Analysis of different lot numbers of the manufacturer’s end-user calibrator or trueness control material is a quality control practice in medical laboratories. This practice involves testing the same control material, which is designed to have a known target value, but obtained from different production lots (batches) of the same manufacturer. The purpose is to assess the consistency and comparability of results between different lots of the same control material.
Here’s how the analysis is done:
- Selecting Control Material Lots: The laboratory chooses the manufacturer’s end-user calibrator or trueness control material, which is designed to have a specific target value. This material is obtained from different lot numbers of the same manufacturer.
- Testing Procedure: The laboratory performs the same testing procedure on the control material from each of the selected lot numbers. This involves the same sample preparation, instrument settings, and measurement protocols that would be used for patient samples.
- Data Collection: The laboratory collects the test results obtained from each lot of the control material. These results reflect how well the laboratory’s testing process performs for each lot.
- Comparison of Results: The laboratory compares the results obtained from different lot numbers of the control material. This involves statistical analysis to assess any differences in the measured values.
- Assessment of Consistency: The analysis aims to determine if the results from different lots of the same control material are consistent and within an acceptable range of variation. This assessment is crucial because it indicates whether the manufacturer’s control material is producing reliable and reproducible results across different production batches.
- Identification of Deviations: If the results from different lots show significant deviations, it could suggest potential issues with the manufacturing process, stability of the control material, or even the laboratory’s testing procedure. In such cases, further investigation might be necessary to understand the cause of these discrepancies.
- Quality Control Decisions: Based on the analysis, the laboratory can make decisions about the ongoing use of the control material for quality control purposes. If the results from different lots are consistent and fall within acceptable limits, the control material can be considered reliable for monitoring the accuracy of testing. If inconsistencies are observed, the laboratory might need to explore alternative control materials or contact the manufacturer for clarification.
Example: Blood Glucose Control Material
Imagine a laboratory that performs blood glucose testing using a control material provided by a manufacturer. This control material is available in different lot numbers. The laboratory decides to analyze two different lot numbers of the control material.
- The target value for the control material is 100 mg/dL (milligrams per deciliter).
- For Lot A, the laboratory tests the control material and obtains a mean result of 99.5 mg/dL.
- For Lot B, the laboratory tests the control material and obtains a mean result of 100.2 mg/dL.
- In this example, the results from both lot numbers are very close to the target value of 100 mg/dL. The small variations could be within an acceptable range of variation, suggesting that the control material is consistent and suitable for quality control purposes
In summary, analyzing different lot numbers of the manufacturer’s control material involves testing the same control material from different production batches to assess its consistency and comparability. It’s an important quality control step to ensure that the control material provides reliable results for monitoring the accuracy of testing methods.
About the author
Dr. Sambhu Chakraborty is a distinguished consultant in quality accreditation for laboratories and hospitals. With a leadership portfolio that includes directorial roles in two laboratory organizations and a consulting firm, as well as chairmanship in a prominent laboratory organization, Dr. Chakraborty is a respected voice in the field. For further engagement or inquiries, Dr. Chakraborty can be contacted through email at director@iaqmconsultants.com and info@sambhuchakraborty.com. Additional resourcesand contact information are available on his websites, https://www.quality-pathshala.com and https://www.sambhuchakraborty.com, or via WhatsApp at +919830051583