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.
Diabetic retinopathy (DR) is a leading cause of preventable visual loss in type 2 diabetes mellitus (T2DM), yet current screening largely detects disease after microvascular damage has occurred. This review synthesizes emerging evidence that three measurable biomarkers - fibroblast growth factor-21 (FGF21), growth differentiation factor-15 (GDF15), and microalbuminuria -capture complementary dimensions of early DR pathobiology. FGF21 reflects hepatometabolic stress and adaptive signaling via the β-Klotho-FGFR1 axis; GDF15 mirrors mitochondrial/integratedstress-response activation with systemic effects through the glial cell-derived neurotrophic factor family receptor-α-like (GFRAL) REarranged during Transfection (RET); and microalbuminuria indicates systemic endothelial dysfunction and increased microvascular permeability. We narratively integrate cross-sectional, cohort, and meta-analytic studies in human T2DM populations (excluding type 1 diabetes and animal experiments) and map these signals onto a unified metabolic-renal-retinal framework. Across studies, higher circulating FGF21 and GDF15 associate with DR presence and severity, while microalbuminuria correlates with DR grade and predicts progression independent of glycemic control. We propose a tri-biomarker model in which chronic lipotoxicity and oxidative stress elevate FGF21/GDF15, drive endothelial injury detectable as microalbuminuria, and together forecast early retinal microangiopathy. Translational implications include risk stratification before funduscopic changes, therapy monitoring for metabolic/mitochondrial targets, and development of multimarker algorithms alongside OCTA imaging. To our knowledge, this is the first review to integrate FGF21, GDF15, and microalbuminuria as a coherent predictive axis for early DR in T2DM, highlighting priorities for longitudinal validation and population-specific cut-offs.
Background:Systemic sclerosis (SSc) is a rare autoimmune disease marked by immune dysregulation, vascular injury, and fibrosis. Antinuclear antibodies (ANA) are pivotal for diagnosis and prognosis, yet Indian data remain scarce. This study assessed ANA patterns and autoantibody profiles in SSc and their clinical relevance. Methods:A cross-sectional study was conducted in the Department of Dermatology, AIIMS Patna, from September 2022 to September 2023. Eighty-five patients fulfilling ACR/EULAR criteria for SSc were enrolled. Clinical features were documented using a structured proforma, and patients were classified into diffuse cutaneous (dcSSc) and limited cutaneous (lcSSc) subsets. ANA screening was performed by indirect immunofluorescence (IIF) on HEp2 cells, followed by autoantibody profiling with line immunoassay (LIA). Statistical analyses were performed using JAMOVI v2.3.28, with p<0.05 considered significant. Results:Of 85 patients, 70 (82.4%) were female (ratio of 5:1), with a mean age of 34.7 ± 10.7 years. dcSSc accounted for 55.3%. Common manifestations included arthralgia (69.4%), respiratory symptoms (68.2%), and interstitial lung disease (ILD) (64.1%). Homogeneous ANA was the predominant IIF pattern (41.2%), followed by centromere (10.6%) and speckled (8.2%). LIA revealed anti-Scl70 as the most frequent autoantibody (58.3%), significantly associated with ILD and Raynaud's phenomenon. Anti-U1 snRNP and anti-PMScl antibodies correlated with musculoskeletal involvement. Conclusion:SSc in this cohort showed female predominance with frequent arthralgia and respiratory symptoms. Anti-Scl-70 antibodies were most common, strongly linked to diffuse disease and ILD. ANA profiling provides disease characterization in Indian SSc.
Background:Laboratory medicine is fundamental to evidence-based healthcare, providing critical data on human properties for diagnosing and managing diseases. The increasing complexity and size of laboratory data necessitate robust information technology (IT) systems for efficient management. Purpose:This manuscript elucidates the roles and infrastructure requirements of laboratory IT systems by stating the purposes of laboratory medicine and examining the challenges and prerequisites associated with their achievement. Methods:We explore the primary purpose of laboratory medicine in supporting clinical decisions and the opportunities for secondary data use. The challenges of data heterogeneity, insufficient and lack of metadata, and the need for standardized terminologies are addressed. We further emphasize the prerequisites including international collaboration and education. Results:Technological advancements have enabled automation in laboratories, reducing errors, improving quality, and increasing efficiency and capacity for 24/7 sample processing. IT systems facilitate rapid results, enhance resource allocation, and manage the entire testing process from ordering to result interpretation. The establishment of two coherent and comprehensive laboratory information models - one for communication in the laboratory and another for communication between diverse health care providers - is proposed as essential for accurate data exchange and maximizing data utility. Conclusion:Achieving successful exchange of laboratory results and optimal use of laboratory data hinge on international collaboration, shared resource commitment, and an approach to standardised terminologies and data structures. This work lays the foundation for ongoing efforts to develop international laboratory information models, critical for advancing patient care and leveraging the full potential of laboratory medicine.
