CAJ | 학술논문

目的比较4种国产乙型肝炎(乙肝)ELISA试剂盒的灵敏度和特异度.方法取慢性乙肝患者和不合格献血员血液样本594份,应用4种国产乙肝ELISA试剂盒检测HBsAg、抗-HBs、HBeAg、抗-HBe和抗-HBc,并与1种国外乙肝化学发光试剂盒(Abbott公司Architect)比较,对结果不一致的样本再用各试剂盒做双孔重复检测,对HBsAg 临界值附近的样本用Abbott HBsAg确证试剂盒(Architect HBsAg confirm)验证;以Abbott试剂盒(Architect)的检测结果为标准,计算4种国产ELISA试剂盒的灵敏度、特异度、总符合率和约登指数.然后用上述试剂盒榆测HBV 5项标志物的灵敏度参比品,比较不同试剂盒的灵敏度.结果与Abbott公司Architect试剂盒相比,国产HBsAgELISA试剂盒的灵敏度低4～10倍;抗-HBs、HBeag、抗.HBe和抗-HBc ELISA试剂盒的灵敏度低4～16倍;且有假阳性.HBsAg、抗-HBs、HBeAg、抗-HBe和抗-HBc的总符合率分别为96.46%～98.15%、94.28%～98.15%、98.15%～99.49%、90.07%～96.30%、92.09%～96.80%.结论国产乙肝ELISA试剂盒的灵敏度和特异度有待进一步提高.
목적 비교4충국산을형간염(을간)ELISA시제합적령민도화특이도.방법 취만성을간환자화불합격헌혈원혈액양본594빈,응용4충국산을간ELISA시제합검측HBsAg、항-HBs、HBeAg、항-HBe화항-HBc,병여1충국외을간화학발광시제합(Abbott공사Architect)비교,대결과불일치적양본재용각시제합주쌍공중복검측,대HBsAg 림계치부근적양본용Abbott HBsAg학증시제합(Architect HBsAg confirm)험증;이Abbott시제합(Architect)적검측결과위표준,계산4충국산ELISA시제합적령민도、특이도、총부합솔화약등지수.연후용상술시제합유측HBV 5항표지물적령민도삼비품,비교불동시제합적령민도.결과여Abbott공사Architect시제합상비,국산HBsAgELISA시제합적령민도저4～10배;항-HBs、HBeag、항.HBe화항-HBc ELISA시제합적령민도저4～16배;차유가양성.HBsAg、항-HBs、HBeAg、항-HBe화항-HBc적총부합솔분별위96.46%～98.15%、94.28%～98.15%、98.15%～99.49%、90.07%～96.30%、92.09%～96.80%.결론국산을간ELISA시제합적령민도화특이도유대진일보제고.
Objective To compare and analyze the sensitivity,specificity of 4 domestic ELISA kits for detection of hepatitis B virus (HBV) markers (HBsAg,anti-HBs,HBeAg,anti-HBe,and anti-HBc).Methods Five hundred and ninety four serum samples collected from patients with chronic hepatitis B and abnormal blood donors were detected for HBV markers and by 4 domestic ELISA kits.Samples with conflicting results by different diagnostic kits were retested.Samples with the HBsAg values close to the cut-off point were detected by Abbott HBsAg confirmation kit (Architect HBsAg confirm).Sensitivity of the kits was determined,using the national sensitivity reference panels for HBsAg,anti-HBs,HBeAg,anti-HBe and anti-HBc.Results The rates of sensitivity on 4 domestic kits for detection of HBsAg were 4 to 10 times lower,and on the 4 domestic kits for detection of anti-HBs,HBeAg,anti-HBc and anti-HBc were 4 to 16 times lower,as compared to Abbott Architect kits.In addition,the domestic HBV ELISA kits had some false positive results.The total coincidence rates of HBsAg,anti-HBs,HBeAg,anti-HBe,anti-HBc were 96.46%-98.15%,94.28%-98.15%,98.15%-99.49%,90.07%-96.30%,92.09%-96.80%,respectively.Conclusion Both sensitivity and specificity of the domestically produced HBV ELISA kits should be improved.