Quantitative nucleic acid assay kit for Pichia pastoris cell residues

The invention discloses a quantitative nucleic acid assay kit for Pichia pastoris cell residues. By adopting the kit, the minimum concentration of Pichia pastoris cell DNA (deoxyribonucleic acid), which can be detected, is 1fg/[mu] l, very good specificity can be achieved while very good sensitivity...

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Hauptverfasser: SUN MINGDI, WANG BOWEI, CHEN TAO, LI YING, CHANG ZISONG, LI TING
Format: Patent
Sprache:chi ; eng
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Zusammenfassung:The invention discloses a quantitative nucleic acid assay kit for Pichia pastoris cell residues. By adopting the kit, the minimum concentration of Pichia pastoris cell DNA (deoxyribonucleic acid), which can be detected, is 1fg/[mu] l, very good specificity can be achieved while very good sensitivity is achieved, and the kit can be adopted to detect Pichia pastoris cell residue DNA in samples suchas half-finished products and finished products of vaccines; and reliable quality control evidences can be provided for production procedures of the half-finished products and the finished products ofthe vaccines, and significant guarantee can be provided for safe production and use of the vaccines. 本发明公开了一种定量Pichia pastoris细胞残留的核酸检测试剂盒,本发明可以检测出Pichia pastoris细胞DNA的最低浓度为1fg/μl,在具有非常好的灵敏度同时还具有很好的特异性,可以用于检测疫苗半成品、成品等样品中Pichia pastoris细胞残留DNA;可为疫苗半成品、成品等生产环节提供等提供可靠的质控证据,为疫苗安全生产与使用提供重要保障。