The evolving Clinical Biochemistry Lab

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UHN medical laboratory staff play a key role in leveraging resources to enhance patient care, often identifying and deciding the best ways to implement or modify testing.

This role is especially true for UHN Clinical Biochemists, who in the last seven years have helped add over 20 new laboratory instruments and have implemented or enhanced over 60 test assays all offering patients a more timely, accurate and sustainable level of care.

Dr. Ivan Blasutig, former LMP Biochemist and now Chief, Biochemistry at the Children’s hospital of Eastern Ontario led many of these advancements and took time to reflect on some of the labs most significant technical accomplishments before leaving UHN.

“Every change we make has a clear purpose and improvement in mind,” says Dr. Blasutig. “And each one, no matter how little, is a step forward in the evolution of the lab and should give patients and physicians greater confidence in the quality of lab results.”

 

2017: Automated Indirect Immunofluorescence testing

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The UHN Biochemistry lab’s most recent undertaking is automating indirect immunofluorescence (IFA) testing.

IFA is an existing test offered at UHN, used to identify autoantibodies present in a patient’s body, which can help diagnose autoimmune disorders and monitor the effectiveness of treatments. It’s currently a fully manual test, where lab technologists collect patient samples, complete written worksheets, manually titre and incubate samples, then examine results under a microscope. And being manual, testing is susceptible to error and offers limited capacity due to time and resources.

However, the lab is now pursuing new technology that automates the process from beginning to end, saving technologists’ time, improving turnaround time and also reducing the risk of error in results.

The new testing process, expected to go live Fall 2017, ensures a positive patient identification throughout each step of testing, eliminates repetitive pipetting, and captures digital microscopy images so data can be archived for future review.

 

2014: Viral serology testing

Due to the volume of UHN patients and complex testing algorithms, all viral serology testing, used to identify the presence of or immunity against viral infections, was sent out to LMP’s partner laboratories. However, when the opportunity came to implement on site serology testing in 2014– LMP’s biochemistry team jumped to the occasion.

The process required collaboration from LMP’s biochemistry and Lab Information Systems teams, and was based on middleware enhancements that enabled existing equipment to follow the same algorithms technologists use.

The change eliminated the potential for human error when following complex algorithms and was able to bring testing in-house, eliminating the cost of outsourcing and creating opportunity for a more streamlined delivery of results.

“The software used can now identify results as positive or negative, assess patient history and order additional testing as required based on these factors. It can even fill and print out a Public Health requisition, ensuring samples are sent out for additional testing when necessary.” says Dr. Blasutig. “You can imagine how much time would be involved in doing all of this manually, and now it takes just seconds for a computer to perform.”

 

2011: Free Light Chain testing

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Free light chain testing is an important test for diagnosing multiple myeloma and monitoring patients undergoing treatment or in remission. It measures the concentration of a specific protein biomarker often over-produced in myeloma patients, and it’s concentration can range in serum from under 1mg/L to over 100,000 mg/L depending on disease progression or treatment – making it difficult to determine errors in results.

Further complicating things – testing is prone to a phenomenon known as antigen excess, which Dr. Blasutig says could lead to results being falsely depressed by as much as 1000 fold, adding, “that when you’re monitoring someone for cancer and you’re trying to determine if therapy is working, you want to be 100 per cent certain in your results.”

To counter potential errors, the lab implemented new instrumentation in 2011 that observes the characteristics of every test reaction and, using an algorithm, determines if there was antigen excess.

“Patients need certainty in their test results,” says Dr. Blasutig. “And by shifting to a more automated testing process – we’ve improved the quality and accuracy of testing, nearly eliminating cases of false results due to antigen excess.”

With over 150,000 results reported since 2012, there has been just one identified case of antigen excess leading to erroneous results.

 

2010: Autoimmune ELISA testing

In 2010, the biochemistry team rethought the method for detecting and measuring antibodies in a patient’s blood and pursued a new innovative technology to replace the lab’s enzyme linked immunosorbent assay (ELISA) testing. The switch in technology took the lab team from having to manually perform multiple individual ELISAs, each requiring several hours to complete, to being able to obtain all the same results in a single automated assay.

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The reactions occurring on each bead are analyzed one by one, with the analyzer identifying which bead is coated in which protein and compiling the results. (Photo: BioRad – Bioplex 2200 Multiplex Testing)

Dr. Blasutig helps explain the testing process like this:

  • ELISAs work by coating a protein onto the bottom of a well, putting a patient sample into that well and then looking for an interaction. Each protein that you want to test for will need its own ELISA assay and its own aliquot of patient sample.
  • Imagine that instead of coating a well with your protein of interest, you can coat a micron-sized bead. This allows you to place thousands of beads into the same amount of patient sample used for a single ELISA well, and observe the reaction occurring on each bead. (It’s like performing the same ELISA a thousand times and averaging the results!)
  • You can further increase the complexity by using coloured beads and observing both the colour of the bead as well as the reaction occurring on its surface. If you place a different protein on each different colour of bead, you can now test for numerous proteins of interest within a single assay. This is referred to as a multiplex assay.

All of this is to say that testing is now significantly more accurate and with turnaround times that are vastly improved. Testing that used to take a week can now be performed in a matter of hours. 

“The UHN Clinical Biochemistry laboratory has evolved greatly over the last seven years and will continue to evolve indefinitely,” says Dr. Blasutig. “I am very excited to see what the future brings and what Clinical Biochemistry laboratories will look like in another decade and beyond.”

 

All of these lab advancements are further detailed in a presentation given by Dr. Blasutig for LMP’s 2017 National Medical Laboratory Week. In addition to these changes to the UHN Biochemistry Lab, Dr. Blasutig also discusses the evolution of biochemistry dating as far back as c. 1,550 BCE Egypt. The full presentation is available HERE via the Ontario Telemedicine Network (USERNAME: UHNNMLW    |    PASSWORD: nmlw2017).

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