中华检验医学杂志
中華檢驗醫學雜誌
중화검험의학잡지
CHINESE JOURNAL OF LABORATORY MEDICINE
2012年
1期
53-58
,共6页
宋美兰%任芙蓉%龚晓燕%姚凤兰%王卓妍%朱家明%刘江
宋美蘭%任芙蓉%龔曉燕%姚鳳蘭%王卓妍%硃傢明%劉江
송미란%임부용%공효연%요봉란%왕탁연%주가명%류강
供血者%核酸类%肝炎病毒,乙型%肝病病毒属%HIV%免疫酶技术
供血者%覈痠類%肝炎病毒,乙型%肝病病毒屬%HIV%免疫酶技術
공혈자%핵산류%간염병독,을형%간병병독속%HIV%면역매기술
Blood donors%Nudeic acids%Hepatitis B Virus%Hepacivirus%HIV%Immunoenzyme techniques
目的 探讨单份及16份混合标本2种检测模式对献血者血液病毒核酸检测(nucleic acid test,NAT)效果的影响.方法 2009年2至6月顺序留取北京无偿献血者标本,用诺华Procleix ULTRIO Assay进行单份(ID)或16份混合标本(P16)乙型肝炎病毒(HBV)、丙型肝炎病毒(HCV)和人类免疫缺陷病毒-1( HIV-1)三项联合核酸检测.单份NAT反应性同时HBsAg、抗-HCV或抗-HIV血清学不合格的标本,血清学合格的单份NAT反应性经双孔NAT复检阳性的标本,以及混合NAT反应性/拆分NAT为阳性的标本,进一步用诺华Procleix HBV、HCV和HIV-1鉴别试剂进行鉴别试验.血清学合格、HBV NAT单独阳性标本进一步用Roche HBV定量实验加以验证和进行病毒含量测定、血清学分析、并进行稀释以模拟是否能被P16-NAT检出.阳性检出率进行四格表连续校正的x2检验.结果 (1)在7613份单份NAT (ID-NAT)标本中,检出NAT阳性26份,ID-NAT阳性率0.34％(26/7613)；(2)在16 064份共1004份P16混合标本NAT(P16-NAT)中,检出NAT阳性27份,P16-NAT阳性率为0.17％ (27/16 064)；(3)在血清学合格标本中,单份检测的NAT单独阳性检出率为0.12％ (9/7438),高于16份混样检测的NAT单独阳性检出率0.01％ (2/15 750)(x2=11.880,P＜0.05).9份ID-NAT及2份P16-NAT单独阳性标本经鉴别均为HBV NAT阳性,未检出 HCV NAT单独阳性或HIV NAT单独阳性；(4)9份ID-NAT HBV单独阳性血样模拟P16-NAT,仅有2份可被检出；(5)对8份ID-NAT及2份P16-NAT单独阳性标本进行Roche HBV定量测定,均可确证其核酸检测结果,但病毒含量很低.其中2份HBV病毒含量为472 IU/ml及15 IU/ml,6份含量＜12 IU/ml,另2份原倍不能定量经10倍浓缩处理后测得含量为＜ 12 IU/ml和14.3 IU/ml;(6)11份HBV NAT单独阳性标本中,3份(27.3％)为潜在的窗口期感染,其余8份(72.7％)抗-HBc阳性或抗-HBe阳性,但抗-HBc-IgM均为阴性,为隐匿性感染；(7) P16-NAT初检呈反应性需要进行拆分试验的混合样本比率为2.49％ (25/1004),其中由血清学合格标本所致初检反应性的混合样本比率为0.20％ (2/1004).结论 ID-NAT单独阳性检出率高于P16-NAT单独阳性检出率.为避免低病毒含量HBV的漏检,应选用灵敏度高的核酸检测试剂,并尽量采用小标本量混合检测,甚至采用单份检测方式.
