一種國(guó)產(chǎn)HIV核酸定量試劑與進(jìn)口試劑的對(duì)比研究
本文選題:型艾滋病病毒 + 病毒載量; 參考:《中國(guó)艾滋病性病》2017年07期
【摘要】:目的對(duì)比研究國(guó)產(chǎn)1型艾滋病病毒(HIV-1)核酸定量試劑與兩個(gè)進(jìn)口試劑的相關(guān)性和差異,以期應(yīng)用國(guó)產(chǎn)核酸定量試劑評(píng)價(jià)中國(guó)抗病毒治療患者病毒學(xué)效果的可行性。方法應(yīng)用美國(guó)國(guó)家衛(wèi)生研究院病毒學(xué)質(zhì)量評(píng)價(jià)項(xiàng)目(VQA)發(fā)放的HIV-1核糖核酸(RNA)血清樣品,比較一種國(guó)產(chǎn)核酸定量試劑與國(guó)內(nèi)市場(chǎng)常規(guī)使用的兩個(gè)進(jìn)口試劑,在測(cè)定病毒載量上的相關(guān)性和一致性。對(duì)國(guó)產(chǎn)和進(jìn)口核酸定量試劑檢測(cè)HIV-1病毒載量的結(jié)果進(jìn)行配對(duì)t檢驗(yàn),線性回歸分析和Bland-Altman分析。結(jié)果國(guó)產(chǎn)試劑和兩個(gè)進(jìn)口試劑的檢測(cè)結(jié)果的線性相關(guān)系數(shù)R2分別為0.94、0.93(P0.000 1);Bland-Altman分析三種試劑病毒載量的結(jié)果具有較高的一致性,國(guó)產(chǎn)試劑定量值與VQA病毒載量值線性相關(guān)系數(shù)R2=0.97,P0.000 1,定量單位轉(zhuǎn)換系數(shù)為1IU/mL=0.79拷貝/mL。結(jié)論國(guó)產(chǎn)HIV-1核酸定量試劑與進(jìn)口試劑在定量檢測(cè)結(jié)果上有較好的相關(guān)性和一致性,而且國(guó)產(chǎn)試劑在價(jià)格上具有優(yōu)勢(shì),在一定范圍內(nèi)可以應(yīng)用于抗病毒治療效果的評(píng)價(jià)。
[Abstract]:Objective to study the correlation and difference between domestic and imported nucleic acid quantitative reagents of HIV-1, and to evaluate the feasibility of using domestic nucleic acid quantitative reagents to evaluate the virological effect of antiviral therapy in China. Methods the serum samples of HIV-1 ribonucleic acid (HIV-1) RNA from the virology quality evaluation project of the National Institutes of Health (NIH) were used to compare a domestic nucleic acid quantitative reagent with two imported reagents which were routinely used in the domestic market. Correlation and consistency in the determination of viral load. The results of detection of HIV-1 viral load by domestic and imported nucleic acid quantitative reagents were analyzed by paired t test, linear regression analysis and Bland-Altman analysis. Results the linear correlation coefficient R ~ 2 of domestic reagent and two imported reagent were 0.94 ~ 0.93 P0.000 ~ (-1) Bland-Altman analysis results of virus load of three reagents had high consistency. The linear correlation coefficient between the quantitative value of domestic reagents and the load value of VQA virus was R _ (2) O _ (97) (P _ (0.000 1)), and the quantification unit conversion coefficient was 1IU/mL=0.79 copy / mL. Conclusion there is good correlation and consistency between domestic HIV-1 nucleic acid quantitative reagents and imported reagents, and domestic reagents have advantages in price and can be used to evaluate the effect of antiviral therapy in a certain range.
【作者單位】: 中國(guó)疾病預(yù)防控制中心性病艾滋病預(yù)防控制中心;
【基金】:國(guó)家自然科學(xué)基金(81471962) 廣西八桂學(xué)者艾滋病防控關(guān)鍵技術(shù)崗位專項(xiàng)經(jīng)費(fèi) 國(guó)家科技重大專項(xiàng)艾滋病和病毒性肝炎等重大傳染病防治(2012ZX10001-002)~~
【分類號(hào)】:R512.91
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