Журнал медицинских методов диагностики
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ISSN: 2168-9784
ISSN: 2168-9784
Wanyama FM, Sekadde-Kigondu C, Maturi P
Background: Good laboratory practice requires that Clinical laboratories verifies the performance claims of a method before results generated by such an instrument can be used for decisions about patient care. Analytical evaluation of a new point of care methods should be done before its introduction into the routine use in order to confirm its declared analytical performance specifications.
Objective: To evaluate the degree of analytical accuracy of the Hemochroma POC haemoglobin reader relative to the Coulter AcT hematology analyzer.
Study design and setting: A comparative study, conducted at the University of Nairobi, Thematic unit of Clinical Chemistry Laboratory and the Department of Obstetrics and Gynecology.
Materials and methods: The evaluation was performed according to the guidelines of the European Committee for Clinical Laboratory Standards (ECCLS) and the guidelines on the evaluation of point of care testing instruments by the Australian Association of Clinical Biochemists (AACB). The analytical ability of Hemochroma POC reader (Boditech Med Inc.) to determine the levels of hemoglobin (Hb) according to the manufacturers claimed accuracy levels was evaluated using the routine 'comparative' method, Coulter AcT (Beckman Coulter Inc, Fulerton, CA 92835).
Results: Hemochroma POC hemoglobin reader yielded a correlation coefficient of 0.976 against the Coulter AcT hematology analyzer. The slope and the y-axis intercept as well as their 95% confidence intervals were 0.990 (95% CI 0.891 to 1.020) and 0.003 (95% CI -0.151 to 1.439), respectively.