HPV L1 蛋白单克隆抗体检测试剂盒用于检测宫颈脱落细胞中人乳头瘤病毒的比较性试验。
Comparative testing of HPV L1 protein monoclonal antibody panel for the detection of HPV in cervical exfoliated cells.
机构信息
The Institute of Pathology, China Three Gorges University, Yichang, Hubei, 443002, China; The Central Laboratory of Yichang Central People's Hospital, Yichang, Hubei, 443003, China; The Central Laboratory of First Clinical Medical College, China Three Gorges University, Yichang, Hubei, 443003, China.
The Institute of Pathology, China Three Gorges University, Yichang, Hubei, 443002, China.
出版信息
J Virol Methods. 2018 Jul;257:33-41. doi: 10.1016/j.jviromet.2018.03.012. Epub 2018 Mar 31.
AIMS
To determine the value of a monoclonal antibody panel against a C-terminal conserved sequence polypeptide of human papillomavirus (HPV) L1 (a major capsid protein) for the detection of HPV in cervical exfoliated cells, as well as the potential of this antibody panel to be developed into an assay kit for the clinical screening of cervical cancer.
METHODS
Cervical exfoliated cells were collected at a gynecology clinic. One part of each sample was sent to the Department of Pathology for HPV genotyping, and the other part was sent to the Department of Pathology for cytologic testing and then to the laboratory for immunological histological chemistry (IHC) assay in which an HPV L1 C-terminal conserved sequence polypeptide-induced mouse monoclonal antibody panel was used to detect HPV L1.
RESULTS
Cervical cell samples were collected from 514 patients at the gynecology clinic; of these, 339 samples were sent for HPV genotyping, and 220 were HPV positive (64.90%, 220/339). Moreover, the duplicate samples from these 339 patients were sent for IHC assay, and 229 samples were positive (67.55%, 229/339). The IHC result was concordant with that obtained by HPV genotyping (Kappa = 0.743, p < 0.001).
CONCLUSION
This study showed that use of the HPV L1 C-terminal conserved sequence polypeptide-induced mouse monoclonal antibody panel was of great value for the detection of HPV in cervical cells; the resulting detection rate was comparable to that obtained using the commercial HPV genotyping kit that is currently in use in clinical practice.
目的
确定针对人乳头瘤病毒 (HPV) L1（主要衣壳蛋白）C 端保守序列多肽的单克隆抗体检测试剂盒在宫颈脱落细胞中检测 HPV 的价值，以及该抗体检测试剂盒用于宫颈癌临床筛查的潜力。
方法
在妇科诊所收集宫颈脱落细胞。每个样本的一部分被送到病理科进行 HPV 基因分型，另一部分被送到病理科进行细胞学检测，然后送到实验室进行免疫组织化学（IHC）检测，该检测使用 HPV L1 C 端保守序列多肽诱导的小鼠单克隆抗体检测试剂盒检测 HPV L1。
结果
从妇科诊所的 514 名患者中收集了宫颈细胞样本；其中，339 个样本被送去进行 HPV 基因分型，220 个样本呈 HPV 阳性（64.90%，220/339）。此外，这些 339 名患者的重复样本被送去进行 IHC 检测，229 个样本呈阳性（67.55%，229/339）。IHC 结果与 HPV 基因分型结果一致（Kappa 值=0.743，p<0.001）。
结论
本研究表明，使用 HPV L1 C 端保守序列多肽诱导的小鼠单克隆抗体检测试剂盒在检测宫颈细胞中的 HPV 方面具有重要价值；检测率与目前临床实践中使用的商用 HPV 基因分型试剂盒相当。
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