METHODS: We performed a systematic review to characterise the diagnostic performance of IMMY CrAg® LFA in HIV-negative populations on serum and cerebrospinal fluid. A systematic electronic search was performed using Medline, Embase, Global Health, CENTRAL, WoS Science Citation Index, SCOPUS, Africa-Wide Information, LILACS and WHO Global Health Library. Studies were screened and data extracted from eligible studies by two independent reviewers. A fixed effect meta-analysis was used to estimate the diagnostic sensitivity and specificity.
RESULTS: Of 447 records assessed for eligibility, nine studies met our inclusion criteria, including 528 participants overall. Amongst eight studies that evaluated the diagnostic performance of the IMMY CrAg® LFA on serum, the pooled median sensitivity was 96% (95% Credible Interval (CrI) 68-100%) with a pooled specificity estimate of 96% (95%CrI 84-100%). Amongst six studies which evaluated the diagnostic performance of IMMY CrAg® LFA on CSF, the pooled median sensitivity was 99% (95%CrI 95-100%) with a pooled specificity median of 99% (95%CrI 95-100%).
CONCLUSIONS: This review demonstrates a high pooled sensitivity and specificity for the IMMY CrAg® LFA in HIV-negative populations, in keeping with findings in HIV-positive individuals. The review was limited by the small number of studies. Further studies using IMMY CrAg® LFA in HIV-negative populations would help to better determine the diagnostic value of this test.
方法:我们进行了系统评价,以描述IMMYCrAg®LFA在HIV阴性人群血清和脑脊液中的诊断性能。使用Medline进行了系统的电子搜索,Embase,全球卫生,中部,WoS科学引文索引,Scopus,非洲信息,LILACS和世卫组织全球卫生图书馆。由两名独立的审阅者筛选研究并从符合条件的研究中提取数据。固定效应荟萃分析用于评估诊断敏感性和特异性。
结果:在评估资格的447条记录中,九项研究符合我们的纳入标准,总共有528名参与者。在评估IMMYCrAg®LFA对血清的诊断性能的八项研究中,合并的中位敏感性为96%(95%可信区间(CrI)68-100%),合并的特异性估计值为96%(95%CrI84-100%).在评估IMMYCrAg®LFA对CSF的诊断性能的六项研究中,合并的中位敏感性为99%(95%CrI95-100%),合并的中位特异性为99%(95%CrI95-100%).
结论:本综述证明了IMMYCrAg®LFA在HIV阴性人群中具有较高的集合敏感性和特异性,与HIV阳性个体的研究结果一致。该综述受到研究数量少的限制。在HIV阴性人群中使用IMMYCrAg®LFA的进一步研究将有助于更好地确定该测试的诊断价值。