摘要
目的了解日常工作中HBsAg漏检情况，为提高临床检验质量提供参考。方法在日常工作中从临床检测备份管随机收集400份经国产A品牌全套试剂ELISA检测乙型肝炎病毒血清学指标（HBVM），其中HBsAg呈阴性结果的血清标本，按HBsAb检测结果分成HBsAb阴性和阳性两类各200例，双份分装-20℃冻存；增加B，C另外两种国产ELISAHBsAg试剂及美国超敏MONOLISAHBsAgULTRA试剂，共四种试剂同时复检HBsAg，阳性标本行双份HBVDNA定量分析、结果取均值。结果A，B，C三种国产试荆复检HBsAg结果一致阴性，美国超敏MONOLISAHBsAgULTRA试剂从HBsAb阴性标本中检出5例HBsAg阳性，从HBsAb阳性标本中未捡出HBsAg阳性结果。HBVDNA定量分析结果显示均小于500copies／ml，其中400～500copies／m／1例，10a～200copies／ml2例，1O～100copies／m｜2例，未发现低于检测下限结果。结论国产常规ELISAHBsAg试剂灵敏度普遍偏低、容易漏检；漏检标本多来自HBsAb阴性个体；漏检个体可能和隐匿性HBV感染相关，临床应重视长时间HBsAb阴性个体的HBVM定期复查工作。
Objective To see the false HBsAg negative results for serum samples in daily work and to improve the clinical laboratory tests quality. Methods According to the HBsAb results,400 case HBsAg negative stochastic serum samples were collected from the copy tubes in daily work for detecting hepatitis B virus markers （HBVM） with national ELISA reagent kits. So 200 serum samples were HBsAb negative and 200 were HBsAb positive and put them -20℃ frostily. The HBsAg markers were counterchecked with other two adding kinds of national ELISA reagent kits and American MONO- LISA HBsAg ULTRA reagents （total 4 kinds） at the 400 samples and filtrated the positive samples. At the last filtrated samples, HBV DNA levels were doubly quantitative analyzed with fluorescence quantitative PCR （FQ-PCR） and taking the mean results. Results Educed the conform HBsAg negative results from the three kinds of national reagents but five posi- tive resuhs from the American reagents in repeating HBsAg detection at the 200 HBsAb negative samples. No positive re- sults were checked out from the 200 HBsAb positive samples with national or foreign reagents. The HBV DNA FQ-PCR quantitative results were all less than 500 copies/ml and divided into one case between 400~500 copies/ml,two cases 100 ~200 copies/ml,two cases 10~100 copies/ml and no results were under the detecting limit. Conclusion The sensitive level of the HBsAg routine test ELISA reagents is generally on the low side and easily bring on the false HBsAg negative results and the false results are more frequently from the HBsAb negative people. This maybe connected with occult HBV infection,should attach importance to the HBVM counterchecking work at these people.
出处
《现代检验医学杂志》
CAS
2009年第4期87-89,共3页
Journal of Modern Laboratory Medicine
基金
基金项目：本课题为深圳市福田区科技计划重点项目（FTWSOgO）.
