检验医学 ›› 2013, Vol. 28 ›› Issue (4): 312-314.DOI: 10.3969/j.issn.1673-8640.2013.04.015

• 技术研究与评价.论著 • 上一篇    下一篇

ELISA检测梅毒抗体复检范围设计探讨

余红,朱卫,阙金亚,崔洋洋   

  1. 阜宁县人民医院,江苏 阜宁 224400
  • 收稿日期:2012-04-09 修回日期:2012-05-08 出版日期:2013-04-30 发布日期:2013-04-05
  • 作者简介:余红,女,1971年生,学士,副主任技师,主要从事免疫学检验工作。

The investigation of the retesting range of the TPAb sample detected by ELISA

  1. Funing People′s Hospital,Jiangsu Funing 224400, China
  • Received:2012-04-09 Revised:2012-05-08 Online:2013-04-30 Published:2013-04-05

摘要: 目的 探讨酶联免疫吸附试验(ELISA)检测梅毒抗体(TPAb)复检范围的设计。 方法 收集ELISA初检梅毒吸光度(A)>0.08的标本1 257例,用相同厂家、相同批号的试剂进行复检,同时做双孔。复检A值仍>0.14者用明胶颗粒凝集试验(TPPA)进行确认。对结果进行统计分析,设计一个合适的标本复查范围。 结果 根据ELISA初检梅毒标本A值结果,将标本分为7组:0.08~0.14、0.15~0.30、0.31~0.60、0.61~0.90、0.91~1.20、1.21~2.00、 >2.00。ELISA复检符合率分别为16.6%(37/223)、21.6%(56/259)、32.0%(66/206)、50.5%(100/198)、78.0%(99/127)、94.8%(147/155)、100.0%(89/89)。TPPA与ELISA复检符合率分别为0.0%(0/37),3.6%(2/56)、22.7%(15/66)、38.0%(38/100)、80.8%(80/99)、93.2%(137/147)、96.6%(86/89)。 结论 在规范操作的前提下,ELISA检测TPAb的复检范围设定A值在0.14~1.20范围内,这样既能保证检验结果的准确性,又能避免人力和试剂的浪费。

关键词: 复检范围, 梅毒抗体, 酶联免疫吸附试验, 明胶颗粒凝集试验

Abstract: Objective To investigate the retesting range of anti-treponema pallidum antibody (TPAb) sample detected by enzyme-linked immunosorbent assay(ELISA).  Methods A total of 1 257 samples were collected in the first TPAb testing with absorbance (A) value > 0.08 by ELISA. They were retested duplicately by the same reagent kit of same lot number. The samples retested with A vaule > 0.14 were comfirmed by treponema pallidum particale agglutination (TPPA) test.The appropriate retesting range was analyzed statistically. Results The samples were classified into 7 groups according to the first A value by ELISA: 0.08-0.14,0.15-0.30,0.31-0.60,0.61-0.90,0.91-1.20,1.21-2.00 and >2.00. The retesting coincidence rates by ELISA were 16.6%(37/223),21.6%(56/259),32.0%(66/206),50.5%(100/198),78.0%(99/127),94.8%(147/155) and 100.0%(89/89). The coincidence rates by TPPA and retesting by ELISA were 0.0%(0/37),3.6%(2/56),22.7%(15/66),38.0%(38/100),80.8%(80/99),93.2%(137/147) and 96.6%(86/89). Conclusions The A value of the retesting range by ELISA is considered appropriate from 0.14-1.20 under a standardized laboratory condition.The appropriate retesting range can assure the accuracy of the testing results and can avoid the waste of manpower and reagents.

Key words: Retesting range, Anti-treponema pallidum antibody, Enzyme-linked immunosorbent assay, Treponema pallidum particale agglutination test