Castle Philip E, Wheeler Cosette M, Solomon Diane, Schiffman Mark, Peyton Cheri L
Division of Cancer Epidemiology and Genetics, National Cancer Institute, National Institutes of Health, DHHS, Bethesda, MD, USA.
Am J Clin Pathol. 2004 Aug;122(2):238-45. doi: 10.1309/BA43-HMCA-J26V-WQH3.
We evaluated the interlaboratory reproducibility of the Hybrid Capture 2 (HC2; Digene, Gaithersburg, MD), a test for oncogenic human papillomavirus (HPV) DNA, using data from 4 clinical center (CC) laboratories and the quality control (QC) laboratory participating in the ASCUS (atypical squamous cells of undetermined significance) and LSIL (low-grade squamous intraepithelial lesion) Triage Study (ALTS). Residual liquid cytology specimens were tested routinely throughout the duration of ALTS at CC laboratories, and a stratified (by time in the study) random sample of specimens was retested by the HPV QC laboratory using equivalent protocols. Of the specimens selected (N = 1,175, 5.50% of all specimens obtained), 1,072 (91.23%) had sufficient specimen volume for retesting. The kappa value between all CC laboratories and the HPV QC laboratory was 0.84 (95% confidence interval, 0.78-0.89), with kappa values for individual CCs and the HPV QC laboratory ranging from 0.79 to 0.89. Agreement between test results was lowest among results for women with negative cytologic findings (0.73); among those with equivocal or abnormal cytologic findings, kappa values were 0.80 or more. These data show that HC2 is a reliable test for detecting clinically relevant oncogenic HPV DNA.
我们利用来自4个临床中心（CC）实验室以及参与非典型鳞状细胞意义不明确（ASCUS）和低度鳞状上皮内病变（LSIL）分流研究（ALTS）的质量控制（QC）实验室的数据，评估了人乳头瘤病毒（HPV）DNA检测方法——杂交捕获2代（HC2；Digene公司，马里兰州盖瑟斯堡）的实验室间可重复性。在ALTS研究期间，CC实验室对剩余的液基细胞学标本进行常规检测，HPV QC实验室使用相同方案对分层（按研究时间）随机抽取的标本进行重新检测。在所选取的标本（N = 1175，占所有获取标本的5.50%）中，1072份（91.23%）标本量充足，可进行重新检测。所有CC实验室与HPV QC实验室之间的kappa值为0.84（95%置信区间为0.78 - 0.89），各个CC实验室与HPV QC实验室之间的kappa值在0.79至0.89之间。细胞学检查结果为阴性的女性中，检测结果之间的一致性最低（0.7
