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RISS 인기검색어
- 검색키워드
- 저자 : Tan Rui Zhen (검색결과 4 건)
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An Objective Approach to Deriving the Clinical Performance of Autoverification Limits
Loh Tze Ping,Tan Rui Zhen,Lim Chun Yee,Markus Corey 대한진단검사의학회 2022 Annals of Laboratory Medicine Vol.42 No.5
This study describes an objective approach to deriving the clinical performance of autoverification rules to inform laboratory practice when implementing them. Anonymized historical laboratory data for 12 biochemistry measurands were collected and Box-Cox-transformed to approximate a Gaussian distribution. The historical laboratory data were assumed to be error-free. Using the probability theory, the clinical specificity of a set of autoverification limits can be derived by calculating the percentile values of the overall distribution of a measurand. The 5th and 95th percentile values of the laboratory data were calculated to achieve a 90% clinical specificity. Next, a predefined tolerable total error adopted from the Royal College of Pathologists of Australasia Quality Assurance Program was applied to the extracted data before subjecting to Box-Cox transformation. Using a standard normal distribution, the clinical sensitivity can be derived from the probability of the Z-value to the right of the autoverification limit for a one-tailed probability and multiplied by two for a two-tailed probability. The clinical sensitivity showed an inverse relationship with between-subject biological variation. The laboratory can set and assess the clinical performance of its autoverification rules that conforms to its desired risk profile.
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Chuah Tyng Yu,Lim Chun Yee,Tan Rui Zhen,Pratumvinit Busadee,Loh Tze Ping,Vasikaran Samuel,Markus Corey 대한진단검사의학회 2023 Annals of Laboratory Medicine Vol.43 No.5
Functional reference limits describe key changes in the physiological relationship between a pair of physiologically related components. Statistically, this can be represented by a significant change in the curvature of a mathematical function or curve (e.g., an observed plateau). The point at which the statistical relationship changes significantly is the point of curvature inflection and can be mathematically modeled from the relationship between the interrelated biomarkers. Conceptually, they reside between reference intervals, which describe the statistical boundaries of a single biomarker within the reference population, and clinical decision limits that are often linked to the risk of morbidity or mortality and set as thresholds. Functional reference limits provide important physiological and pathophysiological insights that can aid laboratory result interpretation. Laboratory professionals are in a unique position to harness data from laboratory information systems to derive clinically relevant values. Increasing research on and reporting of functional reference limits in the literature will enhance their contribution to laboratory medicine and widen the evidence base used in clinical decision limits, which are currently almost exclusively contributed to by clinical trials. Their inclusion in laboratory reports will enhance the intellectual value of laboratory professionals in clinical care beyond the statistical boundaries of a healthy reference population and pave the way to them being considered in shaping clinical decision limits. This review provides an overview of the concepts related to functional reference limits, clinical examples of their use, and the impetus to include them in laboratory reports.
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The Use of Bone-Turnover Markers in Asia-Pacific Populations
Vasikaran Samuel,Thambiah Subashini C.,Tan Rui Zhen,Loh Tze Ping 대한진단검사의학회 2024 Annals of Laboratory Medicine Vol.44 No.2
Bone-turnover marker (BTM) measurements in the blood or urine reflect the bone-remod- eling rate and may be useful for studying and clinically managing metabolic bone diseases. Substantial evidence supporting the diagnostic use of BTMs has accumulated in recent years, together with the publication of several guidelines. Most clinical trials and observa- tional and reference-interval studies have been performed in the Northern Hemisphere and have mainly involved Caucasian populations. This review focuses on the available data for populations from the Asia-Pacific region and offers guidance for using BTMs as di- agnostic biomarkers in these populations. The procollagen I N-terminal propeptide and β-isomerized C-terminal telopeptide of type-I collagen (measured in plasma) are reference BTMs used for investigating osteoporosis in clinical settings. Premenopausal reference in- tervals (established for use with Asia-Pacific populations) and reference change values and treatment targets (used to monitor osteoporosis treatment) help guide the manage- ment of osteoporosis. Measuring BTMs that are not affected by renal failure, such as the bone-specific isoenzyme alkaline phosphatase and tartrate-resistant acid phosphatase 5b, may be advantageous for patients with advanced chronic kidney disease. Further stud- ies of the use of BTMs in individuals with metabolic bone disease, coupled with the har- monization of commercial assays to provide equivalent results, will further enhance their clinical applications.
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Calibration Practices in Clinical Mass Spectrometry: Review and Recommendations
Cheng Wan Ling,Markus Corey,Lim Chun Yee,Tan Rui Zhen,Sethi Sunil Kumar,Loh Tze Ping 대한진단검사의학회 2023 Annals of Laboratory Medicine Vol.43 No.1
Background: Calibration is a critical component for the reliability, accuracy, and precision of mass spectrometry measurements. Optimal practice in the construction, evaluation, and implementation of a new calibration curve is often underappreciated. This systematic review examined how calibration practices are applied to liquid chromatography-tandem mass spectrometry measurement procedures. Methods: The electronic database PubMed was searched from the date of database inception to April 1, 2022. The search terms used were “calibration,” “mass spectrometry,” and “regression.” Twenty-one articles were identified and included in this review, following evaluation of the titles, abstracts, full text, and reference lists of the search results. Results: The use of matrix-matched calibrators and stable isotope-labeled internal standards helps to mitigate the impact of matrix effects. A higher number of calibration standards or replicate measurements improves the mapping of the detector response and hence the accuracy and precision of the regression model. Constructing a calibration curve with each analytical batch recharacterizes the instrument detector but does not reduce the actual variability. The analytical response and measurand concentrations should be considered when constructing a calibration curve, along with subsequent use of quality controls to confirm assay performance. It is important to assess the linearity of the calibration curve by using actual experimental data and appropriate statistics. The heteroscedasticity of the calibration data should be investigated, and appropriate weighting should be applied during regression modeling. Conclusions: This review provides an outline and guidance for optimal calibration practices in clinical mass spectrometry laboratories.
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