LabMed

Background: Timely identification of sepsis in critically ill patients remains challenging. Commonly used biomarkers, including C-reactive protein (CRP) and procalcitonin (PCT), show suboptimal diagnostic performance. Pancreatic stone protein (PSP) has recently been proposed as an early indicator of infection and sepsis. Methods: We performed a retrospective observational study involving 90 adult ICU patients, including septic and non-septic patients selected during the study period. Sepsis was defined according to Sepsis-3 criteria. Diagnostic accuracy was evaluated using receiver operating characteristic curves, and sensitivity, specificity, and predictive values were calculated. The association between PSP levels and in-hospital mortality was examined using multivariable logistic regression analysis. Results: Of the 90 patients included, 45 (50%) were diagnosed with sepsis. PSP levels were significantly higher in septic patients compared to non-septic patients (210 (175–265) vs. 105 (80–135) ng/mL; p < 0.001). PSP demonstrated the best diagnostic performance among the evaluated biomarkers (AUC 0.88, 95% CI 0.81–0.94), compared with PCT (0.82) and CRP (0.74). At a threshold of 150 ng/mL, PSP showed a sensitivity of 84% and a specificity of 80%. Higher PSP values were independently associated with increased in-hospital mortality and longer ICU stay. Conclusions: PSP appears to be a useful biomarker for early identification of sepsis in critically ill non-surgical patients, with better diagnostic performance than CRP and PCT. Its incorporation into clinical assessment may support earlier recognition and improved risk stratification. Further multicenter studies are needed to confirm these findings and to better define its role in clinical decision-making. Full article

Sample adequacy control (SAC) is a validated specimen-specific marker or metric, threshold, and reporting rule used to decide whether a negative molecular result is supported by the submitted specimen. SAC is not simply a cell-count or biomass check. Depending on specimen type and target, an unsupported negative result may reflect insufficient or nonrepresentative material, adequacy-marker degradation, inefficient transfer or extraction, matrix-associated inhibition, or mismatch between marker and anatomical compartment. SAC is therefore best understood as an integrated specimen-process adequacy control for negative-result interpretation. Its result should be reported as valid, borderline, or invalid for the intended negative interpretation, not as detected/not detected like the disease-specific biomarker. This perspective synthesizes quantitative polymerase chain reaction (qPCR) control guidance, preanalytical-quality literature, respiratory and enteric sampling studies, human papillomavirus (HPV) evidence, cartridge-assay precedents, and decentralized workflows. Direct prospective evidence that SAC improves patient or epidemiologic outcomes remains limited; available evidence is outcome-adjacent or operational, including HPV cellularity-control associations, Chlamydia trachomatis/Neisseria gonorrhoeae (CT/NG) and Ebola cartridge precedents, respiratory workflows showing lower pathogen positivity at higher SAC quantification cycle (Cq) strata, and reporting rules that change validity or recollection decisions. We propose a risk-based framework for selecting, validating, reporting, and monitoring SAC, with particular value in direct-amplification, point-of-care, and self-collection workflows where preanalytical failures affect negative-result interpretation. Full article

This review focuses on the analysis of hemoglobin in the clinical laboratory with an emphasis on the structure–function relationships of hemoglobin and the various methodologies used for its measurement. In clinical laboratories, hemoglobin analysis may take on many forms. These include measuring the concentration of hemoglobin, as well as determining the percentage of oxyhemoglobin, deoxyhemoglobin and dyshemoglobins such as carboxyhemoglobin. There are also techniques available to estimate the oxygen affinity of hemoglobin. Hemoglobin separation techniques by means of electrophoresis or chromatography are essential in the diagnosis of hemoglobinopathies (such as sickle cell anemia) and thalassemias, where there is an imbalance in globin chain synthesis. Hemoglobin contains four globin subunits, which create a unique quaternary structure in which the oxygen affinity can be changed by allosteric modifiers, including oxygen itself. The heme iron-containing tetrapyrrole ring not only carries oxygen; it also controls the binding of oxygen to the other globin subunits. The organization and regulation of the globin genes are discussed to provide essential biological context for informed interpretation of clinical test results. Building on this foundation, selected hemoglobinopathies and thalassemias are highlighted to further illustrate structure–function relationships and their implications for diagnostic testing. However, an exhaustive analysis of hemoglobinopathies is beyond the intended scope of this review, which is not meant to be all-encompassing, as these subjects are extensively addressed in many textbooks and published articles and reviews. Full article

