Hormone Immunoassay Interference: A 2021 Update
Khaldoun Ghazal 
, Pharm., Ph.D., Severine Brabant , M.D., Dominique Prie , M.D., Ph.D., and Marie-Liesse Piketty , Pharm., Ph.D.
Review Article l 01 November 2023
Clot Waveform Analysis for Hemostatic Abnormalities
Hideo Wada, M.D., Ph.D. et al.
Ann Lab Med 2023; 43: 531-538
Clot waveform analysis (CWA) observes changes in transparency in a plasma sample based on clotting tests such as activated partial thromboplastin time (APTT), prothrombin time (PT), and thrombin time (TT). Evidence indicates that not only an abnormal...
Keywords: Clot waveform analysis, Fibrinolysis, Hemostasis, Hemostatics, Indicators and reagents, Prothrombin time, Thrombin, Thrombocytopenia, Thrombophilia, Thrombosis
Review Article l 01 September 2023
Artificial Intelligence in Point-of-Care Testing
Adil I. Khan, M.Sc., Ph.D. et al.
Ann Lab Med 2023; 43: 401-407
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 o...
Keywords: Artificial intelligence, Point-of-care testing, Lateral flow immunoassay, Immunoassay, Hematology, Bright-field microscopy, Microscopy, Convolutional neural network, Malaria, Hemoglobin, Anemia
Review Article l 01 September 2023
Functional Reference Limits: Describing Physiological Relationships and Determination of Physiological Limits for Enhanced Interpretation of Laboratory Results
Tyng Yu Chuah, M.B., B.Ch. et al.
Ann Lab Med 2023; 43: 408-417
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 cur...
Keywords: Reference values, Threshold limit values, Homeostasis
Review Article l 01 May 2023
Biomarkers in Heart Failure: From Research to Clinical Practice
Alexander E. Berezin, M.D., Ph.D. and Alexander A. Berezin et al.
Ann Lab Med 2023; 43: 225-236
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 dis...
Keywords: Heart failure, Cardiac Biomarkers, Multiple Biomarker Models, Prediction, Management
Review Article l 01 January 2023
Calibration Practices in Clinical Mass Spectrometry: Review and Recommendations
Wan Ling Cheng, M.Sc., Corey Markus et al.
Ann Lab Med 2023; 43: 5-18
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....
Keywords: Calibration, Mass spectrometry, Regression, Linearity, Statistics
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Review Article2022-01-01 Clinical Chemistry
Abstract : Immunoassays are powerful qualitative and quantitative analytical techniques. Since the first description of an immunoassay method in 1959, advances have been made in assay designs and analytical characteristics, opening the door for their widespread implementation in clinical laboratories. Clinical endocrinology is closely linked to laboratory medicine because hormone quantification is important for the diagnosis, treatment, and prognosis of endocrine disorders. Several interferences in immunoassays have been identified through the years; although some are no longer encountered in daily practice, cross-reaction, heterophile antibodies, biotin, and anti-analyte antibodies still cause problems. Newer interferences are also emerging with the development of new therapies. The interfering substance may be exogenous (e.g., a drug or substance absorbed by the patient) or endogenous (e.g., antibodies produced by the patient), and the bias caused by interference can be positive or negative. The consequences of interference can be deleterious when clinicians consider erroneous results to establish a diagnosis, leading to unnecessary explorations or inappropriate treatments. Clinical laboratories and manufacturers continue to investigate methods for the detection, elimination, and prevention of interferences. However, no system is completely devoid of such incidents. In this review, we focus on the analytical interferences encountered in daily practice and possible solutions for their detection or elimination.
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Review Article2022-09-01 Diagnostic Hematology
Unreliable Automated Complete Blood Count Results: Causes, Recognition, and Resolution
Gene Gulati, Ph.D., Guldeep Uppal, M.D., and Jerald Gong, M.D.
Ann Lab Med 2022; 42(5): 515-530Abstract : Automated hematology analyzers generate accurate complete blood counts (CBC) results on nearly all specimens. However, every laboratory encounters, at times, some specimens that yield no or inaccurate result(s) for one or more CBC parameters even when the analyzer is functioning properly and the manufacturer’s instructions are followed to the letter. Inaccurate results, which may adversely affect patient care, are clinically unreliable and require the attention of laboratory professionals. Laboratory professionals must recognize unreliable results, determine the possible cause(s), and be acquainted with the ways to obtain reliable results on such specimens. We present a concise overview of the known causes of unreliable automated CBC results, ways to recognize them, and means commonly utilized to obtain reliable results. Some examples of unreliable automated CBC results are also illustrated. Pertinent analyzer-specific information can be found in the manufacturers’ operating manuals.
