无偿献血者HBsAg酶免筛查结果分析

目的 了解2006～2010年大连地区无偿献血者血液乙肝病毒感染情况,方法 采用酶联免疫法对245 833名献血者血液标本进行HBsAg检测.结果 历年HBsAg不合格率男女比较差异无统计学意义(P＞0.05);4个年龄组中,18～25岁的HBsAg不合格率最高,HBsAg复检不合格数占本组献血人数的0.40％,不同年龄组的HBsAg总不合格率比较差异有统计学意义(P＜0.05).结论 加强HBsAg初筛人员培训,杜绝人为因素造成的不合格,同时探讨建立适宜的检测模式,既防止漏检,又最大限度降低由假阳性反应导致的血液不合理淘汰.     

溶血对一步法和两步法HBsAg酶联免疫试剂检测结果影响的研究

目的 探讨样本溶血对一步法和两步法HBsAg酶联免疫吸附试验(ELISA)检测结果的影响.方法 分别将60例阴性标本、弱阳性标本和强阳性标本人为造成不同程度的溶血,比较溶血前后不同试剂检测样本OD值的变化差异,分析溶血标本是否对ELISA试验存在干扰,一步法和两步法试剂是否存在差异.结果 对于阴性标本,一步法试剂10 g/L以下溶血样本检测OD值与溶血前比较差异无统计学意义(P＞0.05),10 g/L以上重度溶血后样本孔OD 值、S /CO 值与溶血前比较差异有统计学意义(P＜0.01);两步法试剂15 g/L以下溶血样本检测OD值与溶血前比较差异无统计学意义(P＞0.05),15 g/L以上重度溶血后样本孔OD 值与溶血前比较差异有统计学意义(P＜0.01);对于弱阳性和阳性标本,两种试剂在5 g/L以上溶血后样本检测OD 值与溶血前比较差异有统计学意义(P＜0.01).结论 两步法试剂受溶血影响较一步法轻,轻度溶血样本对阴性标本ELISA试验结果无干扰,对于灰区结果和重度溶血标本需要重新取样,进行再捡.     

HBsAg两步法酶免国产试剂与进口试剂检测结果对比分析

目的 评价国产HBsAg两步法酶免试剂,为实验室选择优质可靠的试剂提供依据.方法 收集550份血清标本用美国伯乐超敏MONOLISA HBsAg ULTRA ELISA试剂检测HBsAg,分成MONOLISA检测阳性组(68例)和MONO-LISA检测阴性组(482例),分别用六种国产HBsAg两步法酶免试剂复检,分析六种国产试剂的灵敏度和特异度.再将2IU/ml HBsAg标准品按1∶2方法系列稀释成5个稀释度,用MONOLISA HBsAg ULTRA ELISA试剂和六种国产试剂检测,考核各试剂的分析灵敏度.结果 MONOLISA检测阳性组(68例)中,国产试剂A,B和E结果相吻合,国产试剂C和D有1例漏检(x2=0.015,P＞0.05);MONOLISA检测阴性组(482例)中,国产试剂A有1例假阳性(x2=0.002,P＞0.05),国产试剂B和E有3例假阳性(x2=0.002,P＞0.05),国产试剂C和D有4例假阳性(x2=0.002,P＞0.05);国产试剂F多次出现“花板”现象,实验失败,不作统计.检测2IU/ml HBsAg标准品系列稀释物,MONOLISA HBsAg ULTRA ELISA试剂分析灵敏度可达0.062 5 IU/ml,国产试剂A,C和D分析灵敏度可达0.25 IU/ml,国产试剂B和E可达到0.125 IU/ml.结论 大部分采用两步法的国产HBsAg酶免试剂灵敏度和特异度能满足临床需求,但仍不及进口试剂,个别小品牌试剂性能不佳.     