Introduction:Diabetes has become a prominent worldwide public health issue, with its prevalence notably higher in lower middle-income countries. Pakistan ranks third globally in terms of number of individuals diagnosed with Type 2 Diabetes Mellitus and have highest prevalence of diabetes throughout the world. The objective of current study was to assess the frequency of diabetes in relation to demographics utilizing laboratory data of individuals residing in Pakistan. Methods:Biochemical data of HbA1c, fasting and random plasma glucose, and oral glucose tolerance test were retrieved from Laboratory Information System analyzed in Pathology and Laboratory Medicine department from Jan 2016 to Dec 2022. Specimens were received from Aga Khan University laboratories' network, which is spread over the country. For interpretation of biochemical tests' values American Diabetes Association (ADA) criteria was applied. Results:After removal of duplicates and missing data, the final sample included 4,260,171 unique individuals. Diabetes was present in 35.9% of the overall population, with the highest incidence (55.6%) recorded in males aged 35 to 59 years. Diabetes was significantly associated with advancing age and gender (p<0.001). Individuals who had the fasting blood glucose ≥ 126 mg/dl were (n=372,050), HbA1c exceeding 6.5% were (n=762,940) the random blood glucose ≥ 200 mg/dl were (n=128,820), OGTT level ≥ 200 mg/dl were (n=487) and diabetes confirmed with more than one diagnostic test were (n=505,609). Conclusion:The study, based on dataset of around 4.2 million individuals, revealed an overall diabetes frequency of 35.9%, with highest prevalence in middle-aged group (55.6%), and significant associations with both advancing age and gender.
Background:Polycystic ovary syndrome (PCOS) represents one of the most prevalent endocrine disorders affecting women of reproductive age, with significant implications for metabolic, reproductive, and psychological health. Early and accurate diagnosis remains challenging due to heterogeneous clinical presentations and the complexity of diagnostic criteria. Objective:This study aimed to develop and compare multiple machine learning algorithms for predicting PCOS diagnosis, evaluating their performance across various metrics to identify the most effective computational approach for clinical decision support. Methods:A comprehensive dataset containing clinical, biochemical, and anthropometric parameters from patients was analyzed using twelve different machine learning algorithms. The dataset underwent rigorous preprocessing including missing value imputation, feature engineering, and categorical encoding. Models evaluated included Logistic Regression, Support Vector Machine, K-Nearest Neighbors, Naive Bayes, Decision Tree, Random Forest, Gradient Boosting, XGBoost, AdaBoost, Neural Network, LightGBM, and HistGradientBoosting. Performance was assessed using accuracy, F1-score, sensitivity, specificity, and ROC-AUC scores. Results:Gradient Boosting, XGBoost, and HistGradientBoosting demonstrated superior performance with accuracy of 92.66%, while ensemble methods generally outperformed single classifiers. Gradient Boosting achieved the highest F1-score of 87.87% and ROC-AUC of 95.39%. Random Forest exhibited exceptional specificity at 98.63%, while Naive Bayes showed the highest sensitivity of 94.44%. Traditional machine learning approaches like SVM and Neural Networks showed comparatively limited performance in this context. Conclusion:Machine learning algorithms, particularly gradient boosting methods, demonstrate substantial potential for accurate PCOS prediction and can serve as valuable tools for clinical decision support, potentially enabling earlier intervention and improved patient outcomes.