Whole blood viscosity (WBV) is a key hemorheological property influenced by cellular and biochemical factors and is associated with cardiovascular, cerebrovascular, and microcirculatory disorders. Despite its clinical relevance, comprehensive reference intervals for WBV and oxygen delivery indices—the ODI (oxygen delivery index) and TODI (tissue oxygen delivery index)—in healthy male and female adults have not been established. The objectives of this study were to (1) determine sex-specific reference intervals of WBV in healthy adults, (2) establish reference intervals for the ODI and TODI, and (3) evaluate the influence of hematologic, biochemical, lipid, and non-lipid determinants—as well as the effects of age—on systolic and diastolic blood viscosity (SBV and DBV). WBV was measured across nine shear rates (1–1000 s⁻¹) in 150 healthy men and 150 healthy women using an automated scanning capillary tube viscometer (SCTV). Hematologic and biochemical profiles were obtained, and correlations with DBV and SBV were assessed. Reference intervals were calculated using CLSI-recommended nonparametric methods. WBV was consistently higher in men than women across all shear rates, with sex-based differences accentuated at low shear. Hemoglobin and hematocrit showed the strongest positive correlations with WBV (r ≈ 0.77–0.80), while RDW and HDL cholesterol showed negative associations. Triglycerides exhibited strong viscosity-enhancing effects in men, whereas total cholesterol, LDL, and triglycerides were all significantly increased viscosity in women. Protein-related determinants (total protein, albumin, and γ-gap) displayed striking sex divergence, with strong positive associations in men but attenuated or negative associations in women. Age showed no meaningful relationship with WBV in either sex. Reference intervals for the ODI and TODI revealed modest sex differences with tighter distributions in women. WBV, ODI, and TODI demonstrate clear sex-specific physiological patterns in healthy adults. Hematocrit remains the dominant determinant of blood viscosity, while lipid and protein-related factors contribute differently in men and women. These newly established reference intervals provide essential benchmarks for clinical interpretation and for understanding viscosity-related risk in cardiovascular and microcirculatory disease. Full article

Helicobacter pylori is the leading cause of chronic gastrointestinal tract diseases, with a worldwide prevalence of around 50%. For identification in medical practice, non-invasive methods such as the immunochromatographic test for antigen in stool (SAT) and the urease breath test (UBT) are widely used. Recently, we developed a highly sensitive and specific nested PCR (NPCR) that involves two amplification reactions and uses primers designed to target the variable regions of the 16S rRNA gene to amplify a short 148 bp amplicon. The aim of this study was to compare two classical methods, SAT and UBT, with the 148 bp amplicon NPCR. We examined samples from 137 volunteers, and found 46 positives with NPCR using stool samples, 34 with UBT, and only 24 with SAT. H. pylori origin of the 148 bp amplicons was confirmed by sequencing. NPCR had the highest detection rate in this cohort, suggesting that a portion of the population may be misdiagnosed, particularly by SAT. Due to the cost and simple performance in practice, SAT is a method of choice for initial screening. However, in cases of negative results and persistent digestive problems, we recommend the more sensitive UBT. NPCR may be a useful complementary method, especially in discordant or clinically suspicious cases. Full article

