四川医学
四川醫學
사천의학
SICHUAN MEDICAL JOURNAL
2015年
1期
32-34
,共3页
HBV-DNA%质控物%均匀性%稳定性
HBV-DNA%質控物%均勻性%穩定性
HBV-DNA%질공물%균균성%은정성
HBV-DNA%quality control materials%homogeneity%stability
目的：制备HBV-DNA荧光定量PCR质控物，评价其均匀性及稳定性。方法利用混合血清样本制备质控物。依据《能力验证样品均匀性和稳定性评价指南》和ISO Guide 35标准随机抽取足够的样本，采用单因子方差分析评价质控物均匀性；用一元线性回归分析评价质控物的稳定性。结果均匀性评价结果显示样品内和样品间均匀性差异无统计学意义(P>0．05)，稳定性评价线性回归分析结果显示， HBV-DNA质控物随时间变化无明显趋势变化(P>0．05)。结论 HBV-DNA质控物制备简单，其均匀性、稳定性符合标准。
目的：製備HBV-DNA熒光定量PCR質控物，評價其均勻性及穩定性。方法利用混閤血清樣本製備質控物。依據《能力驗證樣品均勻性和穩定性評價指南》和ISO Guide 35標準隨機抽取足夠的樣本，採用單因子方差分析評價質控物均勻性；用一元線性迴歸分析評價質控物的穩定性。結果均勻性評價結果顯示樣品內和樣品間均勻性差異無統計學意義(P>0．05)，穩定性評價線性迴歸分析結果顯示， HBV-DNA質控物隨時間變化無明顯趨勢變化(P>0．05)。結論 HBV-DNA質控物製備簡單，其均勻性、穩定性符閤標準。
목적：제비HBV-DNA형광정량PCR질공물，평개기균균성급은정성。방법이용혼합혈청양본제비질공물。의거《능력험증양품균균성화은정성평개지남》화ISO Guide 35표준수궤추취족구적양본，채용단인자방차분석평개질공물균균성；용일원선성회귀분석평개질공물적은정성。결과균균성평개결과현시양품내화양품간균균성차이무통계학의의(P>0．05)，은정성평개선성회귀분석결과현시， HBV-DNA질공물수시간변화무명현추세변화(P>0．05)。결론 HBV-DNA질공물제비간단，기균균성、은정성부합표준。
Objective To prepare quality control Materials of HBV-DNA used in real-time PCR,To evaluate the homoge-neity and stability of it. Methods The quality control materials which prepared with pooled serum. According to Guidance on E-valuating the Homogeneity and Stability of Samples Used for Proficiency Testing and ISO Guide 35,we selected adequate sample at random, then evaluated the homogeneity of the control material by a one-way analysis of variance. At last the stability of the control material was evaluated using a linear regression model. Results In the homogeneity evaluation the results show that there is insig-nificant difference of the within groups and bet ween groups(P>0. 05),A linear regression based on stability evaluation indicated that the linear trend was insignificant(P>0. 05). Conclusion Quality control materials of HBV-DNA have simple preparation,by us meet the needs of the homogeneity and stability of the control material.
