Chen Fei, Hsu Lin Lawrence, Hindi Issa, Sun Wei, Shafizadeh Negin, Szeto Oliver, Brandler Tamar C, Simsir Aylin
Department of Pathology, NYU Langone Health, New York, NY, US.
Am J Clin Pathol. 2023 Aug 1;160(2):137-143. doi: 10.1093/ajcp/aqad026.
The 2019 American Society of Colposcopy and Cervical Pathology management guidelines recommend that patients with an unsatisfactory Papanicolaou (Pap) test (UPT) and negative human papillomavirus (HPV) cotest undergo repeat age-based screening in 2 to 4 months. The rationale is that a negative HPV test in the setting of an UPT may reflect an inadequate sample and therefore should not be interpreted as truly "negative." For patients 25 years and older who are cotested, if HPV is positive for the 16 or 18 genotypes, direct referral for colposcopy is recommended. Our study aimed to determine if a negative HPV cotest result is predictive of the absence of a high-grade squamous intraepithelial lesion (HSIL) and whether these patients may be called back for repeat testing at an interval longer than 2 to 4 months.
Follow-up cervical cytology and biopsy results in women with UPT and HPV cotests from January 2017 to December 2021 were collected. Original UPT and HPV cotest results were correlated with the follow-up Pap and biopsy results.
There were 1,496 (2.28%) UPT cases out of 65,641 total Pap tests. Among the 1,496 UPT cases, 1,010 (67.5%) had HPV cotesting; 676 (45.1%) were followed by repeat Pap or biopsy within 4 months and 850 (56.8%) within 12 months. The total follow-up rate was 81%, with a range of 3 days to 36 months. The HSIL rate in HPV-positive cases was 5.7% (3/53) vs 0.4% (2/539) (P = .006) in HPV-negative cases. In UPT, HPV cotesting showed negative predictive values for low-grade and high-grade squamous intraepithelial lesion detection of 98.5% and 99.6%, respectively, while positive predictive values were 19% and 5.7%.
A negative HPV cotest in individuals with UPT predicted the lack of HSIL in our study. Compliance with the recommended follow-up time of 2 to 4 months for women with UPT was low (45.1%). Our study suggests that women with UPT and negative HPV cotest may be safely called back at an interval longer than 4 months.
2019年美国阴道镜及宫颈病理学会管理指南建议,巴氏试验结果不满意(UPT)且人乳头瘤病毒(HPV)联合检测结果为阴性的患者,应在2至4个月后进行基于年龄的重复筛查。理由是,在UPT情况下HPV检测呈阴性可能反映样本不足,因此不应被解释为真正的“阴性”。对于联合检测的25岁及以上患者,如果HPV 16或18基因型呈阳性,建议直接转诊至阴道镜检查。我们的研究旨在确定HPV联合检测结果为阴性是否可预测高级别鳞状上皮内病变(HSIL)不存在,以及这些患者是否可以间隔超过2至4个月被召回进行重复检测。
收集2017年1月至2021年12月期间UPT且HPV联合检测的女性的后续宫颈细胞学和活检结果。将原始UPT和HPV联合检测结果与后续巴氏试验和活检结果进行关联。
在65641次巴氏试验中,有1496例(2.28%)为UPT病例。在1496例UPT病例中,1010例(67.5%)进行了HPV联合检测;676例(45.1%)在4个月内接受了重复巴氏试验或活检,850例(56.8%)在12个月内接受了检查。总随访率为81%,范围为3天至36个月。HPV阳性病例的HSIL发生率为5.7%(3/53),而HPV阴性病例为0.4%(2/539)(P = .006)。在UPT中,HPV联合检测对低级别和高级别鳞状上皮内病变检测的阴性预测值分别为98.5%和99.6%,而阳性预测值分别为19%和5.7%。
在我们的研究中,UPT个体中HPV联合检测结果为阴性可预测HSIL不存在。UPT女性对建议的2至4个月随访时间的依从性较低(45.1%)。我们的研究表明,UPT且HPV联合检测结果为阴性的女性可以间隔超过4个月安全地被召回。