溶血对ELISA检测HBsAg的实验诊断效能指标的影响

目的探讨标本溶血时酶联免疫吸附实验（ELISA）各实验诊断效能指标的变化及对策研究。方法以时间分辨荧光免疫分析法确诊的结果为金标准,ELISA与之比较求各实验诊断效能指标。标本选择以未溶血时ELISA临界值阴性的标本75例,阳性90例,共165例未溶血标本设为对照组,将165例标本人为处理为轻、中、重度溶血,设为实验A组（试验孔校正前）;同时对实验A组各标本增设试验孔,再进行实验,设为实验B组（试验孔校正后）。对各组标本的各实验诊断效能指标进行比较。结果溶血后ELISA实验的特异性下降、准确度及正确指数均下降、误诊率升高。溶血后ELISA实验经校正孔实验校正后,与校正前比较,特异性升高、准确度及正确指数均升高、误诊率下降。结论溶血对ELISA实验检测HBsAg在特异性、准确度、正确指数及误诊率方面存在影响,通过对溶血样本增设一试验孔,能部分纠正轻、中度溶血时对HBsAg试验结果的影响,从而减轻样本溶血时对实验特异性、准确度、正确指数及误诊率方面的影响,改善实验的诊断效能指标,值得实验室推广使用。     

一种国产HBsAg确认试剂的临床应用评价

目的 评价一种国产HBsAg确认试剂的临床应用价值.方法 对543份经HBsAgELISA初筛吸光度值/临界值(S/CO)10.7的血清标本,用国产HBsAg确认试剂盒进行确认,在双份待确定标本中分别加入特异性抗-HBs试剂和对照试剂,保温后按常规HBsAg ELISA法测定吸光压(A)值,按公式求得加抗-HBs孔的抑制率,如抑制率≥50%即表示该标本被确认为HBsAg阳性.对HBsAg弱阳性的标本进行"延长确认试验",即延长酶反应时间,以提高检测的灵敏度.随机挑选39份弱阳性标本用美国雅培公司Murex HBsAg确认试验进行比对.结果 对543份标本进行确认试验,其中504份初筛HBsAg阳性的标本中,被确认为阴性的有89份(17.7%),按初筛不同S/CO值分区的阴性份数/检测份数分别为:S/CO≤5.0有87/143(60.8%),5.0相似文献   

RIA检测ELISA HBsAg灰区标本204例结果分析

目的探讨放射免疫法(RIA)对ELISA测定乙肝表面抗原灰区标本的乙肝标志物的检测结果。方法采用RIA方法对经ELISA检测HBsAg临界值以下的部分标本进行乙肝5项检测。结果 RIA方法 HBsAg阳性率为49.02%,有85.29%的标本检出了各类HBV的标志物;按照标志物组合模式计以HBsAg抗-HBe抗-HBc阳性(小三阳)最多(34.80%)。结论受方法学限制,ELISA测定乙肝表面抗原存在一定的漏检率,采用高灵敏度的RIA方法可在一定程度上减少漏检的机会。     

一种国产HBsAg确认试剂的临床应用评价

Objective To carry out the clinical validation of a domestic HBsAg kit to evaluate its application value. Methods 543 serum samples with HBsAg ELISA values of S/CO ≥ 0. 7 were tested by HBsAg confirmatory test. Specific anti-HBs reagent and control reagent were added separately into duplicate wells of HBsAg ELISA plate, in which test sample was also added. After incubation at 37℃, HBsAg was detected by routine ELISA, and the inhibition rate was calculated using absorbanee (A) result of anti-HBs reagent well and control reagent well according to the provided formula. The sample was confirmed as HBsAg positive when the inhibition rate was≥50%. For HBsAg weakly positive samples, "prolonged confirmatory test" (conjugate reaction time was prolonged to 120 rain) was applied to increase the sensitivity. 39 samples were randomized selected for testing and comparison with Abbott Murex confirmatory test. Results 543 serum samples in total were tested by the confirmatory test. Among the 504 cases which showed positive reaction in screening HBsAg ELISA, 89 ( 17. 7% ) were confirmed as negative. According to their S/CO value of the screening HBsAg test, the ratio of negative cases / tested eases in the group were:S/CO≤<5.0, 87/143 (60. 8% ) ;5.0 < S/CO ≤ 10. 0,0/25 (0) ;10. 0 < S/CO ≤ 15.0, 1/21 (4. 8% ) ;15.0 < S/CO ≤ 20. 0, 1/23 (4. 4% ) ;S/CO 20. 0, 0/292(0). Among 39 cases with negative HBsAg (0. ≤相似文献   

