一种新HBsAg化学发光试剂盒的研制

Performance of a new chemiluminescent HBsAg quantitative assay

目的评价一种新HBsAg化学发光定量试剂盒主要性能指标。方法对2019年8月16日至2020年1月15日南京医科大学附属苏州科技城医院5035例阴性体检标本、209例阴性住院患者标本和101例潜在交叉反应样本进行了检测。对30个血清盘和434份预选阳性标本(包括基因型和亚型)进行敏感度检测。对25个突变株进行检测。对不同基因型进行敏感度试验。对25例HBsAg阳性和27例HBsAg阴性血清/血浆样本进行血清-血浆等效性检测。结果该HBsAg试剂盒检测特异度为99.96%,敏感度为100.00%。在30个血清盘中,该试剂与雅培HBsAg试剂敏感度相同,比列出的最不敏感试剂早123 d,平均提前4.1 d。突变株的检测能力相同。稀释基因型组中每个样本的敏感度均<0.13 IU/ml。所有配对样本均显示血清-血浆等效性。结论该HBsAg定量试剂性能优良,适合临床应用。

Objective To evaluate the main performance indicators of a new HBsAg chemiluminescence quantitative kit.Methods From August 16,2019 to January 15,2020,5,035 negative physical examination specimens,209 negative inpatients′specimens,and 101 potential cross-reactive specimens were tested in our hospital.Sensitivity testing was performed on 30 serum plates and 434 pre-selected positive samples(genotype and subtype).Twenty-five mutant strains were tested.Sensitivity tests were performed for different genotypes.Serum-plasma equivalence tests were performed on 25 HBsAg-positive and 27 HBsAg-negative serum/plasma samples.Results The detection specificity and the sensitivity of the HBsAg kit were 99.96%and 100.00%,respectively.In the 30 serum plates,the reagent had the same sensitivity as the Abbott HBsAg reagent,123 days earlier than the least sensitive reagent listed,and 4.1 days earlier on average.The detection ability of mutant strains was the same.The sensitivity of each sample in the diluted genotype group was<0.13 IU/ml.All matched samples showed serum-plasma equivalence.Conclusion The HBsAg quantitative kit has excellent performance and is suitable for clinical application.