金标法检测HBsAg漏检原因分析

近几年来，为方便患者着想节省时间，常采用金标试纸检测全血、血清等标本中乙肝表面抗原（HBsAg）。金标试剂具有快速、简便、特异性高、试剂稳定等优点，但由于试纸条的灵敏度和操作方法所限，存在着一定的漏检。为了解漏检原因，我们用已经做过的7200份阴性标本，酶联免疫吸附试验（ELISA）法复检，结果报告如下。     

ELISA检测HBsAg洗板方法的探讨

目的探讨酶联免疫试验(ELISA)检测HBsAg的最佳洗板次数和方式,试图找到一种实用、可靠的ELISA洗板方法。方法选择50例HBsAg阴性体检者完全分离后的血清为检测对象,分别进行3～7次洗板,得到阴性数和假阳性数,得出最佳洗板机洗板次数;收集同一批号试剂盒的阴阳性标准品及质控品,将质控品平行检测31孔,共2板分别用手工和洗板机2种方法各洗板7次。结果不同洗板次数的结果差异有统计学意义,且洗板7次假阳性率最低;2种洗板方式测定值结果差异无统计学意义(P>0.05)。结论洗板7次能达到理想的洗板效果;对标本量少或无洗板机的基层医院可采用标准化手工洗板的方式。     

金标记免疫层析法联合ELISA法在检测HBsAg中的应用

在工作中我们发现单纯使用金标记法或ELISA法检测HBsAg有漏检现象，现报告分析如下。     

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。     

HBsAg胶体金法与ELISA法对比分析

目的 比较胶体金免疫层析(GICA)法与酶联免疫吸附试验(ELISA)法检测HBsAg结果的差异.方法 1 211例血清标本用GICA法和ELISA法测定.结果 1211例HBsAg测定GICA法阳性186例,阳性率15.4％;ELISA法阳性191例,阳性率15.8％;经x2检验,x2=2,P＞0.05,GICA法与ELISA法检测HBsAg无差别,1 211例血清标本GICA法漏检5例.结论 在HBsAg检测工作中酶标仪判读后有疑问的结果,再配合GICA法检测,以保证结果的准确性.     

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。     

增加洗板次数对HBsAg ELISA检测结果的影响

酶联免疫试验因其操作简单、灵敏度和特异性较高，现已被广泛应用，但影响酶免试验结果的因素较多，如加样量、洗板、温度和温育时间，控制不严就会影响试验结果，特别是洗板因素，许多实验室设定洗板次数的随意性较大。通过比较由同一人使用同一洗板设备经不同洗板次数后的两种质控物的检测结果，发现增加洗板次数对HBsAg ELISA检测结果的影响较大，报告如下。     

胶体金法检测HBsAg存在的问题与对策

胶体金免疫层析测定(Gold immnnc chromatography,GICA,简称金标法),是近年来发展起来的一种新技术.从1989年金标法诞生至今,已广泛应用于免疫检测的各个领域.笔者主要是谈谈胶体金法检测HBsAg在平常工作中所存在的问题及对策.     

ELISA检测HBsAg影响因素探析

ELISA方法具有简便、灵敏度高、特异性强等特点而被广泛应用,成为目前检测HBsAg的常用方法。但ELISA进行HBsAg检测时易受试剂、标本、操作等诸多因素影响出现假阳性或假阴性结果,因此应从以下几方面加强监测,减少错误结果的产生。     

酶联免疫法和胶体金法联合检测乙型肝炎表面抗原的结果分析

对我院酶联免疫法和胶体金法联合检测乙型肝炎表面抗原的结果分析如下。1材料与方法1.1标本来源2007-06/2007-12我院门诊和住院患者新鲜采集的全血样本2 909份,2 h内离心分离血清。1.2试剂酶联免疫试剂盒：科华,新创生产;胶体金试剂：新创生产;HB sA g确认试剂,罗氏公司生产。所有试剂均按说明书进行操作。1.3仪器酶标仪：芬兰M K-3雷勃酶标仪;洗板机：科华ST-36W洗板机。1.4方法所有初检标本先选用一个厂家的酶联免疫试剂检测乙型肝炎表面抗原,     

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.     

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   

ELISA法结合MEIA法检测HBsAg阳性结果复查策略的临床应用

对我院2007—09／2007—11 ELISA法结合MEIA法检测HBsAg阳性结果复查策略的临床应用报告如下。1材料和方法1．1材料患者162例的待检标本,均空腹采血2ml,用含速凝剂或分离胶的真空采血管采集,不抗凝。当日检测完成。1．2试剂和仪器“立可读”HBsAg诊断试剂盒（ELISA法,上海科华、广东丽珠）,美国雅培定量HBsAg试剂盒。奥地利CliniBio128C酶标仪;美国AXSYMSYSTEM全自动免疫分析系统。     

溶血标本使用国产HBsAg酶免试剂可用于常规分析

目的 观察标本不同程度溶血对国产两步法乙型肝炎病毒表面抗原（HBsAg）酶联免疫吸附测定（ELISA）试剂检测结果的影响.方法 收集HBsAg阴性和阳性已确定的血液标本各3例,并将其分别作为HBsAg阴性组和阳性组.标本人为处理为无、轻、中、重度溶血,用3种国产HBsAg ELISA试剂对其进行重新检测,分析溶血后标本吸光度值与临界值的比值（S/CO值）的变化.结果 在HBsAg阴性标本中,不同浓度的溶血标本未检出阳性,S/CO值无明显改变（P〉0.05）;在HBsAg阳性标本中,不同浓度的溶血标本和无溶血的标本比较,S/CO值也无明显变化（P〉0.05）.结论 国产两步法HBsAg ELISA试剂可用于溶血标本的常规检测.     

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