near future.

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Mycobacterium chimaera qPCR [MC]

Published: March 10th, 2017

Revised: March 27th, 2019

Background

Mycobacterium chimaera (M. chimaera) is a non-tuberculous mycobacteria (NTM) which has been implicated as a causative agent of a small number of infections post-surgery. NTM are common inhabitants of the environment and have been cultured from water, soil, and animal sources worldwide. They are known to be opportunistic pathogens, mostly affecting the immunocompromised or immunodeficient.

M. chimaera has been found in heater-cooler devices used to regulate patients’ blood temperature during cardiopulmonary bypass. Alerts from Health Canada, CDC, FDA and other health authorities worldwide have been issued based on reports suggesting that invasive infections have resulted from exposure to aerosolized M. chimaera from heater cooler units during cardiac surgery.

Given the dependency on heater-cooler units for improving surgical outcomes, there is a critical need to reduce downtime.  The standard, culture-based analytical techniques are very useful for the identification of Mycobacterium in general, but have the limitations of not always being specific and taking up to four weeks for results. The need arose for a fast testing solution that the traditional culture techniques could not meet; to determine the baseline contamination of devices as well as to confirm disinfection. Polymerase Chain Reaction (PCR) based tests specific for M. chimaera decreases testing time from several weeks to several hours by allowing the direct detection of M. chimaera DNA from mixed samples without the need for culturing.

Mycobacterium chimaera testing by RT-PCR

Real-time PCR (RT-PCR) is a rapid and accurate tool for the detection of M. chimaera DNA. We developed a M. chimaera RT-PCR test based on the methods from a research group at the University of Melbourne. It has been internally validated using the M. chimaera type strain and real-world samples. This method represents the state-of-the-art having been released publicly in February of 2017.

It is important to note that this method cannot distinguish between living and dead cellular material. Analytical results will be reported as positive or negative for M. chimaera DNA.

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Legionella pneumophila qPCR [LqPCR]

Published: September 25th, 2015

Revised: March 27th, 2019

Quantitative real-time PCR (qPCR) DNA-based method specifically for testing Legionella pneumophila in water samples that has the advantage of much greater sensitivity coupled with the potential to provide results in as little as 24 hrs after submission to the lab.

The method involves DNA extraction and DNA testing by quantitative polymerase chain reaction (qPCR). This method has been extensively validated, and has been used widely in Europe for several years. While this test cannot differentiate between active colonization and residual DNA from dead cells, its strength is as a rapid, highly conservative screen for this important pathogen to guide urgent public health decision-making. When rapid turn-around-time and definitive, accurate detection and precise quantification are required, our Legionella pneumophila quantitative (real-time) PCR DNA-based test is the recommend choice.

When to choose qPCR Legionella pneumophila water test

QPCR rush results can be available within 24 hrs or less. Our regular turn-around-time is typically 48 hrs. Most methods for testing fluids for L. pneumophila rely on culture. Although culture-based methods remain the current gold-standard means of determining the presence of this bacterium, this technique has poor sensitivity (negative results cannot reliably predict the absence of contamination), and they typically require 10-14 days to complete testing. This method has been extensively validated, and has been used widely in Europe for many years; it was approved in 2006 by the French Association of Normalization (AFNOR), a parallel standards body to the Canadian Standards Association (CSA). Since 2012, Public Health Ontario changed to a qPCR test for Legionella for lower respiratory tract specimens.

New guideline values are provided in Public Works and Government Service’s MD 15161 – 2013 ”Control of Legionella in Mechanical Systems Standard for Building Owners, Design Professionals, and Maintenance Personnel, Addendum C”, published in March 2016. These guideline values apply to Normal Operation Mode only, for Emergencies and /or outbreaks of disease, additional assessment and measures are required. As illustrated in the table below test levels are the same for all water sources, however, recommended actions may differ depending of the water source.

legionella_qPCR_table

 

Sample collection procedure

  1. Collect water (a 500 mL bottle with preservative is provided by Sporometrics) in sterile, screw-top bottles. For water sources expected to contain disinfectant chemicals such as chlorine, the collection container should include a suitable preservation buffer (the US-CDC recommends sodium thiosulfate to a final concentration of 0.1 M). Sporometrics provides sample collection containers to meet your needs. Please contact us prior to sampling to make arrangements.
  2. Collect culture swabs of internal surfaces of faucets, aerators, and shower heads in a sterile, screw-top container (e.g., 50 mL plastic centrifuge tube, with or without preservation buffer, according to the above guidance). Submerge each swab in approximately 5 mL of sample water taken from the same device from which the sample was obtained.
  3. Transport samples to the laboratory as soon as possible after collection. Samples may be transported at room temperature but must be protected from temperature extremes. Samples not processed with 24 hours of collection must be refrigerated.

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