Institute of Transfusion Medicine and Immunohematology, German Red Cross, Johann Wolfgang Goethe University, Frankfurt, Germany.
Vox Sang. 2010 Jan;98(1):37-46. doi: 10.1111/j.1423-0410.2009.01219.x. Epub 2009 Aug 4.
In 1997 the German Red Cross (GRC) blood donor services introduced mini-pool nucleic acid testing (NAT) for human immunodeficiency virus (HIV)-1, hepatitis C virus (HCV) and hepatitis B virus (HBV) to increase blood safety. With the new cobas s 201/cobas TaqScreen MPX, a fully automated extraction method and a multiplex amplification system specifically adapted to the needs of blood donation services is available.
The cobas s 201 system was evaluated at the GRC BTS locations Hagen, Springe and Frankfurt. In phase A, the analytical sensitivity for the detection of HBV, HCV and HIV-1 was investigated and in phase B, at least 60,000 samples at each test site were screened in parallel with the MPX test on s 201 system and the existing routine mini-pool NAT system to compare the diagnostic specificity and the diagnostic sensitivity.
Comparable analytical sensitivities in a range of 1.6-3.6 IU/ml, 4.9-10.9 IU/ml and 14.7-26.6 IU/ml for HBV, HCV HIV, respectively, for the MPX test on s 201 system (95% probability based on probit analysis) were determined at all test sites. The diagnostic sensitivity was 99.8% and the diagnostic specificity was 99.85%.
The MPX test on s 201 system is a fully automated NAT system suitable for routine blood donor screening. The analytical sensitivity as well as the diagnostic sensitivity fulfilled all requirements of the Paul Ehrlich Institute for blood donor screening in mini-pools up to 96 donations per pool. A major benefit of the automated NAT system is the reduced personnel time and the extensive complete barcode-controlled process documentation.
1997 年，德国红十字会（GRC）血液服务中心引入了用于艾滋病毒（HIV）-1、丙型肝炎病毒（HCV）和乙型肝炎病毒（HBV）的迷你池核酸检测（NAT），以提高血液安全性。随着新的 cobas s 201/cobas TaqScreen MPX 的出现，一种全自动提取方法和专门适应献血服务需求的多重扩增系统得以应用。
cobas s 201 系统在 GRC BTS 地点哈根、斯普林格和法兰克福进行了评估。在 A 阶段，研究了检测 HBV、HCV 和 HIV-1 的分析灵敏度，在 B 阶段，在每个测试地点，至少 60000 个样本与 s 201 系统上的 MPX 测试并行进行筛查，以比较诊断特异性和诊断灵敏度。
在所有测试地点，s 201 系统上的 MPX 测试的分析灵敏度分别为 HBV、HCV 和 HIV-1 的 1.6-3.6 IU/ml、4.9-10.9 IU/ml 和 14.7-26.6 IU/ml（基于概率分析的 95%概率）。诊断灵敏度为 99.8%，诊断特异性为 99.85%。
s 201 系统上的 MPX 测试是一种适用于常规献血者筛查的全自动 NAT 系统。分析灵敏度以及诊断灵敏度均满足保罗埃利希研究所对迷你池每池 96 份样本的献血者筛查的所有要求。自动化 NAT 系统的一个主要优势是减少了人员时间和广泛的完整条码控制过程文档。
