Review Article l 01 September 2022

Unreliable Automated Complete Blood Count Results: Causes, Recognition, and Resolution

Gene Gulati, Ph.D., Guldeep Uppal et al.

Ann Lab Med 2022; 42: 515-530
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 whe...

Keywords: Blood cell counts, Automated analyzer, Specimen handling, Problem solving

Review Article l 01 September 2022

Review of the Use of Liquid Chromatography-Tandem Mass Spectrometry in Clinical Laboratories: Part II–Operations

Brian A. Rappold, B.S.

Ann Lab Med 2022; 42: 531-557
Liquid chromatography-tandem mass spectrometry (LC-MS/MS) is increasingly utilized in clinical laboratories because it has advantages in terms of specificity and sensitivity over other analytical technologies. These advantages come with additional re...

Keywords: Liquid chromatography-tandem mass spectrometry, Operations, Quality control, Troubleshooting, Validation, Verification, Calibration

Review Article l 01 May 2022

Myelodysplastic Syndromes with Bone Marrow Fibrosis: An Update

Akriti G. Jain, M.D., Ling Zhang et al.

Ann Lab Med 2022; 42: 299-305
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 prog...

Keywords: Myelodysplastic syndrome, Bone marrow fibrosis, International prognostic scoring system, Allogeneic stem cell transplantation

Review Article l 01 May 2022

Current State of Blood Management Services in Korea

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

Ann Lab Med 2022; 42: 306-313
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 s...

Keywords: Blood management, Service data, Korea

Review Article l 01 May 2022

Current Issues, Challenges, and Future Perspectives of Genetic Counseling in Korea

Namhee Kim, M.D., Sun-Young Kong et al.

Ann Lab Med 2022; 42: 314-320
Genetic testing has become increasingly integrated into all areas of healthcare, and complex genetic testing usage continues to grow; thus, the demand for genetic counseling (GC) is likely to increase. However, it is unclear whether the current clini...

Keywords: Genetic counseling, Genetic services, Specialists, Healthcare system, Policy

Review Article l 01 May 2022

Promotion to Top-Tier Journal and Development Strategy of the Annals of Laboratory Medicine for Strengthening its Leadership in the Medical Laboratory Technology Category: A Bibliometric Study

Sun Huh, M.D., Ph.D.

Ann Lab Med 2022; 42: 321-330
Background: A bibliometric analysis of the Annals of Laboratory Medicine (ALM) was performed to understand its position in the medical laboratory technology category and to suggest a developmental strategy. Methods: Journal metrics, including the num...

Keywords: Bibliometrics, Journal impact factor, Medical laboratory technology, Annals of Laboratory Medicine

Review Article l 01 March 2022

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: 121-140
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 ...

Keywords: Tandem Mass Spectrometry, Liquid Chromatography, Method Development, Sample Preparation, Calibration, Internal Standards, Matrix Effects, Quality Control

Review Article l 01 March 2022

Clinical Practice Guidelines for Pre-Analytical Procedures of Plasma Epidermal Growth Factor Receptor Variant Testing

Saeam Shin, M.D., Ph.D. et al.

Ann Lab Med 2022; 42: 141-149
Standardization of cell-free DNA (cfDNA) testing processes is necessary to obtain clinically reliable results. The pre-analytical phase of cfDNA testing greatly influences the results because of the low proportion and stability of circulating tumor D...

Keywords: Cell-free nucleic acid, Circulating tumor DNA, Pre-analytical phase, Epidermal growth factor receptor, Clinical practice guidelines

Review Article l 01 January 2022

Hormone Immunoassay Interference: A 2021 Update

Khaldoun Ghazal, Pharm., Ph.D. et al.

Ann Lab Med 2022; 42: 3-23
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...

Keywords: Immunoassay, Hormone, Interference, Heterophile antibodies, Biotin

  • Review Article2021-01-01

    Application of Next Generation Sequencing in Laboratory Medicine

    Yiming Zhong , Ph.D, Feng Xu et al.

    Ann Lab Med 2021; 41(1): 25-43

    Abstract : The rapid development of next-generation sequencing (NGS) technology, including advances in sequencing chemistry, sequencing technologies, bioinformatics, and data interpretation, has facilitated its wide clinical application in precision medicine. This review describes current sequencing technologies, including short- and long-read sequencing technologies, and highlights the clinical application of NGS in inherited diseases, oncology, and infectious diseases. We review NGS approaches and clinical diagnosis for constitutional disorders; summarize the application of U.S. Food and Drug Administration-approved NGS panels, cancer biomarkers, minimal residual disease, and liquid biopsy in clinical oncology; and consider epidemiological surveillance, identification of pathogens, and the importance of host microbiome in infectious diseases. Finally, we discuss the challenges and future perspectives of clinical NGS tests.

  • Review Article2021-03-01

    Role of Genetic Variants and Gene Expression in the Susceptibility and Severity of COVID-19

    Sarita Choudhary , M.D., Karli Sreenivasulu et al.

