類風濕因子質控：背(bei)景(jing)介紹：類(lei)風(feng)濕因子(zi)(zi)(rheumatoid factor, RF)是(shi)以變性IgG的Fc片段為靶抗(kang)(kang)(kang)原的自身(shen)(shen)抗(kang)(kang)(kang)體(ti)。類(lei)風(feng)濕關(guan)節炎(yan)相關(guan)自身(shen)(shen)抗(kang)(kang)(kang)體(ti)之一。RF不(bu)僅(jin)與變性的IgG分(fen)子(zi)(zi)反應，也與自身(shen)(shen)lgG或異體(ti)lgG分(fen)子(zi)(zi)反應，還可與其(qi)他抗(kang)(kang)(kang)原如核蛋白(bai)發生交(jiao)叉反應。

產品(pin)名稱：類風濕因子-質控

包裝規格(ge)：0.5ml/支

性能指標：淡黃色微(wei)濁液體

使用(yong)方法：于室溫適(shi)當平衡，輕啟瓶塞，搖勻即可(ke)使用(yong)

生(sheng)物指標(biao)：HBsAg、HIV-Ab、HCV-AB、RPR-Ab檢測陰性，但仍(reng)需(xu)按(an)臨標(biao)本處理。

互(hu)通(tong)性：本(ben)品為BSA基質加目的(de)標(biao)物制備，與人新鮮血清具(ju)有互(hu)通(tong)性

質控品定值

1.質(zhi)控(kong)(kong)品(pin)(pin)的(de)(de)來(lai)(lai)(lai)源：質(zhi)控(kong)(kong)品(pin)(pin)的(de)(de)來(lai)(lai)(lai)源同(tong)校準品(pin)(pin)大致相同(tong)，廠(chang)商可能會更具自己(ji)的(de)(de)要求添加了(le)很多(duo)物(wu)質(zhi)，此(ci)時(shi)有(you)(you)些(xie)物(wu)質(zhi)的(de)(de)添加量常(chang)常(chang)達到病理狀態的(de)(de)高濃度(du)，在應(ying)(ying)用(yong)于某一(yi)項(xiang)目時(shi)，對(dui)這個(ge)項(xiang)目來(lai)(lai)(lai)說基質(zhi)效應(ying)(ying)將(jiang)更大。 2. 定(ding)(ding)值(zhi)方法(fa)：有(you)(you)些(xie)廠(chang)商會給(gei)自己(ji)的(de)(de)標(biao)準品(pin)(pin)定(ding)(ding)一(yi)個(ge)定(ding)(ding)值(zhi)范圍，這個(ge)定(ding)(ding)值(zhi)范圍是(shi)(shi)(shi)由(you)廠(chang)商聯合(he)幾家使(shi)用(yong)同(tong)樣檢(jian)測(ce)(ce)(ce)系(xi)(xi)統(tong)(tong)(tong)(tong)的(de)(de)用(yong)戶，僅多(duo)次測(ce)(ce)(ce)定(ding)(ding)得出(chu)的(de)(de)均(jun)值(zhi)。此(ci)時(shi)如(ru)果將(jiang)該質(zhi)控(kong)(kong)品(pin)(pin)應(ying)(ying)用(yong)于另一(yi)個(ge)檢(jian)測(ce)(ce)(ce)系(xi)(xi)統(tong)(tong)(tong)(tong)，由(you)于方法(fa)學的(de)(de)不(bu)同(tong)，可能得出(chu)同(tong)廠(chang)商給(gei)出(chu)值(zhi)有(you)(you)較大差異的(de)(de)值(zhi)。此(ci)時(shi)不(bu)能認為該檢(jian)測(ce)(ce)(ce)系(xi)(xi)統(tong)(tong)(tong)(tong)的(de)(de)準確度(du)不(bu)佳。此(ci)時(shi)需要強(qiang)調的(de)(de)是(shi)(shi)(shi)檢(jian)測(ce)(ce)(ce)系(xi)(xi)統(tong)(tong)(tong)(tong)都是(shi)(shi)(shi)用(yong)來(lai)(lai)(lai)測(ce)(ce)(ce)定(ding)(ding)新(xin)鮮血(xue)清(qing)的(de)(de)，不(bu)是(shi)(shi)(shi)用(yong)來(lai)(lai)(lai)測(ce)(ce)(ce)定(ding)(ding)質(zhi)控(kong)(kong)品(pin)(pin)或其他(ta)物(wu)質(zhi)的(de)(de)。檢(jian)測(ce)(ce)(ce)系(xi)(xi)統(tong)(tong)(tong)(tong)只(zhi)有(you)(you)在檢(jian)測(ce)(ce)(ce)新(xin)鮮血(xue)清(qing)是(shi)(shi)(shi)得出(chu)的(de)(de)結果才具有(you)(you)溯源性。不(bu)同(tong)檢(jian)測(ce)(ce)(ce)系(xi)(xi)統(tong)(tong)(tong)(tong)之間只(zhi)有(you)(you)在檢(jian)測(ce)(ce)(ce)新(xin)鮮血(xue)清(qing)時(shi)才具可比性。

類風濕因子質控