Hepatitis B virus (HBV) is the smallest partially double-stranded, reverse-transcribing DNA virus, with four open reading frames (ORFs) encoding viral proteins. It is classified into nine geographically distributed genotypes (A–I). In Kenya, the molecular characterization of HBV among patients seeking medical care remains poorly defined. This observational study aimed to characterize HBV among patients seeking medical care in Kenya’s endemic region, focusing on circulating genotypes and ORF mutations. Serum samples were collected from the outpatient departments of selected health facilities, with demographic and clinical information extracted from patients’ medical records. Hepatitis B surface antigen (HBsAg) was tested at the facilities, and 85 HBsAg-positive samples were collected for molecular analysis. The basal core promoter and pre-core (BCP/PC), polymerase, and surface regions of the viral genome were amplified and sequenced to determine genotypes and to profile their mutations. Out of 85 HBsAg-positive samples, 38 samples tested positive for HBV DNA, and 26 samples were successfully sequenced. HBV genotype A was prevalent at 73.1% (19/26), followed by genotype D at 23.1% (6/26), and genotype E at 3.8% (1/26). Genotype A sequences clustered with both A1 Asian and African subgenotypes, whereas genotype D clustered with subgenotypes D6 and D1. All HBV genotype A, D, and E sequences were serotypes adw2, ayw2, and ayw4, respectively. HBV core promoter mutations (A1762T/G1764A) were detected in both genotype D and genotype A isolates. The pre-core G1896A mutation was highly prevalent in genotype D samples (5/6; 83.3%) but was not observed in genotypes A or E. Analysis of mutations within the “a” determinant region revealed genotype-specific patterns: genotype A predominantly harbored V14A, P46H, S58C, and P67Q substitutions; genotype E showed N59S; and genotype D exhibited V14A, C69stop, S104T, and W182stop mutations. Two drug resistance mutations (V191I and A194T) were present in two chronic patients, one with genotype A and the other with genotype D. In conclusion, HBV genotypes A and D are the most prevalent among Kenyan patients with chronic HBV infection. The presence of point mutations in the ORFs among patients seeking medical care highlights the need for molecular surveillance to better understand the viral diversity and its potential clinical and public health implications. Full article

A 34-year-old healthy man was referred for colonoscopy due to tenesmus and rectal bleeding in the absence of systemic or immunosuppressive conditions. Incomplete bowel preparation limited the examination, but rectal inspection revealed a well-demarcated erythematous lesion with a granular, micronodular surface and fibrinous areas. The mucosa appeared friable and bled with minimal contact. The differential diagnosis included infectious and inflammatory etiologies. Histologic analysis showed granulation tissue with moderate lymphoplasmacytic infiltration, and C-reactive protein (CRP) confirmed Herpes Simplex Virus type 2 (HSV-2). This case underscores the importance of considering sexually transmitted infections (STIs) such as HSV in the differential diagnosis of rectal bleeding, even in immunocompetent individuals. Full article

The ADA 2026 Standards of Care in Diabetes introduces pivotal updates that refine diagnostic and therapeutic workflows. Expanding upon the 2025 guidelines, the 2026 edition broadens continuous-glucose-monitoring (CGM) eligibility to include all individuals on insulin or non-insulin therapies where CGM aids management. Significant new guidance addresses hyperglycemia management in oncology, identifying metformin as the preferred first-line intervention for drug-induced glycemic excursions. Additionally, type 1-diabetes (T1D) risk stratification is refined; a confirmed single IA-2 autoantibody now warrants monitoring levels similar to the Stage 2 disease. Furthermore, prerequisites for automated-insulin-delivery (AID) initiation have been removed to streamline technology access. For laboratory professionals, these revisions emphasize the critical role of advanced glycemic metrics and precise autoantibody profiling in complex clinical contexts. Full article

Sepsis is a life-threatening syndrome caused by dysregulated host response to infection and remains a major global health challenge with high healthcare burden. Early recognition is critical for improving outcomes, yet current diagnostic tools and conventional biomarkers such as C-reactive protein and procalcitonin have important limitations related to kinetics, specificity, and cost. This review examines Monocyte Distribution Width (MDW), a novel hematologic parameter derived from routine complete blood count analysis, as an emerging biomarker for early sepsis detection and prognostic assessment. MDW reflects monocyte morphological heterogeneity associated with innate immune activation and rises early in the inflammatory cascade, often at the time of initial clinical presentation. Evidence from emergency department and intensive care unit studies demonstrates that MDW provides high sensitivity and negative predictive value for early sepsis screening and performs comparably to or better than established biomarkers, particularly when integrated with clinical scoring systems and other laboratory indices. Beyond diagnosis, elevated MDW correlates with disease severity, organ dysfunction, and adverse outcomes, suggesting prognostic utility. Although promising, current evidence is limited by heterogeneity and the need for standardized cut-off values and multicenter validation. Overall, MDW represents a rapid, cost-effective adjunct that may enhance multimodal sepsis assessment and clinical decision-making. Full article

