Journal of Applied Laboratory Medicine最新文献

Background: Nontraditional sites for blood collection, including retail pharmacies, can expand access to laboratory testing. Three studies assessed the BD® MiniDraw™ Capillary Blood Collection System (BD MiniDraw) along with the BD MiniDraw SST™ Capillary Blood Collection Tube (BD MiniDraw SST tube). This system allows trained healthcare workers to collect capillary blood without requiring phlebotomy experience, in accordance with state laws.

Methods: Studies 1 and 2 evaluated clinical equivalence for selected serum chemistry analytes in the BD MiniDraw compared with currently marketed capillary and venous comparators. Study 3 evaluated within-tube stability for selected analytes up to 48 h in BD MiniDraw SST tubes following storage (2°-8°C). Contrived specimens were prepared to cover medically relevant ranges. Testing was performed on one general chemistry core laboratory analyzer in each study. Clinical equivalence was demonstrated if the biases and 95% limits were within a predefined clinical acceptance limit at all medical decision levels and time points for stability.

Results: Clinical equivalence was demonstrated for all analytes for BD MiniDraw vs capillary and venous comparators except alanine aminotransferase and chloride for the venous comparator in study 1. Both showed clinical equivalence at the upper limit of the reference range; the confidence interval exceeded the clinical acceptance limit at the lower limit. Within-tube stability was demonstrated in BD MiniDraw SST tubes up to 48 h for all selected analytes.

Conclusions: The BD MiniDraw presents an option for blood collection in nontraditional settings that is clinically equivalent to conventional capillary and venous collection for the specified analytes.

Background: This study evaluates the performance of the Illumina NextSeq™ 550 and the Element Biosciences AVITI™ next-generation sequencing (NGS) system, in detecting single nucleotide variants (SNVs) and gene fusions.

Methods: A set of 66 NGS libraries, consisting of 33 DNA, 24 cDNA, and triplicates of 3 control libraries, were prepared from bone marrow samples targeting 63 genes and related fusions, and initially sequenced using the NextSeq 550 in the Cleveland Clinic's molecular diagnostic laboratory. The same libraries were subsequently sequenced on the AVITI. The resulting data were analyzed using a combination of Cleveland Clinic developed pipelines and ArcherDx virtual machine software.

Results: The study found that all 105 SNVs and 39 gene fusions identified by the NextSeq 550 were also detected in the AVITI, demonstrating a high degree of concordance between the platforms. The analyses revealed R2 values of 0.86 for read depth and 0.96 for VAF of the 105 DNA variants, and 0.95 for read depth and 0.97 for fusion percentage of the 39 fusion variants. In the reproducibility studies, the VAF and fusion percentage of all variants were within 2 standard deviations of the mean when the same positive controls were sequenced 3 times on the AVITI.

Conclusions: These results indicate that the NextSeq 550 and the AVITI provide comparable performance in terms of accuracy and sensitivity for variant detection. Notably, the AVITI chemistry requires substantially lower PhiX input than the NextSeq 550 needs for this application. This results in substantial cost and efficiency benefits.

Background: In 2021, the United States implemented a federal price transparency mandate to help combat price variability across the country. Initial studies conducted within several months of the mandate showed persistent price variability.

Methods: To assess continued price variability for laboratory tests and factors associated with prices across all licensed hospitals in Tennessee approximately 2.5 years since the mandate, hospital websites were queried for gross, cash, and Blue Cross Blue Shield (BCBS) prices for common laboratory tests (n = 8). Hospital ownership and county demographic data including income, region, and population density were also collected.

Results: All tests showed considerable price variability. Gross price was set higher than cash and BCBS prices. For the majority (n = 6) of tests, cash was higher than BCBS price. Maximum to minimum price ratios for each test ranged from 29 to 114 for gross, 57 to 243 for cash, and 25 to 115 for BCBS prices. Gross and cash prices were associated with median household income of the hospital's county while BCBS prices were not. Overall, prices were associated with hospital county income, for-profit status, and region.

Conclusions: Our study shows continued price variability in Tennessee 2.5 years after the federal price transparency mandate.

Background: Cardiac troponin is the gold-standard biomarker for the evaluation of patients with suspected acute myocardial infarction (MI). Improvements in assay technology have led to high-sensitivity cardiac troponin assays that, when incorporated into accelerated diagnostic pathways, may rapidly diagnose or exclude acute MI more efficiently than conventional troponin assays.

Content: In this narrative review, we provide practical suggestions for implementing high-sensitivity cardiac troponin assays, review accelerated diagnostic pathways incorporating these assays, and review the impact of these assays on resource utilization and cost-effectiveness in relation to the evaluation of individuals with possible acute MI.

Summary: An increasing number of hospitals are transitioning to high-sensitivity cardiac troponin assays. This narrative review provides an overview of the potential benefits of this transition.