Journal of Applied Laboratory Medicine最新文献

Background: Each year, millions of adults present to emergency departments (EDs) with suspected traumatic brain injury (TBI). While more than 80% undergo computed tomography (CT) imaging, the current gold standard for diagnosis, fewer than 10% are found to have acute intracranial abnormalities requiring immediate clinical intervention. This overuse of CT imaging increases costs, length of stay (LOS), and ED crowding. Immunoassays utilizing blood-based biomarkers associated with TBI have shown promise in identifying patients presenting with suspected mild traumatic brain injury (mTBI) who are at low risk for intracranial injury, potentially reducing unnecessary CT scans and ED LOS. The Abbott TBI assay may offer a scalable diagnostic solution; however, real-world performance data remain limited.

Methods: Remnant blood specimens were collected from ED patients being evaluated for mTBI with noncontrast CT imaging. These samples were analyzed using the Abbott TBI immunoassay on the Alinity i system, and patient charts were reviewed by 3 independent ED physicians. Analytical and clinical performance of the assay were evaluated.

Results: The TBI immunoassay demonstrated a sensitivity (95% CI) of 100.0% (67.6, 100.0) and specificity of 32.6% (23.7, 42.9) overall, with a 100% negative predictive value and 12% (10, 13) positive predictive value. Stratification by age showed a higher specificity of 47.2% (34.3, 60.3) in patients <65 years compared to 11.0% (4.4, 25.3) for patients ≥65 years.

Conclusions: The TBI assay on the Alinity i platform demonstrated excellent sensitivity but showed limited specificity, particularly in patients >65 years. Our findings support the safe use of the TBI assay as a rule-out tool in the ED.

Background: High-sensitivity cardiac troponin (hs-cTn) assays performed in the central laboratory have long turnaround times. This study evaluates the clinical performance of a novel bedside point-of-care (POC) hs-cTnI assay (i-STAT® hs-TnI) to aid in the diagnosis of myocardial infarction (MI).

Methods: A prospective multisite cohort study involving emergency department (ED) patients with symptoms suggestive of acute coronary syndrome was conducted at 28 sites across the United States. Serial whole blood samples were collected at 0-1 h and >1-3 h from ED presentation. Primary outcome was MI or non-MI. Sensitivity, specificity, and negative predictive value (NPV) for MI were calculated with 97.5% lower confidence limits (LCL) using the female, male, and overall 99th percentile upper reference limit (URL, 13, 28, and 21 ng/L, respectively). Post hoc analysis was also conducted for initial measurements below the limit of quantification (LoQ, 2.9 ng/L) and <5.0 ng/L.

Results: The cohort included 3582 patients, median age 59 y, 64% female. MI incidence was 8.6%. Sensitivity and specificity at >1-3 h were 96.6% (LCL 91.7%) and 82.1% (80.2%) using the female URL; 90.7% (LCL 84.1%) and 83.9% (LCL 81.4%) using the male URL; and 92.4% (LCL 88.3%) and 85.6% (LCL 84.2%) using the overall URL. NPVs for MI of initial hs-cTnI measurements

Conclusions: The whole blood POC i-STAT hs-TnI assay demonstrated performance characteristics similar to other hs-cTn assays and achieved high sensitivity and NPV for initial measurements

Clinicaltrials.gov registration number: NCT05629572.

Background: Clinical laboratories are essential to healthcare but generate substantial environmental waste through high test volumes, single-use materials, and energy-intensive instrumentation.

Methods: We quantified the solid and liquid waste generated during the performance of basic metabolic panels-the most routinely ordered chemistry panel in hospitalized patients-across 4 commonly used automated chemistry analyzers in US laboratories. Waste generated was categorized into pre- and postanalytical components common to all analyzers, instrument-specific testing-phase waste, and chemical constituents with known environmental hazards.

Results: In performing 100 000 panels, total solid waste exceeded 4000 kg, with over 50% attributed to phlebotomy supplies. Analyzer-specific dry waste varied 24-fold from 67 to 1637 lb (30.4-744 kg). Liquid waste varied 32-fold, from 10.8 to 346.6 L. Heat generation varied 4-fold from 134 853 to 517 925 British thermal units (142 277-546 440 kJ). Reagents sometimes contained sodium azide and other aquatic toxins. Estimated carbon footprint from various categories of pre- and postanalytical waste varied 33-fold from 205 to 6805 kg CO2e, equal to 215 to 7130 miles (346-11 475 km) driven in a mid-sized car.

Conclusions: Our findings highlight substantial variation in waste output across platforms performing identical tests. Reducing laboratory waste will require coordinated interventions, from minimizing unnecessary test orders and optimizing sample collection to selecting low-waste analyzers and integrating sustainability into procurement policies. As high-throughput environments with well-established quality systems, clinical laboratories are well positioned to lead healthcare's broader sustainability efforts, demonstrating how operational excellence and environmental responsibility can align. Quantifying diagnostic waste is a critical first step toward integrating environmental stewardship into patient care.

Background: Sepsis is a life-threatening complication of infection with high mortality. A high-throughput analysis of circulating blood proteins may provide mechanistic insight and potent therapeutic targets for the prevention of sepsis.

Methods: We used multivariable Cox regression analysis to examine the association of 4955 plasma proteins, measured by SomaScan, with the risk of incident sepsis among 11 065 participants of the Atherosclerosis Risk in Communities (ARIC) Study (visit 3 in 1993 to 1995; mean age, 60.1 years, 54.4% female, 21.0% Black). Proteins (false discovery rate [FDR] of P < 0.05) discovered at visit 3 were replicated using data at visit 5 (n = 4869 in 2011 to 2013: mean age, 75.5 years) and in the Cardiovascular Health Study (CHS) (n = 3512 in 1992 to 1993; mean age, 74.5 years). Canonical pathways were identified by enrichment analyses.

Results: At ARIC visit three, 669 proteins were associated with the risk of sepsis; 175 were replicated at visit 5. Of these, 90 were validated in the CHS. The top 20 proteins ranked by P value were relevant to acute inflammatory signaling in innate immunity. Pathway analyses implicated activation of pro-inflammatory pathways (e.g., cytokine storm signaling) as well as inhibition of anti-inflammatory pathways (e.g., liver X receptor/retinoid X receptor [LXR/RXR] activation), which also play relevant roles in lipid metabolism.

Conclusions: In this analysis, levels of acute inflammatory proteins measured during routine visits were associated with the subsequent incidence of sepsis. An increased risk of sepsis associated with the inhibition of anti-inflammatory pathways, such as LXR/RXR warrants further mechanistic investigation.