Evaluation of immunochromatographic assay systems for rapid detection of hepatitis B surface antigen and antibody, Dainascreen HBsAg and Dainascreen Ausab.
We evaluated two immunochromatographic assays (ICAs), Dainascreen HBsAg for detecting human hepatitis hepatitis B surface antigen (HBsAg) and Dainascreen Ausab for detecting human hepatitis B surface antibody (anti-HBs) in human serum. The ICA systems are composed of a comb-shaped device that contains nitrocellulose strips on which complexes of HBsAg and anti-HBs can be visualized. The results can be read within 15 min of incubation. The limit of detection for HBsAg was 3.1 ng/ml and that for anti-HBs was 42 mIU/ml. Results of HBsAg detection agreed completely with those of conventional enzyme immunoassays (EIAs) and showed a 100% sensitivity (158 of 158 samples) and a 100% specificity (304 of 304 samples). The Dainascreen Ausab detected 184 of the 199 EIA-positive samples (sensitivity, 92.5%) and yielded 6 positive results among the 281 EIA-negative samples (specificity, 97.9%). The ICA systems are rapid and sensitive methods for detecting HBsAg and anti-HBs. They are low-cost systems that need no complex instrumentation for analysis and can be recommended for routine use in clinical microbiology laboratories.
Sato
K
K
Department of Clinical Laboratory Medicine, Nagoya University Hospital, Japan.
Ichiyama
S
S
Iinuma
Y
Y
Nada
T
T
Shimokata
K
K
Nakashima
N
N
D002845:Chromatography / Q000295:instrumentation / Q000379:methods / Q000706:statistics & numerical data; D003101:Collodion; D003951:Diagnostic Errors; D005069:Evaluation Studies as Topic; D006509:Hepatitis B / Q000175:diagnosis / Q000276:immunology / Q000821:virology; D006510:Hepatitis B Antibodies / Q000097:blood*; D006514:Hepatitis B Surface Antigens / Q000097:blood*; D006801:Humans; D007118:Immunoassay / Q000295:instrumentation / Q000379:methods* / Q000706:statistics & numerical data; D007124:Immunoenzyme Techniques / Q000706:statistics & numerical data; D012680:Sensitivity and Specificity; D013997:Time Factors
D006510:Hepatitis B Antibodies; D006514:Hepatitis B Surface Antigens; D003101:Collodion