Study on conformance between two kinds of detection method of anti-HBs antibody / 国际检验医学杂志

ABSTRACT

Objective To analyze the conformance between the quantitative and qualitative tests of hepatitis B surface antibody (anti-HBs).Methods The chemiluminecence microparticle enzyme immunoassay(CMIA)was adopted to quantitatively detect anti-HBs and the enzyme linked immunosorbent assay(ELISA)was adopted to qualitatively detect anti-HBs.Results With the CMIA as the reference experiment,Se ,Sp ,J ,PV+ and PV-of anti-HBs detected by ELISA were 0.95,0.53,0.48,0.74 and 0.88 respec-tively,k=0.51;when the absorbance was 0.400 9,Se ,Sp ,J ,PV+ and PV-were 0.50,0.95,0.45,0.93 and 0.43 respectively;for the samples exceeding the absorbance range of 0.104 3 -0.400 9,Se ,Sp ,J ,PV+ and PV-qualitatively detected by ELISA were 0.90,0.91,0.81,0.93 and 0.88 respectively,k =0.81.Conclusion Determining cutoff value with the absorbance value 0.105 as the ELISA detection result has the good detection sensitivity(Se =0.95)and the better negative prediction value(PV-=0.88),the negative anti-HBs detected by ELISA may be considered that the anti-HBs concentration was less than 10 mIU/mL without the conservation value;when the sample absorbance ≥0.400 9,the anti-HBs concentration is ≥10 mIU/mL,which may be considered to have the conservation value;the gray area range of anti-HBs detected by ELISA is mainly the absorbance of 0.105-0.400 9,the true anti-HBs level should be quantitatively detected.