LabMed

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

Antibiotic susceptibility testing (AST) reports classify isolates as “susceptible” despite potential undetected resistant subpopulations—a phenomenon termed susceptibility heterogeneity (SH). Found in 15–97% of clinical isolates of Escherichia coli, Staphylococcus aureus, Pseudomonas aeruginosa, and Klebsiella pneumoniae, SH arises from heteroresistance or polyclonal diversity and may evade standard low-inoculum protocols. Clinically, this can lead to treatment failure, particularly in high-risk cases including immunocompromised patients, bloodstream infections, transplant recipients, and situations where minor resistant subpopulations significantly affect outcome. We argue that ethical principles of non-maleficence, transparency, and equity now compel laboratories to acknowledge this limitation. A simple annotation—“Limited susceptibility possible; resistant subpopulations may not be detected”—should accompany “susceptible” results in immunocompromised patients. High-risk cases warrant enhanced testing. This commentary calls for zone inspection, staff training, and Clinical and Laboratory Standards Institute (CLSI)/European Committee on Antimicrobial Susceptibility Testing (EUCAST) guideline updates to reflect SH. Transparency enhances clinical decision-making without implying diagnostic fault. Full article

Alpha-fetoprotein (AFP) is a biomarker commonly used in the diagnosis of various malignancies but may also be elevated in non-neoplastic conditions, including hypothyroidism. We report the case of a 3-year-old girl with Down syndrome (DS) and newly diagnosed hypothyroidism, who presented with a hypoechoic oval lesion adjacent to the thymic parenchyma on ultrasound and markedly elevated AFP levels (169.2 ng/mL). Further investigations, including MRI, excluded the presence of germ cell tumors. Following initiation of levothyroxine therapy, AFP levels normalized in parallel with thyroid function. No evidence of malignancy was detected despite the initial suspicion. This case underscores the association between elevated AFP and hypothyroidism, highlighting the importance of evaluating thyroid status in patients with increased AFP to avoid unnecessary oncological investigations. In particular, elevated AFP in the context of hypothyroidism and DS warrants careful thyroid assessment and follow-up to prevent redundant diagnostic procedures and reduce patient and family anxiety. Thyroid function testing should be considered before extensive oncological evaluation in children with elevated AFP. Full article

Chronic heart failure (CHF) carries high morbidity and mortality. Circulating biomarkers of myocardial stretch, injury, and remodelling aids diagnosis and prognosis, but utility varies, especially in HFpEF, where natriuretic peptide (NP) values may be lower or normal in obesity. We systematically searched PubMed, Scopus, and Web of Science (2010–2025) for primary adult chronic-HF studies evaluating blood-based biomarkers: NPs, high-sensitivity troponins (hs-cTn), galectin-3, soluble ST2 (sST2), and microRNAs. Secondary sources (reviews/meta-analyses/guidelines) informed context only. Acute-HF studies were not pooled with chronic-HF analyses. Where appropriate, log hazard ratios were meta-analysed with random effects models. Twenty-nine studies met criteria. NT-proBNP remained the diagnostic/prognostic reference; across five prognostic cohorts, the pooled HR was 1.68 (95% CI 1.54–1.82; I² ≈ 55%). hs-cTn consistently improved risk stratification. Galectin-3 and sST2 were associated with adverse outcomes but typically provided modest incremental value beyond NPs/hs-cTn; galectin-3 is influenced by renal function, and sST2 is commonly interpreted around ~28–35 ng/mL. MicroRNAs (e.g., miR-21, miR-210-3p, miR-22-3p) showed promising yet heterogeneous signals across platforms and preanalytical workflows; therefore, findings were synthesised narratively without pooling. NT-proBNP and hs-cTn form the evidence-based backbone for biomarker-guided assessment in chronic HF. Galectin-3 and sST2 add adjunct prognostic information, while microRNAs remain investigational, pending standardised methods and external validation. Overall, evidence supports a multimarker, phenotype-tailored approach, with core NPs + hs-cTn and selective adjunct use of sST2/galectin-3 in context (HFrEF vs. HFpEF, obesity, renal function) to refine risk stratification and guide clinical decision-making. Full article

Dried blood spots (DBSs) are a practical tool for diagnosing infectious diseases, especially in remote or resource-limited settings. This study assessed the efficacy of DBS-based serological assays for syphilis screening. EDTA blood samples from 171 syphilis-seropositive and 122 seronegative individuals were used to prepare DBSs by spotting whole blood onto filter paper. After drying, 12 mm disks were punched, incubated overnight in buffered solution, and centrifuged. Syphilis serological screening was conducted using the Liaison^® Treponema Screen assay, Macro-Vue™ Reagin Plasma Rapid (RPR) card test, and Dual Path Platform (DPP) Syphilis Screen and Confirm test. The Liaison^® assay demonstrated 100% sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) with an optimized cut-off. The nontreponemal RPR test showed very low sensitivity (2.9%) on DBS but perfect specificity (100%). The DPP test for treponemal antibodies achieved high sensitivity (92.1%) and specificity (98.2%) with microreader adjustment. Visual reading of the DPP test had variable accuracy, with sensitivity reaching 100% but lower specificity (42.1%). Nontreponemal antibody detection by DPP showed moderate sensitivity and specificity. Although nontreponemal testing requires refinement, DBS testing combined with point-of-care tests like DPP holds promise for expanding syphilis screening accessibility and decentralization globally, particularly in resource-constrained environments. Full article