    Ann Lab Med 2021; 41(2): 129-138

    Abstract : Since its first report in December 2019, coronavirus disease 2019 (COVID-19), caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), has rapidly emerged as a pandemic affecting nearly all countries worldwide. As the COVID-19 pandemic progresses, the need to identify genetic risk factors for susceptibility to this serious illness has emerged. Host genetic factors, along with other risk factors may help determine susceptibility to respiratory tract infections. It is hypothesized that the ACE2 gene, encoding angiotensin-converting enzyme 2 (ACE2), is a genetic risk factor for SARS-CoV-2 infection and is required by the virus to enter cells. Together with ACE2, transmembrane protease serine 2 (TMPRSS2) and dipeptidyl peptidase-4 (DPP4) also play an important role in disease severity. Evaluating the role of genetic variants in determining the direction of respiratory infections will help identify potential drug target candidates for further study in COVID-19 patients. We have summarized the latest reports demonstrating that ACE2 variants, their expression, and epigenetic factors may influence an individual’s susceptibility to SARS-CoV-2 infection and disease outcome.

  • Review Article2021-11-01
    General Laboratory Medicine

    Biomarkers for Prognosis and Treatment Response in COVID-19 Patients

    Giulia Bivona , M.D., Luisa Agnello et al.

    Ann Lab Med 2021; 41(6): 540-548

    Abstract : During a severe infection such as coronavirus disease 2019 (COVID-19), the level of almost all analytes can change, presenting a correlation with disease severity and survival; however, a biomarker cannot be translated into clinical practice for treatment guidance until it is proven to have a significant impact. Several studies have documented the association between COVID-19 severity and circulating levels of C-reactive protein (CRP) and interleukin-6, and the accuracy of the CRP level in predicting treatment responses has been evaluated. Moreover, promising findings on prothrombin and D-dimer have been reported. However, the clinical usefulness of these biomarkers in COVID-19 is far from proven. The burst of data generation during this pandemic has led to the publication of numerous studies with several notable drawbacks, weakening the strength of their findings. We provide an overview of the key findings of studies on biomarkers for the prognosis and treatment response in COVID-19 patients. We also highlight the main drawbacks of these studies that have limited the clinical use of these biomarkers.

  • Brief Communication2021-03-01

    Surveillance of Coronavirus Disease 2019 (COVID-19) Testing in Clinical Laboratories in Korea

    Hee Jae Huh , M.D., Ki Ho Hong et al.

    Ann Lab Med 2021; 41(2): 225-229

    Abstract : In response to the ongoing coronavirus disease 2019 (COVID-19) pandemic, an online laboratory surveillance system was established to monitor severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) real-time reverse transcription-PCR (rRT-PCR) testing capacities and results. SARS-CoV-2 rRT-PCR testing data were collected from 97 clinical laboratories, including 84 medical institutions and 13 independent clinical laboratories in Korea. We assessed the testing capacities to utilize SARS-CoV-2 rRT-PCR based on surveillance data obtained from February 7th to June 4th, 2020 and evaluated positive result characteristics according to the reagents used and sample types. A total of 1,890,319 SARS-CoV-2 rRT-PCR testing were performed, 2.3% of which were positive. Strong correlations were observed between the envelope (E) gene and RNA-dependent RNA polymerase (RdRp)/nucleocapsid (N) genes threshold cycle (Ct) values for each reagent. No statistically significant differences in gene Ct values were observed between the paired upper and lower respiratory tract samples, except in the N gene for nasopharyngeal swab and sputum samples. Our study showed that clinical laboratories in Korea have rapidly expanded their testing capacities in response to the COVID-19 outbreak, with a peak daily capacity of 34,193 tests. Rapid expansion in testing capacity is a critical component of the national response to the ongoing pandemic.

  • Review Article2021-03-01

    Sustainability in Healthcare: Perspectives and Reflections Regarding Laboratory Medicine

    Aroa Molero , Michele Calabrò , Maguelone Vignes et al.

    Ann Lab Med 2021; 41(2): 139-144

    Abstract : Healthcare structures serve to protect and improve public health; however, they can have negative effects on human well-being and the environment. Thus, sustainability is an important target in a rapidly changing healthcare environment. We analyzed the state of the art in research on healthcare and sustainability by exploring literature on different healthcare systems and their relations with the environment. Our review presents conceptual and practical developments regarding sustainability, as well as an overview of their evolution in the healthcare sector over time. We also discuss how sustainability could be applied to reduce the environmental impact of clinical laboratories by ensuring that resources are used efficiently and responsibly. Finally, we describe how laboratory medicine can contribute to a sustainable healthcare system through integration of innovation and emerging technologies while providing high-quality services to patients and caregivers.

  • Review Article2022-01-01
    Clinical Chemistry

    Hormone Immunoassay Interference: A 2021 Update

    Khaldoun Ghazal , Pharm., Ph.D. et al.

    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.

Journal Information March, 2023
Vol.43 No.2
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  • Original Article2022-03-01

    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. et al.

    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<0.05). The T0 NephroCheck value predicted 30-day mortality (AUC, 0.68; P<0.001). Conclusions: NephroCheck can predict both AKI development and short-term mortality in at-risk ED patients. NephroCheck would be a useful biomarker for early ruling-in or ruling-out of AKI in the ED.

  • Original Article2022-03-01

    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. et al.

    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

    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 et al.

    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.