【摘要】：目的探討HCV RNA、HBV DNA和HIV RNA多標(biāo)記室內(nèi)質(zhì)控品在羅氏COBAS s201核酸血篩系統(tǒng)應(yīng)用的可行性和有效性。方法用已知濃度HCV RNA、HBV DNA和HIV RNA室內(nèi)質(zhì)控標(biāo)準(zhǔn)品與核酸檢測(cè)陰性血漿按1∶2∶5∶22的體積比配制成多標(biāo)記室內(nèi)質(zhì)控品,同時(shí)配制相同濃度的單項(xiàng)目質(zhì)控品作為對(duì)照組,配制當(dāng)天(d1)用COBAS s201核酸檢測(cè)系統(tǒng)單檢模式分別檢測(cè)4次,此后每天檢測(cè)多標(biāo)記質(zhì)控品4次,連續(xù)檢測(cè)7 d,分析多標(biāo)記室內(nèi)質(zhì)控品與單項(xiàng)目質(zhì)控品Ct值的差異以及4℃條件下不同保存時(shí)間Ct值的變化。統(tǒng)計(jì)分析本室2015年1-8月使用多標(biāo)記室內(nèi)質(zhì)控品的質(zhì)控?cái)?shù)據(jù),評(píng)價(jià)該室內(nèi)質(zhì)控模式的可行性和有效性。結(jié)果多標(biāo)記室內(nèi)質(zhì)控品各項(xiàng)目與相同濃度的單項(xiàng)目質(zhì)控品檢測(cè)Ct值比較無(wú)差異(P0.05);在4℃條件下,HCV RNA和HIV RNA 7 d后的Ct值分別為(37.15±0.29)、(36.05±0.24)高于d1(P0.05),HBV DNA 6 d后的Ct值為(33.40±0.62)高于d1(P0.05)。各項(xiàng)目Ct值的均值和標(biāo)準(zhǔn)差(x±s),HCV RNA為36.41±0.77、HBV DNA為33.16±0.61、HIV RNA為35.37±0.54;3項(xiàng)目的 CV%分別為2.11%、1.86%和1.53%,均在允許范圍內(nèi)。結(jié)論核酸檢測(cè)多標(biāo)記室內(nèi)質(zhì)控品不會(huì)發(fā)生基質(zhì)效應(yīng)或被擴(kuò)增抑制,配制后多標(biāo)記室內(nèi)質(zhì)控品在4℃條件下可穩(wěn)定保存至5 d;多標(biāo)記室內(nèi)質(zhì)控品配制簡(jiǎn)便,節(jié)省試劑,可推廣應(yīng)用于血液核酸篩查室內(nèi)質(zhì)量控制。
[Abstract]:Objective to investigate the feasibility and effectiveness of HCV RNA,HBV DNA and HIV RNA multi-label indoor quality control in COBAS s201 nucleic acid screening system. Methods HCV RNA,HBV DNA and HIV RNA indoor quality control standard and nucleic acid negative plasma were used to prepare multi-label indoor quality control products according to the volume ratio of 1: 2: 5: 22, and single item quality control products of the same concentration were prepared as the control group. On the day of preparation (D1), COBAS s201 nucleic acid detection system was used to detect four times respectively, and thereafter, multi-marker quality control products were detected 4 times a day, and continuously detected for 7 days. The difference of Ct value between multi-label indoor quality control product and single item quality control product and the change of Ct value of different preservation time at 4 鈩，

本文編號(hào)：2371610