Nam Khoa Tran

Background/Objectives: Reliable quality control (QC) materials are essential for maintaining the analytical performance of hepatitis C virus (HCV) screening assays. Rapid diagnostic tests (RDTs) are widely used for point-of-care HCV screening; however, standardized plasma-based internal quality control (IQC) materials compatible with both rapid tests and automated immunoassays remain limited. This study aimed to develop and evaluate plasma-based QC materials applicable to multiple anti-HCV RDTs and automated immunoassays. Methods: QC materials were prepared from pooled HCV-positive plasma at strong-positive, weak-positive, and negative levels in liquid and lyophilized formats. Lyophilized preparations were produced with and without trehalose, while liquid samples were prepared with and without a stabilizer. Performance was evaluated using five anti-HCV RDT kits and the Elecsys Anti-HCV II automated immunoassay platform. Stability was assessed under accelerated temperature conditions (45 °C for 28 days) and long-term storage (2–8 °C and 20–30 °C for six months). Signal trends were analyzed using linear regression (p > 0.05), and homogeneity was evaluated using one-way analysis of variance and Cochran’s C test. Results: All QC formulations demonstrated consistent qualitative reactivity across the evaluated RDT kits and stable responses on the automated immunoassay platform. Lyophilized plasma containing trehalose maintained stable cut-off index (COI) values during accelerated and long-term storage, with no significant time-dependent trends (p > 0.05). Conclusions: Trehalose-stabilized lyophilized materials demonstrated enhanced stability and acceptable homogeneity, supporting practical applicability under the tested storage conditions across the evaluated rapid tests, and within the evaluated moderate-to-high positive analytical ranges on the automated anti-HCV immunoassay platform.

Artificial intelligence (AI) is advancing rapidly, transforming biomedical research and health care through software applications ranging from diagnostics to drug discovery. Biobanking resides at a unique intersection of this technological transformation, serving both as a foundation for training new AI models and as a beneficiary of AI-driven optimization. High-quality, well-annotated biospecimens enable robust machine learning, while AI methods in turn support automation, quality control (QC), predictive analytics, and workflow efficiency for biobanking operations. Emerging applications include non-generative AI methods, which have been used to predict sample degradation, stratify populations, and assess tissue integrity. Generative AI and large language models expand these capabilities by enabling synthetic data generation, metadata extraction, natural language–based interaction with biobank systems for both operational needs and training. Furthermore, newer multiagent approaches now demonstrate how distributed AI frameworks can orchestrate end-to-end processes. Case examples highlight early successes in automated image-based QC, natural language processing for metadata extraction, and privacy-preserving synthetic datasets to enable secure data sharing. Looking ahead, AI promises to reshape biobanking as both an operational and scientific engine, with opportunities in business intelligence, workflow optimization, and personalized education. Challenges around data quality, interoperability, governance, and ethics remain, but the convergence of AI and biobanking points to a future where repositories evolve into intelligent, adaptive infrastructures that actively drive discovery, accelerate translational research, and advance precision medicine.

Background/Objectives: Rapid diagnostic tests (RDTs) for human immunodeficiency virus (HIV) are widely used, but most kits lack standardized internal quality control (IQC) materials. In this study, we aimed to develop and evaluate a plasma-based IQC compatible with five HIV RDT brands and with proven long-term stability. Methods: Control samples at three reactivity levels were tested with five HIV RDT kits in lyophilized and liquid forms. Lyophilized samples were produced with and without trehalose, whereas liquid samples were prepared with and without StabilZyme™ SELECT Stabilizer (Stabilizer). Accelerated stability testing was performed at 37 °C and 45 °C for 28 days, and the most stable formulation was selected for long-term storage at 4 ± 2 °C and 25 ± 5 °C. Stability was assessed based on test-line visibility and signal intensity. Signal-intensity trends were analyzed using simple linear regression with a t-test on the slope; samples were considered stable when no significant trend was detected (p > 0.05). Results: Reactivity measured using the Elecsys HIV combi PT assay yielded cutoff index (COI) values of 772.65 (1:8) for the strong-positive control and 269.95 (1:25) for the weak-positive control. Trehalose-containing lyophilized samples maintained reactivity under accelerated testing at 37 and 45 °C and for 6 months at 4 ± 2 °C and 25 ± 5 °C, with no significant change in signal intensity (p > 0.05). Conclusions: The plasma-based IQC materials were compatible with all five HIV RDTs, and trehalose-stabilized lyophilized plasma showed high stability, supporting transport and storage without strict cold-chain requirements.

Background: Growth differentiation factor‐15 (GDF‐15) is a novel biomarker of cardiac stress. GDF‐15 may be a stronger predictor of all‐cause death in patients with acute chest pain than traditional biomarkers such as high‐sensitivity troponin T and BNP (B‐type natriuretic peptide). However, data from US populations are lacking. Our objective was to determine whether GDF‐15 is an independent predictor of all‐cause death or acute myocardial infarction (AMI) at index visit, 30 days, and 90 days. Methods: We conducted a secondary analysis of the STOP‐CP (High Sensitivity Cardiac Troponin T to Optimize Chest Pain Risk Stratification) trial, which prospectively enrolled adults (aged ≥21 years) from 8 US emergency departments with suspected AMI in 2017 to 2018. High‐sensitivity troponin T, BNP, and GDF‐15 assays were performed at a central laboratory on samples from baseline and 3 hours later. The primary outcome was the composite of all‐cause death or AMI at index visit, 30 days, and 90 days. Multiple logistic regression models assessed the association between GDF‐15 and all‐cause death or AMI at index visit, as well as at 30 and 90 days, while adjusting for age, sex, number of cardiac risk factors, ischemic ECG findings, high‐sensitivity troponin T, and N‐terminal pro‐B‐type natriuretic peptide. Results: We studied 1428 patients; median age was 58 (interquartile range, 49–66) years and 353 (25%) had a history of coronary artery disease. The composite outcome of all‐cause death or AMI occurred in 169 (12%) patients at index visit, an additional 21 (1.5%) at 30 days, and an additional 27 (1.9%) at 90 days. In multiple logistic regression models, GDF‐15 was independently associated with all‐cause death or AMI at 30 days (adjusted odds ratio per SD, 1.27 [95% CI, 1.06–1.54]) and 90 days (adjusted odds ratio R per SD, 1.55 [95% CI, 1.26–1.94]), but not during the index visit (adjusted odds ratio per SD, 1.00 [95% CI, 0.83–1.16]). Conclusions: Among adult emergency department patients with suspected AMI, GDF‐15 was independently associated with subsequent 30‐day and 90‐day all‐cause death or AMI. These data suggest a potential role for GDF‐15 in short‐term cardiac risk stratification in emergency department patients without AMI at index visit.

