Clinical Evaluation of an Algorithm for Short Sample Detection on a Multi-analyte Panel Using a Point-of-Care Analyzer

[摘要] Advances in instrument technology have led to extensive automation of the testing process. Use of information systems enables accurate and reliable tracking of laboratory test data and has facilitated the implementation of sophisticated informatics-based quality-control and quality-assurance programs. Application of quality-control systems using commercially available control samples has enabled the detection of analytical errors. In addition, use of laboratory data from patients has been helpful in detecting analytical errors as well as pre- and postanalytical errors. Examples of error detection schemes that rely on use of patient-derived data include checking of patient test results against predetermined limits or against previous values generated for the same patient (1)(2). These detection schemes, referred to as limit checks and delta checks, respectively, are in common use. Other error detection schemes that have been devised include arithmetic checks and “interchecks” on analytes that are physiologically linked, such as the anion gap, and relationships between other analytes, such as albumin and globulin or aspartate and alanine aminotransferase (3). More recently, an automated expert system that can perform thousands of rule-based checks and hundreds of statistical checks of patient test results has been introduced (4).Among the potential errors that can occur during the analytical process is the addition of insufficient sample to the reaction mixture, either by itself or because of improper dilution of the sample with reagent diluent. This type of error may be caused by a variety of factors, including insufficient sample for analysis, insufficient reagent or sample diluent, obstruction of the sample probe by fibrin or other material, or increased viscosity of the sample. This type of error usually leads to abnormally low recovery of analytes and is often referred to as a “short sample”. Many instruments use pressure transducers to verify system pressure and ensure sample integrity. However, …

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