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Background: This paper presents a data-driven strategy for establishing the reportable interval in clinical laboratory testing. The reportable interval defines the range of laboratory result values beyond which reporting should be withheld. The lack of clear guidelines and methodology for determining the reportable interval has led to potential errors in reporting and patient risk., Methods: To address this gap, the study developed an integrated strategy that combines statistical analysis, expert review, and hypothetical outlier calculations. A large data set from an accredited clinical laboratory was utilized, analyzing over 124 million laboratory test records from 916 distinct tests. The Dixon test was applied to identify outliers and establish the highest and lowest non-outlier result values for each test, which were validated by clinical pathology experts. The methodology also included matching the reportable intervals with relevant Logical Observation Identifiers Names and Codes (LOINC) and Unified Code for Units of Measure (UCUM)-valid units for broader applicability., Results: Upon establishing the reportable interval for 135 routine laboratory tests (493 LOINC codes), we applied these to a primary care laboratory data set of 23 million records, demonstrating their efficacy with over 1% of result records identified as implausible., Conclusions: We developed and tested a data-driven strategy for establishing reportable intervals utilizing large electronic medical record (EMR) data sets. Implementing the established interval in clinical laboratory settings can improve autoverification systems, enhance data reliability, and reduce errors in patient care. Ongoing refinement and reporting of cases exceeding the reportable limits will contribute to continuous improvement in laboratory result management and patient safety., (© Association for Diagnostics & Laboratory Medicine 2024.)

Objectives: To inform researchers of central considerations and limitations when applying biochemical laboratory-generated registry data in clinical and public health research., Study Design and Setting: After review of literature on registry-based studies and the utilization of clinical laboratory registry data, relevant paragraphs and their applicability toward the creation of considerations for the use of biochemical registry data in research were evaluated. This led to the creation of an initial ten considerations. These were elaborated, edited, and merged after several read-throughs by all authors and discussed thoroughly under influence by the authors' personal experiences with laboratory databases and research registries in Denmark, leading to the formulation of five central considerations with corresponding items and illustrative examples., Results: We recommend that the following considerations should be addressed in studies relying on biochemical laboratory-generated registry data: why are biochemical laboratory data relevant to examine the hypothesis, and how were the variable(s) utilized in the study? What were the primary indications for specimen collection in the study population of interest? Were there any pre-analytical circumstances that could influence the test results? Are data comparable between producing laboratories and within the single laboratory over time? Is the database representative in terms of completeness of study populations and key variables?, Conclusion: It is crucial to address key errors in laboratory registry data and acknowledge potential limitations., Competing Interests: Declaration of competing interest The authors report no conflicts of interest regarding the study presented in this paper. K.A.D. is now an employee of Novo Nordisk A/S., (Copyright © 2024 The Author(s). Published by Elsevier Inc. All rights reserved.)

This paper proposes a blend of three techniques to select COVID-19 testing centers. The objective of the paper is to identify a suitable location to establish new COVID-19 testing centers. Establishment of the testing center in the needy locations will be beneficial to both public and government officials. Selection of the wrong location may lead to lose both health and wealth. In this paper, location selection is modelled as a decision-making problem. The paper uses fuzzy analytic hierarchy process (AHP) technique to generate the criteria weights, monkey search algorithm to optimize the weights, and Technique for Order of Preference by Similarity to Ideal Solution (TOPSIS) method to rank the different locations. To illustrate the applicability of the proposed technique, a state named Tamil Nadu, located in India, is taken for a case study. The proposed structured algorithmic steps were applied for the input data obtained from the government of India website, and the results were analyzed and validated using the government of India website. The ranks assigned by the proposed technique to different locations are in aligning with the number of patients and death rate., Competing Interests: The authors declare that there is no conflict of interest regarding the publication of this article., (Copyright © 2022 S. Saroja et al.)