目的 探討單份及16份混閤標本2種檢測模式對獻血者血液病毒覈痠檢測(nucleic acid test,NAT)效果的影響.方法 2009年2至6月順序留取北京無償獻血者標本,用諾華Procleix ULTRIO Assay進行單份(ID)或16份混閤標本(P16)乙型肝炎病毒(HBV)、丙型肝炎病毒(HCV)和人類免疫缺陷病毒-1( HIV-1)三項聯閤覈痠檢測.單份NAT反應性同時HBsAg、抗-HCV或抗-HIV血清學不閤格的標本,血清學閤格的單份NAT反應性經雙孔NAT複檢暘性的標本,以及混閤NAT反應性/拆分NAT為暘性的標本,進一步用諾華Procleix HBV、HCV和HIV-1鑒彆試劑進行鑒彆試驗.血清學閤格、HBV NAT單獨暘性標本進一步用Roche HBV定量實驗加以驗證和進行病毒含量測定、血清學分析、併進行稀釋以模擬是否能被P16-NAT檢齣.暘性檢齣率進行四格錶連續校正的x2檢驗.結果 (1)在7613份單份NAT (ID-NAT)標本中,檢齣NAT暘性26份,ID-NAT暘性率0.34％(26/7613)；(2)在16 064份共1004份P16混閤標本NAT(P16-NAT)中,檢齣NAT暘性27份,P16-NAT暘性率為0.17％ (27/16 064)；(3)在血清學閤格標本中,單份檢測的NAT單獨暘性檢齣率為0.12％ (9/7438),高于16份混樣檢測的NAT單獨暘性檢齣率0.01％ (2/15 750)(x2=11.880,P＜0.05).9份ID-NAT及2份P16-NAT單獨暘性標本經鑒彆均為HBV NAT暘性,未檢齣 HCV NAT單獨暘性或HIV NAT單獨暘性；(4)9份ID-NAT HBV單獨暘性血樣模擬P16-NAT,僅有2份可被檢齣；(5)對8份ID-NAT及2份P16-NAT單獨暘性標本進行Roche HBV定量測定,均可確證其覈痠檢測結果,但病毒含量很低.其中2份HBV病毒含量為472 IU/ml及15 IU/ml,6份含量＜12 IU/ml,另2份原倍不能定量經10倍濃縮處理後測得含量為＜ 12 IU/ml和14.3 IU/ml;(6)11份HBV NAT單獨暘性標本中,3份(27.3％)為潛在的窗口期感染,其餘8份(72.7％)抗-HBc暘性或抗-HBe暘性,但抗-HBc-IgM均為陰性,為隱匿性感染；(7) P16-NAT初檢呈反應性需要進行拆分試驗的混閤樣本比率為2.49％ (25/1004),其中由血清學閤格標本所緻初檢反應性的混閤樣本比率為0.20％ (2/1004).結論 ID-NAT單獨暘性檢齣率高于P16-NAT單獨暘性檢齣率.為避免低病毒含量HBV的漏檢,應選用靈敏度高的覈痠檢測試劑,併儘量採用小標本量混閤檢測,甚至採用單份檢測方式.
목적 탐토단빈급16빈혼합표본2충검측모식대헌혈자혈액병독핵산검측(nucleic acid test,NAT)효과적영향.방법 2009년2지6월순서류취북경무상헌혈자표본,용낙화Procleix ULTRIO Assay진행단빈(ID)혹16빈혼합표본(P16)을형간염병독(HBV)、병형간염병독(HCV)화인류면역결함병독-1( HIV-1)삼항연합핵산검측.단빈NAT반응성동시HBsAg、항-HCV혹항-HIV혈청학불합격적표본,혈청학합격적단빈NAT반응성경쌍공NAT복검양성적표본,이급혼합NAT반응성/탁분NAT위양성적표본,진일보용낙화Procleix HBV、HCV화HIV-1감별시제진행감별시험.혈청학합격、HBV NAT단독양성표본진일보용Roche HBV정량실험가이험증화진행병독함량측정、혈청학분석、병진행희석이모의시부능피P16-NAT검출.양성검출솔진행사격표련속교정적x2검험.결과 (1)재7613빈단빈NAT (ID-NAT)표본중,검출NAT양성26빈,ID-NAT양성솔0.34％(26/7613)；(2)재16 064빈공1004빈P16혼합표본NAT(P16-NAT)중,검출NAT양성27빈,P16-NAT양성솔위0.17％ (27/16 064)；(3)재혈청학합격표본중,단빈검측적NAT단독양성검출솔위0.12％ (9/7438),고우16빈혼양검측적NAT단독양성검출솔0.01％ (2/15 750)(x2=11.880,P＜0.05).9빈ID-NAT급2빈P16-NAT단독양성표본경감별균위HBV NAT양성,미검출 HCV NAT단독양성혹HIV NAT단독양성；(4)9빈ID-NAT HBV단독양성혈양모의P16-NAT,부유2빈가피검출；(5)대8빈ID-NAT급2빈P16-NAT단독양성표본진행Roche HBV정량측정,균가학증기핵산검측결과,단병독함량흔저.기중2빈HBV병독함량위472 IU/ml급15 IU/ml,6빈함량＜12 IU/ml,령2빈원배불능정량경10배농축처리후측득함량위＜ 12 IU/ml화14.3 IU/ml;(6)11빈HBV NAT단독양성표본중,3빈(27.3％)위잠재적창구기감염,기여8빈(72.7％)항-HBc양성혹항-HBe양성,단항-HBc-IgM균위음성,위은닉성감염；(7) P16-NAT초검정반응성수요진행탁분시험적혼합양본비솔위2.49％ (25/1004),기중유혈청학합격표본소치초검반응성적혼합양본비솔위0.20％ (2/1004).결론 ID-NAT단독양성검출솔고우P16-NAT단독양성검출솔.위피면저병독함량HBV적루검,응선용령민도고적핵산검측시제,병진량채용소표본량혼합검측,심지채용단빈검측방식.
