Clinical application of Chemiluminescence Microparticle Immunoassay for SARS-CoV-2 infection diagnosis
Clinical application of Chemiluminescence Microparticle Immunoassay for SARS-CoV-2 infection diagnosis
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化学发光微粒免疫分析法在 SARS-CoV-2 感染诊断中的临床应用。
DOI：
10.1016/j.jcv.2020.104576
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发表时间：
2020-09-01
影响因子：
8.8
通讯作者：
Zheng, Shangen
中科院分区：
文献类型：
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作者：
Liu, Wanbing;Kou, Guomei;Zheng, Shangen
背景资料：真实的时间RT-PCR的准确性和能力不理想是由几个不可避免的原因造成的，不能满足COVID-19诊断的需要。方法：收集2020年1月18日至4月4日在解放军中部战区总医院就诊的206例患者血清样本。以270份健康献血员血清为对照。结果：206例SARS患者中，IgM阳性149例（72.3%），总抗体阳性187例（90.8%）; IgM和Ab检测的特异性分别为99.3%和98.9%。CMIA检测Ab的敏感性明显高于IgM。IgM、Ab的阳性率和S/CO值随发病天数的增加而增加。观察了CMIA法检测抗体阳性率在7 d后迅速上升，而IgM在14 d后明显升高。此外，这些患者的年龄和性别在整个疗程中不影响抗体的血清转换和滴度。患者的疾病严重程度对抗体的血清转换没有影响。然而，危重患者具有更高的抗体滴度比非危重病例后14 d.p.o.。结论：CMIA可作为核酸检测的重要补充，有助于提高SARS-CoV-2感染诊断的准确性和能力。
Background: The unsatisfactory accuracy and capacity of real time RT-PCR depends on several unavoidable reasons, which cannot meet the demands for COVID-19 diagnosis.Methods: 206 serum samples were collected from patients who were treated in the General Hospital of the Central Theater Command of the PLA between January 18 and April 4, 2020. 270 serum samples from healthy blood donors were used as control. IgM and total antibodies (Ab) against SARS-CoV-2 were detected by Chemiluminescence Microparticle Immunoassay (CMIA).Results: Among the 206 patients, the positive rate of IgM and Ab were 149/206 (72.3 %) and 187/206 (90.8 %), respectively. And the specificity of IgM and Ab detection were 99.3 % and 98.9 %, respectively. The sensitivity of CMIA for Ab detection was significantly higher than that of IgM. An increase of the positive rate and S/CO value for detecting IgM and Ab accompanied with the increasing of days post-disease onset (d.p.o.) were observed. The positive rate of Ab detected by CMIA increased rapidly after 7 d.p.o., while that of IgM was obviously increased after 14 d.p.o.. In addition, the age and gender of these patients did not affect the seroconversion and titer of antibodies during the whole course. The disease-severity of patients had no effect on the seroconversion of antibodies. However, the critical patients possessed a much higher antibody titers than the no-critical cases after 14 d.p.o..Conclusions: The CMIA can provide important complementation to nucleic acid assay and help to enhance the accuracy and capacity of diagnosis of SARS-CoV-2 infection.