Assessing Phlebotomy Device Preference and Specimen Quality in an Oncology Outpatient Clinic.

BACKGROUND: Oncology patients have frequent venipunctures, which causes scarring, making subsequent draws difficult and painful. Novel blood collection systems may decrease discomfort in patients experiencing repeat blood draws. METHODS: Oncology outpatients (n = 101; criteria excluded 12) were recruited to determine their preference for either of two blood collection systems, the 23-gauge standard BD Vacutainer Push Button Blood Collection Set (Standard Push Button system) or the 25-gauge BD Vacutainer UltraTouch Push Button Blood Collection Set (UltraTouch Push Button system). Subjects received two blinded, randomized blood draws, one with each device and just one device for each arm. Subjects subsequently rated their blinded preference for blood collection system. Specimen quality was assessed for each device with measurements for plasma hemoglobin (Shimadzu UV-1800 spectrophotometer, Shimadzu), lactate dehydrogenase, and potassium (Vitros 4600/5600 analyzer, Ortho Diagnostics). RESULTS: Preference for the 25-gauge UltraTouch Push Button system over the 23-gauge Standard Push Button system was significant (UltraTouch, n = 51; Standard n = 30; no preference, n = 8; P = 0.0196). Regarding sample quality, the 25-gauge UltraTouch Push Button system had significantly lower plasma hemoglobin (average 5.34 mg/dL) vs the 23-gauge Standard Push Button system (9.37 mg/dL; P < 0.0001); serum lactate dehydrogenase and potassium differences were not statistically significant. CONCLUSION: Subjects in an oncology clinic preferred phlebotomy with the 25-gauge UltraTouch Push Button system, and samples using this device had less hemolysis as assessed by plasma hemoglobin.

Performance of 4 Automated SARS-CoV-2 Serology Assay Platforms in a Large Cohort Including Susceptible COVID-19-Negative and COVID-19-Positive Patients.

BACKGROUND: Anti-SARS-CoV-2 serological responses may have a vital role in controlling the spread of the disease. However, the comparative performance of automated serological assays has not been determined in susceptible patients with significant comorbidities. METHODS: In this study, we used large numbers of samples from patients who were negative (n = 2030) or positive (n = 112) for COVID-19 to compare the performance of 4 serological assay platforms: Siemens Healthineers Atellica IM Analyzer, Siemens Healthineers Dimension EXL Systems, Abbott ARCHITECT, and Roche cobas. RESULTS: All 4 serology assay platforms exhibited comparable negative percentage of agreement with negative COVID-19 status ranging from 99.2% to 99.7% and positive percentage of agreement from 84.8% to 87.5% with positive real-time reverse transcriptase PCR results. Of the 2142 total samples, only 38 samples (1.8%) yielded discordant results on one or more platforms. However, only 1.1% (23/2030) of results from the COVID-19-negative cohort were discordant. whereas discordance was 10-fold higher for the COVID-19-positive cohort, at 11.3% (15/112). Of the total 38 discordant results, 34 were discordant on only one platform. CONCLUSIONS: Serology assay performance was comparable across the 4 platforms assessed in a large population of patients who were COVID-19 negative with relevant comorbidities. The pattern of discordance shows that samples were discordant on a single assay platform, and the discordance rate was 10-fold higher in the population that was COVID-19 positive.

Educational and Electronic-Based Tools to Mitigate the Risk of Transfusion Adverse Events.

ABSTRACT: The transfusion of blood products is a widely used practice but comes with the risk of transfusion-associated adverse events and fatalities. The primary aim of this study was to evaluate if strict adherence to transfusion guidelines would lead to a decrease in the rate of transfusion reactions that occurred when blood products were given outside of established indications. Hospital-wide educational programs and dedicated electronic transfusion order sets were used to encourage adherence to guidelines. A secondary aim of this study was to evaluate if a decrease in the incidence of transfusion reactions also lead to a decrease in associated healthcare costs.

Validation of COVID-19 serologic tests and large scale screening of asymptomatic healthcare workers.

OBJECTIVES: Serologic testing for SARS-CoV-2 is an important element in the fight to slow the COVID-19 pandemic. This study aimed to validate two serologic tests for total (IgM, IgG, IgA) SARS-CoV-2 antibodies, (i) the Ortho-Clinical Diagnostics Anti-SARS-CoV-2 Total Antibody assay for the Vitros 5600 analyzers and (ii) a manual laboratory developed ELISA (FDA EUA pending), for use in parallel orthogonal testing of asymptomatic healthcare workers and affiliates of the University of Maryland Medical System. DESIGN AND METHODS: Validation and verification of the two tests was performed using samples from hospitalized patients that were found to be PCR positive for SARS-CoV-2, samples pre-COVID-19, and samples from individuals with current/previous infections with other viruses. Healthcare workers and affiliates from across the University of Maryland Health System were provided testing free of charge and their results were reported as reactive or non-reactive if the two tests were concordance, or indeterminate if the results were discordant. RESULTS: Validation testing found the Ortho Vitros test to be 100% (73/73) sensitive, and 99.3% (152/153) specific, while the UMMC ELISA was found to be 97.6% (204/209) sensitive and 100% (288/288) specific. Real world testing among 8399 healthcare workers found that 2.9% (247/8399) of healthcare workers were positive for anti- SARS-CoV-2 antibodies by both tests. An indeterminate rate of 1.1% (91/8399), in which one test reported reactive results, and one as non-reactive was also seen. CONCLUSIONS: Parallel orthogonal testing improves the positive and negative predictive value of serologic testing in populations with low prevalence. The use of an indeterminate result from parallel orthogonal testing allows for the follow-up and re-testing, which helps resolve discrepancies between assays.

Predictive Performance of Traumatic Brain Injury Biomarkers in High-Risk Elderly Patients.

BACKGROUND: Serum glial fibrillary acidic protein (GFAP) and ubiquitin carboxyl-terminal esterase L1 (UCH-L1) have recently received US Food and Drug Administration approval for prediction of abnormal computed tomography (CT) in mild traumatic brain injury patients (mTBI). However, their performance in elderly patients has not been characterized. METHODS: We performed a posthoc analysis using the A Prospective Clinical Evaluation of Biomarkers of Traumatic Brain Injury (ALERT-TBI) study data. Previously recorded patient variables and serum values of GFAP and UCH-L1 from mTBI patients were partitioned at 65 years of age (herein referred to as ≥65, high-risk; <65, low-risk). We sought to assess the influence of age on predictive performance, sensitivity, and negative predictive value (NPV) of serum UCH-L1 and GFAP to predict intracranial injury by CT. RESULTS: Elderly mTBI patients constituted 25.7% of the patient cohort (n = 504/1959). Sensitivity and NPV of GFAP/UCH-L1 were 100%, with no significant difference from younger patients (P = 0.5525 and P > 0.9999, respectively). Specificity was significantly lower in elderly patients (0.131 vs 0.442; P < 0.0001) and decreased stepwise with older age. Compared to younger patients, elderly mTBI patients without abnormal (i.e., normal) CT findings also had a significantly higher GFAP (38.6 vs 16.2 pg/mL; P < 0.0001) and UCH-L1 (347.4 vs 232.1 pg/mL; P < 0.0001). CONCLUSIONS: Sensitivity and NPV to predict intracranial injury by CT was nearly identical between younger and elderly mTBI patients. Decrements in specificity and increased serum values suggest that special deference may be warranted for elderly patients.