Performance of the Reflotron and the Seralyzer in primary health care

Abstract

Results from an external quality control of 212 Reflotron and 19 Seralyzer primary care users are presented and compared with performance in 60 hospital laboratories. Respondent deviation was assessed by testing for differences in the distribution of individual deviations from an assigned value for hospital laboratories, or from a general average of the measurement procedure for the Reflotron or the Seralyzer users respectively. Respondent deviation in the Reflotron group matched hospital laboratory deviation, whereas deviation in the Seralyzer group was larger for aspartate aminotransferase, cholesterol and potassium. Seralyzer deviation was larger compared with Reflotron deviation. Imprecision was better in the hospital group than in the Reflotron group for alanine aminotransferase, aspartate aminotransferase, bilirubin, and creatinine whereas Reflotron users performed better than hospitals and Seralyzer users for uric acid; the Seralyzer group was inferior to hospitals for aspartate aminotransferase and potassium. The analytical quality of a subgroup of 138 Reflotron and 18 Seralyzer primary care users was assessed and these users were divided into ‘good’ and ‘other’ categories. Good performance was associated independently with use of the Reflotron, with operation by laboratory educated personnel, and with doing comparably few analyses per week. We conclude that the Reflotron is suitable for primary case use whereas the Seralyzer is less suitable.

Key Words:

• dry chemistry instruments
• external quality control
• laboratory deviation
• laboratory
• operating conditions
• imprecision