一种国产HBsAg确认试剂的临床应用评价

Objective To carry out the clinical validation of a domestic HBsAg kit to evaluate its application value. Methods 543 serum samples with HBsAg ELISA values of S/CO ≥ 0. 7 were tested by HBsAg confirmatory test. Specific anti-HBs reagent and control reagent were added separately into duplicate wells of HBsAg ELISA plate, in which test sample was also added. After incubation at 37℃, HBsAg was detected by routine ELISA, and the inhibition rate was calculated using absorbanee (A) result of anti-HBs reagent well and control reagent well according to the provided formula. The sample was confirmed as HBsAg positive when the inhibition rate was≥50%. For HBsAg weakly positive samples, "prolonged confirmatory test" (conjugate reaction time was prolonged to 120 rain) was applied to increase the sensitivity. 39 samples were randomized selected for testing and comparison with Abbott Murex confirmatory test. Results 543 serum samples in total were tested by the confirmatory test. Among the 504 cases which showed positive reaction in screening HBsAg ELISA, 89 ( 17. 7% ) were confirmed as negative. According to their S/CO value of the screening HBsAg test, the ratio of negative cases / tested eases in the group were:S/CO≤<5.0, 87/143 (60. 8% ) ;5.0 < S/CO ≤ 10. 0,0/25 (0) ;10. 0 < S/CO ≤ 15.0, 1/21 (4. 8% ) ;15.0 < S/CO ≤ 20. 0, 1/23 (4. 4% ) ;S/CO 20. 0, 0/292(0). Among 39 cases with negative HBsAg (0. ≤相似文献   

一种国产HBsAg确认试剂的临床应用评价

Objective To carry out the clinical validation of a domestic HBsAg kit to evaluate its application value. Methods 543 serum samples with HBsAg ELISA values of S/CO ≥ 0. 7 were tested by HBsAg confirmatory test. Specific anti-HBs reagent and control reagent were added separately into duplicate wells of HBsAg ELISA plate, in which test sample was also added. After incubation at 37℃, HBsAg was detected by routine ELISA, and the inhibition rate was calculated using absorbanee (A) result of anti-HBs reagent well and control reagent well according to the provided formula. The sample was confirmed as HBsAg positive when the inhibition rate was≥50%. For HBsAg weakly positive samples, "prolonged confirmatory test" (conjugate reaction time was prolonged to 120 rain) was applied to increase the sensitivity. 39 samples were randomized selected for testing and comparison with Abbott Murex confirmatory test. Results 543 serum samples in total were tested by the confirmatory test. Among the 504 cases which showed positive reaction in screening HBsAg ELISA, 89 ( 17. 7% ) were confirmed as negative. According to their S/CO value of the screening HBsAg test, the ratio of negative cases / tested eases in the group were:S/CO≤<5.0, 87/143 (60. 8% ) ;5.0 < S/CO ≤ 10. 0,0/25 (0) ;10. 0 < S/CO ≤ 15.0, 1/21 (4. 8% ) ;15.0 < S/CO ≤ 20. 0, 1/23 (4. 4% ) ;S/CO 20. 0, 0/292(0). Among 39 cases with negative HBsAg (0. ≤相似文献   

一种国产HBsAg确认试剂的临床应用评价

Objective To carry out the clinical validation of a domestic HBsAg kit to evaluate its application value. Methods 543 serum samples with HBsAg ELISA values of S/CO ≥ 0. 7 were tested by HBsAg confirmatory test. Specific anti-HBs reagent and control reagent were added separately into duplicate wells of HBsAg ELISA plate, in which test sample was also added. After incubation at 37℃, HBsAg was detected by routine ELISA, and the inhibition rate was calculated using absorbanee (A) result of anti-HBs reagent well and control reagent well according to the provided formula. The sample was confirmed as HBsAg positive when the inhibition rate was≥50%. For HBsAg weakly positive samples, "prolonged confirmatory test" (conjugate reaction time was prolonged to 120 rain) was applied to increase the sensitivity. 39 samples were randomized selected for testing and comparison with Abbott Murex confirmatory test. Results 543 serum samples in total were tested by the confirmatory test. Among the 504 cases which showed positive reaction in screening HBsAg ELISA, 89 ( 17. 7% ) were confirmed as negative. According to their S/CO value of the screening HBsAg test, the ratio of negative cases / tested eases in the group were:S/CO≤<5.0, 87/143 (60. 8% ) ;5.0 < S/CO ≤ 10. 0,0/25 (0) ;10. 0 < S/CO ≤ 15.0, 1/21 (4. 8% ) ;15.0 < S/CO ≤ 20. 0, 1/23 (4. 4% ) ;S/CO 20. 0, 0/292(0). Among 39 cases with negative HBsAg (0. ≤相似文献   

