一种抗心肌抗体检测试剂盒的验证评价

The verification of an anti-heart autoantibodies detection kit

目的:开发和验证一种高灵敏度和高特异度的抗心肌抗体(AHA)检测试剂盒。方法:合成具有抗原决定簇的心肌线粒体腺苷酸转运酶(ANT)、β1肾上腺素受体(β1-AR)、肌球蛋白重链(MHC)、L-型钙通道(LCC)的多肽,制成相应的AHA检测试剂盒,用ELISA法检测急性病毒性心肌炎(AVMC)患者(176例)、扩张型心肌病(DCM)患者(226例)、其他心脏病患者及健康体检者(共210例)血清中4种AHA,计算检验的灵敏度、特异度,并行kappa一致性检验。结果:抗ANT抗体、抗β1-AR抗体、抗MHC抗体、抗L-CC抗体在AVMC/DCM患者中检测的灵敏度分别为91.5%/90.3%、98.9%/97.3%、88.6%/94.7%、98.9%/98.7%,特异度分别为87.6%、74.3%、81.9%、63.3%;与临床诊断比较,kappa值分别为0.79/0.78、0.71/0.72、0.70/0.77、0.60/0.63,均P<0.01。若同一份血清4种AHA均阳性诊断AVMC/DCM的灵敏度、特异度分别为80.1%/86.7%、91.9%/91.9%;与临床诊断比较,kappa值为0.73/0.79,P<0.01。结论:此自主研发的AHA试剂盒检测AVMC/DCM结果与临床诊断具有高度一致性,可作为AVMC/DCM的辅助诊断指标。

Objective：To develop and verify a kind of anti-heart autoantibodies （AHA） detection kit with high sensitivity and specificity. Method.. Myocardial mitochondrial adenine nucleotide translocase （ANT）, β1 adrenergic receptor （β1-AR）, myosin heavy chain （MHC） and L-type calcium channel （L-CC） polypeptides with antigenic determinant were synthesized and produced as an anti-heart autoantibodies detection kit to detect serum AHA by ELISA. There were 612 individuals enrolled in this study, including acute viral myocarditis （AVMC） patients （176 cases）, dilated cardiomyopathy （DCM） patients （226 cases）, patients with other heart diseases and healthy individuals （a total of 210 cases）. The sensitivity and specificity were calculated. The data were analysed by the kappa in agreement. Result：The sensitivity of anti-ANT antibody, anti-β1-AR antibody, anti-MHC antibody, an- ti-L-CC antibody in AVMC/DCM was 91.5% 90.3%, 98.9%/97.3%, 88.6%/94.7%, 98.9%/98.7%, the specificity was 87.6%, 74.3%, 81.9%, 63.3%. Compared with AVMC/DCM clinical diagnosis, kappa values were 0.79/0.78, 0. 71/0.72, 0. 70/0.77, 0. 60/0.63, P〈0. 01. When the four antibodies were positive simulta- neously,the sensitivity and specificity of four antibodies in diagnosis of AVMC/DCM were 80.1%/86.7% and 91.9 %/91.9 %. Compared with AVMC/DCM clinieal diagnosis, kappa value was 0.73/0.79, P〈0.01. Conclu- sion：The AHA results in AVMC/DCM through these kits are highly consistent with clinical diagnosis. It can be used as an auxiliary diagnostic marker for AVMC/DCM.