Abstract:

Objective　To explore the factors causing the high false-positive rate in human immunodeficiency virus (HIV) detection by chemiluminescence microparticle immunoassay (CMIA). Methods　The medical records of 295 patients positive in HIV detection by CMIA in First Hospital Affiliated to Sun Yat-sen University from January 2018 to December 2020 were retrospectively analyzed. The patients were (47.4±16.7) years old. There were 185 males who were (47.5±17.4) years old and 110 females who were (47.2±15.5) years old. According to the results of HIV confirmatory test, the patients were divided into a true positive group (101 cases) and a false positive group (194 cases). The correlations of false positive results with detection time, gender, age, and S/CO value were analyzed. The case data of 155 patients positive in HIV detection by CMIA were collected, and were divided into a true positive group (77 cases), a false positive group (78 cases), and a negative group (78 cases). The relations of false positive with the patients' diagnosis and other laboratory indicators were analyzed. SPSS 24.0 was used for the statistical analysis. The ratios were compared by χ² test. Results　The false positive rates in 2018, 2019, and 2020 were 47.6% (39/82), 67.3% (66/98), and 77.4% (89/115), respectively, indicating that the false positive rate of HIV screening by CMIA increased year by year. The false positive rate in the patients under 20 or over 70 years old was relatively higher (P<0.05). The false positive rate in the female patients was higher than that in the male patients [87.3% (96/110) vs. 53.0% (98/185)], with a statistical difference (P<0.05). The S/CO value of the most patients with false positives was low; the false positive rates of the patients with diseases of the circulatory system, digestive system, urinary system, and reproductive system were higher. Conclusion　Age, gender, S/CO value, and complications of circulatory system and digestive system may cause a higher false positive rate.

Key words:

Human immunodeficiency virus, Chemiluminescent microparticle immunoassay, Screening test, False positive, Retrospective analysis

摘要：

目的　探讨化学发光微粒子免疫分析法（CMIA）检测人类免疫缺陷病毒（HIV）出现假阳性率较高的原因。方法　采用回顾性分析，收集中山大学附属第一医院2018年1月至2020年12月经CMIA法检测HIV呈阳性的病历资料295例，年龄（47.4±16.7）岁；其中，男185例，年龄（47.5±17.4）岁；女110例，年龄（47.2±15.5）岁。根据HIV确证试验的结果，将收集的病例分为真阳性组（101例）、假阳性组（194例），分析假阳性结果与患者检测时间、性别、年龄和S/CO值的关系。收集CMIA法检测HIV呈阳性的病历资料155例，分为真阳（77例）、假阳（78例）、阴性组（78例），分析假阳性与患者诊断及其他实验室检验项目的关系。采用SPSS24.0进行统计分析，率的比较采用χ²检验。结果　2018年假阳率为47.6%（39/82），2019年假阳率为67.3%（66/98），2020年假阳率为77.4%（89/115），CMIA法筛查HIV的假阳性率逐年增加。20岁以下及70岁以上的患者呈现检测假阳性率较高（P<0.05）。女性患者假阳性率比男性患者高［87.3%（96/110）比53.0%（98/185）］，差异有统计学意义（P<0.05）。假阳性患者S/CO值绝大部分偏低，有循环系统、消化系统、泌尿系统与生殖系统疾病的患者假阳性比例较高。结论　年龄、性别、S/CO值和伴发循环、消化系统疾病可能是导致假阳性率增高的原因。

关键词:

人类免疫缺陷病毒, 化学发光微粒子免疫分析法, 筛查试验, 假阳性, 回顾性分析