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

  • Review Article2022-01-01 Clinical Chemistry

    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.

    Ann Lab Med 2022; 42(1): 3-23

    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.

  • 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): 515-530

    Abstract : 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.

  • Review Article2022-05-01 Diagnostic Hematology

    Myelodysplastic Syndromes with Bone Marrow Fibrosis: An Update

    Akriti G. Jain , M.D., Ling Zhang , M.D., John M. Bennett , M.D., and Rami Komrokji , M.D.

    Ann Lab Med 2022; 42(3): 299-305

    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.

  • 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 , Ph.D., Shin Young Yun , M.D., Yunhee Lee , B.D., Hyukmin Lee , M.D., Dongeun Yong , M.D., Kyungwon Lee , M.D.

    Ann Lab Med 2022; 42(2): 188-195

    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.

  • Review Article2022-05-01 Transfusion Medicine

    Current State of Blood Management Services in Korea

    Hyun Ok Kim , M.D., Ph.D.

    Ann Lab Med 2022; 42(3): 306-313

    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.

  • 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 , B.S.

    Ann Lab Med 2022; 42(2): 121-140

    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.

Annals of Laboratory Medicine
Journal Information March, 2024
Vol.44 No.2
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  • Original Article2022-03-01 Clinical Chemistry

    Biomarker Rule-in or Rule-out in Patients With Acute Diseases for Validation of Acute Kidney Injury in the Emergency Department (BRAVA): A Multicenter Study Evaluating Urinary TIMP-2/IGFBP7

    Hyun Suk Yang , M.D., Ph.D., Mina Hur , M.D., Ph.D., Kyeong Ryong Lee , M.D., Ph.D., Hanah Kim , M.D., Ph.D., Hahn Young Kim , M.D., Ph.D., Jong Won Kim , M.D., Ph.D., Mui Teng Chua , M.D., Win Sen Kuan , M.D., Horng Ruey Chua , M.D., Chagriya Kitiyakara , M.D., Phatthranit Phattharapornjaroen , M.D., Anchalee Chittamma , Ph.D., Thiyapha Werayachankul , M.Sc., Urmila Anandh , M.D., Sanjeeva Herath , M.B., Ch.B., Zoltan Endre , M.D., Ph.D., Andrea Rita Horvath , M.D., Ph.D., Paola Antonini , M.D., and Salvatore Di Somma , M.D., Ph.D. on behalf of the GREAT Network

    Ann Lab Med 2022; 42(2): 178-187

    Abstract : Background: Urine tissue inhibitor of metalloproteinases-2/insulin-like growth factor-binding protein 7 (TIMP-2/IGFBP7) (NephroCheck, Ortho Clinical Diagnostics, Raritan, NJ, USA) is a US Food and Drug Administration-approved biomarker for risk assessment of acute kidney injury (AKI) in critically ill adult patients in intensive care units; however, its clinical impact in the emergency department (ED) remains unproven. We evaluated the utility of NephroCheck for predicting AKI development and short-term mortality in the ED. Methods: This was a prospective, observational, five-center international study. We consecutively enrolled ED patients admitted with ≥30% risk of AKI development (assessed by ED physician: ED score) or acute diseases. Serum creatinine was tested on ED arrival (T0), day 1, and day 2 (T48); urine for NephroCheck was collected at T0 and T48. We performed ROC curve and reclassification analyses. Results: Among the 529 patients enrolled (213 females; median age, 65 years), AKI developed in 59 (11.2%) patients. The T0 NephroCheck value was higher in the AKI group than in the non-AKI group (median 0.77 vs. 0.29 (ng/m)2/1,000, P=0.001), and better predicted AKI development than the ED score (area under the curve [AUC], 0.64 vs. 0.53; P=0.04). In reclassification analyses, adding NephroCheck to the ED score improved the prediction of AKI development (P

  • Original Article2022-03-01 Diagnostic Immunology

    Comparison of Non-Invasive Clinical Algorithms for Liver Fibrosis in Patients With Chronic Hepatitis B to Reduce the Need for Liver Biopsy: Application of Enhanced Liver Fibrosis and Mac-2 Binding Protein Glycosylation Isomer

    Mina Hur , M.D., Ph.D., Mikyoung Park , M.D., Ph.D., Hee-Won Moon , M.D., Ph.D., Won Hyeok Choe , M.D., Ph.D., and Chae Hoon Lee , M.D., Ph.D.

