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首页> 外文期刊>Transfusion: The Journal of the American Association of Blood Banks >A mathematical approach to estimate the efficacy of individual-donation and minipool nucleic acid amplification test options in preventing transmission risk by window period and occult hepatitis B virus infections
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A mathematical approach to estimate the efficacy of individual-donation and minipool nucleic acid amplification test options in preventing transmission risk by window period and occult hepatitis B virus infections

机译：一种数学方法来估计个人捐赠和minipool核酸扩增测试选项在预防通过窗口期和隐匿性乙型肝炎病毒感染引起的传播风险中的功效

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Background Sensitivity data from a head-to-head comparison study in South Africa were used to compare the efficacy of the Ultrio Plus assay in individual-donation (ID) and minipool (MP)4 and MP8 formats with that of TaqScreen MP6 in preventing hepatitis B virus (HBV) transmission risk.Study Design and Methods The replicate nucleic acid test (NAT) results on 106 HBV NAT (Ultrio)-yield samples and 29 HBV DNA (Ultrio)-negative, hepatitis B surface antigen (HBsAg)-positive samples were used to determine the viral load in copies/mL against the Eurohep HBV standard by probit analysis. Random viral load distributions were established in 32 pre-HBsAg window period (WP), 15 post-HBsAg WP, and 56 occult HBV infection (OBI) donations. Regression analysis of log viral load and Poisson distribution statistics of infectious HBV particles in blood components was used to predict infectivity and efficacy of NAT options in removing HBV transmission risk.Results For red blood cell transfusions (20 mL of plasma), the modeling predicted an Ultrio Plus ID-NAT efficacy of 68 and 83% in removing WP and (antibody to hepatitis B surface antigen-negative) OBI transmission risk, respectively, compared to 52 and 49% by TaqScreen MP6. For 200 mL of fresh-frozen plasma the estimated efficacy levels by these ID- and MP6-NAT options reduced to 57 and 44% for WP and to 67 and 34% for OBI donations, respectively.Conclusion The efficacy of the currently available commercial NAT systems in reducing HBV transmission risk is mainly driven by the pool size and the transfusion plasma volume. The modeled OBI transmission risk and NAT efficacy levels were in line with those recently reported in three lookback studies and give more insight in the incremental safety provided by HBsAg and antibody to hepatitis B core antigen testing of ID-NAT screened blood.
机译：背景来自南非的一项正面对头比较研究的敏感性数据用于比较Ultrio Plus分析在个人捐赠（ID）和minipool（MP）4和MP8格式中与TaqScreen MP6在预防肝炎中的功效B病毒（HBV）传播风险研究设计和方法对106份HBV NAT（Ultrio）产量样本和29份HBV DNA（Ultrio）阴性，乙型肝炎表面抗原（HBsAg）阳性的重复核酸测试（NAT）结果样本用于通过概率分析确定相对于Eurohep HBV标准的病毒载量，以拷贝/ mL为单位。在32个HBsAg前窗期（WP），15个HBsAg后WP和56个隐性HBV感染（OBI）捐赠中建立了随机的病毒载量分布。对数病毒载量的回归分析和血液成分中传染性HBV颗粒的泊松分布统计数据用于预测NAT选项消除HBV传播风险的传染性和功效。结果对于红细胞输注（血浆20 mL），模型预测了与TaqScreen MP6的52％和49％相比，Ultrio Plus ID-NAT在去除WP和（对乙型肝炎表面抗原阴性的抗体）OBI传播风险中的功效分别为68％和83％。对于200 mL新鲜冷冻血浆，通过这些ID-和MP6-NAT选项估计的功效水平对于WP分别降至57％和44％，对于OBI捐赠分别降至67％和34％。结论当前可用的商业NAT的功效降低HBV传播风险的系统主要由池大小和输血血浆量驱动。建模的OBI传播风险和NAT功效水平与最近在三项回顾性研究中报告的水平一致，并为HBsAg和针对ID-NAT筛查血液的乙型肝炎核心抗原检测抗体提供的增量安全性提供了更多见识。

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