【摘要】 目的 分析化学发光灰区标本的临床特征及核酸检测对化学发光灰区标本结果判断的指导性意义。方法 收集2021年7月—12月全国不同地区的5家综合医院入院患者术前/输血前血源性传播疾病样本检测结果，对化学发光灰区检测结果的标本进行核酸检测结果及临床特征分析。结果 5 723例样本中总计检出HBV免疫灰区样本28例(占比0.49%)，HCV灰区样本20例(占比0.35%)。经核酸检测验证，28例HBV灰区样本中，15例HBV样本核酸检测为阳性(占比53.5%)，其HBcAb也均为阳性；13例HBV样本核酸检测为阴性(占比46.5%)，其中HBcAb阳性4例。HBV与HCV免疫检测灰区在临床各个科室均有发现，出现HBV灰区样本最多的前三科室为骨科、妇科、泌尿科，灰区样本核酸验证假阳性最多的临床科室为妇科与骨科。HCV灰区样本最多的前三科室为泌尿、肾内、外科，且均为假阳性。HBV灰区样本患者临床诊断结果有35.7%(10/28)为肿瘤类疾病，HCV灰区样本患者临床诊断结果有40%(8/20)为肿瘤类疾病。结论 化学发光法容易造成假阳性结果，应注意复检验证，且设置灰区并非必要。灰区样本可见于多个临床科室，具有一定的临床分布特征。核酸检测可以提高检测灵敏度并且更大限度保证结果的准确性，能够验证免疫检测灰区。更多还原

【Abstract】 Objective To analyze the clinical characteristics and nucleic acid testing (NAT) to guide the interpretation of gray zone (GZ) sample results detected by chemiluminescence technology.Methods The results of patients admitted to 5 general hospitals in different regions of the country from July to December 2021 were collected for Transfusion Transmissible Infection (TTI) screening tests before surgery/transfusion.NAT detection and clinical characteristics analysis were performed on GZ samples.Results Among the 5 723 samples,28 (0.49%) were GZ for HBV and 20 (0.35%) for HCV.NAT results showed that 15 of the 28 HBV GZ (53.5%) were NAT-positive,and their HBcAb were all positive;13 HBV samples (46.5%) were NAT-negative,of which 4 positive for HBcAb.HBV and HCV GZ samples were found in all clinical departments.The top three departments of HBV GZ samples were orthopedics,gynecology,and urology and the largest number of false positives were gynecology and orthopedics.The top three departments for HCV GZ samples were urology,nephrology,and surgery,and all of them were false positives.35.7% (10/28) of patients with HBV GZ samples and 40% (8/20) of patients with HCV GZ samples were diagnosed as neoplastic diseases.Conclusion Chemiluminescence methods are prone to false-positive results,so attention should be paid to retest for verification and it is not necessary to set up GZ.Gz samples can be found in some clinical departments exhibiting specific clinical distribution characteristics.NAT can improve detection sensitivity and ensure accuracy to verify GZ.更多还原