Objective To investigate the causes and disposal scheme for grey zone samples of anti-hepatitis C virus(HCV) antibody determination. Methods Anti-HCV antibody were determined by 5 domestic kits [4 kits using indirect enzyme-linked immunosorbent assay(ELISA) and 1 kit using double antigen sandwich method] and 1 imported kit using chemiluminescence immunoassay. Samples with inconsistent results were further determined by recombinant immunoblot assay(RIBA). Then,real-time fluorescence quantitation polymerase chain reaction (PCR) was used to determine indeterminate samples for HCV RNA in RIBA. A total of 12 samples in window period were determined by HCV RNA for copies and genotypes. Results Except kit F,the other 5 kits showed review negative coincidence rates ≥ 90%. Review positive coincidence rates were increased with the increasing of initial S/CO ratio. When S/CO ratio was >15.01,6 kits showed review positive coincidence rates > 95%. The false negative rates of single 1 kit were 27.8%-94.4%. The false negative rates of 2 domestic kits randomly were 8.3%-61.1%,the false negative rates of 2 domestic kits randomly with 1 imported kit were 5.6% -22.2%,and the false negative rates of 2 domestic kits randomly using indirect ELISA with 1 domestic kit using double antigen sandwich method were 2.2%-13.9%. The results of 12 samples in window period by 6 kits were negative or positive partly in grey zone,the results by RIBA were negative or indeterminate,and the results for HCV RNA was weakly positive. The 8 of 12 samples in window period were genotype 1b,and the other 4 samples had no genotype. Conclusions When the results are in grey zone,it should use at least 2 different kits for reviewing. Kit using double antigen sandwich method or imported kit can be introduced for supplement. In order to reduce the missing determination of samples in window period,it suggests that HCV RNA determination can be used as supplement.%目的：探讨抗丙型肝炎病毒（HCV）抗体灰区样本产生的原因和处置方案及临床提示。方法采用5种国产试剂[4种试剂为间接酶联免疫吸附试验（ELISA）、1种试剂为双抗原夹心法]和1种进口试剂（化学发光法）检测血清中抗HCV抗体，结果不一致且在灰区范围内的样本再用重组免疫印迹法（RIBA）检测确认，并对RIBA测定结果为不确定的样本用实时荧光定量聚合酶链反应（PCR）测定HCV RNA。对12例处于窗口期的特殊样本分析HCV RNA的拷贝数和基因型。结果除F试剂外，其他5种抗HCV抗体检测试剂的复检阴性符合率均≥90%；复检阳性符合率随着初检S/CO值的增大而增高，当S/CO值>15.01时，6种抗HCV抗体检测试剂的复检阳性符合率均>95%。采用6种抗HCV抗体检测试剂分别检测36例灰区样本，单种试剂检测的假阴性率为27.8%～94.4%；2种国产试剂随机组合后检测的假阴性率为8.3%～61.1%；2种国产试剂加进口试剂组合后假阴性率降至5.6%～22.2%；2种国产试剂加国产双抗原夹心法试剂组合后假阴性率降至2.2%～13.9%。6种试剂检测12例特殊样本抗HCV抗体的结果为阴性或部分处于厂家规定的灰区范围内，RIBA确认结果为阴性或不确定，而HCV RNA为弱阳性。12例特殊样本中有8例RNA基因分型为1b型，4例为无分型。结论对于抗HCV抗体检测试剂灰区结果，建议至少采用2种不同的初筛试剂组合对样本进行复检；必要时可引入双抗原夹心法或进口试剂作为复检的补充。为减少窗口期样本的漏检，建议将HCV RNA检测作为补充试验。
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