Platelet-rich plasma (PRP) is widely used in orthopedics and sports medicine as an autologous product; however, substantial heterogeneity in manufacture and incomplete reporting of preparation parameters limits reproducibility and inter-study comparability.: We performed a PRISMA-guided methodological review of studies describing PRP preparation, subsequently focusing on orthopedic applications. MEDLINE/PubMed, Embase, Scopus, the Cochrane Library, Web of Science, and Google Scholar were searched. 7330 records were retrieved; following merging and de-duplication, more than 2500 unique records were screened. The inclusion criteria for our study required studies on PRP that focused on orthopedic use of this preparation and studies that reported a defined methodology for PRP, reported in the abstract or in the manuscript. Extracted variables covered collection and anticoagulation, centrifugation strategy, cellular composition, activation/lysis, processing environment, storage, and time-to-use. Twenty-three orthopedic studies met the inclusion criteria. Whole blood draw volume and anticoagulant were reported in 15/23 studies each; centrifugation parameters (relative centrifugal force/RPM and duration) in 12/23; and PRP phenotype (e.g., leukocyte-poor vs. leukocyte-rich) in 15/23. Platelet metrics (baseline and/or final platelet count/concentration) were reported in 6/23. Sterility/environmental controls were mentioned in 17/23, whereas storage conditions and time-to-use were described in only 3/23. An explicit exogenous activation agent was reported on 1/23. Orthopedic PRP studies frequently omit critical manufacturing and handling descriptors—particularly platelet dose, leukocyte/lymphocyte handling, temperature control, storage/freezing conditions, and time-to-administration—impairing reproducibility and dose comparability. We propose a pragmatic, standardized protocol for preparation of leucocyte/lymphocyte-depleted PRP for orthopedic use (PRP only, without gelification), together with a minimum set of data and parameters to be evaluated. In our opinion these parameters should be included in future studies in order to standardize the production process. The quality of PRP itself could be impacted by such standardization, and the ability to objectively evaluate the results of studies could be enhanced by facilitating the comparison of data emerging from the literature. Full article

Lung cancer remains one of the most formidable health challenges globally, with significant morbidity and mortality rates. Despite advancements in diagnostic and treatment technologies, the disease’s high prevalence, late-stage detection, and complex variations continue to hinder effective management. Early detection and accurate diagnosis play a pivotal role in improving survival rates. Crucially, the clinical and translational relevance of AI-based prediction lies in its potential to significantly reduce the incidence of late-stage diagnoses, thus increasing the chance of successful intervention. Lung cancer was first identified by medical professionals in the mid-19th century. Today, cancer remains a significant global health challenge, affecting an estimated 14 million individuals annually and causing 8.2 million fatalities worldwide. Lung cancer ranks among the leading causes of death associated with cancer. This research aims to bridge gaps in lung cancer diagnosis by exploring various learning methodologies. By focusing on studies from the last 10 years, this survey provides a contemporary understanding of the field, emphasizing the importance of automated diagnostic systems in reducing human error and improving efficiency. The selection of relevant research is based on a rigorous methodology, including specific inclusion and exclusion criteria, which are later discussed in detail with supporting figures and comparative data. Ultimately, this work underscores the critical need for innovative diagnostic solutions and comprehensive screening programs to combat lung cancer, save lives, and advance the field of medical research. Full article

A 75-year-old male was admitted with worsening anemia and spontaneous bruising in the left abdominal wall and paraspinal region. Laboratory workup revealed low factor XIII (FXIII) activity levels. Cryoprecipitate transfusions raised his FXIII level, but still fluctuated drastically, ranging from 4 to 43% was discharged 3 days later once his bleeding was managed. Three days later, he was readmitted for severe pain and new bruising in his latissimus dorsi and lateral right thigh. CT-scan revealed hemothorax and arterial bleeding requiring an urgent angiogram with embolization. Chromogenic and functional FXIII assays were unable to elucidate an inhibitor at this time. Management included FXIII concentrate, rituximab, and prednisone; the patient was discharged 12 days later with FXIII levels of 50%. After prednisone tapering, FXIII levels decreased drastically. This case exemplified that higher levels of FXIII are required to prevent bleeding diatheses rather than the previously reported minimum of 5% activity. Despite the diagnostic uncertainty of laboratory testing, the shortened half-life of FXIII activity following replacement therapy and favorable response to immunotherapy indicates that the bleeding diathesis was caused by an acquired inhibitor. Full article

