Biomarkers for Prognosis and Treatment Response in COVID-19 Patients
Giulia Bivona 
, M.D., Luisa Agnello , Ph.D., and Marcello Ciaccio , M.D., Ph.D.
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Review Article2021-11-01 General Laboratory Medicine
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.
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Review Article2021-11-01 General Laboratory Medicine
Application of Single-Domain Antibodies (“Nanobodies”) to Laboratory Diagnosis
Tahir S. Pillay
Ann Lab Med 2021; 41(6): 549-558, MBChB., Ph.D. and Serge Muyldermans , Ph.D.Abstract : Antibodies have proven to be central in the development of diagnostic methods over decades, moving from polyclonal antibodies to the milestone development of monoclonal antibodies. Although monoclonal antibodies play a valuable role in diagnosis, their production is technically demanding and can be expensive. The large size of monoclonal antibodies (150 kDa) makes their re-engineering using recombinant methods a challenge. Single-domain antibodies, such as “nanobodies,” are a relatively new class of diagnostic probes that originated serendipitously during the assay of camel serum. The immune system of the camelid family (camels, llamas, and alpacas) has evolved uniquely to produce heavy-chain antibodies that contain a single monomeric variable antibody domain in a smaller functional unit of 12–15 kDa. Interestingly, the same biological phenomenon is observed in sharks. Since a single-domain antibody molecule is smaller than a conventional mammalian antibody, recombinant engineering and protein expression in vitro using bacterial production systems are much simpler. The entire gene encoding such an antibody can be cloned and expressed in vitro. Single-domain antibodies are very stable and heat-resistant, and hence do not require cold storage, especially when incorporated into a diagnostic kit. Their simple genetic structure allows easy re-engineering of the protein to introduce new antigen-binding characteristics or attach labels. Here, we review the applications of single-domain antibodies in laboratory diagnosis and discuss the future potential in this area.
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Original Article2022-01-01 General Laboratory Medicine
Economic Evaluation of Total Laboratory Automation in the Clinical Laboratory of a Tertiary Care Hospital
KyungYi Kim
Ann Lab Med 2022; 42(1): 89-95, M.S., Sang-Guk Lee , M.D., Ph.D., Tae Hyun Kim , Ph.D., and Sang Gyu Lee , M.D., Ph.D., M.B.A.Abstract : Background: Total laboratory automation (TLA) is an innovation in laboratory technology; however, the high up-front costs restrict its widespread adoption. To examine whether the capital investment for TLA is worthwhile, we analyzed its clinical- and cost-effectiveness for the expected payback period. Methods: Clinical chemistry tests and immunoassays performed in the clinical laboratory of a tertiary care hospital were divided into a post-TLA group, including 1,182,419 tests performed during December 2019, and a pre-TLA group, including 1,151,501 tests performed during December 2018. Laboratory information system data were used to measure clinical effectiveness, and depreciation data were used to calculate TLA costs. Results: Laboratory performance improved after TLA adoption in all four key performance indicators: mean turn-around time (TAT), representing the timeliness of result reporting, decreased by 6.1%; the 99th percentile of TAT, representing the outlier rate, decreased by 13.3%; the TAT CV, representing predictability, decreased by 70.0%; and weighted tube touch moment (wTTM), representing staff safety, improved by 77.6%. Based on these effectiveness results, economic evaluation was performed using two approaches. First, the incremental cost-effectiveness ratio and wTTM were used as the most cost-effective performance indicators. Second, the expected payback period was calculated. Considering only staff cost reduction, it was anticipated that 4.75 yrs would be needed to payback the initial investment. Conclusions: TLA can significantly enhance laboratory performance, has a relatively quick payback period, and can reduce total hospital expenses in the long term. Therefore, the capital investment for TLA adoption is considered to be worthwhile.
