Clinical Epidemiology Unit, Clinical Genetic Branch, Division of Cancer Epidemiology and Genetics, National Cancer Institute, Rockville, Maryland, USA.
Department of Obstetrics, Gynecology, and Perinatology, The Obafemi Awolowo University, Ile-Ife, Osun State, Nigeria.
Int J Cancer. 2022 Oct 1;151(7):1142-1149. doi: 10.1002/ijc.34151. Epub 2022 Jun 24.
Accelerated cervical cancer control will require widespread human papillomavirus (HPV) vaccination and screening. For screening, sensitive HPV testing with an option of self-collection is increasingly desirable. HPV typing predicts risk of precancer/cancer, which could be useful in management, but most current typing assays are expensive and/or complicated. An existing 15-type isothermal amplification assay (AmpFire, Atila Biosystems, USA) was redesigned as a 13-type assay (ScreenFire) for public health use. The redesigned assay groups HPV types into four channels with differential cervical cancer risk: (a) HPV16, (b) HPV18/45, (c) HPV31/33/35/52/58 and (d) HPV39/51/56/59/68. Since the assay will be most useful in resource-limited settings, we chose a stratified random sample of 453 provider-collected samples from a population-based screening study in rural Nigeria that had been initially tested with MY09-MY11-based PCR with oligonucleotide hybridization genotyping. Frozen residual specimens were masked and retested at Atila Biosystems. Agreement on positivity between ScreenFire and prior PCR testing was very high for each of the channels. When we simulated intended use, that is, a hierarchical result in order of clinical importance of the type groups (HPV16 > 18/45 > 31/33/35/52/58 > 39/51/56/59/68), the weighted kappa for ScreenFire vs PCR was 0.90 (95% CI: 0.86-0.93). The ScreenFire assay is mobile, relatively simple, rapid (results within 20-60 minutes) and agrees well with reference testing particularly for the HPV types of greatest carcinogenic risk. If confirmed, ScreenFire or similar isothermal amplification assays could be useful as part of risk-based screening and management.
加速宫颈癌防控需要广泛应用人乳头瘤病毒（HPV）疫苗接种和筛查。对于筛查而言，人们越来越希望采用敏感度高的 HPV 检测方法，并提供自我采样的选择。HPV 分型可预测癌前病变/癌症风险，这在管理中可能有用，但大多数当前的分型检测方法昂贵且/或复杂。现有的 15 型等温扩增检测（AmpFire，Atila Biosystems，美国）被重新设计为一种 13 型检测（ScreenFire），用于公共卫生用途。重新设计的检测将 HPV 类型分为四个具有不同宫颈癌风险的通道：(a) HPV16，(b) HPV18/45，(c) HPV31/33/35/52/58 和 (d) HPV39/51/56/59/68。由于该检测方法在资源有限的环境中最有用，我们选择了从尼日利亚农村地区一项基于人群的筛查研究中随机抽取的 453 个由提供者采集的样本，这些样本最初使用基于 MY09-MY11 的 PCR 与寡核苷酸杂交基因分型进行了检测。冷冻的剩余标本在 Atila Biosystems 进行了盲法和重新检测。ScreenFire 与之前的 PCR 检测在每个通道的阳性结果一致性都非常高。当我们模拟预期用途时，即按照类型组的临床重要性（HPV16>18/45>31/33/35/52/58>39/51/56/59/68）的顺序进行分层结果，ScreenFire 与 PCR 的加权 Kappa 值为 0.90（95%CI：0.86-0.93）。ScreenFire 检测方法具有移动性、相对简单、快速（20-60 分钟内出结果），并且与参考检测结果吻合良好，尤其是对于致癌风险最大的 HPV 类型。如果得到证实，ScreenFire 或类似的等温扩增检测方法可能有助于基于风险的筛查和管理。