Hepatitis B virus (HBV) infection is a silent epidemic; many infected people are asymptomatic and not aware of the infection. In 2022, it was reported that approximately 254 million people were living with chronic HBV infection globally, majority being in sub-Saharan Africa and Asia. In Kenya, the national HBV prevalence is estimated to be 3.5%. Our study was aimed at identifying key predictors and transmission trends that could inform the development of sustainable prevention models needed to address existing gaps in the national framework towards HBV elimination. We targeted participants seeking health services in Baringo and Kisumu county health facilities and conducted community mass testing in the two counties. Participants were interviewed using a study questionnaire and were tested for hepatitis B surface antigen (HBsAg) using an HBsAg rapid test. Venous blood was collected from participants who tested HBsAg+ for further infection confirmation and linkage to care. Logistic regression was performed to assess factors correlated with HBV infection. Out of 3034 participants, 192 tested positive for HBsAg and the prevalence of HBV infection was 6.3% (95% CI = 0.055–0.072). Intrafamilial infections in Baringo were 15.0%. HBV infection prevalence exceeded 10% among those aged 25–49 years, peaking at 13.1% in the 45–49-year age group and lowest at 1.8% in the 16–19-year age group. Overall, males had a higher prevalence in younger ages, while females above 60 years old were more affected. In multivariable logistic regression, individuals residing in Baringo (aPR = 8.1; 95% CI = 2.2–29.4), users of other injectable drugs (aPR = 6.7; 95% CI = 1.3–204.0), those traditionally circumcised (aPR 1.02; 95% CI = 0.56, 1.88), and staying >5 km from a health care facility (aPR = 10.4; 95% CI = 2.2–49.4) had significantly higher prevalence ratios of being infected with HBV. These different infection predictors underscore the need for different care and prevention approach models. Full article

Measurement of vitamin E levels is used to evaluate the health status in humans. For routine analytics in clinical laboratories, an accurate, quick, and simple determination method is required. An option for the quantification of vitamin E (α-tocopherol) in human blood samples is the use of high-performance liquid chromatography (HPLC) in combination with a UV detector. Several sample preparation methods for this purpose have been reported in the literature. Our aim was to generate an overview and comparison of the different methods. The online database PubMed was searched for published HPLC methods. Of 77 reports screened, 16 methods were selected and summarized in tables. These present the parameters of the sample preparation procedure, HPLC settings, and some validation criteria (limit of detection (LOD), limit of quantification (LOQ), and intra- and inter-assay values, recovery rates) of the reported methods. In the frame of our methodological review, we could find some extraction approaches. The liquid–liquid extraction with hexane or the double extraction with hexane were often used. Another possibility is the single extraction approach. This systematic review highlights the similarities and differences in methods, and it can therefore be used to develop and establish methods in a laboratory. Full article

Plasma cell disorders often have urinary excretion of monoclonal immunoglobulins and renal injury that are evaluated using total protein assays and electrophoresis. Proteinuria was evaluated for 100 patients with plasma cell disorders and 24 h collections. A turbidimetric method on the Abbott Alinity quantified protein. Electrophoresis used agarose gels. Most specimens (66%) had protein concentrations below the manufacturer’s limit of quantitation (LOQ), 6.8 mg/dL (68 mg/L). After validating an LOQ of 3 mg/dL (30 mg/L), 34% of urine specimens still were below the LOQ. After excluding 40 patients with other causes of increased protein excretion (decreased estimated glomerular filtration rate (eGFR), diabetes mellitus, or overflow proteinuria), almost all patients had protein excretion below an upper reference limit of 150 mg/d. Median total protein excretion for these 60 patients was 75 mg/d; only one patient excreted >132 mg/d. However, 32% of these patients without increased total protein excretion had albumin excretion ≥ 30 mg/d, suggestive of kidney injury. Electrophoretic patterns included glomerular, tubular, and overflow proteinuria; 32 specimens contained monoclonal immunoglobulins. Protein concentrations of urine are often below LOQs of total protein assays, raising questions about whether LOQs should be improved. Urine albumin measurements and electrophoretic patterns may serve as more sensitive indicators of kidney injury in patients with plasma cell disorder than measurements of total protein excretion or increased serum creatinine. Full article