Background: This study aimed to investigate the implementation and quality control of the quantitative detection of serum Helicobacter pylori (H. pylori) antibody in clinical laboratories in China., Methods: Online external quality assessment (EQA) questionnaires were distributed to the clinical laboratories by National Center for Clinical Laboratories (NCCL) of China. We collected information on the quantitative detection procedures of serum H. pylori antibody in clinical laboratories, including detection reagents, methods, instruments, calibrators, and internal quality control (IQC). We distributed quality control products to some select laboratories that conducted quantitative detection and analyzed the obtained test data. We evaluated the quantitative detection procedure based on the standard evaluation criteria set at a target value of ±30%., Results: 70.9% (146/206) of the laboratories conducted quantitative detection of H. pylori antibody; 29.1% (60/206) of the laboratories performed qualitative detection. Domestic reagents and matching calibrators accounted for more than 97.1% (200/206) of all reagents. Latex-enhanced immunoturbidimetry was used in 89.7% (131/146) of the laboratories for quantitative determination, while the colloidal gold method was used in 66.7% (40/60) of the laboratories for qualitative determination. A total of 130 laboratories participated in the EQA; 123 completed the assessment, and the pass rate was 75.6% (93/123)., Conclusion: Clinical quantitative detection of serum H. pylori antibody is performed at a high rate in China. Thus, further studies on the specificity of commercial detection reagents are needed. EQAs are useful to monitor and improve the detection quality of H. pylori antibodies., (© 2021 The Authors. Journal of Clinical Laboratory Analysis published by Wiley Periodicals LLC.)

Background and Purpose: Currently there are no widely accepted guidelines for chimerism analysis testing in hematopoietic cell transplantation (HCT) patients. The objective of this review is to provide a practical guide to address key aspects of performing and utilizing chimerism testing results. In developing this guide, we conducted a survey of testing practices among laboratories that are accredited for performing engraftment monitoring/chimerism analysis by either the American Society for Histocompatibility & Immunogenetics (ASHI) and/or the European Federation of Immunogenetics (EFI). We interpreted the survey results in the light of pertinent literature as well as the experience in the laboratories of the authors., Recent Developments: In recent years there has been significant advances in high throughput molecular methods such as next generation sequencing (NGS) as well as growing access to these technologies in histocompatibility and immunogenetics laboratories. These methods have the potential to improve the performance of chimerism testing in terms of sensitivity, availability of informative genetic markers that distinguish donors from recipients as well as cost., Summary: The results of the survey revealed a great deal of heterogeneity in chimerism testing practices among participating laboratories. The most consistent response indicated monitoring of engraftment within the first 30 days. These responses are reflective of published literature. Additional clinical indications included early detection of impending relapse as well as identification of cases of HLA-loss relapse., Competing Interests: Declaration of Competing Interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Dr. Askar has received compensation as a member of the scientific advisory board for CareDx, Inc. Dr. Blouin, Dr. Ye, and Ms. Williams declare no potential competing interests., (Copyright © 2021 American Society for Histocompatibility and Immunogenetics. Published by Elsevier Inc. All rights reserved.)

Introduction: There have been no specific guidelines regarding which genes should be tested in the clinical setting for Parkinson's disease (PD) or parkinsonism. We evaluated the types of clinical genetic testing offered for PD as the first step of our gene curation., Methods: The National Institutes of Health (NIH) Genetic Testing Registry (GTR) was queried on 12/7/2020 to identify current commercial PD genetic test offerings by clinical laboratories, internationally., Results: We identified 502 unique clinical genetic tests for PD, from 28 Clinical Laboratory Improvement Amendments (CLIA)-approved clinical laboratories. These included 11 diagnostic PD panels. The panels were notable for their differences in size, ranging from 5 to 62 genes. Five genes for variant query were included in all panels (SNCA, PRKN, PINK-1, PARK7 (DJ1), and LRRK2). Notably, the addition of the VPS35 and GBA genes was variable. Panel size differences stemmed from inclusion of genes linked to atypical parkinsonism and dystonia disorders, and genes in which the link to PD causation is controversial., Conclusion: There is an urgent need for expert opinion regarding which genes should be included in a commercial laboratory multi-gene panel for PD., (Copyright © 2021 The Author(s). Published by Elsevier Ltd.. All rights reserved.)