    Ann Lab Med 2022; 42(2): 249-257

    Abstract : Background: Non-invasive clinical algorithms for the detection of liver fibrosis (LF) can reduce the need for liver biopsy (LB). We explored the implementation of two serum biomarkers, enhanced liver fibrosis (ELF) and Mac-2 binding protein glycosylation isomer (M2BPGi), in clinical algorithms for LF in chronic hepatitis B (CHB) patients. Methods: Two clinical algorithms were applied to 152 CHB patients: (1) transient elastography (TE) followed by biomarkers (TE/ELF and TE/M2GPGi); (2) biomarker test followed by TE (ELF/TE and M2BPGi/TE). Using the cut-off value or index for the detection of advanced LF (TE≥F3; 9.8 in ELF and 3.0 in M2BPGi), LB was expected to be performed in cases with discordant TE and biomarker results. Results: In both algorithms, the expected number of LBs was lower when using M2BPGi than when using ELF (TE/ELF or ELF/TE, 13.2% [N=20]; TE/M2BPGi or M2BPGi/TE, 9.9% [N=15]), although there was no statistical difference (P=0.398). In the TE low-risk group (TE≤F2), the discordance rate was significantly lower in the TE/M2BPGi approach than in the TE/ELF approach (1.5% [2/136] vs. 11.0% [15/136], P=0.002). In the biomarker low-risk group, there was no significant difference between the ELF/TE and M2BPGi/TE approaches (3.9% [5/126] vs. 8.8% [13/147], P=0.118). Conclusions: Both ELF and M2BPGi can be implemented in non-invasive clinical algorithms for assessing LF in CHB patients. Given the lowest possibility of losing advanced LF cases in the low-risk group when using the TE/M2BPGi approach, this combination seems useful in clinical practice.

  • Original Article2022-01-01 Diagnostic Immunology

    Clinical Performance of Two Automated Immunoassays, EliA CTD Screen and QUANTA Flash CTD Screen Plus, for Antinuclear Antibody Screening

    Sumi Yoon , M.D., Hee-Won Moon , M.D., Ph.D., Hanah Kim , M.D., Ph.D., Mina Hur , M.D., Ph.D., and Yeo-Min Yun , M.D., Ph.D.

    Ann Lab Med 2022; 42(1): 63-70

    Abstract : Background: Recently, two fully automated immunoassays for antinuclear antibody (ANA) screening were introduced: EliA CTD Screen (Thermo Fisher Scientific, Freiburg, Germany) and QUANTA Flash CTD Screen Plus (Inova Diagnostics, San Diego, USA). We evaluated their clinical performance in comparison with the indirect immunofluorescence assay (IIFA) and analyzed samples with discrepant results. Methods: In total, 406 serum samples (206 from patients undergoing routine checkups and 200 from rheumatology clinic patients) were assayed using EliA, QUANTA Flash, and IIFA. We evaluated assay concordance and agreement and confirmed the presence of anti-extractable nuclear antigen (ENA) antibodies in samples with discrepant automated immunoassay and IIFA results. Additionally, we compared the clinical performance of each assay in diagnosing ANA-associated rheumatic disease (AARD) and adjusted the cut-off values. Results: In rheumatology clinic samples, the concordance and agreement were 91.5% and strong between EliA and QUANTA Flash, 79.0% and weak between EliA and IIFA, and 80.5% and moderate between QUANTA Flash and IIFA, respectively. In automated immunoassay-positive, IIFA-negative samples (N=15), all anti-ENA antibodies detected (6/15) were anti-Sjögren’s syndrome antigen A/Ro (Ro60) antibodies. The automated immunoassays and IIFA showed high accuracy for diagnosing AARD, and adjusted cut-off values improved their sensitivities (EliA with 0.56 ratio, 82.9% sensitivity; QUANTA Flash with 9.7 chemiluminescent units, 87.8% sensitivity). Conclusions: The two automated immunoassays showed reliable performance compared with IIFA and can be efficiently used with the IIFA in clinical immunology laboratories. Clinical cut-off values can be adjusted according to the workflow in each laboratory.