Case study · Early-stage cannabis testing labs
A day of validation analysis, cut to about an hour
New labs burning runway needed validated methods for every required test. We supplied them, automated the analysis and targeted the retests, so reports went out sooner.
The situation
Before a new testing lab can sell a single test, it has to validate the method behind every test on its license. Until then, it is spending runway: rent on the building, salaries for the team, and time with investors, all before the first paid sample.
A lab in that position can’t afford to wait on its own validation analysis.
The problem
Validation is judged by the numbers. In nearly every jurisdiction, a method passes when its relative standard deviation (RSD) falls within the acceptance ranges set by AOAC’s Standard Method Performance Requirements (SMPRs). The lab also has to establish its limits of detection and quantitation (LOD and LOQ). Done by hand, that analysis could take a full day or more for each round.
A lab without a validation method in place has a bigger problem. Before any of that math, it needs a method that satisfies the state’s requirements, and building one from scratch can stall the launch.
What we did
We gave each lab a method for the full suite of tests it needed to run. Then our automation software processed the validation data and showed which analytes were out of spec, and by how much.
That turned a failed run into a targeted retest: only the analytes that missed, requested as soon as the numbers came in. Faster retest requests meant less of the downtime a lab spends before it can sell tests.
The result
Validation reports went out as quickly as the labs could run their samples. No one waited on days of analysis, and no one had to invent a method from the state’s requirements. Analyses that could take a full day or more took roughly an hour.
What it means for your lab
If you’re building a lab, the clock started before your first sample. The building, the payroll and the investor updates don’t wait for validation. Three things decide how long you wait:
- Methods. If you don’t have a validated method for every test on your license, start there. We bring methods for the full suite, built to your state’s requirements, so you aren’t writing one while the rent runs.
- The math. Your validations will be judged on RSD against the SMPR acceptance ranges, plus LOD and LOQ. Automated, that analysis takes about an hour instead of a day or more.
- Retests. When a run fails, you should know which analytes missed, and by how much, in time to retest only those.
That is the core of our Instruments & methods and Lab data & LIMS work: a faster path to the validation report, and to your first paid sample.
Written from our own account of the work. The client is anonymous.
Try itAn illustrative tool with sample data
Where the numbers start.
For LC and GC methods, the validation statistics start as peak areas on a chromatogram like this one. The trace is sample data.
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