National Institute of Cholera and Enteric Diseases, Kolkata, India.
Virol J. 2012 Nov 26;9:290. doi: 10.1186/1743-422X-9-290.
HIV, HBV and HCV pose a major public health problem throughout the world. Detection of infection markers for these agents is a major challenge for testing laboratories in a resource poor setting. As blood transfusion is an important activity saving millions of live every year, it also carries a risk of transfusion transmissible infections caused by these fatal blood borne pathogens if the quality of testing is compromised. Conventional ELISA is regarded as the mostly used screening technique but due to limitations like high cost, unavailability in many blood banks and testing sites, involvement of costly instruments, time taking nature and requirement of highly skilled personnel for interpretation, rapid tests are gaining more importance and warrants comparison of performance.
A comparative study between these two techniques has been performed using commercially available diagnostic kits to assess their efficacy for detection of HIV, HBV and HCV infections. Rapid kits were more efficient in specificity with synthetic antigens along with high PPV than ELISA in most cases. Comparison between different ELISA kits revealed that Microlisa HIV and Hepalisa (J. Mitra & Co. Pvt. Ltd.); ERBA LISA HIV1 + 2, ERBA LISA Hepatitis B and ERBA LISA HCV (Transasia Bio-medicals Ltd.) gives uniform result with good performance in terms of sensitivity, specificity, PPV, NPV and efficiency, whereas, Microlisa HCV (J. Mitra & Co. Pvt. Ltd.), Microscreen HBsAg ELISA and INNOVA HCV (Span Diagnostics Ltd.) did not perform well. Rapid kits were also having high degree of sensitivity and specificity (100%) except in HIV Comb and HCV Comb (J. Mitra & Co. Pvt. Ltd.). The kit efficiency didn't vary significantly among different companies and lots in all the cases except for HCV ELISA showing statistically significant variation (p < 0.01) among three kit types.
ELISA is a good screening assay for markers of HIV, HBV and HCV infections. Rapid tests are useful for further detection of false positive samples. ELISA seems the appropriate assay in blood bank. For availability of quality commercial diagnostic assays, evaluation of kit may be helpful.
HIV、HBV 和 HCV 是全球范围内的重大公共卫生问题。在资源匮乏的环境下，检测这些病原体的感染标志物是检验实验室面临的主要挑战。由于输血是一项重要的活动，每年挽救了数百万人的生命，但如果检测质量受到影响，它也会带来由这些致命的血源性病原体引起的输血传播感染的风险。传统的 ELISA 被认为是最常用的筛选技术，但由于成本高、许多血库和检测点无法使用、涉及昂贵的仪器、耗时和需要高度熟练的人员进行解释等限制，快速检测越来越受到重视，并且需要比较其性能。
使用市售诊断试剂盒对这两种技术进行了比较研究，以评估它们在检测 HIV、HBV 和 HCV 感染方面的效果。在大多数情况下，快速试剂盒使用合成抗原具有更高的特异性和更高的 PPV，比 ELISA 更有效。不同 ELISA 试剂盒之间的比较表明，Microlisa HIV 和 Hepalisa（J. Mitra & Co. Pvt. Ltd.）；ERBA LISA HIV1 + 2、ERBA LISA 乙型肝炎和 ERBA LISA HCV（Transasia Bio-medicals Ltd.）在灵敏度、特异性、PPV、NPV 和效率方面具有良好的性能，而 Microlisa HCV（J. Mitra & Co. Pvt. Ltd.）、Microscreen HBsAg ELISA 和 INNOVA HCV（Span Diagnostics Ltd.）则表现不佳。快速试剂盒的灵敏度和特异性也很高（100%），除了 HIV Comb 和 HCV Comb（J. Mitra & Co. Pvt. Ltd.）。除 HCV ELISA 外，所有情况下不同公司和批次的试剂盒效率差异均无统计学意义（p < 0.01），但 HCV ELISA 显示三种试剂盒类型之间存在统计学显著差异（p < 0.01）。
ELISA 是检测 HIV、HBV 和 HCV 感染标志物的良好筛选检测方法。快速检测可用于进一步检测假阳性样本。ELISA 似乎是血库的合适检测方法。由于存在高质量的商业诊断检测试剂盒，评估试剂盒可能会有所帮助。
