Pugia M J, Lott J A, Luke K E, Shihabi Z K, Wians F H, Phillips L
Diagnostics Business Group, Bayer Corporation, Elkhart, Indiana, USA.
J Clin Lab Anal. 1998;12(5):280-4. doi: 10.1002/(sici)1098-2825(1998)12:5<280::aid-jcla5>3.0.co;2-a.
Three hospital sites evaluated the Bayer two-pad urine dipstick as a screening test for microalbuminuria. One pad estimates albumin concentrations between 10 and 150 mg/L, and the second estimates creatinine values between 300 and 3,000 mg/L. The Boehringer Mannheim (BMD) Micral dipstick was also compared and evaluated. The accuracy of the dipsticks was judged by comparison with cuvet-based immunonephelometry for albumin and to standard rate-Jaffe methods for creatinine; these assays were well standardized and controlled and were assumed to give accurate values. Precision of these methods and that of the dipsticks was determined by multiple assays of control materials. Visual or instrument (Clinitek 50 or 100) evaluation of the Bayer or visual checks of the BMD albumin dipstick pad with patients' urines gave clinically acceptable accuracy. The albumin/creatinine ratio from the Bayer dipsticks gave better accuracy for albumin excretion than the albumin pads alone from either manufacturer. This ratio should permit making a good estimate of the 24-hr albumin excretion in a randomly collected urine.
三个医院站点对拜耳双垫尿试纸作为微量白蛋白尿的筛查测试进行了评估。一个试纸垫用于估计白蛋白浓度在10至150毫克/升之间，另一个试纸垫用于估计肌酐值在300至3000毫克/升之间。同时对罗氏（BMD）微量白蛋白尿试纸进行了比较和评估。通过与基于比色杯的白蛋白免疫比浊法以及肌酐的标准速率-贾菲法进行比较来判断试纸的准确性；这些检测方法经过了良好的标准化和控制，并假定能给出准确值。通过对对照材料进行多次检测来确定这些方法和试纸的精密度。对拜耳试纸进行视觉或仪器（Clinitek 50或100）评估，或对罗氏白蛋白试纸垫与患者尿液进行视觉检查，均获得了临床可接受的准确性。与单独使用任一制造商的白蛋白试纸垫相比，拜耳试纸的白蛋白/肌酐比值在白蛋白排泄方面具有更高的准确性。该比值应有助于对随机收集尿液中的24小时白蛋白排泄量做出良好估计。
