Lien T X, Tien N T, Chanpong G F, Cuc C T, Yen V T, Soderquist R, Laras K, Corwin A
Pasteur Institute, Ho Chi Minh City, Vietnam.
Am J Trop Med Hyg. 2000 Feb;62(2):301-9. doi: 10.4269/ajtmh.2000.62.301.
An evaluation of three new rapid diagnostic test kits for human immunodeficiency virus types 1 and 2 (HIV-1/2), hepatitis B surface antigen (HBsAg), and syphilis involved a two-phase comparison of rapid diagnostic assays using prospectively collected from hospitals and clinics in Ho Chi Minh City, Vietnam. After specificity and sensitivity testing, three new rapid diagnostic test kits were tested in parallel with six commonly used diagnostic test kits. The Determine HIV-1/2 test had fewer indeterminate or equivocal results than the Capillus HIV-1/HIV-2 or HIV Blot 2.2 tests. However, the Determine HIV-1/2 test yielded one false-positive result when compared with the Serodia HIV, HIV Blot 2.2, and microparticle enzyme immunoassay (IMx) HIV tests. The Serodia HBsAg test yielded more false-negative results when compared with the Determine HBsAg diagnostic test kit. The results of the syphilis diagnostic tests evaluated in this clinical trial consistently agreed with those of the rapid plasma reagin test for syphilis. The Determine Syphilis Treponema pallidum (TP) test had three false-positive results compared with the Serodia TP and the Serodia TP x particle agglutination (PA) tests, which had two false-positive results that were confirmed as negative by an ELISA. Application of these serologic tests within this comparative evaluation framework, using the World Health Organization alternative testing strategies, proved to be an effective way to determine serostatus related to HIV, hepatitis B, and syphilis.
一项针对三种新型快速诊断试剂盒的评估，这些试剂盒用于检测1型和2型人类免疫缺陷病毒（HIV-1/2）、乙型肝炎表面抗原（HBsAg）和梅毒，该评估涉及在越南胡志明市的医院和诊所前瞻性收集样本，对快速诊断检测进行两阶段比较。在进行特异性和敏感性测试后，将三种新型快速诊断试剂盒与六种常用诊断试剂盒进行平行测试。Determine HIV-1/2检测产生的不确定或疑似结果比Capillus HIV-1/HIV-2或HIV Blot 2.2检测更少。然而，与Serodia HIV、HIV Blot 2.2和微粒酶免疫分析（IMx）HIV检测相比，Determine HIV-1/2检测产生了一个假阳性结果。与Determine HBsAg诊断试剂盒相比，Serodia HBsAg检测产生了更多假阴性结果。在该临床试验中评估的梅毒诊断测试结果与梅毒快速血浆反应素试验的结果始终一致。与Serodia TP和Serodia TP x颗粒凝集（PA）检测相比，Determine梅毒螺旋体（TP）检测有三个假阳性结果，而Serodia TP和Serodia TP x PA检测有两个假阳性结果，经ELISA确认为阴性。在这个比较评估框架内，使用世界卫生组织的替代检测策略应用这些血清学检测方法，被证明是确定与HIV、乙型肝炎和梅毒相关血清状态的有效方法。
