Tiwari Aseem K, Pandey Prashant K, Dara Ravi C, Rawat Ganesh S, Raina Vimarsh, Bhargava Richa
Department of Transfusion Medicine, Medanta, The Medicity, Gurgaon, Haryana, India.
Department of Laboratory and Transfusion Services, Medanta, The Medicity, Gurgaon, Haryana, India.
Asian J Transfus Sci. 2015 Jan-Jun;9(1):65-9. doi: 10.4103/0973-6247.150955.
Syphilis is a transfusion transmissible infections and it is mandatory to do serological test for syphilis (STS) on all donor blood samples. STS is usually based on detection of antibodies against the cardiolipin-lecithin antigen or against the Treponema-specific antigen. STS with good sensitivity and specificity helps enhance blood safety and consolidation of STS along with other transfusion transmittable infections such as human immunodeficiency virus, hepatitis-C virus, and hepatitis-B virus helps in reducing the errors and enhances efficiency.
This study was designed to evaluate the performance of newly introduced VITROS(®) syphilis Treponema pallidum agglutination (TPA) assay based on enhanced chemiluminescence principle for its analytical performance for use as a STS on donor blood samples at a tertiary care health center in National Capital Region, India.
A total of 108 random blood units collected from the donors (both voluntary and replacement donors) and 28 known syphilis sero-reactive samples stored at -20°C, were used to evaluate the performance of VITROS(®) syphilis TPA assay based on enhanced chemiluminescence assay on VITROS(®) ECiQ immunodiagnostics system along with its analytical performance in terms of its sensitivity, precision, cross-reactivity and interference studies.
VITROS(®) syphilis TPA showed 100% sensitivity and specificity with precision (20 days study) of <10% co-efficient of variation. There was no cross-reactivity with other viral and auto-immune antibodies. No interference was observed from endogenous interfering substances like free hemoglobin or fats.
Performance of the VITROS(®) syphilis TPA assay meets the requirements for its use as STS in blood bank, thus allowing consolidation with other transfusion transmittable infections screening assay on chemiluminescence platform, which is highly valuable for optimizing workflow and efficiency.
梅毒是一种可通过输血传播的感染病，对所有献血样本进行梅毒血清学检测（STS）是强制性要求。STS通常基于检测抗心磷脂 - 卵磷脂抗原或抗梅毒螺旋体特异性抗原的抗体。具有良好敏感性和特异性的STS有助于提高血液安全性，将STS与其他输血传播感染（如人类免疫缺陷病毒、丙型肝炎病毒和乙型肝炎病毒）检测相结合，有助于减少误差并提高效率。
本研究旨在评估新引入的基于增强化学发光原理的VITROS（®）梅毒苍白螺旋体凝集（TPA）检测法在印度国家首都地区一家三级医疗保健中心用于献血样本STS分析性能。
共收集了108份来自献血者（包括自愿献血者和替代献血者）的随机血液样本，以及28份保存在-20°C的已知梅毒血清反应性样本，用于评估基于VITROS（®）ECiQ免疫诊断系统增强化学发光检测法的VITROS（®）梅毒TPA检测法，及其在灵敏度、精密度、交叉反应性和干扰研究方面的分析性能。
VITROS（®）梅毒TPA检测法显示出100%的灵敏度和特异性，精密度（20天研究）变异系数<10%。与其他病毒和自身免疫抗体无交叉反应。未观察到游离血红蛋白或脂肪等内源性干扰物质的干扰。
VITROS（®）梅毒TPA检测法的性能满足其在血库用作STS的要求，从而允许与化学发光平台上的其他输血传播感染筛查检测相结合，这对于优化工作流程和效率非常有价值。
