现代检验医学杂志
現代檢驗醫學雜誌
현대검험의학잡지
JOURNAL OF MODERN LABORATORY MEDICINE
2015年
1期
126-127,131
,共3页
陈芳芳%李家亮%张中书%王国洪
陳芳芳%李傢亮%張中書%王國洪
진방방%리가량%장중서%왕국홍
泌乳素%性能验证%精密度%准确度%线性范围
泌乳素%性能驗證%精密度%準確度%線性範圍
비유소%성능험증%정밀도%준학도%선성범위
prolactin%performance verification%precision%accuracy%linear range
目的:对BECKMAN DxI 800全自动化学发光仪检测泌乳素(PRL)的分析性能进行验证。方法参照美国临床实验室标准化协会(NCCLS)的文件,选取病人血清和质控室间质评质控品,对 PRL的批内精密度、批间精密度、准确度、线性范围等方面进行验证。结果 PRL的批内和批间精密度CV值均小于厂家声明的CV值,在允许范围内;PRL线性范围验证结果显示,a值为1.0114,r值为0.9974,均在仪器要求范围内,并具有良好的线性;PRL准确度验证结果显示,测定5份室间质评的检测结果与“靶值”的偏倚为-1.18%~-7.78%,均在室间质评的测量范围之内。结论 BECKMAN DxI 800全自动化学发光仪测定PRL在精密度、准确度、线性范围等性能指标均在仪器要求范围内,符合要求,可应用于临床检测。
目的:對BECKMAN DxI 800全自動化學髮光儀檢測泌乳素(PRL)的分析性能進行驗證。方法參照美國臨床實驗室標準化協會(NCCLS)的文件,選取病人血清和質控室間質評質控品,對 PRL的批內精密度、批間精密度、準確度、線性範圍等方麵進行驗證。結果 PRL的批內和批間精密度CV值均小于廠傢聲明的CV值,在允許範圍內;PRL線性範圍驗證結果顯示,a值為1.0114,r值為0.9974,均在儀器要求範圍內,併具有良好的線性;PRL準確度驗證結果顯示,測定5份室間質評的檢測結果與“靶值”的偏倚為-1.18%~-7.78%,均在室間質評的測量範圍之內。結論 BECKMAN DxI 800全自動化學髮光儀測定PRL在精密度、準確度、線性範圍等性能指標均在儀器要求範圍內,符閤要求,可應用于臨床檢測。
목적:대BECKMAN DxI 800전자동화학발광의검측비유소(PRL)적분석성능진행험증。방법삼조미국림상실험실표준화협회(NCCLS)적문건,선취병인혈청화질공실간질평질공품,대 PRL적비내정밀도、비간정밀도、준학도、선성범위등방면진행험증。결과 PRL적비내화비간정밀도CV치균소우엄가성명적CV치,재윤허범위내;PRL선성범위험증결과현시,a치위1.0114,r치위0.9974,균재의기요구범위내,병구유량호적선성;PRL준학도험증결과현시,측정5빈실간질평적검측결과여“파치”적편의위-1.18%~-7.78%,균재실간질평적측량범위지내。결론 BECKMAN DxI 800전자동화학발광의측정PRL재정밀도、준학도、선성범위등성능지표균재의기요구범위내,부합요구,가응용우림상검측。
Objective To detect the prolactin (PRL)analytical performance verification by BECKMAN DxI 800 automated chemiluminescence analyzer.Methods According to the American Society for Clinical Laboratory Standards (NCCLS)doc-uments,selected the patient’s serum and EQA control materials,the precision,accuracy and linearity of the BECKMAN DxI 800 automated chemiluminescence analyzer system in detecting PRL were detected.Results The CV values of intra-and in-ter-precision were less than manufacturer’s declaration,and within the allowable range.The validation results of linear range showed that,a value of 1.0114,r value of 0.9974,both within the requirements of the instrument,and has excellent lineari-ty;the relative bias between the measured results and the EQA control samples at five levels was -1.18%~-7.78%,both within the scope of the EQA measurement.Conclusion The BECKMAN DxI 800 automated chemiluminescence analyzer system in detecting PRL in precision,accuracy,linearity and other performance indicators were within the requirements of the instrument,tomeet the requirements,can be used in clinical testing.