Journal of Applied Laboratory Medicine最新文献

Background: Diagnostic stewardship is the science of improving diagnostic test use. Whether electronic health record (EHR) design influences clinician diagnostic testing behavior and electronic medical record interventions can improve diagnostic stewardship outcomes are key questions. We leveraged the natural experiment of a recent change in EHR platforms to investigate if changing how 2 commonly misused tests, blood cultures for acid-fast bacilli (AFB) and fungi, are displayed affected their use.

Methods: We performed a retrospective chart review of all AFB and fungal blood cultures at 4 hospitals with a shared EHR. The preintervention and postintervention periods were 52 and 26 weeks, respectively. The culture rate was standardized per 1000 patient-days and segmented into 2-week periods. Pre- and postintervention median rates were compared with the Wilcoxon rank sum test and further analyzed with an interrupted time series (ITS) analysis using a quasi-Poisson regression model.

Results: The biweekly median AFB blood culture rate decreased by 41.6% in the postintervention period (0.46/1000 patient-days vs 0.79/1000 patient-days, P < 0.001). The median rate of fungal blood cultures decreased by 54.3% in the postintervention period (0.42/1000 patient-days vs 0.92/1000 patient-days, P < 0.001). In ITS analysis, the EHR change was associated with a level change in AFB (-31.8%, 95% CI: -54.6% to +2.6%) and fungal (-44.6%, 95% CI: -59.3% to -24.7%) blood culture use.

Conclusions: An electronic medical record design change resulted in decreased use of 2 commonly misused diagnostic tests. This highlights the impact of EHR design on clinician behavior and diagnostic stewardship programs' potential to reduce waste.

Background: Exploring polymorphisms in vitamin D-related genes (VDR) within the Brazilian population provides a valuable model to contribute to the influence of the host genetic variants on chronic viral hepatitis B (CHB).

Methods: 126 CHB patients were enrolled in the current study and clinical, laboratory, and 25-hydroxyvitamin D [25(OD)D] level data were obtained. Four VDR (rs7975232, rs1544410, rs10735810, rs731236) and 2 vitamin D-binding protein/carrier globulin (GC) polymorphisms (rs4588 and rs7041) were determined using TaqMan assays and nucleotide sequencing. Association studies were conducted among viral infection parameters and the patient's genetic variants.

Results: Most patients were male (52.38%) with a mean age of 44.28 (±14.24) years, self-identified as White (32.54%), and exhibited vitamin D insufficiency status (42.06%). The hepatitis B virus (HBV) genotype A was predominant (50%) and 62.7% of the patients had detectable HBV DNA levels ≤log10 3 IU/mL. A significant association was observed between HBV genotype A with ApaI and FokI single nucleotide polymorphisms. However, no statistical association between VDR polymorphisms and viral load, viral polymerase mutations, or vitamin D status was found. Vitamin D concentration did not correlate to HBV viral load.

Conclusions: Most HBV-infected individuals presented vitamin D insufficiency, and VDR polymorphism was not associated with virological characteristics except with HBV genotype A, demonstrating that some human genetic signatures are related to HBV genotype distribution.

Introduction: Specimens suspected of errors related to low hemoglobin or changes in hemoglobin beyond that of clinically explained variations during hospital stays are frequently redrawn under the auspices that they are contaminated. When lack of an indwelling IV eliminates contamination as a possibility, evaluation of the specimen between the time of collection and testing should occur.

Methods: As part of a quality improvement project, we investigated the impact of sedimentation on collected blood specimens not immediately transferred to their respective tubes from a syringe. Each syringe of blood was allowed to stand in a vertical position on the transfer device. After 10 min, each syringe was divided into a bottom half and top half into fresh blood tubes, with half of the samples inverted prior to division. Samples were then analyzed for complete blood count.

Results: These results indicate that implementing an inversion of collected specimens prior to transferring will effectively eliminate variations related to sedimentation of blood.

Conclusions: Results highlight the importance of specimen handling after collection, including appropriate mixing to avoid erroneous results caused by erythrocyte sedimentation. Mixing syringes before transferring blood to collection tubes ensures a uniform sample and accurate result.

