Extended clinical trial and evaluation of urea nitrogen determination with the Ektachem GLU/BUN analyzer. 1981

Z L Bandi, and J B Fuller, and D E Bee, and G P James

We followed the "abbreviated precision protocol" of the National Committee for Clinical Laboratory Standards for the evaluation of precision, accuracy, and carryover in analysis for urea nitrogen with the multilayer film analysis system ("Ektachem"). We analyzed 456 clinical samples with this instrument, by the manual urease/glucose dehydrogenase method, and with the Beckman System I GLU/BUN Analyzer. Precision and accuracy were estimated for 50, 220, 270, and 500 mg/L urea nitrogen concentrations in 100, 30, or 20 microL of serum. Potential interference of 15 compounds was evaluated. Random error (defined as 1.965 X SD) was 7, 10, 12, and 18 mg/L. Systematic error was 3, 4, 5, and 15 mg/L. Total analytical error was 11, 14, 17, and 34 mg/L for analysis of 100 microL of serum at the above-stated urea nitrogen concentrations. The greatest interference (6 mg/L) was caused by ethanol (300 mg/L) and by hemoglobin (500 mg/L) in the urea nitrogen (at 260 mg/L) determination. Urea nitrogen concentration, as determined with the Ektachem was linearly related to the expected concentration, at least up to 1187 mg/L. Carryover was not statistically significant.

UI MeSH Term Description Entries
D001806 Blood Urea Nitrogen The urea concentration of the blood stated in terms of nitrogen content. Serum (plasma) urea nitrogen is approximately 12% higher than blood urea nitrogen concentration because of the greater protein content of red blood cells. Increases in blood or serum urea nitrogen are referred to as azotemia and may have prerenal, renal, or postrenal causes. (From Saunders Dictionary & Encyclopedia of Laboratory Medicine and Technology, 1984) BUN,Nitrogen, Blood Urea,Urea Nitrogen, Blood
D002986 Clinical Trials as Topic Works about pre-planned studies of the safety, efficacy, or optimum dosage schedule (if appropriate) of one or more diagnostic, therapeutic, or prophylactic drugs, devices, or techniques selected according to predetermined criteria of eligibility and observed for predefined evidence of favorable and unfavorable effects. This concept includes clinical trials conducted both in the U.S. and in other countries. Clinical Trial as Topic
D006801 Humans Members of the species Homo sapiens. Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D001322 Autoanalysis Method of analyzing chemicals using automation. Autoanalyses

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