【摘要】：目的評(píng)價(jià)國(guó)產(chǎn)透景試劑(透景HPV)用于HR-HPV DNA檢測(cè)及宮頸病變?cè)\斷的有效性和可行性。方法 602例來(lái)自醫(yī)院門(mén)診健康體檢的婦女或者宮頸上皮內(nèi)瘤變(CIN)住院治療的患者,經(jīng)病理學(xué)明確診斷。采用透景試劑和Roche試劑(cobas HPV)平行檢測(cè)子宮頸脫落細(xì)胞標(biāo)本,比較兩種方法的一致性。以病理診斷結(jié)果作為金標(biāo)準(zhǔn),評(píng)估透景試劑和Roche試劑篩查子宮頸上皮內(nèi)瘤變的敏感性和特異性。結(jié)果透景試劑與Roche試劑總一致率為94.62%(Kappa=0.881),陽(yáng)性一致率為96.85%,陰性一致率為90.53%;透景試劑與Roche試劑HPV16、HPV18及其他12種高危型HPV的總一致率分別為95.92%(Kappa=0.906),98.70%(Kappa=0.885)和92.76%(Kappa=0.805)。校正后兩種檢測(cè)的總一致率為98.51%(Kappa=0.967),陽(yáng)性一致率為98.87%,陰性一致率為97.81%;校正后HPV16,HPV18及其他12種高危型HPV的總一致率分別為97.40%(Kappa=0.940),100%(Kappa=1.00)和97.58%(Kappa=0.950)。透景試劑篩查CIN2+的敏感性和特異性分別為91.52%和52.06%,Roche試劑篩查CIN2+的敏感性和特異性分別為91.52%和54.29%,無(wú)統(tǒng)計(jì)學(xué)差異(P0.05)。結(jié)論國(guó)產(chǎn)透景試劑與進(jìn)口Roche試劑檢測(cè)HR-HPV的一致性高,是有效的HPV DNA檢測(cè)方法,可用于人群中宮頸癌和癌前病變的篩查。
[Abstract]:Objective to evaluate the effectiveness and feasibility of domestic HPV for detection of HR-HPV DNA and diagnosis of cervical lesions. Methods 602 patients with cervical intraepithelial neoplasia (CIN) were diagnosed by pathology. Parallel detection of exfoliated cells of cervix with Roche reagent and Roche reagent was used to compare the consistency of the two methods. The sensitivity and specificity of screening cervical intraepithelial neoplasia were evaluated with the diagnostic results of pathology and Roche reagent. Results the total consistent rate of Roche reagent and transparent reagent was 94.62% (Kappa=0.881), the positive consistency rate was 96.85 and the negative consistency rate was 90.53%. The concordance rates of permeation reagent with Roche reagent, HPV16,HPV18 and other 12 high risk HPV were 95.92% (Kappa=0.906), 98.70% (Kappa=0.885) and 92.76% (Kappa=0.805), respectively. After correction, the total consistency rate of the two tests was 98.51% (Kappa=0.967), the positive consistency rate was 98.87%, and the negative consistency rate was 97.81%. The total consistent rates of HPV16,HPV18 and other high risk HPV were 97.40% (Kappa=0.940), 100% (Kappa=1.00) and 97.58% (Kappa=0.950), respectively. The sensitivity and specificity of roche reagent in screening CIN2 were 91.52% and 52.06%, respectively. The sensitivity and specificity of Roche reagent were 91.52% and 54.29%, respectively. There was no statistical difference (P0.05). Conclusion there is a high consistency between domestic and imported Roche reagent for detection of HR-HPV, which is an effective method for HPV DNA detection and can be used for screening cervical cancer and precancerous lesions in the population.
【作者單位】： 北京協(xié)和醫(yī)學(xué)院/中國(guó)醫(yī)學(xué)科學(xué)院腫瘤醫(yī)院流行病學(xué)研究室;大連醫(yī)科大學(xué)公共衛(wèi)生學(xué)院流行病與衛(wèi)生統(tǒng)計(jì)學(xué)教研室;
【分類(lèi)號(hào)】：R737.33

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