海南医学
海南醫學
해남의학
Hainan Medical Journal
2015年
19期
2882-2884
,共3页
胶乳增强免疫透射比浊法%中性粒细胞明胶酶相关脂质运载蛋白%性能%评价
膠乳增彊免疫透射比濁法%中性粒細胞明膠酶相關脂質運載蛋白%性能%評價
효유증강면역투사비탁법%중성립세포명효매상관지질운재단백%성능%평개
Latex-enhanced immunoturbidimetric assay%Neutrophil gelatinase-associated lipocalin%Perfor-mance%Evaluation
目的 评价胶乳增强免疫透射比浊法商品化试剂盒测定中性粒细胞明胶酶相关脂质运载蛋白(NGAL)的性能.方法 分析商品化NGAL胶乳增强免疫透射比浊法试剂盒在全自动生化分析仪上检测的精密度、准确度、线性、抗干扰能力和比对实验等性能.结果 检测的准确度较好,批内精密度(CV)≤10%,批间精密度(CV)≤15%,NGAL浓度在25~2 565 ng/ml范围内,理论值与实测值均呈线性相关,相关系数r≥0.990;检测不同浓度干扰物(甘油三酯、胆红素、血红蛋白、抗坏血酸)时,其干扰程度≤10%,NGAL试剂盒的检测结果均不受影响.两个不同全自动生化分析仪厂家间比较,相关系数为0.996,线性回归方程为y=0.994x-5.388,预期偏差可接受.结论 该商品化NGAL试剂盒的准确度、精密度、线性范围和抗干扰能力均良好,可批量测定,且快速、操作方便、简单,可作为临床常规NGAL测定方法使用.
目的 評價膠乳增彊免疫透射比濁法商品化試劑盒測定中性粒細胞明膠酶相關脂質運載蛋白(NGAL)的性能.方法 分析商品化NGAL膠乳增彊免疫透射比濁法試劑盒在全自動生化分析儀上檢測的精密度、準確度、線性、抗榦擾能力和比對實驗等性能.結果 檢測的準確度較好,批內精密度(CV)≤10%,批間精密度(CV)≤15%,NGAL濃度在25~2 565 ng/ml範圍內,理論值與實測值均呈線性相關,相關繫數r≥0.990;檢測不同濃度榦擾物(甘油三酯、膽紅素、血紅蛋白、抗壞血痠)時,其榦擾程度≤10%,NGAL試劑盒的檢測結果均不受影響.兩箇不同全自動生化分析儀廠傢間比較,相關繫數為0.996,線性迴歸方程為y=0.994x-5.388,預期偏差可接受.結論 該商品化NGAL試劑盒的準確度、精密度、線性範圍和抗榦擾能力均良好,可批量測定,且快速、操作方便、簡單,可作為臨床常規NGAL測定方法使用.
목적 평개효유증강면역투사비탁법상품화시제합측정중성립세포명효매상관지질운재단백(NGAL)적성능.방법 분석상품화NGAL효유증강면역투사비탁법시제합재전자동생화분석의상검측적정밀도、준학도、선성、항간우능력화비대실험등성능.결과 검측적준학도교호,비내정밀도(CV)≤10%,비간정밀도(CV)≤15%,NGAL농도재25~2 565 ng/ml범위내,이론치여실측치균정선성상관,상관계수r≥0.990;검측불동농도간우물(감유삼지、담홍소、혈홍단백、항배혈산)시,기간우정도≤10%,NGAL시제합적검측결과균불수영향.량개불동전자동생화분석의엄가간비교,상관계수위0.996,선성회귀방정위y=0.994x-5.388,예기편차가접수.결론 해상품화NGAL시제합적준학도、정밀도、선성범위화항간우능력균량호,가비량측정,차쾌속、조작방편、간단,가작위림상상규NGAL측정방법사용.
Objective To evaluate the performance of latex-enhanced immunoturbidimetric assay in the de-termination of neutrophil gelatinase-associated lipocalin (NGAL). Methods The precision, accuracy, linearity and anti-jamming performances were evaluated during the tests on a fully automatic biochemical analyzer with the com-mercialized kit of latex-enhanced immunoturbidimetric assay for NGAL. Results A good accuracy was obtained, with the intra specific variation coefficient (CV) of≤10%and the inter specific variation coefficient (CV) of≤15%. The measured values were linearly related to the theoretical values when the concentrations of NGAL were in the range of 25~2 565 ng/ml (r≥0.990). It was observed that the interfering components had no impact on the test results from NGAL kits when different concentrations of the interfering components (such as triglycerides, bilirubin, hemo-globin, ascorbic acid) were presented in the test, with the degree of interference≤10%. Comparison between two dif-ferent automatic biochemical analyzer manufacturer showed r2=0.996, y=0.994x-5.388. The bias was acceptable be-tween the two systems. Conclusion The accuracy, precision, linearity and anti-interference ability of commercial-ized kit for NGAL evaluation are excellent. The kit is suitable for a great quantity samples analyzing, and the assay is fast, simple, and can be easily operated, which can be used as a routine clinical method for NGAL determination.
