Most Read (Last 3 years)
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Review Article2024-01-01 Clinical Chemistry
Abstract : Physicians increasingly use laboratory-produced information for disease diagnosis, patient monitoring, treatment planning, and evaluations of treatment effectiveness. Bias is the systematic deviation of laboratory test results from the actual value, which can cause misdiagnosis or misestimation of disease prognosis and increase healthcare costs. Properly estimating and treating bias can help to reduce laboratory errors, improve patient safety, and considerably reduce healthcare costs. A bias that is statistically and medically significant should be eliminated or corrected. In this review, the theoretical aspects of bias based on metrological, statistical, laboratory, and biological variation principles are discussed. These principles are then applied to laboratory and diagnostic medicine for practical use from clinical perspectives.
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Review Article2023-05-01 Clinical Chemistry
Biomarkers in Heart Failure: From Research to Clinical Practice
Alexander E. Berezin
Ann Lab Med 2023; 43(3): 225-236, M.D., Ph.D. and Alexander A. Berezin
, M.D.
Abstract : The aim of this narrative review is to summarize contemporary evidence on the use of circulating cardiac biomarkers of heart failure (HF) and to identify a promising biomarker model for clinical use in personalized point-of-care HF management. We discuss the reported biomarkers of HF classified into clusters, including myocardial stretch and biomechanical stress; cardiac myocyte injury; systemic, adipocyte tissue, and microvascular inflammation; cardiac fibrosis and matrix remodeling; neurohumoral activation and oxidative stress; impaired endothelial function and integrity; and renal and skeletal muscle dysfunction. We focus on the benefits and drawbacks of biomarker-guided assistance in daily clinical management of patients with HF. In addition, we provide clear information on the role of alternative biomarkers and future directions with the aim of improving the predictive ability and reproducibility of multiple biomarker models and advancing genomic, transcriptomic, proteomic, and metabolomic evaluations.
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Review Article2024-03-01 Clinical Chemistry
Exploring Renal Function Assessment: Creatinine, Cystatin C, and Estimated Glomerular Filtration Rate Focused on the European Kidney Function Consortium Equation
Hans Pottel
Ann Lab Med 2024; 44(2): 135-143, Ph.D., Pierre Delanaye
, M.D., Ph.D., and Etienne Cavalier
, Ph.D.
Abstract : Serum creatinine and serum cystatin C are the most widely used renal biomarkers for calculating the estimated glomerular filtration rate (eGFR), which is used to estimate the severity of kidney damage. In this review, we present the basic characteristics of these biomarkers, their advantages and disadvantages, some basic history, and current laboratory measurement practices with state-of-the-art methodology. Their clinical utility is described in terms of normal reference intervals, graphically presented with age-dependent reference intervals, and their use in eGFR equations.
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Review Article2024-03-01 Clinical Chemistry
The Use of Bone-Turnover Markers in Asia-Pacific Populations
Samuel Vasikaran
Ann Lab Med 2024; 44(2): 126-134, M.D., Subashini C. Thambiah
, M.Path., Rui Zhen Tan
, Ph.D., and Tze Ping Loh
, M.B., B.ch., B.A.O.; APFCB Harmonization of Reference Interval Working Group
Abstract : Bone-turnover marker (BTM) measurements in the blood or urine reflect the bone-remodeling 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 observational 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 diagnostic 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 intervals (established for use with Asia-Pacific populations) and reference change values and treatment targets (used to monitor osteoporosis treatment) help guide the management 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 studies of the use of BTMs in individuals with metabolic bone disease, coupled with the harmonization of commercial assays to provide equivalent results, will further enhance their clinical applications.
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Brief Communication2023-09-01 Diagnostic Hematology
Implications of the 5th Edition of the World Health Organization Classification and International Consensus Classification of Myeloid Neoplasm in Myelodysplastic Syndrome With Excess Blasts and Acute Myeloid Leukemia
Cheonghwa Lee
Ann Lab Med 2023; 43(5): 503-507, M.D., Ha Nui Kim
, M.D., Ph.D., Jung Ah Kwon
, M.D., Ph.D., Soo-Young Yoon
, M.D., Ph.D., Min Ji Jeon
, M.D., Ph.D., Eun Sang Yu
, M.D., Dae Sik Kim
, M.D., Ph.D., Chul Won Choi
, M.D., Ph.D., and Jung Yoon
, M.D., Ph.D.
Abstract : The fifth edition of the WHO classification (2022 WHO) and the International Consensus Classification (2022 ICC) of myeloid neoplasms have been recently published. We reviewed the changes in the diagnosis distribution in patients with MDS with excess blasts (MDS-EB) or AML using both classifications. Forty-seven patients previously diagnosed as having AML or MDS-EB with available mutation analysis data, including targeted next-generation and RNA-sequencing data, were included. We reclassified 15 (31.9%) and 27 (57.4%) patients based on the 2022 WHO and 2022 ICC, respectively. One patient was reclassified as having a translocation categorized as a rare recurring translocation in both classifications. Reclassification was mostly due to the addition of mutation-based diagnostic criteria (i.e., AML, myelodysplasia-related) or a new entity associated with TP53 mutation. In both classifications, MDS diagnosis required the confirmation of multi-hit TP53 alterations. Among 14 patients with TP53 mutations, 11 harbored multi-hit TP53 alterations, including four with TP53 mutations and loss of heterozygosity. Adverse prognosis was associated with multi-hit TP53 alterations (P=0.009) in patients with MDS-EB, emphasizing the importance of detecting the mutations at diagnosis. The implementation of these classifications may lead to the identification of different subtypes from previously heterogeneous diagnostic categories based on genetic characteristics.