一种国产HBsAg确认试剂的临床应用评价

Objective To carry out the clinical validation of a domestic HBsAg kit to evaluate its application value. Methods 543 serum samples with HBsAg ELISA values of S/CO ≥ 0. 7 were tested by HBsAg confirmatory test. Specific anti-HBs reagent and control reagent were added separately into duplicate wells of HBsAg ELISA plate, in which test sample was also added. After incubation at 37℃, HBsAg was detected by routine ELISA, and the inhibition rate was calculated using absorbanee (A) result of anti-HBs reagent well and control reagent well according to the provided formula. The sample was confirmed as HBsAg positive when the inhibition rate was≥50%. For HBsAg weakly positive samples, "prolonged confirmatory test" (conjugate reaction time was prolonged to 120 rain) was applied to increase the sensitivity. 39 samples were randomized selected for testing and comparison with Abbott Murex confirmatory test. Results 543 serum samples in total were tested by the confirmatory test. Among the 504 cases which showed positive reaction in screening HBsAg ELISA, 89 ( 17. 7% ) were confirmed as negative. According to their S/CO value of the screening HBsAg test, the ratio of negative cases / tested eases in the group were:S/CO≤<5.0, 87/143 (60. 8% ) ;5.0 < S/CO ≤ 10. 0,0/25 (0) ;10. 0 < S/CO ≤ 15.0, 1/21 (4. 8% ) ;15.0 < S/CO ≤ 20. 0, 1/23 (4. 4% ) ;S/CO 20. 0, 0/292(0). Among 39 cases with negative HBsAg (0. ≤相似文献   

一种国产HBsAg确认试剂的临床应用评价

Objective To carry out the clinical validation of a domestic HBsAg kit to evaluate its application value. Methods 543 serum samples with HBsAg ELISA values of S/CO ≥ 0. 7 were tested by HBsAg confirmatory test. Specific anti-HBs reagent and control reagent were added separately into duplicate wells of HBsAg ELISA plate, in which test sample was also added. After incubation at 37℃, HBsAg was detected by routine ELISA, and the inhibition rate was calculated using absorbanee (A) result of anti-HBs reagent well and control reagent well according to the provided formula. The sample was confirmed as HBsAg positive when the inhibition rate was≥50%. For HBsAg weakly positive samples, "prolonged confirmatory test" (conjugate reaction time was prolonged to 120 rain) was applied to increase the sensitivity. 39 samples were randomized selected for testing and comparison with Abbott Murex confirmatory test. Results 543 serum samples in total were tested by the confirmatory test. Among the 504 cases which showed positive reaction in screening HBsAg ELISA, 89 ( 17. 7% ) were confirmed as negative. According to their S/CO value of the screening HBsAg test, the ratio of negative cases / tested eases in the group were:S/CO≤<5.0, 87/143 (60. 8% ) ;5.0 < S/CO ≤ 10. 0,0/25 (0) ;10. 0 < S/CO ≤ 15.0, 1/21 (4. 8% ) ;15.0 < S/CO ≤ 20. 0, 1/23 (4. 4% ) ;S/CO 20. 0, 0/292(0). Among 39 cases with negative HBsAg (0. ≤相似文献   