Introduction:Porphyrias are rare inherited disorders of heme synthesis caused by reduced activity of one of the eight enzymes in the pathway. When early precursors accumulate, acute hepatic porphyrias occur, which present as severe neurovisceral attacks. When later, light-sensitive porphyrins accumulate, they cause cutaneous forms with chronic photosensitivity, blistering and skin fragility. Although these patterns are usually distinct, acute, and cutaneous features may appear together. This may reflect two separate genetic defects, but more often occurs when oxidative stress, such as from iron overload, chronic infection, or drugs, secondarily inhibits the fifth enzyme, uroporphyrinogen decarboxylase. This creates a mixed porphyrin pattern in which the usual distinctions between acute and cutaneous porphyrias are blurred, making diagnosis challenging. Case Presentation:A 22-year-old woman living with human immunodeficiency virus (HIV) infection presented with recurrent abdominal pain during the luteal phase of menstruation, autonomic instability, and limb weakness that improved following heme arginate therapy. Urine porphobilinogen was markedly elevated, and hydroxymethylbilane synthase (HMBS) gene sequencing confirmed acute intermittent porphyria (AIP). However, her porphyrin studies also demonstrated pronounced urinary uroporphyrin elevation together with faecal isocoproporphyrins, a pattern characteristic of porphyria cutanea tarda (PCT). Discussion:The findings are consistent with AIP complicated by secondary hepatic inhibition of uroporphyrinogen decarboxylase. In this patient, secondary uroporphyrinogen decarboxylase (UROD) inhibition was likely driven by persistent HIV viraemia, antiretroviral-associated hepatic oxidative stress, and chronic inflammatory activation which are well-recognised risk factors for acquired PCT-like biochemical patterns. Conclusion:This case demonstrates how co-morbidities can modify classical porphyria biochemical patterns and reinforces the need for integrated urine, plasma, and faecal interpretation, especially when biochemical profiles appear mixed. Clinically, patients living with HIV who have porphyria may benefit from closer monitoring for factors that increase liver stress, especially ongoing viraemia, hepatotoxic or porphyrinogenic drugs, alcohol use and iron overload. When virological control is poor, the risk of secondary UROD inhibition and mixed biochemical findings may increase. Regular review of HIV virological control, liver function, medication safety and porphyrin profiles may therefore help prevent recurrent attacks and reduce diagnostic confusion.
Homocysteine is an intermediate product of the biosynthesis of methionine and cysteine and a sulfhydryl-containing amino acid. The study aims to assess the difference between the estimated levels of homocysteine by different automated systems on Biorad External Quality Assurance Services samples and the imprecision of examination of homocysteine levels below the limit of detection in External Quality Assurance Services samples by proficiency testing providers. This study involves the analysis of Biorad External Quality Assurance Services sample reports of two cycles (cycles 10 and 11) for homocysteine level evaluation performance. Our study demonstrates the wide difference in the bias percentage of homocysteine levels when bias was calculated with the peer mean and the method mean. There was a substantial increase in bias percentage for the Siemens Advia Centaur XP machine for samples with levels of homocysteine below the limit of detection. Our study also demonstrated that Siemens Advia and Siemens Atellica were evidently underestimating homocysteine levels when compared with other platforms. The use of Standard Reference Material for traceability of calibrators will ensure the standardization of assays between different manufacturers. The variation observed in the External Quality Assurance Services results of homocysteine highlights the impending requirement of standardization of assays using Standard Reference Materials.
Background:The primary treatment for tuberculosis, which includes isoniazid, rifampicin, pyrazinamide, and ethambutol, is vital for managing the disease but often leads to drug-induced liver injury (DILI), especially in older adults. It is important to accurately identify and manage hepatotoxicity caused by this treatment to safely continue therapy. Objective:This report discusses a case of liver injury induced by first-line anti-tubercular drugs in an elderly patient, emphasiz-ing the importance of de-challenge, alternative non-hepatotoxic treatments, and a carefully monitored stepwise rechallenge. Methods:An 84-year-old woman with pulmonary tuberculosis and hypertension (treated with amlodipine) experienced abnormal liver function tests after starting first-line anti-tubercular therapy. A thorough clinical evaluation, laboratory tests, causality assessment, de-challenge, alternative treatment, and stepwise rechallenge were conducted with close biochemical monitoring. Results:Initial tests showed significant hyperbilirubinemia (total bilirubin 5.2 mg/dL), elevated aspartate aminotransferase (AST 176-247 U/L), slightly increased Alanine Aminotransferase (ALT 40-55 U/L), and an R-ratio of about 2.6, indicating a predominantly cholestatic pattern with mixed features of liver injury. After discontinuing the hepatotoxic treatment and starting alternative medications (Moxifloxacin, Streptomycin, and Ethambutol), liver function tests improved significantly within 3-5 days. Once liver parameters normalized, Rifampicin was gradually reintroduced, and liver function tests remained stable four days after rechallenge, with no return of hepatotoxicity. Conclusion:This case illustrates that early detection of liver injury from anti-tubercular therapy, prompt de-challenge, use of alternative non-hepatotoxic drugs, and a carefully monitored stepwise rechallenge can enable the safe continuation of tuberculosis treatment in elderly patients. Close biochemical monitoring, along with consideration of therapeutic drug monitoring, may further improve patient safety.