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Editorial2023-05-01
Apolipoprotein B, Non-HDL Cholesterol, and LDL Cholesterol as Markers for Atherosclerotic Cardiovascular Disease Risk Assessment
Ann Lab Med 2023; 43(3): 221-222 -
Review Article2023-09-01 Clinical Chemistry
Artificial Intelligence in Point-of-Care Testing
Adil I. Khan
Ann Lab Med 2023; 43(5): 401-407, M.Sc., Ph.D., Mazeeya Khan
, M.Sc., and Raheeb Khan
, B.Sc.
Abstract : With the projected increase in the global population, current healthcare delivery models will face severe challenges. Rural and remote areas, whether in developed or developing countries, are characterized by the same challenges: the unavailability of hospitals, lack of trained and skilled staff performing tests, and poor compliance with quality assurance protocols. Point-of-care testing using artificial intelligence (AI) is poised to be able to address these challenges. In this review, we highlight some key areas of application of AI in point-of-care testing, including lateral flow immunoassays, bright-field microscopy, and hematology, demonstrating this rapidly expanding field of laboratory medicine.
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Review Article2024-05-01 Transfusion and Cell Therapy
Current Challenges in Chimeric Antigen Receptor T-cell Therapy in Patients With B-cell Lymphoid Malignancies
Seok Jin Kim
Ann Lab Med 2024; 44(3): 210-221, M.D., Ph.D., Sang Eun Yoon
, M.D., Ph.D., and Won Seog Kim
, M.D., Ph.D.
Abstract : Chimeric antigen receptor (CAR) T-cell therapy is a promising immunotherapy based on genetically engineered T cells derived from patients. The introduction of CAR T-cell therapy has changed the treatment paradigm of patients with B-cell lymphoid malignancies. However, challenging issues including managing life-threatening toxicities related to CAR T-cell infusion and resistance to CAR T-cell therapy, leading to progression or relapse, remain. This review summarizes the issues with currently approved CAR T-cell therapies for patients with relapsed or refractory B-cell lymphoid malignancies, including lymphoma and myeloma. We focus on unique toxicities after CAR T-cell therapy, such as cytokine-related events and hematological toxicities, and the mechanisms underlying post-CAR T-cell failure.
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Review Article2024-07-01 Transfusion and Cell Therapy
Manufacturing Cell and Gene Therapies: Challenges in Clinical Translation
Na Kyung Lee
Ann Lab Med 2024; 44(4): 314-323, Ph.D. and Jong Wook Chang
, Ph.D.
Abstract : The safety and efficacy of both cell and gene therapies have been demonstrated in numerous preclinical and clinical trials. Chimeric antigen receptor T (CAR-T) cell therapy, which leverages the technologies of both cell and gene therapies, has also shown great promise for treating various cancers. Advancements in pertinent fields have also highlighted challenges faced while manufacturing cell and gene therapy products. Potential problems and obstacles must be addressed to ease the clinical translation of individual therapies. Literature reviews of representative cell-based, gene-based, and cell-based gene therapies with regard to their general manufacturing processes, the challenges faced during manufacturing, and QC specifications are limited. We review the general manufacturing processes of cell and gene therapies, including those involving mesenchymal stem cells, viral vectors, and CAR-T cells. The complexities associated with the manufacturing processes and subsequent QC/validation processes may present challenges that could impede the clinical progression of the products. This article addresses these potential challenges. Further, we discuss the use of the manufacturing model and its impact on cell and gene therapy.
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Original Article2023-07-01 Diagnostic Hematology
Development of a Next-generation Sequencing-based Gene Panel Test to Detect Measurable Residual Disease in Acute Myeloid Leukemia
Jin Ju Kim
Ann Lab Med 2023; 43(4): 328-336, M.D., Ji Eun Jang
, M.D., Hyeon Ah Lee
, M.S., Mi Ri Park
, B.S., Hye Won Kook
, M.D., Seung-Tae Lee
, M.D., Jong Rak Choi
, M.D., Yoo Hong Min
, M.D., Saeam Shin
, M.D., and June-Won Cheong
, M.D.
Abstract : Background: AML is a heterogeneous disease, and despite intensive therapy, recurrence is still high in AML patients who achieve the criterion for cytomorphologic remission (residual tumor burden [measurable residual disease, MRD]0.99). The test reproducibly detected MRD in three dilution series samples, with a sensitivity of 0.25% for single-nucleotide variants. More than half of samples from patients with morphologic remission after one month of chemotherapy had detectable mutations. NGS-MRD positivity for samples collected after one month of chemotherapy tended to be associated with poor overall survival and progression-free survival. Conclusions: Our highly sensitive and accurate NGS-MRD panel can be readily used to monitor most AML patients in clinical practice, including patients without gene rearrangement. In addition, this NGS-MRD panel may allow the detection of newly emerging clones during clinical relapse, leading to more reliable prognoses of AML.
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