The ID NOW COVID-19 (IDNCOV) assay performed on the ID Now Instrument (Abbott Diagnostics, Scarborough, Inc. Scarborough, ME) is a rapid diagnostic test that can be performed in a point of care setting equivalent to CLIA waived testing.…

Alcohol and drug use have been associated with increased mortality and morbidity from thermal injury. To determine whether substance users (SUs) differed from controls, 398 burn patients were studied, of whom, 161 had a positive drug screen for either ethanol, cannabinoids, cocaine metabolites, amphetamines, phencyclidine, or benzodiazepines. SUs versus controls showed no difference in age, but had a significantly greater percentage of total burn surface area (TBSA) (25 vs. 17%), inhalation injury (29 vs. 7%), and mortality (14 vs. 3%). The alcohol users (AUs) and drug users (DUs) were similar in relation to sex, age, inhalation injury, percentage of TBSA, and type of burn. DU patients experienced the same increase in inhalation injury as the AU group compared to controls. The mortality of AU patients was twice that of DU patients and six times that of controls. The best independent predictors of death were age, inhalation injury, percentage of TBSA (p < 0.001), and ethanol use (p < 0.02).

Results between different clinical laboratory measurement procedures (CLMP) should be equivalent, within clinically meaningful limits, to enable optimal use of clinical guidelines for disease diagnosis and patient management. When laboratory test results are neither standardized nor harmonized, a different numeric result may be obtained for the same clinical sample. Unfortunately, some guidelines are based on test results from a specific laboratory measurement procedure without consideration of the possibility or likelihood of differences between various procedures. When this happens, aggregation of data from different clinical research investigations and development of appropriate clinical practice guidelines will be flawed. A lack of recognition that results are neither standardized nor harmonized may lead to erroneous clinical, financial, regulatory, or technical decisions. Standardization of CLMPs has been accomplished for several measurands for which primary (pure substance) reference materials exist and/or reference measurement procedures (RMPs) have been developed. However, the harmonization of clinical laboratory procedures for measurands that do not have RMPs has been problematic owing to inadequate definition of the measurand, inadequate analytical specificity for the measurand, inadequate attention to the commutability of reference materials, and lack of a systematic approach for harmonization. To address these problems, an infrastructure must be developed to enable a systematic approach for identification and prioritization of measurands to be harmonized on the basis of clinical importance and technical feasibility, and for management of the technical implementation of a harmonization process for a specific measurand.

Objectives-This is the first systematic review of the effectiveness of barcoding practices for reducing patient specimen and laboratory testing identification errors. Design and Methods-The CDC-funded Laboratory Medicine Best Practices Initiative systematic review methods for quality improvement practices were used. Results-A total of 17 observational studies reporting on barcoding systems are included in the body of evidence; 10 for patient specimens and 7 for point-of-care testing. All 17 studies favored barcoding, with meta-analysis mean odds ratios for barcoding systems of 4.39 (95% CI: 3.05-6.32) and for point-of-care testing of 5.93 (95% CI: 5.28-6.67). Conclusions-Barcoding is effective for reducing patient specimen and laboratory testing identification errors in diverse hospital settings and is recommended as an evidence-based "best practice." The overall strength of evidence rating is high and the effect size rating is substantial. Unpublished studies made an important contribution comprising almost half of the body of evidence.

We studied the magnitude, significance, and origin of an analytic bias that emerged between our point-of-care (POC) and our central laboratory (CL) methods for the measurement of hemoglobin A1c (HbA1c) and evaluated the analytic accuracy of 7 commonly used HbA1c methods relative to the National Glycohemoglobin Standardization Program (NGSP) reference method. The POC and CL methods were compared by split-sample analysis of clinical specimens and time series analyses of the HbA1c results reported for a 33-month period. The relative accuracies of 7 HbA1c methods were evaluated using College of American Pathologists proficiency survey results. Long-term drifts in the CL- and POC-analyzed test results caused the median intermethod bias [(POC result)-(CL result)] to increase from -0.4% to -0.9% HbA1c. Systematic biases, drifts in analytic performance over time, and intermethod variability were frequently observed among the 7 NGSP-certified HbA1c methods. Intermethod variability is a potential source of inaccuracy whenever HbA1c results are interpreted relative to universal, fixed, clinical decision thresholds.

A large percentage of children admitted to the PICU with RSV infection have myocardial damage as detected by the use of commercially available troponin assays. Additionally, in a portion of these patients, this damage is clinically significant, leading to cardiovascular instability and the need for inotropic support.

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