金标数码定量阅读仪QPAD的性能验证

Performance verification for quantitative gold standard digital reading device QPAD

目的评价金标数码定量阅读仪QPAD检测尿HCG的分析性能。方法选取48个反应板分别连续在本仪器上读数10次,验证仪器精密度;14份标本一天内分别重复检测10次,计算批内的标准差(s)和变异系数(CV),用于批内精密度验证;选择2份样本每天早、晚各测1次,连续10天,计算批间精密度;190份标本用试剂条法和反应板法平行检测计算两者符合率,选择高、中、低标本各2份在QPAD和CI8200上平行测定,计算相对偏倚;用含量为5 810mIU/mL的标本进行倍比稀释,确定仪器灵敏度,且结果同CI8200进行回归分析;观察混浊尿、血尿标本对检验结果的影响。结果反应板连续读数10次,结果显示平均CV为1.1%;批内试验平均CV为6.23%,其中8份标本CV在4.60%以下,批间试验CV分别是14.29%、15.36%。QPAD和试剂条结果符合率98.95%;QPAD和CI8200相对偏倚为-10.65%～-4.34%。标本稀释试验确定QPAD检测尿HCG的灵敏度为21mIU/mL;QPAD和CI8200检测尿HCG相关系数为R2=0.976 7。2例花板,尿标本经离心、过滤后重测,结果为阴性,背景清晰。结论金标数码定量阅读仪QPAD的主要分析性能满足临床检验尿HCG检测有关技术要求,可用于临床检验。

Objective To evaluate the analytical performance of quantitative gold standard digital reading device QPAD on detec- tion of HCG in urine. Methods 48 reaction boards were selected to read 10 times continuously on QPAI） respectively to verify in- strument precision. 14 specimens were tested 10 times respectively within a day and the standard deviation and coefficient of varia tion CV were ealculated as within-run precision vahdation. Two samples were detected twice per day in the morning and evening for 10 consecutive days so as to calculate between run precision. 190 specimens were parallelly detected with the reagent strip method and reaction plate method and the coincidence rate was calculated. Each two samples of high,low,medium groups were collected and measured twice with QPAD and （318200 respectively and the relative bias was calculated. One sample with the content of 5810 mlU/ mE was diluted and measured to determine the instrument sensitivity, and the results was carried out regression analysis with C18200. The effects of turbid urine and blood urine specimen on test results were observed. Results Consecutive readings 10 times of reaction board showed an average CV of 1.1%. The average CV of withln-run precision was 6.23% with 8 specimens CV below 4.60%and the between--run precision was 14.29% and 15.36% respectively. The consistent rate of the reagent strip method and reaction plate method reached to 98.95% and the relative bias for QPAD and CI8200 was - 10.65%- 4.34%. The sensitivity of detection HCG in urine was 21 mIU/mL determined by sample dilution test. The correlation coefficient of QPAD and C18200 on de tection of HCG was R2=0. 9767.2 cases of reaction plate variegated, urine samples were retested after centrifugation and filtration, the results were negative with clear background. Conclusion The main analytical performance for quantitative gold standard digital reading device QPAD can meet the technical requirements related to clinical laboratory detection of HCG in urine, so QPAD could be used for clinical examination.