快速核酸檢測(cè)儀性能的測(cè)定方法 編制說明

3 3 4 4 4 5 5 5 6 47 47 47 47 47 47 47快速核酸檢測(cè)儀通常是基于實(shí)時(shí)熒光PCR技術(shù)或等溫?cái)U(kuò)增技術(shù)的小型化個(gè)體化用藥檢測(cè)等多種快速核酸檢測(cè)，應(yīng)用面及數(shù)量都仍在不斷提升。2020年復(fù)雜度的實(shí)驗(yàn)室級(jí)別。經(jīng)過多年發(fā)展，目前快速核酸檢測(cè)儀產(chǎn)品包括卡尤迪全國(guó)儀器分析測(cè)試標(biāo)準(zhǔn)化技術(shù)委員會(huì)對(duì)《快速核酸檢測(cè)儀性能的測(cè)定方法》標(biāo)準(zhǔn)申報(bào)稿起草單位中國(guó)海關(guān)科學(xué)技術(shù)研究中心會(huì)同中國(guó)測(cè)試技術(shù)研究院、GB/T41521多指標(biāo)核酸恒溫?cái)U(kuò)增檢4、符合我國(guó)當(dāng)前大力提升檢測(cè)技術(shù)的要求，能夠滿足我國(guó)對(duì)進(jìn)口儀器性能NuRapid-Ⅱpocket25.17799Max=T1-T2/tV升Max=T1-7799Max=T1-T2/tV升Max=T1-3355Max=T1-T2/tV升Max=T1-7799Max=T1-T2/tV升Max=T1-≥6.2設(shè)定溫度(℃)平均溫度(℃)溫度偏差(℃)升溫速率(℃)≥1.5℃/秒≥1.5℃/秒≥3.5℃/秒≥3.5℃/秒間42℃42℃間t1(42.342.242.425.042.9626.3226.3≥4.5設(shè)定溫度(℃)平均溫度(℃)溫度偏差(℃)降溫速率(℃)≥1.5℃/秒≥1.5℃/秒12345228.6478238.6488268.6△T1=(TMax-△T1=(TMax-△T1=(TMax-△T1=(TMax-△T1=(TMax-△T1=(TMax-△T1=(TMax-△T1=(TMax-△T1=(TMax-△T1=(TMax-△T1=(TMax-△T1=(TMax-△T1=(TMax-△T1=(TMax-△T1=(TMax-最大值△Tmax最大值△Tmax最大值△Tmax℃≤0.1度溫度(℃)度溫度(℃)精度(℃)ΔT1=(TMax-4241.84241.942.141.842.141.842.442.142.442.2123228.6478238.6488248.6498258.6268.6278.6402.5288.6412.5298.6422.5℃≤0.1溫度(℃)溫度(℃)溫度(℃)41.941.842.441.941.842.441.841.842.441.841.842.441.941.842.441.942.042.441.842.042.441.842.042.341.941.842.241.941.842.341.942.042.342.042.042.342.042.042.342.042.042.341.942.042.341.942.042.342.042.042.342.042.042.442.042.042.441.942.042.441.942.142.441.942.042.441.942.042.441.941.942.442.041.942.442.042.042.441.942.042.441.942.042.242.042.042.441.942.042.4424242控溫精度△T=TMax-控溫精度△T=TMax-控溫精度△T=TMax-℃≤0.4溫度(℃)溫度(℃)溫度(℃)溫度(℃)溫度(℃)溫度(℃)溫度(℃)溫度(℃)溫度(℃)溫度(℃)溫度(℃)溫度(℃)度度△T=TMax--1℃<△T<1℃-1℃<△T<1℃-1℃<△T<1℃42.041.942.242.142.242.142.242.142.142.142.242.142.242.142.142.142.142.142.142.142.242.142.242.142.242.142.242.142.242.142.242.142.242.142.242.142.142.142.242.142.142.142.242.142.242.142.242.142.242.142.142.142.242.142.142.142.142.142.242.142.242.142.242.142.142.142.142.142.242.142.242.142.242.142.242.142.242.140.640.4t1t2t3t4t5差%±5≤±5%測(cè)試記錄周期：30s下---溫度持續(xù)時(shí)42.041.942.242.142.242.142.242.142.142.142.242.142.242.142.142.142.142.142.142.142.242.142.242.142.242.142.242.142.242.142.242.142.242.142.242.142.142.142.242.142.142.142.242.142.242.142.242.142.242.142.142.142.242.142.142.142.142.142.242.142.242.142.242.142.142.142.142.142.242.142.242.142.242.142.242.142.242.140.640.4高中低高中低高中低123456789高中低高中低123456789Atto425%≤0.5均528096.829198.427121.54045值1234Atto425%4.98%4.87%4.95%28096.829198.427121.5熒光參比物質(zhì)各濃度的熒光強(qiáng)度值與稀釋比例的線性回歸相關(guān)系數(shù)（r）應(yīng)r度孔1孔2孔3孔1孔2孔3074986842883947606166762977015745475096278419469888812324612789043474423825480258033749281149317514907310693337700777367723706581764187940411801608774R/≥0.9905R性能指標(biāo)PCR技術(shù)恒溫?cái)U(kuò)增技術(shù)P1000FDx優(yōu)思達(dá)UP0102宏微特斯HWTS-迪械檢驗(yàn)研究所P1000FDxab-NT1優(yōu)思達(dá)UC0104優(yōu)思達(dá)UC0104優(yōu)思達(dá)UC0208優(yōu)思達(dá)UC0208NuRapid-Ⅱ訊識(shí)平均升溫速率29.782.9平均降溫速率//////溫度波動(dòng)度(控溫精度)±0.2℃A55℃:A72℃:A95℃:B55℃:±0.2℃/B72℃:B95℃:0.139℃0.035℃0.139℃0.035℃溫度偏差±0.5℃A55℃:A72℃:A95℃:B55℃:0.334（Max）±0.5℃0.01/ 0.21模塊溫度均勻度獨(dú)立模塊A95℃:A55℃:A72℃:B95℃:B55℃:/獨(dú)立模塊/獨(dú)立模塊//溫度持續(xù)時(shí)間誤差±10%2.22.082.852.7±10%2.772.5%/熒光強(qiáng)度重復(fù)性%~0.:::熒光強(qiáng)度均勻度獨(dú)立模塊2.02.04.014.07%~4.2.5/:::2.11%FAM：2.32FAM：2.322.412.414.1399/熒光強(qiáng)度線性0.995946210.99770.9948～0.9985/全流程檢測(cè)時(shí)間40min/46min/58min22min40min48min2