Earley Amy, Lamont Jenny L, Dahabreh Issa J, Cowan Janet, Feldman Sarah, Uhlig Katrin
1Center for Clinical Evidence Synthesis and 2Institute of Clinical Research and Health Policy Study, Tufts Medical Center, Boston, MA; 3Center of Evidence-Based Medicine and 4Department of Health Services Policy & Practice, Program in Public Health, Brown University, Providence, RI; 5Division of Cytogenetics, Department of Pathology and Laboratory Medicine, Tufts Medical Center, Boston, MA; 6Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, Brigham & Women's Hospital, Boston, MA; and 7Division of Nephrology, Department of Medicine, Tufts Medical Center, Boston, MA.
J Low Genit Tract Dis. 2014 Jul;18(3):218-27. doi: 10.1097/LGT.0000000000000007.
We examined the diagnostic performance of fluorescence in situ hybridization (FISH) tests on cervical cytology for precancerous lesions or cancer on cervical histology.
A search was conducted in MEDLINE, the Cochrane Central Register of Controlled Trials, and Scopus through September 3, 2013. Eleven studies examined FISH tests for telomerase RNA component gene (TERC), myelocytomatosis oncogene (MYC), or human papillomavirus (HPV) type 16 or 18 in samples exhibiting atypical squamous cells of unknown significance (ASC-US) or low-grade squamous intraepithelial lesions (LSIL). None examined HPV-positive, cytologically normal samples. We extracted data on the sensitivity and specificity for high-grade cervical intraepithelial neoplasia (CIN 2+ or CIN 3+).
Fluorescence in situ hybridization test probes and thresholds varied across studies. Included populations were convenience samples. Only 1 study testing for TERC specified HPV status. In meta-analysis, FISH for TERC in LSIL (9 studies, 1,082 cases) had a summary sensitivity of 0.76 (95% confidence interval = 0.63-0.85) and a summary specificity of 0.78 (95% confidence interval = 0.57-0.91) for CIN 2+. Fluorescence in situ hybridization for TERC in ASC-US (3 studies, 839 cases) showed sensitivities ranging from 0.75 to 1.00 and specificities from 0.87 to 0.93 for CIN 2+. For CIN 3+, sensitivity and specificity appeared similar, although a small number of studies preclude firm conclusions. For FISH tests for HPV, we found only few studies with small sample sizes.
The evidence on FISH testing is limited given the small number of studies for each cytology subgroup and the lack of studies in well-defined screening contexts stratifying participants by HPV status.
我们研究了宫颈细胞学荧光原位杂交（FISH）检测对宫颈组织学癌前病变或癌症的诊断性能。
截至2013年9月3日，在MEDLINE、Cochrane对照试验中心注册库和Scopus中进行了检索。11项研究检测了显示意义不明确的非典型鳞状细胞（ASC-US）或低级别鳞状上皮内病变（LSIL）的样本中的端粒酶RNA组分基因（TERC）、髓细胞瘤癌基因（MYC）或16或18型人乳头瘤病毒（HPV）的FISH检测。没有研究检测HPV阳性、细胞学正常的样本。我们提取了高级别宫颈上皮内瘤变（CIN 2+或CIN 3+）的敏感性和特异性数据。
各研究中FISH检测探针和阈值各不相同。纳入人群为便利样本。仅1项检测TERC的研究明确了HPV状态。在荟萃分析中，LSIL中TERC的FISH检测（9项研究，1082例）对CIN 2+的汇总敏感性为0.76（95%置信区间=0.63-0.85），汇总特异性为0.78（95%置信区间=0.57-0.91）。ASC-US中TERC的FISH检测（3项研究，839例）对CIN 2+的敏感性范围为0.75至1.00,特异性范围为0.87至0.93。对于CIN 3+，敏感性和特异性似乎相似，尽管研究数量较少，无法得出确凿结论。对于HPV的FISH检测，我们仅发现少数样本量较小的研究。
鉴于每个细胞学亚组的研究数量较少，且缺乏在明确的筛查背景下按HPV状态对参与者进行分层的研究，FISH检测的证据有限。