Background:Bisalbuminemia is a rare abnormality characterized by detection of two distinct albumin bands or double peaks through serum protein agarose gel electrophoresis or capillary electrophoresis, suggesting the coexistence of normal and modified albumin in the same patient. However, it is challenging to visualize the double bands due to the limited resolution of agarose gel electrophoresis. Besides, capillary electrophoresis cannot directly visualize serum proteins. Methods:Serum samples were obtained from the Hematology Hospital of the Chinese Academy of Medical Sciences and analyzed using agarose gel electrophoresis and capillary electrophoresis. Agarose gel electrophoresis and capillary electrophoresis were performed using a SPIFE4000 electrophoresis apparatus from Helena or Capillarys3 Tera system. Results:Three samples of bisalbumin were detected in the albumin region in patients diagnosed with multiple myeloma via agarose gel electrophoresis and capillary electrophoresis techniques. Conclusions:These findings suggest that capillary electrophoresis technology combined with traditional agarose gel electrophoresis methods can significantly improve the detection rate of bisalbuminemia. Serum dilution or depolymerization may be utilized to enhance detection when bisalbumin bands are not readily identifiable in agarose gel electrophoresis, thereby ensuring the accuracy of bisalbuminemia diagnosis.
Background:Chemical pathology is a fast-growing field, with an even greater demand for pathologists in Pakistan. This study aims to evaluate the current landscape of FCPS-certified chemical pathologists in Pakistan, evaluating their training experiences and current leadership roles in their field. Methods:This was a nationwide cross-sectional survey conducted of FCPS-trained chemical pathologists. The study was conducted via an online questionnaire (Google Forms) containing questions regarding the demographics, training experiences and current roles. Results:A total of 82 respondents were included in the study and most of them were females (68%, n=56). Over half of the respondents were aged 31-40 years (51%). Most participants were from Punjab (57%) and were employed full-time (79%), primarily in government (38%) or private (43%) sectors. The majority worked in urban areas (89%), and the type of work setting varied significantly by gender (p = 0.034). 63% practised solely in chemical pathology, while 70% reported that their work involved other pathology disciplines as well. Research involvement was high overall (85%), with all male participants engaged in research compared to 79% of female participants (p = 0.011). The majority of the participants rated their training experience positively as either excellent (30%) or very good (29%). Conclusion:FCPS-certified chemical pathologists are overall satisfied with their training experiences. This study highlights the need for structured mentorship and institutional support to strengthen the future chemical pathology workforce.
Background:Internal Quality control (IQC) is essential as it ensures analytical accuracy. However, IQC may have certain limitations, for example, it may miss intermittent or matrix-related errors. Patient-Based Real-Time Quality Control (PBRTQC) can overcome this limitation by continuously monitoring the patient data and also aids in early detection of shifts. Hence, integration of PBRTQC with IQC enhances the error detection and the cost efficiency in clinical laboratories. Aim:To study the effect of integrating Patient-Based Real-time Quality Control with Conventional Quality Control for improved detection of errors, cost benefit and risk-based cost benefits. Methods:Four parameters, creatinine, urea, Aspartate Transaminase (AST), and Thyroid Stimulating Hormone (TSH), were selected based on low sigma value and high monthly sample load. Historical patient data was collected from the laboratory information system. Data was divided into training and validation sets. Truncation limits were calculated using the interquartile range method. Simple Moving Average (SMA) was calculated for various block sizes. Control limits were set using the maximum/minimum of the moving average or percentiles. A bias simulation study was performed by introducing bias from -50% to +50% to plot bias detection curves and determine the optimum block size and ANPed. Optimized PBRTQC parameters were validated. The optimized algorithm was applied to daily patient data and integrated with IQC. Moving average alarm rate and percentage increase in error detection were calculated. Potential cost-benefit and risk-based benefits were determined. Results:optimum block size and (ANPed) at TEa was 50 for creatinine (161), 25 for urea (207), 50 for AST (22), and 25 for TSH (68). The MA alarm percentage remained below 1% for all analytes. Integration improved error detection by 28.57% for creatinine, 25% for urea, and 20% for TSH. Net cost benefit demonstrated total savings of 426.92 through QC reductions (264.56) and avoided reanalysis costs (162.36). Conclusion:PBRTQC integration with IQC significantly improves error detection for low sigma performance assays, is cost-effective and provides a strong risk-based cost-benefit advantage.
