A preliminary report on the feasibility of regression-based alignment of diagnostic thresholds for harmonized use of international classification criteria for antiphospholipid syndrome.

Background: In 2023, international rheumatology societies issued new classification criteria for antiphospholipid syndrome (APS). The criteria require scoring antiphospholipid antibody (aPL) titers as moderate or high using the traditional thresholds of 40U or 80U determined by "standardized" ELISA. With current popularity of non-standardized aPL assays (non-ELISA), we aimed to broaden the application of the criteria by estimating equivalent thresholds for them.

The Utility of a Prediction Model Using Neurological Examination Findings for Diagnosing Degenerative Cervical Myelopathy.

Background: The diagnostic accuracy of neurological examination findings for identifying degenerative cervical myelopathy (DCM) is not apparent, given the paucity of studies with appropriate control groups. In order to address this knowledge gap, we conducted a community cervical spine screening project and examined subjects without DCM or evidence of myelopathy on cervical magnetic resonance imaging (MRI).

Methods: This study included a total of 229 patients diagnosed with DCM, based on MRI evidence of spinal cord compression and improvement after surgery, and 807 controls without DCM (40 to 79 years of age) enrolled in the screening project.

Serial cerebrospinal fluid concentrations of high mobility group box 1 in bacterial meningitis: a retrospective cohort study.

Background: Bacterial meningitis (BM) is a life-threatening central nervous system infection with potential for severe neurological sequelae. High mobility group box 1 (HMGB1) is known as a late inflammatory mediator associated with lethal pathology. This study aims to investigate the serial cerebrospinal fluid (CSF) concentrations of HMGB1 in children with BM and its relationship to neurological prognosis.

Correction: Determination of reference intervals for common chemistry and immunoassay tests for Kenyan adults based on an internationally harmonized protocol and up-to-date statistical methods.

[This corrects the article DOI: 10.1371/journal.pone.

Combination Assay of Methylated with Tumor Markers Shows High Sensitivity for Detection of Early-Stage Hepatocellular Carcinoma.

Introduction: Patients with hepatitis virus-related hepatocellular carcinoma (viral HCC) are decreasing as hepatitis control improves, but those with non-viral-related HCC (non-viral HCC) are increasing in Japan. No established surveillance system exists for patients with non-viral HCC, so they are often diagnosed at an advanced stage. To address this, we performed this study.

Derivation of Russian-specific reference intervals for complete blood count, iron markers and related vitamins.

Objectives: This study aimed to establish reference intervals (RIs) for Russian adults for hematological parameters including related iron markers and vitamins. Sources of variation of reference values (RVs) and needs for secondary exclusion were explored for proper derivations of RIs.

Methods: Following the harmonized protocol of the IFCC Committee on Reference Intervals and Decision Limits (C-RIDL), 506 healthy Russians (age 18-80; 46% male) were recruited.

A Nationwide Nepalese Study to Establish Reference Intervals for Major Biochemical Analytes with Elucidation of Nepalese Features of Reference Values.

Unlabelled: Despite immense importance of reference intervals (RIs) for clinical diagnosis, there have been no reliable RIs available for Nepalese. Hence, this nationwide study was organized to establish RIs for 30 common biochemical parameters. This study was conducted following the harmonized protocol provided by IFCC Committee on Reference Interval and Decision Limits (C-RIDL) with recruitment of 617 apparently healthy volunteers (18 - 65 years) by near-equal gender balance from 5 major cities.

Reappraisal of serum retinol-binding protein as a surrogate marker for retinol and discovery of a novel retinol estimation formula.

Background & Aims: Serum retinol (ROH) is commonly used for population level assessment of vitamin A status. High-performance liquid chromatography (HPLC) is considered most accurate method for measuring ROH. However, with the technical difficulty of using HPLC for routine assays, serum retinol-binding protein (RBP) measured by immunological assays is expected to be a surrogate marker for ROH, with reports of a close correlation between serum RBP and ROH.

Reference intervals for knee functions specific to outpatients with knee osteoarthritis: a cross-sectional study.

Background: Reference values (RVs) for knee function tests have been reported in perioperative patients with knee osteoarthritis (KOA); however, such values for practical use in outpatient setting has yet to be determined. Therefore, we aimed to establish the reference intervals (RIs) for outpatients with mild to moderate KOA.

Methods: This cross-sectional study enrolled 202 outpatients with KOA from 8 Japanese orthopedic clinics and measured knee extensor/flexor muscle strength (MS) and knee extension/flexion range of motion (ROM).

The Utility of a Novel Stacked Microvascular Imaging for Enhanced Detection of Fibrosis in Chronic Liver Diseases.

Objective: Ultrasonographic imaging plays a primary role to detect fibrotic changes in patients with chronic liver disease (CLD). To enhance detectability of fibrosis in its early stage, we developed a novel stacked microvascular imaging (SMVI) that enables continuous visualization of fibrotic changes in intrahepatic vessels.

Methods: SMVI was produced by accumulating 3-5 seconds of high-definition color images in tilted-scan mode.

Establishment of reference interval for hemoglobin A1C and other hemoglobin subfractions for healthy Saudi adults.

