鐵蛋白測定試劑盒(免疫比濁法)產(chǎn)品技術(shù)要求北檢

鐵蛋白測定試劑盒（免疫比濁法）適用范圍：本產(chǎn)品用于體外定量測定人血清中鐵蛋白的含量。規(guī)格具體產(chǎn)品規(guī)格見下表:包裝規(guī)格試劑1:20ml,試劑2:10ml；2:20ml；試劑1:40ml,試劑2:20ml；2:20mlX2；試劑1:40mlX3,試劑2:20mlX3；試劑1:40mlX4,試劑2:40mlX2；X4；試劑1:50ml,試劑2:25ml；2:25mlX2；試劑1:50mlX3,試劑2:25mlX3；試劑1:50mlX4,試劑2:50mlX2；X4；試劑1:60ml,試劑2:30ml；2:30mlX2；試劑1:60mlX3,試劑2:30mlX3；試劑1:60mlX4,試劑2:60mlX2；試劑1:20mlX2,試劑試劑1:40mlX2,試劑試劑1:40mlX2,試劑2:40ml；試劑1:40mlX8,試劑2:40ml試劑1:50mlX2,試劑試劑1:50mlX2,試劑2:50ml；試劑1:50mlX8,試劑2:50ml試劑1:60mlX2,試劑試劑1:60mlX2,試劑2:60ml；試劑1:60mlX8,試劑2:60mlX4X4。X4X4。X4；試劑1:70ml,試劑2:35ml；2:35mlX2；試劑1:70mlX3,試劑2:35mlX3；試劑1:70mlX4,試劑2:70mlX2；X4；試劑1:80ml,試劑2:40ml；2:40mlX2；試劑1:80mlX3,試劑2:40mlX3；試劑1:80mlX4,試劑2:80mlX2；X4；試劑1:90ml,試劑2:45ml；2:45mlX2；試劑1:90mlX3,試劑2:45mlX3；試劑1:90mlX4,試劑2:90mlX2；X4；試劑1:100ml,試劑2:50ml；2:50mlX2；試劑1:100mlX3,試劑2:50mlX3；2:100ml；試劑1:100mlX4,試劑2:100mlX2；試劑1:70mlX2,試劑試劑1:70mlX2,試劑2:70ml；試劑1:70mlX8,試劑2:70ml試劑1:80mlX2,試劑試劑1:80mlX2,試劑2:80ml；試劑1:80mlX8,試劑2:80ml試劑1:90mlX2,試劑試劑1:90mlX2,試劑2:90ml；試劑1:90mlX8,試劑2:90ml試劑1:100mlX2,試劑試劑1:100mlX2,試劑試劑1:100mlX8,試劑2:100ml15%；15%；170mmol/L170mmol/L試劑空白吸光度不大于170mmol/L170mmol/L試劑空白吸光度不大于組成成分試劑1：氨基乙酸緩沖液試劑2：氨基乙酸緩沖液包被抗鐵蛋白抗體的膠乳顆粒 0.07%外觀外包裝完整無破損；試劑1：無色澄清透明液體；試劑2：乳白色懸濁液體。凈含量凈含量不低于標(biāo)示值。試劑空白吸光度在主波長570nm、副波長800nm、37℃條件下，1.5。線性線性范圍[10,450]ng/ml,相關(guān)系數(shù)r>0.990。線性偏差(50,450]ng/ml線性范圍內(nèi)，相對偏差不超過土[10,50]ng/ml線性范圍內(nèi)，絕對偏差不超過±10ng/ml。分析靈敏度檢測濃度為200ng/ml的樣本時(shí)，吸光度變化不小于0.13。重復(fù)性測試低、中、高濃度的新鮮人血清或質(zhì)控品，重復(fù)測試10次，低值：CVW15%；中值：CVW12%；高值：CVW10%。批間差用三個(gè)不同批號的試劑測試同一樣本，重復(fù)測試3次，相對極差RW10%。準(zhǔn)確度測定1