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一

欧洲、美国指南对HPVmRNA与p16的定位

（一）“WhereasHPVDNAtestsdetectthepresenceorabsenceofHPVvirusgenomes,HPVRNAtestsaredesignedtodetecttheexpression(mRNA)ofgenesthatarerelatedtocancerdevelopment.OverexpressionofHPVE6andE7viralgenesisrequiredformalignanttransformation.DetectionofmRNAofE6andE7genesmayallowadistinctionbetweentransientinfectionsandthosethatwillprogresstocancer”

“HPVDNA检测的是HPV病毒基因组是否存在，而HPVRNA检测方法被用来检测与癌症进展相关基因的表达（即mRNA）。HPVE6和E7病毒基因的过表达是恶性转化的必要条件。检测E6和E7基因的mRNA可以区分一过性感染者及那些能够进展为癌的患者。”

——Europeanguidelinesforqualityassuranceincervicalcancerscreening，Secondedition-Supplements

（二）“Approvedassaysincludetarget-andsignal-amplificationassaysofHPVDNA,aswellasHPVmRNA.”

“推荐HPV检测方法包括HPVDNA和HPVmRNA的靶标扩增和信号扩增。”

——ASCCPRisk-BasedManagementConsensusGuidelinesforAbnormalCervicalCancerScreeningTestsandCancerPrecursors

（三）“ImmaturesquamousmetaplasiaandatrophicsquamousepitheliumaredocumentedsourcesofmisinterpretationandmaybemistakenforCIN1-2(Crumetal.,).Insuchcasesp16stainingandrepeatbiopsyafteroestrogenmaybehelpful(Klaesetal.,,seealsosection5.6).”

“未成熟的鳞状上皮化生和萎缩性鳞状上皮是常被误诊为CIN1-2的主要来源，对于这种情况，p16染色和重复活检可能有所帮助。”

——Europeanguidelinesforqualityassuranceincervicalcancerscreening，SecondEdition

（四）“Apositivep16immunostainsupportsthediagnosisofhistologicHSILifthemorphologicalassessmentofHEslidesisconsistentwithCIN2orCIN3.Thereisariskofovercallingcervicalhistologyresultswhenp16isusedincorrectly.Mostimportantly,amorphologicCIN1onHEshouldnotbeupgradedtohistologicHSIL(CIN2)evenifp16positive”

“HSIL治疗的管理也将CIN2和CIN3的管理方案根据不同风险进行推荐，并继续推荐p16免疫组织化学在HSIL（CIN2或CIN3）组织形态学的应用。但应避免p16应用不当，造成宫颈组织学过度诊断的风险，例如组织形态为CIN1，即使p16阳性也不应升级为HSIL（CIN2）。”

——ASCCPRisk-BasedManagementConsensusGuidelinesforAbnormalCervicalCancerScreeningTestsandCancerPrecursors

二

欧洲、美国指南对HPVmRNA与p16诊断性能的评价

（一）“Nevertheless,lowerproportionsofmRNA-positiveresultswereobservedinnormalcases,ASCUS,andLSIL,whichcouldbeinterpretedasapossibleincreaseinspecificity