Objective To investigate the effect of individual donation-nucleic acid amplification test (ID-NAT) and minipool of 16 donations-NAT (P16-NAT) on the results of NAT of blood donors.Methods From February 2009 to June 2009,samples randomly collected from voluntary blood donors in Beijing were tested individually or in pooling of 16 donations by the PROCLEIX ULTRIO assay.For ID-NAT reactive samples with HBsAg,anti-HCV,or anti-HIV serologically unqualified,ID-NAT repeat reactive samples with serologically qualified,and P16-NAT reactive and followed resolution ID-NAT reactive samples,were performed for further discriminatory assays for HIV-1,samples and followed resolution ID-NAT reactive samples,were performed for further discriminatory assays for HBV,HCV and HIV-1 discriminatory reagents.Samples which were HBV NAT + alone with serologically qualified were further quantified and confirmed of HBV DNA by Roche HBV quantitative PCR,analyzed by HBV serology and were diluted to simulate if they could be detected in P16-NAT.Results ( 1 ) Among 7613 samples tested by ID-NAT,26 were NAT positive,i.e.the ID-NAT positive rate was 0.34％ ( 26/7613 ). ( 2 ) Among 1004 P16 samples from 16 064 blood donations,27 were NAT positive,i.e.the P16-NAT positive rate was 0.17％ (27/16 064).(3)In serological qualified donations,ID-NAT yield rate (1 in 826,9/7438 ) was much higher than P16-NAT ( 1 in 7875,2/15 750) (x2 =11.880,P ＜ 0.05 ).All these 9 ID-NAT positive and 2 P16-NAT positive donations were discriminated as HBV NAT positive.There were no HCV NAT yield or HIV NAT yield samples. (4) Dilution assay showed only 2 of the 9 (22.22％ ) ID-NAT HBV yields were detected by P16-NAT.(5)Eight ID-NAT and 2 P16-NAT positive samples were quantified for HBV DNA and confirmed as HBV NAT yield,although the virus loads were very low:2 samples had HBV viral loads of 15 IU/ml and 472 IU/ml,6 samples ＜ 12 IU/ml,and 2 could not be detected in the original samples while had ＜ 12 IU/ml and 14.3 IU/ml in the 10 times concentrated samples.(6)Among 11 HBV NAT yield cases,3 (27.3％ ) were possible HBV window-period donors with all HBV seromarkers negative,the other 8 (72.7％ ) had occult HBV infections with anti-HBc or anti-HBe positive,however anti-HBc IgM negative.(7) The rate of initial P16-NAT reactive pools needed to be further tested by ID-NAT was 2.49％(25/1004).Initial P16-NAT reactive pools which caused by serologically qualified donations was 0.20％(2/1004).Conclusions HBV NAT yield cases are detected at a higher frequency with ID-NAT than P16-NAT.In order to avoid samples with low viral loads would be undetected,NAT assay with high sensitivity should be selected and tested in minimized minipool donations or even with individual donation.
