Heparin-Calibrated Anti-Factor Xa Assay for the Measurement of Direct Anticoagulants such as Apixaban, Rivaroxaban, and Edoxaban.

Background: The first purpose of this study was to determine whether a measurement of the level of direct oral anticoagulants (DOACs) was possible with heparin-calibrated chromogenic anti-factor Xa activity (AXA). The second purpose of this study was to evaluate whether the antidote treatment decision level (30 or 50 ng/mL of DOAC) can be determined by unfractionated heparin (UHF)/low molecular weight heparin (LMWH)-calibrated AXA.

Methods: AXA was measured by using two reagents and dedicated analyzers (Sysmex CS-5100 analyzer and STA R Max3).

Performance Evaluation of Two Kinds of Rapid Antigen Test Kits for Detection of COVID-19 Infection.

Background: The diagnostic standard for COVID-19 infection is real-time reverse transcription-polymerase chain reaction (rRT-PCR) of nasopharyngeal swab and oropharyngeal swab specimens. Rapid antigen tests are cheaper and easier to use than the rRT-PCR method. Although the COVID-19 pandemic is settling down, seasonal epi¬demic is expected.

Distinguishing nontuberculous mycobacterial lung disease and Mycobacterium tuberculosis lung disease on X-ray images using deep transfer learning.

Background: Nontuberculous mycobacterial lung disease (NTM-LD) and Mycobacterium tuberculosis lung disease (MTB-LD) have similar clinical characteristics. Therefore, NTM-LD is sometimes incorrectly diagnosed with MTB-LD and treated incorrectly. To solve these difficulties, we aimed to distinguish the two diseases in chest X-ray images using deep learning technology, which has been used in various fields recently.

Quality improvement of outpatient clinical chemistry tests through a novel middleware-laboratory information system solution.

Objectives: Rapid and accurate laboratory tests are essential to support clinical decision-making. Despite the various efforts to control quality in the laboratory, our outpatient chemistry turnaround time (TAT) has deteriorated since 2018. Moreover, these difficulties have accelerated further due to the COVID-19 pandemic.

Comparison of ACCEL ELISA COVID-19 with Elecsys Anti-SARS-CoV-2 for Screening of COVID-19.

Objective: Although real-time reverse transcription-PCR (RT-PCR) is the gold standard for diagnosing coronavirus disease 2019 (COVID-19), simpler and faster antibody detection tests can be complementary for diagnosis of COVID-19. To manage the COVID-19 pandemic, the need for serologic testing has increased. In this report, the newly developed antibody detection assays ACCEL ELISA COVID-19 (ACCEL) and Elecsys anti-SARS-CoV-2 (Elecsys) were evaluated.

Development of machine learning model for diagnostic disease prediction based on laboratory tests.

The use of deep learning and machine learning (ML) in medical science is increasing, particularly in the visual, audio, and language data fields. We aimed to build a new optimized ensemble model by blending a DNN (deep neural network) model with two ML models for disease prediction using laboratory test results. 86 attributes (laboratory tests) were selected from datasets based on value counts, clinical importance-related features, and missing values.

Comparison of the ASTA MicroIDSys and VITEK MS matrix-assisted laser desorption/ionization time-of-flight mass spectrometry systems for identification of clinical bacteria and yeasts.

The ASTA MicroIDSys system (ASTA, Suwon, Korea) is a newly developed Matrix-assisted laser desorption/ionization time-of-flight mass spectrometry (MALDI-TOF MS) system for identification of microorganisms. We compared the performance of the ASTA MicroIDSys system with that of the VITEK MS system (bioMérieux, Marcy l'Etoile, France) for identifying clinical microorganisms. A total 2055 isolates including 1910 bacteria and 145 yeasts were tested.

Stromal cell-derived factor-1 as a serologic biomarker for the diagnosis of colon ischemia with chronic cardiovascular disease.

Colon ischemia (CI) is the most common ischemic disorder of the gastrointestinal tract. Although some markers of CI, such as procalcitonin and alkaline phosphatase, have been reported, few specific serum markers have been identified. We investigated whether serum stromal cell-derived factor-1 (SDF-1) is a specific marker of CI and clarified the relationship between serum SDF-1 level and CI according to a history of combined chronic cardiovascular disease (CVD).

Development of Statistical Software for the Korean Laboratory Accreditation Program Using R Language: LaboStats.

Background: In Korea, the Korean Laboratory Accreditation Program (KLAP) has set minimum standards for verification of clinical test performance. This verification process is time-consuming and labor-intensive when performed manually. We developed a free, statistical software program for KLAP, using the R language (R Foundation for Statistical Computing, Vienna, Austria).

Evaluation of AdvanSure AlloScreen Max Panel With 92 Different Allergens for Detecting Allergen-Specific IgE.

Objectives: The objective of this study was to examine the performance of AdvanSure AlloScreen Max with 92 different allergens compared to Polycheck Allergy and ImmunoCAP. The relationship of serum IgE concentration with the number and the highest class/level of positive allergen-specific IgEs was also examined.

Methods: A total of 406 serum samples were included in this study.

Comparison between creatine kinase MB, heart-type fatty acid-binding protein, and cardiac troponin T for detecting myocardial ischemic injury after cardiac surgery.

