New Hanover Regional Medical Center, Wilmington, NC 28402, USA.
Int J Gynecol Cancer. 2013 Mar;23(3):513-8. doi: 10.1097/IGC.0b013e318280f3bc.
Mexican Cervical Cancer Screening Study II (MECCS II) seeks to develop a highly sensitive and highly specific screening program able to be adapted to all socioeconomic levels in Mexico. The objectives of MECCS II are (1) to compare the sensitivity and specificity for cervical intraepithelial neoplasia (CIN) 3 or cancer of self-collected vaginal specimens tested for high-risk types of the human papillomavirus (HR-HPV) by APTIMA with those tested for HR-HPV by Hybrid Capture 2 (HC2); and (2) determine the efficacy of cryotherapy in the treatment of HR-HPV-positive and acetic acid-aided visual inspection (VIA)-positive and -negative women after VIA triage.
The study was conducted in rural Mexico. Women aged 30 to 50 years, nonpregnant, with no history of hysterectomy or pelvic irradiation and varied histories of screening, participated. A direct endocervical sample was tested for cytology, HC2, and APTIMA assay (AHPV). Subjects positive on any test were recalled for triage VIA, biopsies, and immediate cryotherapy. Tests were compared using McNemar test.
Two thousand forty-nine patients have complete results. Mean age of the patients was 39.2 years; 7.7% presented with ≥atypical squamous cells of uncertain significance (ASCUS), 1.8% ≥low-grade squamous intraepithelial neoplasia, and 0.5% ≥high-grade squamous intraepithelial neoplasia. Two percent of patients had ≥CIN2, and 0.78% had ≥CIN3 (including 2 with invasive disease). The sensitivity of ThinPrep (>ASCUS), HC2, and AHPV for >CIN3 for direct endocervical collection was 87.5%, 100%, and 100%, respectively. The specificity of ThinPrep (>ASCUS), HC2, and AHPV for >CIN3 was 94.1%, 92.2%, and 93.5%, respectively. Specificities of HC2 and AHPV differed significantly. The overall percentage of agreement among HPV assays (HC2 vs APTIMA) is 97%. Four hundred sixty-nine women returned for VIA. Two hundred ninety-one women were treated with cryotherapy.
The specificity of the APTIMA assay along with high sensitivity is an advantage for primary screening. Follow-up evaluation will be important to determine the true impact of potential undertreatment in the screening algorithm. Self-sampling applications are explored.
墨西哥宫颈癌筛查研究 II（MECCS II）旨在开发一种高度敏感且高度特异的筛查方案，使其能够适应墨西哥所有社会经济水平。MECCS II 的目标是：（1）比较自我采集的阴道标本中高危型人乳头瘤病毒（HR-HPV）的 APTIMA 检测与 Hybrid Capture 2（HC2）检测用于检测宫颈上皮内瘤变（CIN）3 或癌症的敏感性和特异性；（2）确定在醋酸辅助肉眼检查（VIA）初筛阳性且 HR-HPV 阳性的妇女中，使用冷冻疗法治疗 HR-HPV 阳性和 VIA 初筛阳性及阴性妇女的疗效。
该研究在墨西哥农村进行。参与研究的是年龄在 30 岁至 50 岁之间、非妊娠、无子宫切除术或盆腔放疗史且筛查史各异的妇女。对直接宫颈标本进行细胞学、HC2 和 APTIMA 检测（AHPV）。任何检测阳性的患者均被召回进行 VIA 初筛、活检和立即冷冻治疗。使用 McNemar 检验比较检测结果。
2049 例患者的结果完整。患者的平均年龄为 39.2 岁；7.7%的患者出现≥非典型鳞状细胞意义不明确（ASCUS），1.8%的患者出现≥低级别鳞状上皮内瘤变，0.5%的患者出现≥高级别鳞状上皮内瘤变。2%的患者出现≥CIN2，0.78%的患者出现≥CIN3（包括 2 例浸润性疾病）。直接宫颈采集的液基细胞学检查（≥ASCUS）、HC2 和 AHPV 对>CIN3 的敏感性分别为 87.5%、100%和 100%。液基细胞学检查（≥ASCUS）、HC2 和 AHPV 对>CIN3 的特异性分别为 94.1%、92.2%和 93.5%。HC2 和 AHPV 的特异性有显著差异。HPV 检测（HC2 与 APTIMA）之间的总符合率为 97%。469 例妇女返回进行 VIA 检查。291 例妇女接受了冷冻治疗。
APTIMA 检测的高灵敏度和特异性是初级筛查的优势。后续评估对于确定筛查算法中潜在过度治疗的真正影响非常重要。正在探索自我采样的应用。
