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.