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  • Writer's pictureMLPAO

Novel Testing: Instrumentation and Processes for Initiating a New Lab Test

Updated: Jul 21, 2020

By Greg Young, MBA, MLT, Past MLPAO Board Member - Greg Young Consulting

I have seven quarters in my pocket that I keep moving from one pair of pants to the next since the pandemic began in mid-March. Like everyone else, I have been listening to the news about COVID-19 testing scaling up as testing opens to asymptomatic people.

Public Health has increased their capacity, and private and hospital labs have joined in testing because they have the knowledge, equipment (in some cases), and the ability to do this testing. Some of them just needed the test kits/chemicals/reagents to do the testing.

Unfortunately, this is not all there is to starting up a new test, especially one that is so “novel.” Every new laboratory that wants to do this testing has to complete many things, crunch numbers, and secure the appropriate technology.

In a pandemic, like in normal times, setting up a new test is about helping primary care providers to treat their patients.

Here is how this usually works: The Laboratory gets a request to start performing a test. Medical laboratory and administrative staff take stock of costs, equipment (existing and needed), capacity, and space. Here is the checklist (Lazzari, 2009):

1. Review available lab space

2. Connect with vendors to ensure service and support

3. Explore possibilities of batching work

4. Confirm staffing and training requirements

5. Investigate preanalytical variables

6. Review performance sensitivity and specificity

7. Confirm reliability and quality

8. Assess test complexity

9. Receive approval from Food and Drug Administration/Health Canada

10. Negotiate turnaround times

11. Source and procure reagents.

12. Determine protocol for disposing of waste produced

13. Establish environmental conditions in lab (temperature, humidity, and lighting)

After everything has been considered, we go ahead and contact the company who sells the test.

Sorry, forgot one thing: If we need to purchase new equipment or the total contract value for doing the test is over a certain value ($100,000), we may have to go to tender: we would have to put a proposal out and invite applications from companies. That’s from the Broader Public Sector (BPS) Procurement Directive (Ontario Government, 2019). This process can take months. The great news is the Ministry expedited this process during the pandemic.

So, let us assume that we have the equipment and need the chemicals (reagents) to perform the test.

Since the test is approved by Health Canada, we can just plug and play, right? Wrong. The laboratory must prove that the claims of the company who sold the test to us really do what they say that they do. That is called validation. In Ontario, all medical labs are accredited under an International Standards Organization standard. It is called ISO 15189. It requires this type of validation for every new test.

During our validation, there are many tests that are performed, and many numbers crunched to prove that the claims made by the manufacturer are true. We must make certain that we are satisfied with the results. We cannot have false positives or false negatives creating issues for people who need to know their results are accurate.

So, say we have received the chemicals, start the validation and then the border between the US and Canada closes. The US says, “we want those chemicals for our patients in the United States.” With most, if not all, manufacturing of these chemicals occurring in the US, we can no longer obtain them to continue our validation, never mind testing our patients. We would have to develop our own chemicals and all the regulatory rigmarole that goes with that. That could take months or years.

So, what does a sane lab do now?

We could try another company and start the validation all over again. We could buy a new piece of equipment and go that direction but again - there is that BPS Directive we will have to worry about.

Some labs will send their specimens to a site that can perform these tests at a lower cost and quicker turn around time, which is what Public Health Ontario is doing now. Why do that? If we centralize testing in some cases the cost per test is lower due to the high volumes and economies of scale. The problem is that Ontario is a big place, and centralized testing makes most sites send the specimens to the testing site. That can take more time. Considering all of this, Public Health Labs have been doing a fantastic job!

Perhaps some places can perform point of care tests. That is where the test is done on site, usually one test at a time. A few companies have promoted these tests, but there may be issues with this as well. The World Health Organization have a statement on these tests and seem to be concerned about their use. (WHO, 2020)

It is important to know the steps are needed to start a new test. At the best of times it can take months. Unfortunately, we do not have that kind of time, but we cannot cut corners when it comes to doing this right.

Labs across Ontario have implemented COVID-19 in a tremendous short period of time. Change is part of the Lab culture in Ontario and they continue not only to provide accurate test results, but they make sure that they are doing it the right way.

I heard that car washes are now open—I can finally get rid of those quarters.


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