一种国产HBsAg确认试剂的临床应用评价

Objective To carry out the clinical validation of a domestic HBsAg kit to evaluate its application value. Methods 543 serum samples with HBsAg ELISA values of S/CO ≥ 0. 7 were tested by HBsAg confirmatory test. Specific anti-HBs reagent and control reagent were added separately into duplicate wells of HBsAg ELISA plate, in which test sample was also added. After incubation at 37℃, HBsAg was detected by routine ELISA, and the inhibition rate was calculated using absorbanee (A) result of anti-HBs reagent well and control reagent well according to the provided formula. The sample was confirmed as HBsAg positive when the inhibition rate was≥50%. For HBsAg weakly positive samples, "prolonged confirmatory test" (conjugate reaction time was prolonged to 120 rain) was applied to increase the sensitivity. 39 samples were randomized selected for testing and comparison with Abbott Murex confirmatory test. Results 543 serum samples in total were tested by the confirmatory test. Among the 504 cases which showed positive reaction in screening HBsAg ELISA, 89 ( 17. 7% ) were confirmed as negative. According to their S/CO value of the screening HBsAg test, the ratio of negative cases / tested eases in the group were:S/CO≤<5.0, 87/143 (60. 8% ) ;5.0 < S/CO ≤ 10. 0,0/25 (0) ;10. 0 < S/CO ≤ 15.0, 1/21 (4. 8% ) ;15.0 < S/CO ≤ 20. 0, 1/23 (4. 4% ) ;S/CO 20. 0, 0/292(0). Among 39 cases with negative HBsAg (0. ≤相似文献   

一种国产HBsAg确认试剂的临床应用评价

Objective To carry out the clinical validation of a domestic HBsAg kit to evaluate its application value. Methods 543 serum samples with HBsAg ELISA values of S/CO ≥ 0. 7 were tested by HBsAg confirmatory test. Specific anti-HBs reagent and control reagent were added separately into duplicate wells of HBsAg ELISA plate, in which test sample was also added. After incubation at 37℃, HBsAg was detected by routine ELISA, and the inhibition rate was calculated using absorbanee (A) result of anti-HBs reagent well and control reagent well according to the provided formula. The sample was confirmed as HBsAg positive when the inhibition rate was≥50%. For HBsAg weakly positive samples, "prolonged confirmatory test" (conjugate reaction time was prolonged to 120 rain) was applied to increase the sensitivity. 39 samples were randomized selected for testing and comparison with Abbott Murex confirmatory test. Results 543 serum samples in total were tested by the confirmatory test. Among the 504 cases which showed positive reaction in screening HBsAg ELISA, 89 ( 17. 7% ) were confirmed as negative. According to their S/CO value of the screening HBsAg test, the ratio of negative cases / tested eases in the group were:S/CO≤<5.0, 87/143 (60. 8% ) ;5.0 < S/CO ≤ 10. 0,0/25 (0) ;10. 0 < S/CO ≤ 15.0, 1/21 (4. 8% ) ;15.0 < S/CO ≤ 20. 0, 1/23 (4. 4% ) ;S/CO 20. 0, 0/292(0). Among 39 cases with negative HBsAg (0. ≤相似文献   

一种国产HBsAg确认试剂的临床应用评价

Objective To carry out the clinical validation of a domestic HBsAg kit to evaluate its application value. Methods 543 serum samples with HBsAg ELISA values of S/CO ≥ 0. 7 were tested by HBsAg confirmatory test. Specific anti-HBs reagent and control reagent were added separately into duplicate wells of HBsAg ELISA plate, in which test sample was also added. After incubation at 37℃, HBsAg was detected by routine ELISA, and the inhibition rate was calculated using absorbanee (A) result of anti-HBs reagent well and control reagent well according to the provided formula. The sample was confirmed as HBsAg positive when the inhibition rate was≥50%. For HBsAg weakly positive samples, "prolonged confirmatory test" (conjugate reaction time was prolonged to 120 rain) was applied to increase the sensitivity. 39 samples were randomized selected for testing and comparison with Abbott Murex confirmatory test. Results 543 serum samples in total were tested by the confirmatory test. Among the 504 cases which showed positive reaction in screening HBsAg ELISA, 89 ( 17. 7% ) were confirmed as negative. According to their S/CO value of the screening HBsAg test, the ratio of negative cases / tested eases in the group were:S/CO≤<5.0, 87/143 (60. 8% ) ;5.0 < S/CO ≤ 10. 0,0/25 (0) ;10. 0 < S/CO ≤ 15.0, 1/21 (4. 8% ) ;15.0 < S/CO ≤ 20. 0, 1/23 (4. 4% ) ;S/CO 20. 0, 0/292(0). Among 39 cases with negative HBsAg (0. ≤相似文献   