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Review Article2021-11-01 General Laboratory Medicine
Early Laboratory Preparedness of the Korea Disease Control and Prevention Agency and Response to Unknown Pneumonia Outbreak from Wuhan, China, in January 2020
Il-Hwan Kim
Ann Lab Med 2021; 41(6): 532-539, Ph.D., Byung-Hak Kang , Ph.D., Seung Hee Seo , M.S., Ye Eun Park , M.S., Gab Jung Kim , Ph.D., Sang Won Lee , Ph.D., Jun Hyeong Jang , Ph.D., Su Kyoung Jo , M.S., Jun Ho Jeon , Ph.D., Jeong-Min Kim , Ph.D., Yoon-Seok Chung , Ph.D., Myung-Guk Han , Ph.D., Sang-Oun Jung , Ph.D., Junyoung Kim , Ph.D., Kyu-Jam Hwang , Ph.D. , Cheon-Kwon Yoo , Ph.D., and Gi-eun Rhie , Ph.D.Abstract : We report the response process of the Laboratory Analysis Task Force (LATF) for Unknown Disease Outbreaks (UDOs) at the Korea Disease Control and Prevention Agency (KDCA) during January 2020 to coronavirus disease 2019 (COVID-19), which developed as a UDO in Korea. The advanced preparedness offered by the laboratory diagnostic algorithm for UDOs related to respiratory syndromes was critical for the rapid identification of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and enabled us to establish and expand the diagnostic capacity for COVID-19 on a national scale in a timely manner.
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Review Article2022-05-01 General Laboratory Medicine
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
Ann Lab Med 2022; 42(3): 321-330, M.D., Ph.D.Abstract : 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 number of articles by publication type, country of authors, total citations, 2-year impact factor, country of cited authors, journals citing ALM, and Hirsch-index, were obtained from the Journal Citation Report and Web of Science Core Collection. Target data included ALM content in the Web of Science from January 1, 2012, to October 5, 2021. Bibliometric analysis was performed using Biblioshiny. Results: The impact factor increased from 1.481 in 2013 to 3.464 in 2020. Authors belonging to the USA, China, and Korea cited ALM articles the most. Plos One, Scientific Reports, and Frontiers in Microbiology most frequently cited ALM, besides ALM itself. The Hirsch-index was 34. The co-occurrence network of Keyword Plus indicated four clusters: diagnosis, identification, prevalence, and risk. The conceptual structure map of Keyword Plus based on multiple correspondence analysis showed two clusters: bacterial susceptibility at the bench and clinical courses. The co-citation network showed that ALM was in the cluster of the New England Journal of Medicine, The Lancet, JAMA, and the Annals of Internal Medicine. The collaboration network showed that Korean authors collaborated mainly with authors from the USA, Germany, and Italy. Conclusions: The journal’s promotion to an international top-tier journal has been successful. “Principles of transparency and best practice in scholarly publishing” and a preprint policy are yet to be added.
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Original Article2023-09-01 General Laboratory Medicine
Status of Pre-analytical Quality Management of Laboratory Tests at Primary Clinics in Korea
Jeonghyun Chang
Ann Lab Med 2023; 43(5): 493-502, Ph.D., Jinsook Lim , Ph.D., Jae-Woo Chung , Ph.D., Yong-Hak Sohn , Ph.D., Min Joong Jang , M.D., and Sollip Kim , Ph.D.Abstract : Background: The quality of laboratory test results is crucial for accurate clinical diagnosis and treatment. Pre-analytical errors account for approximately 60%–70% of all laboratory test errors. Laboratory test results may be largely impacted by pre-analytical phase management. However, primary care clinics currently do not have pre-analytical quality management audit systems. We aimed to understand the current status of pre-analytical quality management in laboratory medicine in Korean primary care clinics. Methods: Questionnaires were designed to focus on essential components of the pre-analytical process of primary care clinics. An online survey platform was used to administer the survey to internal medicine or family medicine physicians in primary care clinics. Results: A total of 141 physicians provided a complete response to the questionnaire. In 65.2% of the clinics, patient information was hand-labeled rather than barcoded on the specimen bottles; 14.2% of clinics displayed only one piece of patient information (name or identification number), and 19.9% of clinics displayed two pieces of information. Centrifuges were not available in 29.1% of the clinics. Institutions carrying out the National Health Screening Program (NHSP) used more barcode system and had more centrifuges than institutions that did not carrying out the NHSP. Conclusions: Pre-analytical quality management is inadequate in many primary clinics. We suggest implementation of a mandatory management system, allowing for a pre-analytical quality management to be carried out in primary care clinics.
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