Introduction:Approximately 70% of clinical decisions depend on laboratory test results, underscoring the critical importance of examination accuracy. Among the phases of the total testing process, the pre-examination phase accounts for the highest proportion of errors; therefore, interventions aimed at reducing these errors can significantly enhance overall laboratory quality. This study aims to evaluate the effectiveness of risk assessment and corrective strategies through the implementation of the Failure Reporting, Analysis, and Corrective Action System (FRACAS) by comparing Risk Priority Number (RPN) scores before and after implementing corrective strategies. Methodology:This retrospective observational quality-improvement study obtained approval from the institutional ethics committee. It analyzed two years of data from a clinical biochemistry laboratory. A total of 573 samples were rejected in a NABL-accredited, ISO 15189-compliant tertiary-care hospital in South India. Each nonconformance (NC) was categorized, and its frequency, percentage distribution, and RPN were calculated for both study periods. The effectiveness of risk assessment and corrective strategies was evaluated by comparing pre- and post-corrective RPN values and percentage reductions in NCs. Results:Data from 573 rejected samples (216 pre-corrective in 2021; 357 post-correctives in 2022) were analysed. Mean RPN decreased from 18.0 ± 16.1 to 10.9 ± 15.3 (mean difference 6.0, 95% CI 2.0-24.0, p = 0.041); paired Bayesian t-test showed BF10 = 1.15, evidence for effectiveness. Four NCs were eliminated; however, three new NCs emerged post-STAT lab launch. Conclusion:FRACAS-guided interventions reduce pre-examination NCs and lower RPNs for high-risk processes, supporting their use for pre-examination quality improvement.
This study aimed to assess the laboratory professional perceptions on how the College of American Pathologists (CAP) Laboratory Accreditation Program (LAP) is associated with the laboratory processes and patient safety across multiple countries in the Middle East and South Asia. The objective was to determine how CAP LAP influences laboratory quality and safety culture, and participants reported that error-related events appeared to decrease following the CAP LAP. A quantitative, cross-sectional design was used, employing a structured electronic questionnaire distributed to CAP-accredited laboratories in Saudi Arabia, other Gulf countries, Egypt, and Pakistan. A total of 300 valid responses were analyzed using descriptive statistics and marginal homogeneity testing to compare the respondents' perceived condition pre- and post-accreditation performance in areas such as staff competency, quality management, turnaround time, and safety practices. Respondents assessed conditions before and after accreditation in pre-analytical, analytical, and post-analytical areas, including quality management systems, staff competence, turnaround time, equipment upkeep, communication, and safety culture. We examined paired ordinal responses using marginal homogeneity tests. The CAP LAP was therefore viewed as highly valuable for improving both laboratory performance and patient safety. This study provides empirical evidence from multi-country CAP LAP accredited laboratories, filling a regional gap in accreditation research. It demonstrates that the CAP LAP functions as a strong governance mechanism enhancing quality and safety within diverse healthcare systems. It is advisable to conduct future longitudinal and comparative studies among CAP, ISO 15189:2022, and national accreditation systems to evaluate the durability of enhancements and their impact on laboratory personnel behavior. These results indicate that laboratory professionals view CAP LAP as linked to significant enhancements in laboratory operations and safety protocols. However, the results are based on people's own reports of their perceptions and don't show cause-and-effect relationships or measure objective safety outcomes. Future research incorporating objective performance metrics and longitudinal methodologies is essential to assess the causal influence of accreditation on patientsafety.
