恶性疟/间日疟LDH检测试剂（免疫层析法）批件通知书

准 11-1758恶性疟/间日疟LDH检测试剂（免疫层析法）

目的用氯金酸标记抗恶性疟原虫乳酸脱氢酶(LDH)单克隆抗体(McAb),研制用于诊断恶性疟原虫和间日疟原虫感染的胶体金免疫层析(GICA)试纸。方法采用柠檬酸盐还原法制备胶体金颗粒、标记抗恶性疟原虫重组乳酸脱氢酶单克隆抗体,制成免疫层析检测试纸条。用该试纸条检测已知疟疾病人及健康人血样,鉴定方法的敏感性和特异性。结果检测重组LDH抗原的最小量为5 ng/ml;对30例恶性疟病人血样及40例间日疟病人血样进行检测,敏感性分别为83。33%和57。50%,检测100例健康者血样特异性为98。00%。结论初步建立了同时诊断恶性疟原虫和间日疟原虫感染的GICA检测法。
Objective To establish a gold-immunochromatographic assay(GICA) stripe for detecting both falciparum and tertian malaria using chloroauric acid-labelled monoclonal antibody against lactate dehydrogense(LDH) of Plasmodium falciparum.Methods Collodial gold was coupled with monoclonal P.falciparum LDH antibody to prepare a GICA test paper.The-gold-anti-LDH conjugate reacted with LDH in serum and migrates up the nitrocellose stripe on which anti-LDH was immobilized,thus producing the detection reaction.GICA str...

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