Solving the calibration headache — by simply automating it!

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Solving the calibration headache - by simply automating it!

In an ideal scenario, most clinical lab professionals would love to have every process and workflow fully automated so they could focus their attention on the highest-value tasks, such as interpreting and reporting results. But in reality, attempts to automate various protocols often leave lab staff worried that unforeseen or undetected problems could lead to less reliable results compared to the tried-and-true manual processes they have used for years.

Still, these often-laborious manual techniques cannot meet rapidly increasing demand for clinical lab services. As more and more healthcare decisions depend on results generated by the laboratory, automation is one key element that can help make workflows more scalable and sustainable.

With more opportunities to incorporate automation within the laboratory, it is important for lab teams to ensure that they adopt only the tools that can deliver high-confidence results — results that would match those produced under the careful oversight of a trained staff member performing those processes manually.

Can calibrations really be automated?

At the recent annual meeting of the American Association for Clinical Chemistry, scientists from TriCore Research Institute in the United States reported results from an evaluation of a new feature that performs automated calibration for instruments used to generate glucose, cholesterol, and other chemistry readouts.

Automated calibration was designed to streamline the processes required to produce these frequently needed lab results. Traditionally, these instruments are run after lab staff perform manual calibration and quality controls for each batch of patient samples. Automating the calibration process reduces hands-on time and streamlines the overall workflow to help generate results faster.

But are those results trustworthy? In the TriCore study, scientists used two comparable analysers, one with automated calibration and the other with traditional manual calibration. They assessed concordance of test results as well as time efficiency for 18 clinical chemistry assays over five consecutive days. They found negligible difference between results from the two analysers, calling them “interchangeable.” They also noted that automated calibration decreased both hands-on time and system operation time for running the assays.

How are calibrations automated?

Instrument manufacturers have been able to automate this process by calculating a calibration curve based on two metrics: a fixed instrument-specific value and a variable reagent-specific value. When the assay is installed for the first time, the clinical lab staff performs the usual, manual calibration process. From those results, the instrument calculates its own specific value. Reagent-specific values are encoded within the reagent pack provided by the manufacturer. After the first calibration, subsequent calibrations can be automated by relying on the original instrument value plus the reagent-specific value assigned to each lot of reagents.

After the automated calibration curve is calculated, the user proceeds to the usual quality control (QC) step. If the QC results are within the target range, the user can move on to loading patient samples and running the desired assay. If the QC results are not within the target range — which could happen if the reagents were not stored at the ideal temperature, for example — the user would go back and perform a manual calibration which resets the values of the reagent and system. The system-specific values generated from the latest manual calibration will then be used for future automated calibrations going forward.

A small but potent shift

Unlike automation approaches that radically change a clinical laboratory workflow, automated calibration is an easily incorporated step that fits into the standard workflow and can be checked by clinical lab staff through the QC process for peace of mind. It represents a small but important change that can save time for clinical lab members and generate results more quickly for patients.

You can read more about the concept of automated calibration at this link below: 

 

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