海南省临床实验室检测乙肝标志物五项水平评价

Clinical laboratory assessment of levels of five HBV markers in Hainan Province

目的了解海南省临床实验室检测乙肝标志物的质量控制水平,以提高检测质量控制能力。方法在2003～2006年间,发放参比样品到各临床实验室进行乙肝表面抗原(HBsAg)、乙肝表面抗体(HBsAb)、乙肝e抗原(HBeAg)、乙肝e抗体(HBeAb)、乙肝核心抗体(HBcAb)进行ELISA检测,通过计算灵敏度、特异性、阴性预告值、阳性预告值、符合率等指标对实验室进行评价。结果乙肝表面抗原、乙肝表面抗体、乙肝e抗原和乙肝e抗体的灵敏度、特异性、阴性预告值、阳性预告值和符合率除乙肝e抗体灵敏度为80.7%外,其他皆达90%以上,但乙肝核心抗体:83.4%(1484/1779)、特异性86.2%(249/289)、阴性预告值45.8%(249/544)、阳性预告值97.4%(1484/1524)、符合率83.8%(1733/2068)。结论全省检测乙肝表面抗原、乙肝表面抗体、乙肝e抗原、乙肝e抗体的各项评价指标均达优良以上水平,检测质量可以满足临床需求;检测乙肝核心抗体的各项评价指标均不理想,应加强对该项目检测质量方面的监控。

Objective To evaluate the test level of HBV markers in clinical laboratories in Hainan Province for intensification of quality control. Methods The levels of HBsAg, HBsAb, HBeAg, HBeAb and HBcAb of known HBV samples from various clinical laboratories in Hainan Province were tested. The sensitivity, specificity, negative predictive value, positive predictive value and coincidence of the results of various laboratories were capmared, Results The sensitivity, specificity, negative predictive value,positive predictive value and coincidence of HBsAg were 93.7% （ 1009/1077）, 99.2% （974/982）, 93,5% （974/1042） 98,2% （1009/1027） and 96,3% （1983/2059） respectively; that of HBsAb were 95.5% （745/780）, 96.6% （1244/1288）, 97.3% （1244/1279）94.4% （745/789） and 96.2% （1989/2068） respectively; that of HBeAg were 91.3% （264/289）, 98.9% （1759/ 1779）, 98.6% （1759/1784）, 92.9% （264/284） and 97.8% （2023/2068） respectively; that of HBeAb were 80.7% （432/535）, 97.3%（1491/1533）, 93.5% （1491/1594）91.1% （432/474） and 92.9% （1923/2068） respectively and that of HBcAb were 83.4%（1484/1779）, 86.2% （249/289）, 45.8% （249/544）, 97.4% （1484/1524） and 83.8% （1733/2068） respectively. Conclusion The quality of test of HBsAg, HBsAb, HBeAg and HBeAb in clinical laboratories of this province is excellent and can meet the need of clinical purpose. But the test level of HBeAb needs to be enhanced.