Kusendová Katarína, Gavorník Peter, Sabaka Peter, Sviteková Klára
Vnitr Lek. 2016 Jan;62(1):9-16.
The goal of the retrospective observatory cross-sectional study was to evaluate the benefit of alanine aminotransferase screening of blood donors in prevention of hepatitis B and C transmission by haemotherapy in context of actual screening methods.
Donations with elevated ALT more than the defined limit (ALT men 80 IU/l, women 64 IU/l, spectrophotometric UV test, KUADRO(TM), BPC BioSed Srt, Castelnuovo di Porto Roma, Italy) and/or reactivity any of the hepatitis screening parameters HBsAg, anti-HBc, anti-HCV (chemiluminescence method, ARCHITECT i2000(TM), Illinois, USA) were evaluated. Donors were confirmatory retested. They were classified into groups with common biological properties according to their final virological status and statistically evaluated in programs Graph Pad Prism 6.05 and Microsoft Excel 2003.
From a total of 61 214 donations elevated ALT was found in 420 (0.69 %), active HBV in 25 (0.04 %), active HCV infection in 5 (0.01 %) blood donors. Coincidental elevation of ALT and active HBV infection occured in 1 donor (0.002 %), as well as HCV (0.002 %). Levels of ALT were higher in the group with elevated ALT without active HBV or HCV infection than in groups with active HCV and HCV infection (p < 0.05). Occurence of blood donor in seronegative anti-HCV window was not observed. Elevated ALT was low specific (69.14 %) and senzitive (6.45 %) for active hepatitis. We did not prove positive correlation of ALT and S/CO (signal-to-cut-off) anti-HBc (Spearman r = -0,565, p < 0.0001), ALT and S/CO anti-HCV (Spearman r = -0.1046, p = 0.0022), in ALT and S/CO HBsAg the result was not statistically significant (Spearman r = -0.00968, p = 0.77). Positive but statistically insignificant correlation ALT and S/CO anti-HCV occured in the group of 5 blood donors with active HCV infection (Spearman r = 0.4, p = 0.51). Screening scheme for HCV infection testing anti-HCV + ALT was per one donation by € 0.18 more expensive than the scheme anti-HCV + HCV RNA due to amount of waisted donations with ALT elevation (825 TU, € 41 388.89).
Elevation of ALT in blood donors was not pathognomonic for hepatitis B and C infection. Screening of HCV consisting of anti-HCV + HCV RNA (nucleic acid testing method, COBAS AmpliScreen HCV 2.0(TM), ROCHE Diagnostics, Hague Road, Indianapolis, USA) is more cost-effective than the scheme anti-HCV + ALT.
这项回顾性观察性横断面研究的目的是,在现有筛查方法的背景下,评估对献血者进行丙氨酸氨基转移酶筛查在预防通过血液疗法传播乙型和丙型肝炎方面的益处。
对丙氨酸氨基转移酶(ALT)升高超过规定限度(男性ALT为80 IU/l,女性为64 IU/l,采用分光光度法紫外线检测,KUADRO™,BPC BioSed Srt,意大利罗马卡斯泰尔诺沃迪波尔托)和/或任何一项肝炎筛查参数(乙肝表面抗原[HBsAg]、乙肝核心抗体[anti-HBc]、丙肝抗体[anti-HCV],采用化学发光法,ARCHITECT i2000™,美国伊利诺伊州)呈反应性的献血进行评估。对献血者进行确认性复测。根据他们最终的病毒学状态将其分为具有共同生物学特性的组,并在Graph Pad Prism 6.05软件和Microsoft Excel 2003软件中进行统计学评估。
在总共61214份献血中,发现420份(0.69%)ALT升高,25份(0.04%)存在活动性乙肝病毒(HBV)感染,5份(0.01%)献血者存在活动性丙肝病毒(HCV)感染。1名献血者(0.002%)同时出现ALT升高和活动性HBV感染,1名献血者(0.002%)同时出现ALT升高和活动性HCV感染。在无活动性HBV或HCV感染但ALT升高的组中,ALT水平高于存在活动性HCV和HBV感染的组(p < 0.05)。未观察到献血者处于抗-HCV血清阴性窗口期的情况。ALT升高对活动性肝炎的特异性较低(69.14%),敏感性也较低(6.45%)。我们未证实ALT与抗-HBc的S/CO(信号与临界值)之间存在正相关(Spearman秩相关系数r = -0.565,p < 0.0001),ALT与抗-HCV的S/CO之间也不存在正相关(Spearman秩相关系数r = -0.1046,p = 0.0022),在ALT与HBsAg的S/CO之间,结果无统计学意义(Spearman秩相关系数r = -0.00968,p = 0.77)。在5名存在活动性HCV感染的献血者组中,ALT与抗-HCV的S/CO之间存在正相关但无统计学意义(Spearman秩相关系数r = 0.4,p = 0.51)。由于ALT升高导致的废弃献血量(825 TU,41388.89欧元),检测抗-HCV + ALT的HCV感染筛查方案每份献血比抗-HCV + HCV RNA方案贵0.18欧元。
献血者ALT升高并非乙型和丙型肝炎感染的特征性表现。由抗-HCV + HCV RNA(核酸检测方法,COBAS AmpliScreen HCV 2.0™,罗氏诊断公司,美国印第安纳波利斯海牙路)组成的HCV筛查比抗-HCV + ALT方案更具成本效益。