Background: The 2023 American College of Rheumatology and modified Sapporo criteria for antiphospholipid syndrome (APS) recommend ELISA to detect anticardiolipin (aCL) and anti-β2-glycoprotein I (aβ2GP1) IgG/IgM antibodies, focusing on moderate to high levels or exceeding the 99th percentile. This study aims to establish the 99th percentile threshold for anti-phospholipid (aPL) antibodies and compare the diagnostic accuracies of these thresholds with manufacturer cutoffs using 2 methodologies.

Methods: The 99th percentile cutoffs for aPL antibodies from 305 healthy donors were established using Aptiva, Particle-Based Multi-Analyte Technology (PMAT), and QUANTA Lite (QL) ELISA, following nonparametric reference interval estimation. Sera from 34 APS patients and 190 APS controls were tested. Diagnostic performances were compared at the 99th percentile-, manufacturer-, receiver operating characteristic (ROC) derived optimal-, and 95% specificity-optimized cutoffs. An expanded cohort of 61 APS patients and 1299 APS controls from a 2-year retrospective review was also included.

Results: For ELISA, the 99th percentile cutoffs for aCL (IgG/IgM) and aβ2GP1 (IgG) were at the assay limit of quantification. Optimal cutoffs from the ROC curves, 95% specificity-matched and manufacturer cutoffs, showed better diagnostic accuracy than the 99th percentile. On the Aptiva PMAT platform, the 99th percentile cutoffs were lower but provided comparable diagnostic accuracies to manufacturer and optimal cutoffs, although specificity was below 95%.

Conclusions: The clinical utility of 99th percentile cutoffs is assay dependent. For QL, these cutoffs were unsuitable, while Aptiva showed better alignment with clinical thresholds. Manufacturer-recommended cutoffs, supported by extensive validation, offer a reliable alternative when clinical studies are infeasible.

Background: There is growing interest in the use of capillary blood sampling (CBS) for testing biochemical analytes owing to the advantages it offers including home surveillance of chronic conditions. In this study, we aimed to determine whether the use of CBS was a viable and feasible method for testing total prostate-specific antigen (TPSA) concentrations in men with prostate disease.

Methods: Men with known prostate disease were recruited from a urology clinic where they were being treated or followed up. Samples were collected in serum separating tubes by the finger-prick method using validated devices. Simultaneously, venous blood was collected by venipuncture. We used validated immunoassays on both the Roche (Cobas 801) and Beckman (DXi) platforms to measure TPSA.

Results: In total, 66 adult men between 26 and 64 years of age were tested. Across the concentration range of normal (0.3 µg/L) to pathological (314 µg/L), the results between CBS and venous samples were highly comparable and correlated (r = 0.997). The average bias was 0.112 µg/L or 1.07% and was not significant (P = 0.274). Overall, there was no apparent proportional or constant bias observed. Our data showed that TPSA may be stable in CBS stored at ambient temperature for up to 8 days in the samples tested using either the Roche or Beckman assays.

Conclusions: This feasibility study shows that CBS and venous samples are highly correlated and there was negligible bias. Further validation work is now required for the measurement of TPSA in CBS and determining outcomes in men with prostate disease.

Background: Myocardial fibrosis is associated with a poor outcome for patients with cardiovascular disease (CVD). Growth differentiation factor 15 (GDF-15) concentrations predict the risk of death in patients with CVD, but the underlying pathophysiological mechanisms are poorly understood. We aimed to assess the associations between biomarkers of cellular stress and inflammation (GDF-15), cardiac injury (cardiac troponin T [cTnT]), and stretch (N-terminal pro-B-type natriuretic peptide [NT-proBNP]), and subsequent focal and diffuse myocardial fibrosis assessed by cardiac magnetic resonance (CMR) imaging.

Methods: We measured GDF-15, cTnT, and NT-proBNP in 200 study participants without known coronary artery disease or renal dysfunction from the population-based Akershus Cardiac Examination 1950 Study at baseline in 2012 to 2015. Focal myocardial scars and diffuse fibrosis were assessed by late gadolinium enhancement imaging and septal extracellular volume fraction (ECV) by CMR 4 to 7 years later. The relationships between cardiac biomarkers and CMR parameters were assessed by logistic regression analysis adjusted for common cardiovascular risk factors.

