Dysglycemia is common among hospitalized patients. Accurate point-of-care (POC) glucose monitoring is necessary for the safe administration of insulin. Unfortunately, POC glucose meters are not all created equal.
View Article and Find Full Text PDFBackground: The 2019 novel coronavirus infectious disease (COVID-19) pandemic resulted in a surge of assays aimed at detecting severe acute respiratory syndrome (SARS) - coronavirus (CoV) - 2 infection and prior exposure. Although both molecular and antigen testing have clearly defined uses, the utility of serology remains uncertain and is presently not recommended for assessing immunity.
Methods: We conducted a pragmatic, observational study evaluating four commercially available emergency use authorized laboratory-based COVID-19 serology assays (Assays A-D).
Elevated blood biotin levels may interfere with some biotin-streptavidin immunoassays, used in clinical laboratories to aid diagnosis. The objective of this study was to determine the prevalence of elevated blood biotin levels in three at risk patient cohorts, where misclassification of disease status would have a high clinical impact. This retrospective, single-center study screened residual, de-identified plasma samples (N = 700) from adult patients undergoing routine thyroid stimulating hormone (TSH) (n = 500), procalcitonin (PCT) (n = 100), or human immunodeficiency virus (HIV) (n = 100) testing using the Elecsys® BRAHMS PCT (Roche Diagnostics), Access TSH (3rd IS) (Beckman Coulter Inc), and ARCHITECT HIV Ag/Ab Combo (Abbott Laboratories) immunoassays, respectively, for elevated levels of biotin (quantified by gas chromatography-time of flight mass spectrometry).
View Article and Find Full Text PDFBackground: Our purpose was to evaluate the performance of the ACCU-CHEK® Inform II blood glucose monitoring system (Roche Diagnostics GmbH) compared with the perchloric acid hexokinase (PCA-HK) comparator method on the cobas® 6000 analyzer (Roche Diagnostics International Ltd) in critically ill patients.
Methods: Overall, 476 arterial (376 pediatric/adult, 100 neonate), 375 venous, and 100 neonatal heel-stick whole-blood samples were collected and evaluated from critical care settings at 10 US hospitals, including the emergency department, medical and surgical intensive care units (ICUs), and neonatal and pediatric ICUs. The ACCU-CHEK Inform II system was evaluated at 2 cutoff boundaries: boundary 1 was ≥95% of results within ±12 mg/dL of the reference (samples with blood glucose <75 mg/dL) or ±12% of the reference (glucose ≥75 mg/dL), and boundary 2 was ≥98% of results within ±15 mg/dL or ±15% of the reference.
Highly accurate testing for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) at the point of care (POC) is an unmet diagnostic need in emergency care and time-sensitive outpatient care settings. Reverse transcription-PCR (RT-PCR) technology is the gold standard for SARS-CoV-2 diagnostics. We performed a multisite U.
View Article and Find Full Text PDFStudy Objective: Our objective is to describe the rates of diagnostic reclassification between conventional cardiac troponin I (cTnI) and high-sensitivity cardiac troponin T (hs-cTnT) and between combined and sex-specific hs-cTnT thresholds in adult emergency department (ED) patients in the United States.
Methods: We conducted a prospective, single-center, before-and-after, observational study of ED patients aged 18 years or older undergoing single or serial cardiac troponin testing in the ED for any reason before and after hs-cTnT implementation. Conventional cTnI and hs-cTnT results were obtained from a laboratory quality assurance database.