Background: Heart-type fatty acid-binding protein (H-FABP) is a cytoplasmic protein and is released form necrotic cardiac myocytes, as well as ischemic cardiac myocytes. In this study, we compared creatine kinase MB (CK-MB), H-FABP, and cardiac troponin T (cTnT) after coronary artery bypass grafting (CABG), heart valve surgery, or septal defect surgery to evaluate the difference in detecting myocardial injury between three markers.

Methods: A total of 69 patients (CABG, 32; valve surgery, 27; and septal defect surgery, 10) were prospectively enrolled.

Comparison of Four Automated Carcinoembryonic Antigen Immunoassays: ADVIA Centaur XP, ARCHITECT I2000sr, Elecsys E170, and Unicel Dxi800.

Background: Carcinoembryonic antigen (CEA) is one of the tumor markers available for evaluating disease progression status after initial therapy and monitoring subsequent treatment modalities in colorectal, gastrointestinal, lung, and breast carcinoma. We evaluated the correlations and differences between widely used, automated CEA immunoassays at four different medical laboratories.

Methods: In total, 393 serum samples with CEA ranging from 3.

Pentraxin 3 and lipid profile status in pregnancy.

Hyperlipidaemia and hypercholesterolaemia are risk factors of atherosclerosis and cardiovascular disease. The reference range of lipids during pregnancy has not yet been clearly set. This study sought to measure lipid parameters and pentraxin (PTX) 3 levels in low-risk pregnant women.

Evaluation of the Performance of Two Point-of-Care Analyzers for Total Cholesterol, Triglyceride, and High-Density Lipoprotein Cholesterol Analysis.

Background: In this study, we evaluated the analytic performance of two POCT devices and compared the results with a central laboratory method.

Methods: A total of 100 patients were enrolled in this study. LipidPro (Infopia, USA) and LandMark (Infopia, Korea), were used for measuring total cholesterol (TC), triglyceride (TG), and high density lipoprotein cholesterol (HDL-C).

Usefulness of biological variation in the establishment of delta check limits.

Background: Biological variation is used in the calculation of reference change values (RCVs) for a delta check. In this study, we examined the correlation between intra-individual biological coefficients of variation (CV) and delta check limits according to population distribution.

Methods: A total of 1,533,359 paired test results of nine routine chemistry tests were used to make the population distributions of delta percent changes.

Direct Identification of Urinary Tract Pathogens From Urine Samples Using the Vitek MS System Based on Matrix-Assisted Laser Desorption Ionization-Time of Flight Mass Spectrometry.

Background: We evaluated the coincidence rate between Vitek MS system (bioMérieux, France) and Vitek 2 in identifying uropathogens directly from urine specimens.

Methods: Urine specimens submitted to our microbiology laboratory between July and September 2013 for Gram staining and bacterial culture were analyzed. Bacterial identification was performed by using the conventional method.

Polymorphisms of the heart-type fatty acid-binding protein as a prognostic factor in patients with atherosclerosis.

The amount of heart-type fatty acid-binding protein (FABP3) in cardiomyocytes may affect the prognosis of patients with coronary atherosclerosis. In this study, we examined whether single nucleotide polymorphisms (SNPs) of the FABP3 gene were prognostic factors in patients with coronary atherosclerosis. We enrolled 100 patients with myocardial infarction and coronary atherosclerosis and 100 healthy individuals to assess the genotypes of four SNPs of the FABP3 gene (RS2271072, RS16834408, RS2279885, and RS10914367).

Evaluation of enzymatic BM Test HbA1c on the JCA-BM6010/C and comparison with Bio-Rad Variant II Turbo, Tosoh HLC 723 G8, and AutoLab immunoturbidimetry assay.

Background: A novel enzymatic HbA1c assay was introduced for use in an automated chemistry analyzer. With this unique method, HbA1c and plasma glucose can be measured from the same EDTA tube. We evaluated the analytical performance of this enzymatic HbA1c assay in a JCA-BM6010/C analyzer and compared the HbA1c values with the results from other widely used methodological instruments.

C3435T polymorphism of MDR1 gene with warfarin resistance.

Background: Some patients show warfarin resistance needing more than 70 mg of warfarin per week. In this study, we examined if C3435T polymorphism of MDR1 gene could be a factor of warfarin resistance.

Methods: We examined 196 blood specimens from the patients who took warfarin more than 42 mg/week for at least 1 year.

Adjuvant laboratory marker of Kawasaki disease; NT-pro-BNP or hs-CRP?

Background: The diagnosis of Kawasaki disease (KD) is based on clinical data and non-pathognomonic symptoms. As no specific diagnostic test for KD exists, BNP or NT-pro-BNP might be of importance in identifying KD. We compared serum hs-CRP and NT-pro-BNP level in the acute phase of 59 KD patients and evaluated the diagnostic performance of these laboratory markers in KD to estimate the cut-off level for differentiating KD from other febrile illnesses as age-matched controls.

[Usefulness of total IgE in predicting positive allergen specific IgE Tests in Korean subjects].

Background: Total IgE levels in allergic patients tend to be higher than those in healthy individuals. We evaluated the usefulness of total IgE levels in predicting positive results of allergen specific IgEs in multiple allergen simultaneous tests.

Methods: A total of 133 patients with allergic symptoms were evaluated.