一种国产HBsAg确认试剂的临床应用评价

Objective To carry out the clinical validation of a domestic HBsAg kit to evaluate its application value. Methods 543 serum samples with HBsAg ELISA values of S/CO ≥ 0. 7 were tested by HBsAg confirmatory test. Specific anti-HBs reagent and control reagent were added separately into duplicate wells of HBsAg ELISA plate, in which test sample was also added. After incubation at 37℃, HBsAg was detected by routine ELISA, and the inhibition rate was calculated using absorbanee (A) result of anti-HBs reagent well and control reagent well according to the provided formula. The sample was confirmed as HBsAg positive when the inhibition rate was≥50%. For HBsAg weakly positive samples, "prolonged confirmatory test" (conjugate reaction time was prolonged to 120 rain) was applied to increase the sensitivity. 39 samples were randomized selected for testing and comparison with Abbott Murex confirmatory test. Results 543 serum samples in total were tested by the confirmatory test. Among the 504 cases which showed positive reaction in screening HBsAg ELISA, 89 ( 17. 7% ) were confirmed as negative. According to their S/CO value of the screening HBsAg test, the ratio of negative cases / tested eases in the group were:S/CO≤<5.0, 87/143 (60. 8% ) ;5.0 < S/CO ≤ 10. 0,0/25 (0) ;10. 0 < S/CO ≤ 15.0, 1/21 (4. 8% ) ;15.0 < S/CO ≤ 20. 0, 1/23 (4. 4% ) ;S/CO 20. 0, 0/292(0). Among 39 cases with negative HBsAg (0. ≤相似文献   

溶血标本对ELISA法检测HBsAg结果的影响及消除对策

ELISA法仍然是国内检测HBsAg的常用方法之一,但实验操作中各个环节对实验结果影响较大,特别是以辣根过氧化物酶（HRP）为标记的酶结合物的试剂检测HBsAg时,溶血标本可导致假阳性结果,从而影响临床诊断和治疗,给患者带来不必要的经济损失和精神负担。本组通过对大批量标本进行HBsAg的筛查也同样发现溶血标本对检测结果的影响较大,特别是对弱阳性结果影响更为明显。同时,其他因素（如采血过程、洗板不干净等）也可出现假阳性。通过对弱阳性结果标本的重新测试,探讨标本质量对ELISA结果的影响及消除假阳性的对策。     

酶联免疫吸附试验检测HBsAg的应用体会

目的总结酶联免疫吸附试验(ELISA)测定HBsAg的经验,提高乙肝检测水平。方法利用酶标记物作为指示物,以抗原-抗体的特异性结合反应为基础,在酶标记物同抗原-抗体结合后,由于酶的催化放大作用,使得ELISA既保持抗原抗体反应的特异性又体现酶催化放大的敏感性。针对检测过程,总结应用体会。结果仪器设备、试剂、标本、操作过程、环境、质量控制等方面都会影响检测结果,操作时一定要严格控制。结论控制影响检测结果的因素,可为临床提供准确可靠的检测结果。     

酶联免疫吸附试验一步法检测HBsAg的分析体会

乙型肝炎表面抗原的检测是诊断乙型肝炎的主要指标。随着检测技术的不断发展，ELISA一步法检测HBsAg的试剂、方法均已成熟，因其方法简便、灵敏度高、特异性强、实验要求条件不高而被各级医疗机构广泛采用。但其方法的缺点是干扰因素特别多，在实际操作中每一步控制不好都可能影响检测结果的质量，现针对操作中可能出现的问题进行分析，旨在提高HBsAg检测结果的准确性。     

酶免法检测乙肝表面抗原实验精密度研究

目的探讨酶免法检测HBsAg实验精密度的影响因素及实验精密度对检验结果的影响。方法检测卫生部临检中心0.5ng/ml质控血清,计算精密度;比较手工操作与全自动酶免分析仪法检测的精密度;检测不同效价的阳性血清,比较精密度,并作统计学分析。结果临界值附近的标本可能引起误判,手工操作与全自动酶免分析仪法检测实验精密度差异有统计学意义（t=4.72,P〈0.01）。结论实验精密度的高低对酶免法检测HBsAg实验存在影响,检验结果的判定应设置灰区并进行复检或进一步检测。