Method Comparison in medical laboratory verification is a process where a new method of testing is compared with a standard or established method. This is done to ensure that the new method is reliable, accurate, and consistent with the existing method. The new method should yield results that are clinically equivalent to the established method.
During this process, a variety of samples are tested using both methods and the results are compared. If the new method's results are within acceptable limits of the established method, the new method can be considered for implementation.
Method Comparison can be performed on Qualitative and Quantitative tests.
Cualia Recommendations: Verifications: Quantitative 20-30 samples. Qualitative 10-30 samples. Validations/LDTs: 80-100 samples
Other Names - Comparison of Methods, Comparative Method Analysis, Intermethod Comparison, Cross-Method Validation, Method Equivalence Study, Analytical Method Comparison, Benchmark Method Comparison, Performance Comparison Study, Parallel Method Testing, Method Correlation Study, Alternative Method Evaluation
Method Comparison is one of the primary MV experiments. It involves comparing your instrument’s actual results with those of a true reference instrument. This verifies that the new method produces results that are in agreement
Sample Selection
Sample Selection
Choose a representative set samples that reflect the diversity and variability expected in routine testing. Ensure samples cover the full range of analyte concentrations and conditions relevant to the test.
It is recommended that most of the samples come from the true population. Some manufacturer products such as commercial kits and controls may be used. These may often be necessary for particularly difficult to obtain concentrations and conditions.
Testing Samples
Measure each sample on a reference method (expected) and on your new instrumentation (actual). Record the results, label and source either in the Cualia app or on your own platform. Include the label and the source.
Use the Cualia MV App
Make sure the data is entered into the experiment with the right acceptance criterias.