Background: Blood collection tubes (BCTs) are critical in vitro diagnostic devices used in clinical laboratory testing. Innomed tubes are novel BCTs coated with heparin and anti-glycolytic agents (Innomed 1) and clot activators combined with anti-glycolytic agents (Innomed 2). This study, we focus on the verification and multicenter validation of Innomed tubes, aiming to assess their performance in glucose stability, hemolysis resistance, and biochemical interferences relevant to diabetes and non-communicable disease (NCD) monitoring. Methods: Two types of Innomed tubes were evaluated. The verification process, conducted in a reference laboratory, assessed biochemical interferences, glucose stability, and the potential for hemolysis due to centrifugation and blood collection techniques. The multicenter validation of biochemical interferences was carried out across five hospital laboratories. Subsequently, samples were centrifuged at 3500 rpm for 5–10 min and analyzed immediately after separation, not exceeding 2 h from collection. Results: Glucose levels in Innomed 1 and 2 remained stable within 8% of up to 8 h post-collection. No hemolysis was observed under varying centrifugation times (at 3500 rpm) and blood collection techniques, as confirmed through visual inspection and lactate dehydrogenase level determinations. Innomed tubes were suitable BCTs for glucose, HbA1c, thyroid stimulating hormone, free triiodothyronine, free thyroxin, triiodothyronine, carcinoembryonic antigen, and prostate-specific antigen, as well as for 19 routine biochemical assays. Conclusions: Innomed 1 and 2 BCTs maintain blood glucose stability for 8 h, ensuring accurate biochemical, HbA1c, thyroid, and tumor marker testing. Their hemolysis resistance supports diabetes screening and Non-Communicable Diseases (NCD) monitoring. thereby emphasizing their clinical relevance in chronic disease management.

Background: Evaluation of the performance of Cobas ^® Pulse (Roche Diagnostics GmbH, Mannheim, Germany), a new blood glucose (BG) monitoring system (BGMS; referred to here as BGMSA) intended for point-of-care testing using samples from patients in diverse clinical settings by intended point-of-care test operators. Methods: Arterial, capillary, venous, or heel stick whole blood (WB) samples from patients in non-critical and critical care settings were collected and analyzed using BGMSA and the Nova StatStrip ^® BGMS (Nova Biomedical, Waltham, MA; referred to here as BGMSB), and a hexokinase comparator (Cobas 6000 Analyzer Series; Roche Diagnostics GmbH). The blood glucose measurement accuracy was assessed by the Food and Drug Administration guidance criteria. Results: Two studies are presented. In the first, 2678 samples (622 arterial, 706 capillary, 1203 venous, 147 heel stick) were collected from 1577 patients in 14 US and three European sites. All accuracy criteria were met for arterial and venous samples considering all data combined. BGMSA showed better accuracy than BGMSB for arterial, venous, and heel stick, and similar results to BGMSB for capillary WB vs venous comparator. No endogenous interference from pO ₂ , hematocrit, and sodium was identified. BGMSA was also accurate when analyzing contrived samples used to show accuracy over a wide range of glucose concentrations, alone and when combined with extreme hematocrit. In the second study, 117 capillary fingerstick samples collected at one US site were measured on both BGMSA and the comparator, and all accuracy criteria were met. No clinically significant medical risks were observed via Diabetes Technology Society Error Grids. Conclusions: BGMSA was effective for determining blood glucose in venous, arterial, neonatal arterial, neonatal heel stick, and capillary WB samples.

While current systems for continuous glucose monitoring (CGM) are safe and effective, there is a high degree of variability between readings within and across CGM systems. In current CGM performance studies, device readings are compared with glucose concentrations obtained with a comparator (“reference”) measurement procedure (usually capillary or venous glucose). However, glucose concentrations from capillary and venous samples can systematically differ, often by as much as 5 to 10%. Different comparator methods have shown biases of up to 8%, and comparator devices of the same brand can systematically differ by more than 5%. To address these issues, the Working Group on CGM of the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC WG-CGM) recommends standardizing study procedures and the comparator measurement process in CGM performance studies. The majority of IFCC WG-CGM members recommend the use of capillary samples as reference, mainly because CGM readings will then be aligned better with results from self-monitoring of blood glucose (SMBG). Even with factory-calibrated CGM systems, manufacturers require CGM users to perform SMBG in some situations, eg, manual calibration, confirmation of extreme readings, discordance between CGM readings and symptoms of hyper- or hypoglycemia, or intermittent signal loss. Comparator devices should meet defined analytical performance specifications for bias and imprecision. Comparator bias can be reduced by retrospective correction of comparator values based on measurements with a method or materials of higher metrological order. Once manufacturers align CGM readings of their systems with comparator results using standardized procedures, variability across CGM systems will be reduced.