LabMed, Volume 3, Issue 3 (September 2026) – 7 articles

The hepatitis B virus (HBV) remains highly endemic in Sub-Saharan Africa, where perinatal and early childhood transmission contribute substantially to chronic infection. Although routine infant vaccination is widely implemented, the birth-dose coverage remains inconsistent in many settings. This study, carried out in strict compliance with ethical rules, evaluated serological markers of HBV exposure and vaccine-induced immunity among fully vaccinated infants in Cameroon. It was a cross-sectional study involving 9-to-15-month-old infants, fully vaccinated against hepatitis B and HIV negative, living in the towns of Douala and Yaoundé. Infants born to mothers known to be HBsAg-positive were excluded. Their serum samples were tested for HBV serological markers, using lateral flow immunochromatography techniques and indirect ELISA. Whereas 84.85% (56/66) of theses infants achieved seroprotective antiHBs levels, 16.67% (11/66) were antiHBc-seropositive and were all born to antiHBc-seropositive mothers. Overall, 63.64% of these antiHBc-seropositive infants were significantly less likely to demonstrate seroprotection compared with antiHBc-seronegative infants (adjusted OR 30.3; 95% CI 5.58–164.75). These results, highlighting the association between antiHBc positivity and reduced seroprotection, warrant further investigation, including molecular testing to distinguish passive maternal antibody transfer from occult or resolved infection. Strengthening perinatal HBV prevention strategies remains critical to achieving elimination targets. Full article

Invasive pulmonary aspergillosis (IPA) is a major cause of morbidity and mortality in patients with hematological malignancies. Serum galactomannan (GM) is widely used for diagnosis, but the prognostic value of the initial GM level is not well established. We aimed to assess the association between the initial serum GM level at IPA diagnosis and the radiological and clinical outcomes at 42 and 90 days. We retrospectively reviewed adult patients with hematological malignancies, including hematopoietic stem cell transplant (HSCT) recipients, diagnosed with proven or probable IPA at Sultan Qaboos University Hospital between 2014 and 2017, according to the 2008 EORTC/MSG criteria. Demographic, microbiological, radiological, and clinical data were collected. Outcomes were assessed using dichotomous and balanced multi-level GM cut-off categories. Seventy-eight patients were included. The median age was 44.5 years (range 18–76); 53.8% were male. Lymphoma (30.7%) and acute leukemia (25.6%) were the leading underlying diseases. Voriconazole was the most frequently used antifungal agent (74.3%). Prolonged neutropenia was present in 61.9%, and 30.7% had received HSCT. The mean serum GM at diagnosis was 1.95 (range 0.5–7.89). At 90 days, follow-up imaging showed a complete radiological response in 22 patients (29.3%), a partial response in 28 (37.3%), and no response in 25 (33.3%). Overall, 90-day mortality was 35.9%. There was no statistically significant association between initial GM level and 90-day mortality across categories (GM 0.5–3.0: 34.2% mortality; GM > 3.0: 60%; p = 0.243). Within the GM 0.5–3.0 group, complete radiological response was strongly associated with survival (95.2% alive at 90 days; p < 0.001). The initial serum GM level was not significantly associated with clinical or radiological outcomes at 42 or 90 days in patients with hematological malignancies and IPA. However, an early complete radiological response was strongly associated with improved survival, supporting the use of follow-up CT chest imaging to guide management. Full article

The instability of ibrutinib in plasma at room temperature necessitates temperature-controlled sample transport, complicating therapeutic drug monitoring (TDM) and multicenter studies. Dried plasma spots (DPSs) offer a potential advantage by enabling sample storage and transport under ambient conditions. The aim of this study was to develop and validate an LC-MS/MS method for the simultaneous quantification of ibrutinib and ritonavir in plasma and DPSs. Following validation of an extended plasma calibration range, DPS method development included card selection and subsequent validation in accordance with ICH M10 and EMA guidelines. The analytical method demonstrated robust performance in plasma for both analytes. For DPS sampling, ritonavir fulfilled all validation criteria. In contrast, ibrutinib showed significant instability in DPS samples at room temperature after 48 h and did not meet the predefined acceptance criteria under these conditions. Refrigerated storage improved stability within the acceptance criteria for at least one week. The developed method is suitable for simultaneous quantification of ibrutinib and ritonavir in plasma and for ritonavir in DPSs. While DPS sampling may offer logistical advantages, its successful application is dependent on analyte stability. For ibrutinib, the requirement for refrigerated storage limits the anticipated benefits, and further research is needed to optimize dried sampling strategies. Full article

Antibody glycosylation is a critical quality attribute (CQA) in disease research and quality control of therapeutic antibodies. This study presents a streamlined approach for the direct analysis of N-glycans released from IgG by PNGase F using matrix-assisted laser desorption/ionization time-of-flight mass spectrometry (MALDI-TOF MS) without any prior purification. By utilizing a 1,5-diaminonaphthalene (DAN)/2,5-dihydroxybenzoic acid (DHB) matrix, multiple glycan-derived peaks were selectively detected directly from the protein-rich digestion mixture, demonstrating the superior glycan selectivity of the DAN/DHB system. Furthermore, systematic dilution of the digest was found to significantly enhance the signal-to-noise ratio, enabling the detection of sialylated glycans while simultaneously suppressing the formation of undesirable DAN adducts. Comparative evaluation of three matrices—DAN/DHB, DHB/0.1% TFA, and DHB—across varying IgG concentrations revealed that the DAN/DHB matrix offers the highest sensitivity and robustness for unpurified samples. Although there are some limitations for quantitative analysis, especially for minor and sialylated glycoform, this novel, purification-free methodology provides a rapid and easily automatable platform for IgG glycan profiling. Full article

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