Background:ISO 15189:2022 requires accredited medical laboratories to establish advisory and interpretative services to support appropriate test selection, result interpretation, and effective utilization of laboratory examinations.Direct-to-consumer and patient-initiated laboratory testing is reshaping traditional healthcare communication. Patients increasingly seek direct consultation with laboratory physicians for test selection and result interpretation. This study describes the drivers, patterns and perceived value of such interactions in routine laboratory practice. Methods:A prospective observational study was conducted over 12 months at a high-volume ISO 15189:2022 accredited referral laboratory. All unsolicited, patient-initiated advisory consultations with laboratory physicians were systematically documented using a structured logbook. Consultations were categorized by type (pre-examination advice, post-examination interpretation, clarification of abnormal findings, and resolution of inter-laboratory discrepancies). All abnormal or discordant results discussed during consultation had undergone analytical verification in accordance with internal quality control and validation procedures. Patient satisfaction was assessed using a 5-point Likert scale. Descriptive statistics were applied. Results:A total of 1,800 advisory consultations were recorded during the study period. The most common categories were postexamination interpretative consultation (35.6%) and clarification of abnormal results (28.3%), followed by pre-examination advice (20.0%) and resolution of inter-laboratory discrepancies (12.2%). Frequently discussed analytes included glucose profiles, lipid parameters, infectious disease serology, and screening tests. Satisfaction data were available for 1,625 consultations, with a mean score of 4.5 ± 0.6; 90% of respondents rated the consultation as satisfactory or very satisfactory. Conclusions:These findings highlight the growing demand for professional laboratory interpretation in patient-initiated testing environments and support the inclusion of advisory consultations as a measurable quality indicator within laboratory management systems.
Many cases of encephalitis are caused by an autoimmune response, and some are associated with underlying malignancies. Here we present the case of a 17-year-old female patient who was admitted to the pediatric ward with acute gastroenteritis, seizures, and behavioral changes. A brain computed tomography (CT) scan ruled out acute infarction, haemorrhage, mass lesions, and other intracranial injuries, while the initial EEG showed no epileptic discharges. In the absence of a definitive diagnosis, midazolam was administered to treat tonic-clonic seizures, while ceftriaxone and acyclovir were started for suspected infection. However, her condition deteriorated further and she was transferred to the ICU, where she was intubated. A Cell-Based Assay (CBA) revealed the presence of anti-NMDAR antibodies and a contrast-enhanced brain MRI showed leptomeningeal enhancement without limbic involvement. She was subsequently treated with intravenous immunoglobulins and high-dose corticosteroids. A subsequent transabdominal ultrasound scan revealed an oval, fluid-filled ovarian cyst. Based on these findings, her right ovary was removed, resulting in a gradual improvement in her condition. This case highlights that paraneoplastic autoimmune encephalitis may be misclassified due to persistent psychiatric symptoms with negative EEG and CSF findings. When clinical suspicion remains high despite negative initial instrumental and laboratory findings, it is essential to repeat these investigations. In such cases, neuroantibody testing may play a crucial role in establishing the diagnosis.
Background:Delta check is a quality control tool in clinical laboratory that compares a patient's current test results with previous ones. It is often considered to be a useful tool to identify pre-analytical errors. Delta check procedures vary across labs. A survey was conducted to determine national delta check practices. Method:An online survey was sent to pathologists. Data was analyzed by Microsoft excel and figures were generated via R statistical software. Results:The survey was sent out to 84 participants. There were 30 (35.7%) final responses, after exclusion of duplicates and incomplete entries. Respondents varied in their designations from Professor 2(6.7%) to Assistant Professor 10(33.3%). Most respondents 25 (83.3%) were Fellows of College of Physicians and Surgeons, while there were 3(10%) PhDs. Work experience varied from less than 3 years, 5(16.7%) to more than 10 years, 17(56.7%). 25 labs surveyed were from tertiary care hospitals. Most laboratories were in Sindh Province, 13 (43.3%). Delta check procedures were used by 19(63.3%) labs, of which 6(31.6%) used automated checks, 12(63.2%) had defined delta limits for different tests, 15(78.9%) had defined time limits to check delta results, 17(89.5%) had a checklist for its investigation and 10(52.6%) had a Laboratory Information System or middleware to block failed delta results. Most of the respondents considered the smallest available option as the ideal delta difference value for blocking results. Conclusion:Delta check procedures vary among surveyed labs and efforts are required for the formulation of national guidelines to synchronise and standardize delta check practices.
