Celiac Disease (CD) is an immune-mediated enteropathy where serological testing, centered on IgA anti Tissue Transglutaminase 2 (anti-TG2) and IgA anti Endomysium antibodies (anti-EMA), is the diagnostic cornerstone. Anti-TG2 is recognized as the most sensitive marker, while anti-EMA is the most specific. This review examines the performance characteristics, advantages, and limitations of traditional and emerging technologies for CD serology. Traditional platforms include ELISA - a cost-effective, open platform used for quantitative anti-TG2 and anti-DGP detection and IIF for anti-EMA, which, despite being labor-intensive and operator-dependent, maintains high specificity by detecting anti-TG2 in its native conformation. Newer technologies prioritize automation in view of clinical laboratory demands. CLIA and FEIA are fully automated systems that offer enhanced analytical sensitivity and rapid workflow. Meta-analyses confirm that the diagnostic accuracy of IgA anti-TG2 is statistically equivalent across CLIA (Sens. 0.98, Spec. 0.97), FEIA (Sens. 0.97, Spec. 0.99), and ELISA (Sens. 0.96, Spec. 0.97). However, CLIA often requires higher diagnostic thresholds for biopsy-sparing protocols. Emerging solutions include Multiplex Flow Immunoassays (MFI) /Microarrays, which enable simultaneous multi-isotype antibody detection with high concordance to reference assays (PPA 96.0 %, NPA 98.0 % for IgA anti-TG2) while Point-of-Care Tests (POCTs) provide rapid, equipment-free screening for primary care, though they exhibit moderate sensitivity compared to laboratory assays. The overall trend favors automated and multiplexed methods, improving efficiency and supporting biopsy-sparing strategies based on robust quantitative autoantibody profiling.
Accurate estimation of low-density lipoprotein cholesterol (LDL-C) is critical for lipid assessment and cardiovascular risk stratification, yet conventional calculation methods may fail in specific clinical contexts in pediatric population. The Friedewald equation, long considered standard, is unreliable in moderately elevated TG (TG ≥400 mg/dL) and in low total cholesterol (TC) scenarios. Alternative equations, including Martin-Hopkins and Sampson-NIH, have been developed to improve accuracy, but pediatric validation remains limited. We present two pediatric cases highlighting these challenges. Case 1 involved a 5-year-old male with perinatally acquired HIV/AIDS, low TC, and moderately elevated triglyceride (TG) <300 mg/dL. Friedewald-calculated LDL-C was negative, while direct beta-quantification revealed LDL-C of 36 mg/dL and Martin-Hopkins equation underestimated LDL-C by 70%. Case 2 involved a female with type 2 diabetes and high-risk B-cell acute lymphoblastic leukemia, with extreme hypertriglyceridemia >1000 mg/dL and elevated TC. In this case, both Friedewald and Martin-Hopkins calculations failed, whereas Sampson-NIH 2025 provided a calculable LDL-C of 26 mg/dL. These cases demonstrate that TG-to-TC ratios, rather than TG alone, predict calculation failure, and that alternative equations, particularly Sampson-NIH 2025, offer improved reliability. These findings are especially relevant for patients receiving cholesterol-lowering therapies, in whom low LDL-C and elevated TG may lead to significant underestimation of residual atherogenic risk. Further studies using comparative beta-quantification are needed to identify the most accurate LDL-C estimation methods across diverse pediatric populations and low-cholesterol states.
