The top-down approach to measurement uncertainty

Introduction: By quantifying the measurement uncertainty (MU), both the laboratory and the physician can have an objective estimate of the results’ quality. There is significant flexibility on how to determine the MU in laboratory medicine and different approaches have been proposed by Nordtest, Eurolab and Cofrac to obtain the data and apply them in formulas. The purpose of this study is to compare three different top-down approaches for the estimation of the MU and to suggest which of these approaches could be the most suitable choice for routine use in clinical laboratories. Materials and methods: Imprecision and bias of the methods were considered as components of the MU. The bias was obtained from certified reference calibrators (CRC), proficiency tests (PT), and inter-laboratory internal quality control scheme (IQCS) programs. The bias uncertainty, the combined and the expanded uncertainty were estimated using the Nordtest, Eurolab and Cofrac approaches. Results: Using different approaches, the expanded uncertainty estimates ranged from 18.9-40.4%, 18.2-22.8%, 9.3-20.9%, and 7.1-18.6% for cancer antigen (CA) 19-9, testosterone, alkaline phosphatase (ALP), and creatinine, respectively. Permissible values for MU and total error ranged from 16.0-46.1%, 13.1-21.6%, 10.7-26.2%, and 7.5-17.3%, respectively. Conclusion: The bias was highest using PT, followed by CRC and IQCS data, which were similar. The Cofrac approach showed the highest uncertainties, followed by Eurolab and Nordtest. However, the Eurolab approach requires additional measurements to obtain uncertainty data. In summary, the Nordtest approach using IQCS data was therefore found to be the most practical formula.

A Quality Control Scheme for a Commercial Pozzolana Plant: A Case Study of Pozzolana Ghana Ltd

A Quality control scheme was developed for a 200 ton per day commercial pozzolana plant. The scheme was evaluated for the first 34 days of production. Statistical Process Control tech­niques were specifically applied to the mechanical properties of setting times and compressive strength. Results obtained showed that pozzolana samples tested were chemically suitable with total SiO2, Al2O3 and Fe2O3 content ≥ 70%. Mechanical tests performed were mostly under control and when out-of-control, they gave valuable indication to plant malfunction or operator errors which were promptly corrected. The results of mechanical properties tested against the three major brands of cement on the Ghanaian market showed that pozzolana gave highest compressive strengths with Dangote CEM I 42.5R ranging between 21.3 MPa - 36.3 MPa at 7 days and 33.8 MPa - 45.1 MPa at 28 days whilst lowest compressive strengths were obtained with Ghacem CEM II B-L 32.5R cement ranging between 16.3 MPa – 23.6 MPa at 7 days and 23.3 MPa – 30.7 MPa at 28 days. Compressive strengths obtained with Diamond CEM II B-L 42.5N cement were average. A mean compressive strength for all brands of ce­ment of 25.2 MPa and 33.6 MPa at 7 days and 28 days respectively were obtained. Keywords: Pozzolana cement, statistical process control, Shewhart chart, compressive strength, setting time

A Clinical TB Detection Method Based on Molecular Typing Technique with Quality Control

The gold standard for diagnosing pulmonary Mycobacterium tuberculosis (TB) is the detection of tubercle bacillus in patient sputum samples. However, current methods either require long waiting times to culture the bacteria or have a risk of getting false-positive results due to cross-contamination. In this study, a method to detect tubercle bacillus based on the molecular typing technique is presented. This method can detect genetic units, variable number of tandem repeat (VNTR), which are the characteristic of tuberculosis (TB), and performs quality control using a mathematical model, ensuring the reliability of the results. Compared to other methods, the proposed method was able to process and diagnose a large volume of samples in a run time of six hours, with high sensitivity and specificity. Our method is also in the pipeline for implementation in clinical testing. Reliable and confirmed results are stored into a database, and these data are used to further refine the model. As the volume of data processed from reliable samples increases, the diagnostic power of the model improves. In addition to improving the quality control scheme, the collected data can be also used to support other TB research, such as that regarding the evolution of the tubercle bacillus.