Cross comparison of AmpFire HPV genotyping assay and Roche human papillomavirus (HPV) linear array for HPV genotyping of anal swab samples.
Cross comparison of AmpFire HPV genotyping assay and Roche human papillomavirus (HPV) linear array for HPV genotyping of anal swab samples.
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AmpFire HPV基因分型检测试剂盒和Roche人乳头瘤病毒（HPV）线性阵列用于肛门拭子样本HPV基因分型的交叉比较。
DOI：
10.1016/j.jviromet.2021.114113
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发表时间：
2021-06
影响因子：
3.1
通讯作者：
Jordan JA
中科院分区：
文献类型：
--
作者：
Connors KA;Abbott S;Jair K;Daniels J;Lintner M;Klein D;Wimpleberg A;Jordan JA
虽然肛门癌仅占美国所有新发癌症病例的0.5%，艾滋病毒感染率显著上升，感染艾滋病毒的男男性行为者的感染率最高。美国癌症协会估计，2021年将有约9，090例新病例和约1，420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）检测的一致性和协议，以检测151个肛门标本中的15种HR-HPV类型。在50个肛门标本上评估AmpFire的运行内精密度。Roche Combo阳性和HPV 33、HPV 35和/或HPV 58阳性结果的标本使用HPV 52特异性TaqMan检测试剂盒进行进一步检测。AmpFire对149/151（98.7%）份标本产生了有效结果; AmpFire或Roche分别对135/149（90.6%）和134/149（89.9%）份标本产生了可检测的HR-HPV DNA。总体一致性为89.8%（2007/2235，κ=0.65）。HPV 16显示出最高的总体一致性，为93.3%（139/149，κ=0.84）。HPV 68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，Kappa值被解释为中度或良好。运行内精密度生成744/750一致结果; R2值=0.97（p<0.0001）（Mantel检验）。总之，AmpFire和Roche在检测肛门样本中的大多数HR-HPV类型方面表现出良好的检测间一致性，AmpFire检测更广泛的HPV 68亚型，并检测HPV 52，而无需进行确证性检测。
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 ~9,090 new cases and ~1,420 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; R2 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.
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