4种检测血清抗环瓜氨酸肽抗体的方法学比较

Comparison of four methods for detecting serum anti-cyclic citrullinated peptide antibody

目的评估4种抗环瓜氨酸肽(抗CCP)抗体检测方法,并筛选出符合临床要求的检测方法。方法分别用酶联免疫法、免疫胶体金法、免疫透色比浊法和化学发光法检测该院有关节炎症状的100例患者血清抗CCP抗体。以国家卫生健康委临床检验中心室间质评采用的定性方法(酶联免疫法)作为参比方法,分别比较其他3种方法与其检测结果的符合率。根据WS/T505-2017指南对符合率较高的方法进行精密度和准确度评价。结果免疫胶体金法、免疫透色比浊法和化学发光法与酶联免疫法的阳性符合率分别为:100.0%[95%CI(83.9%,100.0%)]、90.0%[95%CI(69.9%,97.2%)]和100.0%[95%CI(83.9%,100.0%)];阴性符合率分别为:62.5%[95%CI(51.6%,72.3%)、82.5%[95%CI(72.7%,89.3%)]和98.8%[95%CI(93.1%,99.8%)];总体符合率分别为:70.0%[95%CI(60.4%,78.1%)]、84.0%[95%CI(75.6%,89.9%)]和99.0%[95%CI(94.4%,99.8%)];κ值分别为:0.40、0.59和0.97。化学发光法的精密度和准确度满足厂家说明及临床要求。结论化学发光法与酶联免疫法有良好的结果一致性,化学发光法的精密度和准确度满足临床要求,适用于抗CCP抗体的临床检测。

Objective To evaluate four methods for the detection of anti-cyclic citrullinated peptide(anti-CCP)antibody,and to screen out the detection methods that meet the clinical requirements.Methods The serum level of anti-CCP antibody of 100 patients with arthritis symptoms in this hospital was detected by enzyme-linked immunoassay(ELISA),immunogold staining assay(IGSA),transmission turbidimetry immunoassay(TTIA)and chemiluminescence immunoassay(CLIA),respectively.ELISA,a qualitative method adopted by the National Health Commission for Clinical Laboratory for inter-laboratory quality assessment,was used as the reference method,and the determination of anti-CCP by ELISA was compared with the other three assays in coincidence rates.The precision and accuracy of the assays with high coincidence rates were evaluated according to WS/T505-2017 guideline.Results Compared with ELISA,the positive coincidence rates of IGSA,TTIA and CLIA were 100.0%[95%CI(83.9%,100.0%)],90.0%[95%CI(69.9%,97.2%)]and 100.0%[95%CI(83.9%,100.0%)],respectively;the negative coincidence rates were 62.5%[95%CI(51.6%,72.3%)],82.5%[95%CI(72.7%,89.3%)]and 98.8%[95%CI(93.1%,99.8%)],respectively;the total coincidence rates were 70.0%[95%CI(60.4%,78.1%)],84.0%[95%CI(75.6%,89.9%)]and 99.0%[95%CI(94.4%,99.8%)],respectively;and theκvalues were 0.40,0.59 and 0.97,respectively.The precision and accuracy of CLIA met the manufacturer’s instructions and clinical demands.Conclusion There is an excellent concordance between CLIA and ELISA.The precision and accuracy of CLIA meet the clinical de-mands,and CLIA can be suitably used for the determination of anti-CCP antibody in clinical practices.