国际检验医学杂志
國際檢驗醫學雜誌
국제검험의학잡지
INTERNATIONAL JOURNAL OF LABORATORY MEDICINE
2014年
13期
1778-1780
,共3页
马艳侠%肇玉博%王丽%陈静宏
馬豔俠%肇玉博%王麗%陳靜宏
마염협%조옥박%왕려%진정굉
纤维蛋白原%实验室技术和方法%等效性
纖維蛋白原%實驗室技術和方法%等效性
섬유단백원%실험실기술화방법%등효성
fibrinogen%laboratory techniques and procedures%equivalent
目的：某国产纤维蛋白原凝固法-Clauss 法试剂在日本 Sysmex CA1500血凝仪上的临床性能验证。方法国产纤维蛋白原试剂为 A 试剂，德国西门子 Dade Thrombin Reagent 试剂为 D 试剂，均采用 Clauss 法，分别测试两个水平质控品的批内精密度、批间精密度；165例正常临床样本用 A 试剂进行参考值范围验证；用 A 试剂和 D 试剂的200例临床样本纤维蛋白原结果比对，进行显著性检验和等效性检验。结果A 试剂和 D 试剂两个水平质控的批内精密度 CV 分别为4．28％、6．98％和3．45％、5．22％，A 试剂和 D 试剂两个水平质控的批间精密度 CV 分别为6．23％、10．34％和6．20％、9．89％，差异均无统计学意义（P ＞0．05）；A 试剂参考值范围为2．08～3．92 g/L；A 试剂和 D 试剂临床样本的纤维蛋白原结果比对，差异有统计学意义（P ＝0．025）；但是，两组试剂结果均数之差的90％双侧可信区间（90％CI ：-0．09，0．15）位于等效区间（-0．27，0．27）内。结论国产纤维蛋白原凝固法-Clauss 法试剂结果可靠，适用于日本 Sysmex CA1500血凝仪，和德国西门子 Dade 试剂临床应用等效。
目的：某國產纖維蛋白原凝固法-Clauss 法試劑在日本 Sysmex CA1500血凝儀上的臨床性能驗證。方法國產纖維蛋白原試劑為 A 試劑，德國西門子 Dade Thrombin Reagent 試劑為 D 試劑，均採用 Clauss 法，分彆測試兩箇水平質控品的批內精密度、批間精密度；165例正常臨床樣本用 A 試劑進行參攷值範圍驗證；用 A 試劑和 D 試劑的200例臨床樣本纖維蛋白原結果比對，進行顯著性檢驗和等效性檢驗。結果A 試劑和 D 試劑兩箇水平質控的批內精密度 CV 分彆為4．28％、6．98％和3．45％、5．22％，A 試劑和 D 試劑兩箇水平質控的批間精密度 CV 分彆為6．23％、10．34％和6．20％、9．89％，差異均無統計學意義（P ＞0．05）；A 試劑參攷值範圍為2．08～3．92 g/L；A 試劑和 D 試劑臨床樣本的纖維蛋白原結果比對，差異有統計學意義（P ＝0．025）；但是，兩組試劑結果均數之差的90％雙側可信區間（90％CI ：-0．09，0．15）位于等效區間（-0．27，0．27）內。結論國產纖維蛋白原凝固法-Clauss 法試劑結果可靠，適用于日本 Sysmex CA1500血凝儀，和德國西門子 Dade 試劑臨床應用等效。
목적：모국산섬유단백원응고법-Clauss 법시제재일본 Sysmex CA1500혈응의상적림상성능험증。방법국산섬유단백원시제위 A 시제，덕국서문자 Dade Thrombin Reagent 시제위 D 시제，균채용 Clauss 법，분별측시량개수평질공품적비내정밀도、비간정밀도；165례정상림상양본용 A 시제진행삼고치범위험증；용 A 시제화 D 시제적200례림상양본섬유단백원결과비대，진행현저성검험화등효성검험。결과A 시제화 D 시제량개수평질공적비내정밀도 CV 분별위4．28％、6．98％화3．45％、5．22％，A 시제화 D 시제량개수평질공적비간정밀도 CV 분별위6．23％、10．34％화6．20％、9．89％，차이균무통계학의의（P ＞0．05）；A 시제삼고치범위위2．08～3．92 g/L；A 시제화 D 시제림상양본적섬유단백원결과비대，차이유통계학의의（P ＝0．025）；단시，량조시제결과균수지차적90％쌍측가신구간（90％CI ：-0．09，0．15）위우등효구간（-0．27，0．27）내。결론국산섬유단백원응고법-Clauss 법시제결과가고，괄용우일본 Sysmex CA1500혈응의，화덕국서문자 Dade 시제림상응용등효。
Objective To validate the clinical performance of a domestic fibrinogen reagent by freezing method(Clauss method) on the coagulometer Japan Sysmex CA1500.Methods The domestic fibrinogen reagent as the reagent A and the Germany Siemens Dade thrombin reagent as the reagent D,the Clauss method was adopted to measure the within-run precision and between-run preci-sion in two levels of quality control respectively.The reference value range was verified by the reagent A in 165 cases of normal clin-ical samples.The fibrinogen detection results in 200 cases of clinical samples were compared between by the reagent A and the rea-gent D.The significance test and the equivalence test were performed.Results The within-run precision CV of the reagent A and D in two levels of quality control were 4.28%,6.98% and 3.45%,5.22% respectively,the between-run precision CV of the reagent A and D in two levels of quality control were 6.23%,10.34% and 6.20%,9.89% respectively,the differences had no statistical significance(P >0.05).The reference value range of the reagent A was 2.08 -3.92 g/L.The fibrinogen detection results of the clinical samples by the reagent A and D had the statistically significant differences (P =0.025).But the 90% bilateral confidence in-terval(90%CI :-0.09,0.15)of the difference in the mean detection results by these two reagents located in the equivalent interval (-0.27,0.27).Conclusion The domestic fibrinogen reagent for Clauss method has reliable detection results and is suitable for the coagulometer Japan Sysmex CA1500,which is equivalent to the clinical application of Germany Siemens Dade thrombin reagent.
