目的:AtilaBiosystems的人乳头瘤病毒(HPV)筛查方法,包括新的AmpFire(14型)和ScreenFireRS(13型),进行了一系列验证测试。
方法:我们使用了一组来自中国多点筛查试验的样本(先前使用cobas4800和下一代SeqHPV进行了测试),以满足Meijer的临床终点验证标准。我们在cobas4800和SeqHPV上选择了556个自我收集的标本,这些标本由273个高危HPV(hrHPV)阳性和283个hrHPV阴性组成。在273例hrHPV阳性病例中,108人的疾病终点为宫颈上皮内瘤变2级(CIN2)或更高,其中47例宫颈上皮内瘤变3级(CIN3+)或更高。我们模拟了VALGENT实验室间和实验室内验证框架,并以分层方式评估了新的4通道风险分层ScreenFire测定。
结果:在108例CI为N2或更高的病例中,AmpFire和ScreenFire均检测到106(98.1%),特异性分别为56.7%和58.1%,分别。2次AmpFire和ScreenFire的流产内一致性分别为95.13%和96.03%,分别,对于整体的hrHPV类型和99.10%和99.46%,分别,HPV16总体hrHPV的AmpFire和ScreenFire的实验室间一致性分别为93.68%和94.04%,分别为98.92%和99.28%,分别,HPV16其他基因型相关百分比同样高,κs范围从0.86到0.94。ScreenFireRS分析以分层方式(仅注意最高风险通道)评估“临床指导”时,显示出出色的“基因型特异性一致性”,cobas4800和SeqHPV均低于N2,CIN2和CIN3或更高。
结论:良好的实验室内和实验室间可重复性和既定的临床表现,与平台的简单性一起,使这些测定特别适用于低资源的设置。
OBJECTIVE: The human papillomavirus (HPV) screening assays from Atila Biosystems, including the new AmpFire (14 type) and ScreenFire RS (13 type), were subjected to a series of validation tests.
METHODS: We used a set of samples from the Chinese Multi-Site Screening
Trial (previously tested with cobas 4800 and the next-generation SeqHPV) to satisfy Meijer\'s criteria for clinical end-point validation. We selected 556 self-collected specimens composed of 273 high-risk HPV (hrHPV) positives and 283 hrHPV negatives on the cobas 4800 and SeqHPV. Of the 273 hrHPV-positive cases, 108 had a disease end point of cervical intraepithelial neoplasia grade 2 (CIN2) or higher, including 47 with cervical intraepithelial neoplasia grade 3 (CIN3+) or higher. We simulated the VALGENT framework for inter- and intralaboratory validation and evaluated the new 4-channel risk-stratified ScreenFire assay in a hierarchal fashion.
RESULTS: Both AmpFire and ScreenFire detected 106 (98.1%) of 108 cases with CIN2 or higher, with specificities of 56.7% and 58.1%, respectively. Intralaboratory concordance for 2 runs of AmpFire and ScreenFire was 95.13% and 96.03%, respectively, for overall hrHPV types and 99.10% and 99.46%, respectively, for HPV 16. The interlaboratory concordance of AmpFire and ScreenFire was 93.68% and 94.04% for overall hrHPV and 98.92% and 99.28%, respectively, for HPV 16. Other genotype correlation percentages were similarly high, with κs ranging from 0.86 to 0.94. The ScreenFire RS assay demonstrated excellent \"genotype-specific concordance\" when evaluated for \"clinical guidance\" in a hierarchal fashion (noting only the highest risk channel) with both the cobas 4800 and SeqHPV for less than CIN2, CIN2, and CIN3 or higher.
CONCLUSIONS: The excellent intra- and interlaboratory reproducibility and the established clinical performance, together with the platforms\' simplicity, make these assays particularly applicable to low-resource settings.