全自动加样仪加样时间差对ELISA检测结果的影响
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摘要
STAR加样仪加样以48个4混定值质控血清作为标本进行HBsAg、抗-HCV、抗-HIV、抗-TP检测,每次加样后人为暂停5 min再加第2次,依次类推,在人为干预下, 6排标本的先后加样时间差分别为25、20、15、10、5、0 min,加样后按要求进入FAME全自动酶免分析仪检测,以探讨全自动加样仪加样时间差对ELISA法检测结果的影响。结果表明:HBsAg、Anti-HCV、Anti-HIV项目加样时间差为5、10 min的检测结果吸光度/判定阈值(D/CO)较0 min结果无显著差异,而间隔为15、20及25 min与0 min结果D/CO均有显著差异; Anti-TP检测结果与加样时间差关系不明显。为保证检测结果的准确性,采供血机构在进行经血传染疾病的检测时,应尽量缩短加样时间及孵育前的等待时间并尽量控制在10 min以内。
48 quadruple fixed-value quality control sera were used as samples for HBsAg, hepatitis C antibody, human immunodeficiency virus antibody and syphilis antibody by STAR automatic sampling instrument. After each addition, the samples were suspended for 5 min and then for the second time. By analogy, under human intervention, the time difference of six rows of samples was 25, 20, 15, 10, 5 and 0 min. After the addition was completed, the samples were entered into FAME full automatic enzyme immunity analyzer as required. The final results were obtained. to investigate the influence of the time difference of automatic sampling instrument on the results of ELISA. There was no significant difference between the time difference of 5 min and 10 min for the detection of HBsAg, hepatitis C antibody and human immunodeficiency virus antibody by ELISA and the D/CO mean value of 0 min, but There were significant differences in the D/CO mean between the 15, 20, and 25 min intervals and the 0 min results. The anti-TP test results were not significantly related to the time difference of the sample loading. To ensure the accuracy of the test results, the blood supply mechanism should minimize the loading time and waiting time before hatching, and try to control within 10 min when testing blood-borne diseases.
48 quadruple fixed-value quality control sera were used as samples for HBsAg, hepatitis C antibody, human immunodeficiency virus antibody and syphilis antibody by STAR automatic sampling instrument. After each addition, the samples were suspended for 5 min and then for the second time. By analogy, under human intervention, the time difference of six rows of samples was 25, 20, 15, 10, 5 and 0 min. After the addition was completed, the samples were entered into FAME full automatic enzyme immunity analyzer as required. The final results were obtained. to investigate the influence of the time difference of automatic sampling instrument on the results of ELISA. There was no significant difference between the time difference of 5 min and 10 min for the detection of HBsAg, hepatitis C antibody and human immunodeficiency virus antibody by ELISA and the D/CO mean value of 0 min, but There were significant differences in the D/CO mean between the 15, 20, and 25 min intervals and the 0 min results. The anti-TP test results were not significantly related to the time difference of the sample loading. To ensure the accuracy of the test results, the blood supply mechanism should minimize the loading time and waiting time before hatching, and try to control within 10 min when testing blood-borne diseases.
引文
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[5] 马小燕,张弘.ELISA检测中温育前延搁时间对质控品检测结果的影响 [J].海南医学,2012,21(6):105-106.
[6] 王胜虎,曹向红,李媛.全自动酶联免疫分析仪与手工酶联免疫法的检测结果比较 [J].昆明医科大学学报,2016,37(10):96-99.
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[8] 李燕.加样操作时差对ELISA检测的影响 [J].北方药学,2015,12(12):101-102.
[9] 张春艳.酶联免疫吸附试验检测结果的影响因素和应对措施 [J].中国医药指南,2014,12(29):393-394.
[10] 高梅,张凌峰,付永航.ELISA法检验乙型肝炎标志物的影响因素分析 [J].中国医药指南,2013,11(32):581-582.
[11] 任忠国.不同加样方式对抗HCV ELISA检测结果的影响 [J].中国实用医药,2013,8(1):54.
[12] 周国平,谢云峥,王迅.做好假反应性献血者归队是血站的责任 [J].中国输血杂志,2014,27(10):1079-1082.
[13] TYNELL E,NORDA R,EKERMO B,et al.False-reactive microbiologic screening test results in Swedish blood donors-how big is the problem?A survey among blood centers and deferred donors [J].Transfusion,2007,47(1):80-89.
[2] SCHEIBLAUER H,EL-NAGEH M,DIAZ S,et al.Performance evaluation of70 hepatitis B virus (HBV) surfaceantigen (HBsAg) assays from around the world by ageographically diverse panel with an array of HBV genotypesand HBsAg subtypes [J].Vox Sang,2010,98(3):403-414.
[3] 张巧琳,王露楠,谢晓艳.ELISA试剂检测HBsAg不合格标本的假阳性率调查 [J].中国输血杂志,2018,31(2):110-113.
[4] FDA Guidance for Industry.Use of nucleic acid tests on pooled and individual samples from donors of whole blood and blood components,including source plasma,to reduce the risk of transmission of hepatitis B virus [S].2012-10.
[5] 马小燕,张弘.ELISA检测中温育前延搁时间对质控品检测结果的影响 [J].海南医学,2012,21(6):105-106.
[6] 王胜虎,曹向红,李媛.全自动酶联免疫分析仪与手工酶联免疫法的检测结果比较 [J].昆明医科大学学报,2016,37(10):96-99.
[7] 钱厚明,赵江燕,周樱.加样时差对不同试剂检测乙肝病毒标志物的影响 [J].临床输血与检验,2007,9(1):44-45.
[8] 李燕.加样操作时差对ELISA检测的影响 [J].北方药学,2015,12(12):101-102.
[9] 张春艳.酶联免疫吸附试验检测结果的影响因素和应对措施 [J].中国医药指南,2014,12(29):393-394.
[10] 高梅,张凌峰,付永航.ELISA法检验乙型肝炎标志物的影响因素分析 [J].中国医药指南,2013,11(32):581-582.
[11] 任忠国.不同加样方式对抗HCV ELISA检测结果的影响 [J].中国实用医药,2013,8(1):54.
[12] 周国平,谢云峥,王迅.做好假反应性献血者归队是血站的责任 [J].中国输血杂志,2014,27(10):1079-1082.
[13] TYNELL E,NORDA R,EKERMO B,et al.False-reactive microbiologic screening test results in Swedish blood donors-how big is the problem?A survey among blood centers and deferred donors [J].Transfusion,2007,47(1):80-89.