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Review Article2022-05-01 Diagnostic Hematology
Myelodysplastic Syndromes with Bone Marrow Fibrosis: An Update
Akriti G. Jain
Ann Lab Med 2022; 42(3): 299-305, M.D., Ling Zhang , M.D., John M. Bennett , M.D., and Rami Komrokji , M.D.Abstract : Myelodysplastic syndrome (MDS) is a diverse hematological malignancy with a wide spectrum of presentations and implications. Treatment strategies for patients with MDS heavily rely on prognostic scoring systems, such as the revised international prognostic scoring system (IPSS-R). Bone marrow fibrosis (BMF) has been identified as an independent risk factor for poor survival in patients with MDS, irrespective of the IPSS-R risk category. However, BMF is not widely included in scoring systems and is not always considered by clinicians when making treatment decisions for patients. In this review, we discuss the available literature about the presentation and prognosis of patients with MDS and concurrent BMF. The prognostic impact of BMF should be factored in when deciding on transplant candidacy, especially for intermediate-risk patients.
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Original Article2022-03-01 Clinical Microbiology
Clinical Differences in Patients Infected with Fusobacterium and Antimicrobial Susceptibility of Fusobacterium Isolates Recovered at a Tertiary-Care Hospital in Korea
Myungsook Kim
Ann Lab Med 2022; 42(2): 188-195, Ph.D., Shin Young Yun , M.D., Yunhee Lee , B.D., Hyukmin Lee , M.D., Dongeun Yong , M.D., Kyungwon Lee , M.D.Abstract : Background: Fusobacterium species are obligately anaerobic, gram-negative bacilli. Especially, F. nucleatum and F. necrophorum are highly relevant human pathogens. We investigated clinical differences in patients infected with Fusobacterium spp. and determined the antimicrobial susceptibility of Fusobacterium isolates. Methods: We collected clinical data of 86 patients from whom Fusobacterium spp. were isolated from clinical specimens at a tertiary-care hospital in Korea between 2003 and 2020. In total, 76 non-duplicated Fusobacterium isolates were selected for antimicrobial susceptibility testing by the agar dilution method, according to the Clinical and Laboratory Standards Institute guidelines (M11-A9). Results: F. nucleatum was most frequently isolated from blood cultures and was associated with hematologic malignancy, whereas F. necrophorum was mostly prevalent in head and neck infections. Anti-anaerobic agents were more commonly used to treat F. nucleatum and F. varium infections than to treat F. necrophorum infections. We observed no significant difference in mortality between patients infected with these species. All F. nucleatum and F. necrophorum isolates were susceptible to the antimicrobial agents tested. F. varium was resistant to clindamycin (48%) and moxifloxacin (24%), and F. mortiferum was resistant to penicillin G (22%) and ceftriaxone (67%). β-Lactamase activity was not detected. Conclusions: Despite the clinical differences among patients with clinically important Fusobacterium infections, there was no significant difference in the mortality rates. Some Fusobacterium spp. were resistant to penicillin G, ceftriaxone, clindamycin, or moxifloxacin. This study may provide clinically relevant data for implementing empirical treatment against Fusobacterium infections.
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Review Article2022-05-01 Transfusion Medicine
Current State of Blood Management Services in Korea
Hyun Ok Kim
Ann Lab Med 2022; 42(3): 306-313, M.D., Ph.D.Abstract : Blood is lifesaving; however, it can neither be limitlessly acquired nor artificially produced. The supply and use of blood, as an invaluable biological commodity, necessitate systematic and rational management under governmental guidance to ensure safe and reliable transfusions. Despite Korea’s blood donation rate of 5.04%, which is higher than the 3.15% in high-income countries as reported by the WHO, the demand for blood exceeds the availability. This is due to the birthrate decline, dearth of young donors, and growing and aging recipient population. This review outlines the Korean blood management system, with a focus on blood service data from 2020, with the aim to delineate the current state of Korea’s blood management system and the policies established to address the imminent blood shortage. Each policy is described in detail to provide helpful information for blood management services in other countries.
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Review Article2022-03-01 Clinical Chemistry
Review of the Use of Liquid Chromatography-Tandem Mass Spectrometry in Clinical Laboratories: Part I-Development
Brian A. Rappold
Ann Lab Med 2022; 42(2): 121-140 , B.S.Abstract : The process of method development for a diagnostic assay based on liquid chromatography-tandem mass spectrometry (LC-MS/MS) involves several disparate technologies and specialties. Additionally, method development details are typically not disclosed in journal publications. Method developers may need to search widely for pertinent information on their assay(s). This review summarizes the current practices and procedures in method development. Additionally, it probes aspects of method development that are generally not discussed, such as how exactly to calibrate an assay or where to place quality controls, using examples from the literature. This review intends to provide a comprehensive resource and induce critical thinking around the experiments for and execution of developing a clinically meaningful LC-MS/MS assay.
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