Background:Testosterone is the main circulating androgen in adult males and serves a crucial role in reproductive function, skeletal health, metabolic regulation, and overall physiological stability. In recent decades, concern has emerged regarding possible secular changes in serum testosterone concentrations, independent of aging. However, findings across populations remain inconsistent, and most evidence originates from high-income settings. Objective:This study aimed to evaluate long-term temporal patterns in serum testosterone levels among adult men, with particular emphasis on distributional shifts and population-wide hormonal instability, rather than solely on a mean decline. Methods:A retrospective observational analysis was conducted using anonymized laboratory-based serum testosterone measurements from adult males aged ≥18 years between 2008 and 2025. Only the earliest measurement per individual was included to reduce repeat testing bias. Annual descriptive statistics were calculated, and temporal trends were assessed using linear regression. Age-stratified analysis, percentile drift evaluation, and reference interval shifts were used to explore changes across the testosterone distribution over time. Results:A total of 104,559 testosterone measurements were analysed over 17 years. Linear regression demonstrated a statistically significant but clinically minimal association between calendar year and testosterone concentration (β = +1.97 ng/dL/year, p < 0.001; R2 = 0.002). Substantial overlap in testosterone distribution was observedacross age groups, with notable inter year variability. Percentile drift analyses indicated parallel movement across the distribution, suggesting population-wide hormonal fluctuation rather than a uniform secular decline. Conclusion:Mean testosterone levels did not demonstrate a consistent age-independent decline. Instead, findings support a temporal instability and persistent low exposure subgroups, emphasising the importance of distributional approaches in understanding contemporary hormonal epidemiology.
Background:Point-of-care testing (POCT) glucose systems are widely used in clinical practice due to their rapid turnaround time and operational convenience. However, concerns remain regarding their analytical agreement with laboratory reference methods, particularly in relation to accuracy and potential clinical impact. Methods:This cross-sectional analytical study included 196 adult outpatients at Dr. Soetomo General Academic Hospital, Surabaya, Indonesia. Capillary blood glucose was measured using three POCT devices (StatStrip, Accu-Chek Inform II, and Rightest), while venous plasma glucose was analyzed using a hexokinase-based reference method (Alinity C). Analytical performance was evaluated using correlation analysis, Bland-Altman plots, Passing-Bablok regression, and ISO 15197 accuracy criteria. Results:All POCT devices demonstrated strong correlations with the reference method (r = 0.967-0.982; p < 0.001). StatStrip showed a small negative bias (-2.89 mg/dL; p = 0.003), while Accu-Chek Inform II exhibited a larger deviation (-7.80 mg/dL; p < 0.001). In contrast, Rightest showed no statistically significant bias (-0.14 mg/dL; p = 0.870) and demonstrated the closest agreement with the reference method. Agreement analysis confirmed minimal systematic and proportional bias for Rightest, whereas Accu-Chek Inform II showed wider variability. ISO 15197 evaluation indicated the highest accuracy for Rightest and lower compliance for Accu-Chek Inform II, particularly at glucose levels <200 mg/dL. Conclusion:Although all POCT systems showed strong correlations with the reference method, clinically relevant differences in analytical agreement and accuracy were identified. Rightest demonstrated the best overall performance. These findings highlight the importance of evaluating agreement beyond correlation and support the use of POCT primarily for glucose monitoring rather than definitive diagnosis.
Background:Monoclonal gammopathies are characterised by the presence of a serum or urine monoclonal protein (M-pro-tein), typically detected as a single narrow band on serum protein electrophoresis (SPEP). Rarely, double M-bands may appear, raising the suspicion of biclonal gammopathy. Distinguishing true biclonality from paraprotein polymerization is crucial to prevent diagnostic misclassification and inform appro-priate clinical decisions. Case:We report a case series of four multiple myeloma patients with twin M-bands who presented to AIIMS Patna between March 2023 and March 2024. All four patients exhibited two discrete M-bands on SPEP, initially suggestive of biclonal gammopathy. However, immunofixation electrophoresis confirmed that both bands in each case belonged to the same immunoglobulin isotype and light chain, establishing a monoclonal origin. Treatment of samples with β-mercaptoethanol resulted in the collapse of double bands into a single monoclonal band, confirming paraprotein polymerization. IgA and IgM paraproteins were most frequently implicated in dual-band appearance. Conclusion:The presence of double M-band on serum protein electrophoresis does not necessarily indicate biclonal gammopathy. Depending on SPEP results alone may lead to misclassification, and confirmatory techniques such as IFE and reducing agent studies are essential to establish the correct diagnosis.
