Dara Ravi C, Tiwari Aseem Kumar, Mitra Subhasis, Acharya Deviprasad, Aggarwal Geet, Arora Dinesh, Bhardwaj Gunjan
Department of Transfusion Medicine, Manipal Hospital, Jaipur, Rajasthan, India.
Department of Transfusion Medicine, Medanta-The Medicity, Gurgaon, Haryana, India.
Asian J Transfus Sci. 2019 Jul-Dec;13(2):115-119. doi: 10.4103/ajts.AJTS_116_17. Epub 2019 Dec 3.
Semi-automated equipment using Column agglutination technology (CAT) is widely used where centrifugation and incubation are automated but substantial amount of the work is still executed manually. Larger laboratories are moving towards automation to eliminate errors, reducing exposure to bio-hazardous samples, assuring traceability, reliability, turnaround time (TAT) and throughput. Moving towards automation and greater reliability, we therefore, decided to install an automated immunohematological (IH) analyzer "Vision". In this study we evaluated reliability and performance before clearing "Vision" for routine use.
Study was conducted in the Department of Transfusion-Medicine. The primary objective was to assess the reliability of results and compare with routine use semi-automated BIOVUE system (Reference system). Secondary objective was to evaluate the performance (TAT and throughput) of the Vision to handle routine and emergency workload.
Total of 1276 known samples were used to assess 2640 pre-transfusion tests (1229 ABO/Rh D typing; 1229 antibody screening; 54 antibody identification; 86 crossmatch and 42 DAT). All 1229 ABO Rh typing results were concordant between the two systems. Overall agreement between the Vision IH analyzer and reference system for ABO Rh typing was 99.95%. All antibody screening, crossmatch and DAT results were concordant between the two systems. TAT of Vision was substantially shorter than the reference system for all test profiles.
Based on study results, Vision was approved for routine use in laboratory. It was found to be reliable with considerably shorter TAT and capable of handling high throughput of immunohematological tests.
使用柱凝集技术（CAT）的半自动设备在离心和孵育自动化但大量工作仍需手动完成的情况下被广泛使用。大型实验室正朝着自动化方向发展，以消除误差、减少暴露于生物危害样本的风险、确保可追溯性、可靠性、周转时间（TAT）和通量。为了实现更高的自动化和可靠性，我们决定安装一台自动化免疫血液学（IH）分析仪“Vision”。在本研究中，我们在批准“Vision”用于常规使用之前评估了其可靠性和性能。
研究在输血医学科进行。主要目的是评估结果的可靠性，并与常规使用的半自动BIOVUE系统（参考系统）进行比较。次要目的是评估Vision处理常规和紧急工作量的性能（TAT和通量）。
总共使用了1276个已知样本进行2640次输血前检测（1229次ABO/Rh D血型鉴定；1229次抗体筛查；54次抗体鉴定；86次交叉配血和42次直接抗球蛋白试验）。两个系统之间所有1229次ABO Rh血型鉴定结果均一致。Vision IH分析仪与参考系统在ABO Rh血型鉴定方面的总体一致性为99.95%。两个系统之间所有抗体筛查、交叉配血和直接抗球蛋白试验结果均一致。对于所有检测项目，Vision的TAT明显短于参考系统。
根据研究结果，Vision被批准在实验室常规使用。发现它可靠，TAT明显更短，并且能够处理高通量的免疫血液学检测。