Background: The establishment of Reference Intervals (RIs) for Hemoglobin A1C and other hemoglobin subfractions (A1A, A1B, F, LA1C, A0) is of utmost importance in screening, diagnosing, and monitoring diabetes and other hemoglobin abnormalities through the application of high-pressure liquid chromatography (HPLC) technique. Because there are no locally established RIs for these parameters, it is essential to establish RIs specific to the Saudi population to accurately diagnose and monitor diabetic individuals and identify abnormal levels in hemoglobin subfractions.

Methods: As part of the IFCC global multicenter study of laboratory reference values, a cross-sectional study was conducted in Saudi Arabia.

Critical appraisal of two Box-Cox formulae for their utility in determining reference intervals by realistic simulation and extensive real-world data analyses.

Background: The reference interval (RI) is defined as the central 95 % range of reference values (RVs) from healthy individuals. The ideal method for determining RIs is to transform RV distribution into Gaussian and estimate its 95 % range parametrically. One-parameter Box-Cox formula (1pBC) is widely used for correcting skewness (Sk) or kurtosis (Kt) in data distribution.

Establishment of reference intervals for free light chains and immunoglobulins in Saudi population.

Objectives: Testing of serum-free light chains kappa (κ) and lambda (λ), along with ratio (FLCR) is essential for the diagnosis and management of monoclonal gammopathies. Accurate clinical diagnosis depends upon appropriate local population reference intervals (RIs). This study examined the Saudi population for serum-free light chains and other immunoglobulins to establish RIs and to explore variations in the test results by using the International Federation for Clinical Chemistry and Laboratory Medicine's global protocol for harmonized implementation of RI study.

Reference intervals and sources of variation of pressure pain threshold for quantitative sensory testing in a Japanese population.

Quantitative sensory testing (QST) is useful when analysing musculoskeletal pain disorders. A handheld algometer is most commonly used for pressure pain threshold (PPT) tests. However, reference intervals for PPTs are not elucidated.

Establishment of reference intervals for hematological parameters of adult population in the western region of Saudi Arabia.

Background: Most of hematology laboratories in Saudi Arabia utilize the reference intervals (RIs) provided by instrument manufacturers. This study aimed to define RIs of hematological parameters for adult population in the western region of Saudi Arabia and to explore their specific features from an international perspective.

Method: This study was conducted according to the harmonized protocol of IFCC Committee on RIs and Decision Limits.

Determination of diagnostic threshold in harmonization and comparison of clinical utility for five major antiphospholipid antibody assays used in Japan.

Background: Anticardiolipin antibodies (aCL) and anti-β -glycoprotein I antibodies (aβ GPI) are essential in diagnosing antiphospholipid syndrome (APS) according to the international APS guideline. Five commercial assays for aCL and aβ GPI are available in Japan, but their test results are quite discordant. For harmonization of diagnosing APS, upper reference limit (URL) and diagnostic accuracy of each assay were evaluated and compared by testing common sets of specimens across all assays.

Exploring the seasonal and regional features of cat-scratch disease on the basis of anti-Bartonella henselae IgM/IgG positive rates in Japan.

Objectives: This study aimed to explore the seasonal and regional features of cat-scratch disease (CSD) based on 15-years of test results for anti-Bartonella henselae IgG and IgM by immunofluorescence assay (IFA) performed as a laboratory specialized in diagnostic testing of CSD in Japan. A literature search was performed to put our findings in perspective.

Methods: A total of 956 sera from patients suspected of CSD were submitted to our laboratory from nationwide.

Nomogram of age-specific anti-Müllerian hormone levels in healthy Egyptian females.

Background: Anti-Müllerian hormone (AMH) is an important determinant of ovarian reserve in fertility workups in many clinical settings. Thus, we investigated the age dependent decline in AMH specific to the Egyptian population and sought to establish an age dependent reference interval parametrically.

Methods: Serum samples were collected from 841 apparently healthy women.

Comparison of reference intervals derived by direct and indirect methods based on compatible datasets obtained in Turkey.

Background: Indirect derivation of reference intervals (RIs) from the laboratory information system (LIS) has been recently pursued. We aimed at evaluating the accuracy of indirectly predicted RIs compared to the RIs established directly from healthy subjects in the nationwide RI study in Turkey, targeting 25 major chemistry analytes.

Methods: LIS data were retrieved from the laboratory that performed measurements for the direct study.

Determination of reference intervals for knee motor functions specific to patients undergoing knee arthroplasty.

Background: In patients with knee osteoarthritis (KOA) undergoing knee arthroplasty (KA), lower-limb motor function tests are commonly measured during peri-surgical rehabilitation. To clarify their sources of variation and determine reference intervals (RIs), a multicenter study was performed in Japan.

Methods: We enrolled 545 KOA patients (127 men; 418 women; mean age 74.

Factors characterizing gait performance of patients before and soon after knee arthroplasty.

[Purpose] For monitoring patients with knee osteoarthritis undergoing knee arthroplasty, the Timed Up and Go and maximum walking speed tests are commonly used. To provide appropriate peri-surgical rehabilitation, we evaluated the factors associated with postsurgical changes in Timed Up and Go and maximum walking speed results. [Participants and Methods] We enrolled 545 knee osteoarthritis patients undergoing either of the following knee arthroplasties: conventional total knee arthroplasty, minimally invasive total knee arthroplasty, and unicompartmental knee arthroplasty.