Source plasma centers sustain hematology therapeutics by safeguarding testing, traceability, and cold-chain integrity before fractionation. Despite regulatory requirements (21 CFR 606/640; EU Directive 2005/62/EC), published pre-operational validation frameworks demonstrating deviation-readiness before first collections remain sparse. We conducted a simulation-based pre-operational validation of an electronic quality management system (eQMS) with an Incident → Deviation → Corrective Action and Preventive Action (CAPA) pathway at a new source plasma center, performing 20 chairside mock runs, 3 freezer-alarm drills, and a document-control stress test. Primary endpoints were anomaly rate, alarm-response time relative to a 15 min service-level agreement (SLA), and deviation-closure SLA compliance. Analyses were descriptive and designed to demonstrate system functionality, not long-term process stability. Minor anomalies occurred in 6/20 mock runs (30.0%; 95% CI 11.9–54.3); no major/critical events were observed (0/20; 95% CI 0–16.8). Deviation-closure SLAs were met in 6/6 tests (100%; 95% CI 54.1–100). Alarm-response times averaged 7.0 min (SD 1.0; range 6–8 min; 95% CI 4.5–9.5), and all drills met the 15 min vendor SLA, illustrating a preliminary readiness margin (Cpu ≈ 2.7) rather than a statistically stable capability estimate. Simulation-based pre-operational validation produced inspection-ready documentation and quantitative acceptance criteria aligned to U.S./EU expectations, supporting reproducible multi-site deployment. By protecting cold-chain integrity and traceability before first collections, the validated QMS helps preserve supply reliability for plasma-derived therapeutics central to hematology care and establishes the measurement infrastructure for post-operational performance validation. Full article

The Infectious Diseases Society of America (IDSA) guidelines for community-acquired pneumonia (CAP) recommend pneumococcal urinary antigen testing (UAT) for a subset of inpatients admitted with pneumonia. Despite this, UAT testing is frequently performed on inpatients who do not meet the official IDSA criteria, and current evidence regarding antibiotic de-escalation in UAT-positive cases remains inconclusive. To explore this further, we conducted a retrospective cohort study examining antibiotic de-escalation patterns among hospitalized CAP patients who underwent UAT over a 60-day period during peak respiratory illness season (November and December, 2023). Patients with positive UAT results were compared to those who had negative UAT; the primary outcome was whether a positive UAT impacted antibiotic de-escalation prescribing. A total of 268 patients were analyzed—235 UAT-negative and 33 UAT-positive. Both groups were comparable in terms of disease severity, underlying health conditions, and readmission rates. Empiric therapy targeting Pseudomonas aeruginosa (P. aeruginosa) and methicillin-resistant Staphylococcus aureus (MRSA) was used in 40% of patients (36% in the UAT-positive group and 46% of the UAG-negative group). The use of atypical coverage, MRSA coverage, or anti-pseudomonal β-lactams was frequently de-escalated in both cohorts (p < 0.05); however, the UAT-positive group had significantly shorter durations of anti-pseudomonal therapy (p = 0.03) and anti-MRSA therapy (p = 0.02). Despite this, the UAT-positive group was more commonly given fluoroquinolones, such as levofloxacin or moxifloxacin, over narrow-spectrum β-lactams for final antibiotic coverage (p = 0.021). Overall, positive UAT appeared to support earlier discontinuation of anti-MRSA and anti-pseudomonal antibiotics; however, it did not impact fluoroquinolone use. Future antimicrobial stewardship efforts may benefit from promoting greater use of narrow-spectrum β-lactams in these patients. Full article