Department of Epidemiology, School of Public Health, The George Washington University, Washington, DC, USA.
Whitman-Walker Health, Washington, DC, USA.
J Virol Methods. 2021 Jun;292:114113. doi: 10.1016/j.jviromet.2021.114113. Epub 2021 Feb 27.
Although anal cancers represent just 0.5 % of all new cancer cases in U.S., rates have increased markedly, with highest rates in HIV-infected MSM. American Cancer Society estimates there will be ∼9090 new cases and ∼1420 deaths in 2021. We compared Roche Linear Array HPV Genotyping (Roche) and AmpFire HPV Genotyping (AmpFire) assays for concordance and agreement to detect 15 hr-HPV types from 151 anal specimens. Within run precision of AmpFire was assessed on 50 anal specimens. Specimens with Roche Combo-positive and HPV33, HPV35 and/or HPV58-positive results were further tested using HPV52-specific TaqMan assay. AmpFire generated valid results on 149/151 (98.7 %) specimens; 135/149 (90.6 %) and 134/149 (89.9 %) had detectable HR-HPV DNA by AmpFire or Roche, respectively. Overall concordance was 89.8 % (2007/2235, κ = 0.65). HPV16 showed highest overall concordance at 93.3 % (139/149, κ = 0.84). HPV68 had lowest overall concordance at 77.2 % (115/149, κ = 0.28). Kappa values were interpreted as being moderate or good for all other HR-HPV types. Within run precision generated 744/750 concordant results; R value = 0.97 (p < 0.0001) (Mantel Test). In conclusion, AmpFire and Roche demonstrated good inter-assay agreement for detecting most HR-HPV types from anal samples, with AmpFire detecting a broader range of HPV68 subtypes and detecting HPV52 without the need for confirmatory testing.
尽管在美国，肛门癌仅占所有新发癌症病例的 0.5%，但其发病率却显著上升，HIV 感染的男男性行为者（MSM）中发病率最高。美国癌症协会估计，2021 年将有约 9090 例新发病例和 1420 例死亡。我们比较了罗氏线性阵列 HPV 基因分型（罗氏）和 AmpFire HPV 基因分型（AmpFire）检测 151 份肛门标本中 15 种高危型 HPV 的一致性和吻合度。在 50 份肛门标本中评估了 AmpFire 的批内精密度。对罗氏 Combo 阳性且 HPV33、HPV35 和/或 HPV58 阳性的标本进一步使用 HPV52 特异性 TaqMan 检测进行检测。AmpFire 在 149/151（98.7%）标本中生成有效结果；AmpFire 或罗氏分别检测到 135/149（90.6%）和 134/149（89.9%）的 HR-HPV DNA 可检测到。总一致性为 89.8%（2007/2235，κ=0.65）。HPV16 的总体一致性最高，为 93.3%（139/149，κ=0.84）。HPV68 的总体一致性最低，为 77.2%（115/149，κ=0.28）。对于所有其他 HR-HPV 类型，κ 值均被解释为中度或良好。批内精密度产生 744/750 个一致结果；R 值=0.97（p<0.0001）（Mantel 检验）。总之，AmpFire 和罗氏在检测肛门样本中的大多数 HR-HPV 类型方面表现出良好的试验间一致性，AmpFire 检测到更广泛的 HPV68 亚型，并且无需确认性检测即可检测到 HPV52。