Results: The median age was 63.9 (interquartile range 63.4-64.5) years and 49% were women. GDF-15 (adjusted odds ratio [aOR] 4.40, 95% CI 1.09-17.72) and cTnT (aOR 1.59, 95% CI 1.01-2.50) were associated with nonischemic scars in the fully adjusted model. cTnT (aOR 2.45, 95% CI 1.41-4.25) and NT-proBNP (aOR 3.12, 95% CI 1.55-6.28) were associated with ischemic scars. None of the biomarkers were significantly associated with elevated ECV.

Conclusions: In a general population cohort, GDF-15, an emerging biomarker of cellular stress and inflammation, associates with nonischemic scars. Biomarkers of myocardial injury and stretch associate with ischemic scars, while no biomarker was associated with diffuse fibrosis as assessed by CMR.

Background: We sought to evaluate key performance indicators related to an internally developed and deployed artificial intelligence (AI)-augmented kidney stone composition test system for potential improvements in test quality, efficiency, cost-effectiveness, and staff satisfaction.

Methods: We compared quality, efficiency, staff satisfaction, and financial data from the 6 months after the AI-augmented laboratory test system was deployed (test period) with data from the same 6-month period in the previous year (control period) to determine if AI-augmentation improved key performance indicators of this laboratory test.

Results: In the 6 months following the deployment (test period) of the AI-augmented kidney stone composition test system, 44 830 kidney stones were analyzed. Of these, 92% of kidney stones were eligible for AI-assisted interpretation. Out of these AI-eligible stones, 45% were able to be auto-released by the AI-augmented test system without human secondary review. Furthermore, the new AI-augmented kidney stone test system resulted in an apparent 40% reduction in incorrect laboratory results. Additionally, the new AI-augmented test system improved laboratory efficiency by 20%, improved staff satisfaction, and reduced the average analysis cost per kidney stone by $0.23.

Conclusions: The AI-augmented test system improved test quality, efficiency, cost-effectiveness and staff satisfaction related to this kidney stone composition test.

Background: We evaluated reporting of diagnostic test accuracy (DTA) systematic reviews using Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA)-DTA and PRISMA-DTA for abstracts.

Methods: We searched MEDLINE for recent DTA systematic reviews (September 2023-Mar 2024) to achieve a sample size of 100. Analyses evaluated adherence to PRISMA-DTA (and abstracts), on a per-item basis. Association of reporting with journal, country, impact factor (IF), index-test type, subspecialty area, use of supplemental material, PRISMA citation, word count, and PRISMA adoption was evaluated. Comparison to the baseline evaluation from 2019 was done. Protocol: https://doi.org/10.17605/OSF.IO/P25TE.

Results: Overall adherence (n = 100) was 78% (20.3/26.0 items, SD = 2.0) for PRISMA-DTA and 52% (5.7/11.0 items, SD = 1.6) for abstracts. Infrequently reported items (<33% of studies): eligibility criteria, definitions for data extraction, synthesis of results, and characteristics of the included studies. Infrequently reported items in abstracts were characteristics of the included studies, strengths and limitations, and funding. Reporting completeness for full text was minimally higher in studies in higher IF journals [20.7 vs 19.8 items; 95% confidence interval (95%CI) (0.09; 1.77)], as well as studies that cited PRISMA [21.1 vs 20.1 items; 95%CI (0.04; 1.95)], or used supplemental material (20.7 vs 19.2 items; 95%CI (0.63; 2.35)]. Variability in reporting was not associated with author country, journal, abstract word count limitations, PRISMA adoption, structured abstracts, study design, subspecialty, open-access status, or index test. No association with word counts was observed among full text or abstracts. Compared to the baseline evaluation, reporting was improved for full texts [71% to 78%; 95%CI (1.18; 2.26)] but not for abstracts [50% to 52%; 95%CI (-0.20; 0.60)].

Conclusions: Compared to the baseline evaluation published in 2019, we observed modest improved adherence to PRISMA-DTA and no improvement in PRISMA-DTA for abstracts reporting.