The first and second generation tests for hepatitis B antigen(HBsAg), namely, gel
diffusion, counterimmunoelectrophoresis are considered relatively insensitive tests. But it
is not clear which of the more sensitive third generation tests would be most boilable
for routine use. Because radioimmunoassay (RIA) is generally accepted as being the
most sensitive method currently available, sensitivity and specificity of other third
generation testis including ELISA and RPHA with different commercial kits were
compared with the results of RIA.
Comparisons were also made in terms of procedural simplicity, amount of time
required to complete the test and cost of the assay kit. Study subjects consisted of 235
in-patient blood samples requested for HBsAg test and 206 blood samples from
voluntary blood donors in Yonsei University Medical Center during the period of 5
months from July to December in 1980.
The results are summarized as follows;
1) The seropositive cages for HBsAg in 235 patients were 86(36.6%) by RIA(Abbott)
and 85(36.2%)by ELISA(Abbott)(p>0.05).
2) The detection rates of HBsAg in 59 Positive samples by RIA were 57(96.6%) by
Cellognost(Behring), 58(98.3%) by Serodia(Fujizoki), and 54(91.5%) by Raphadex
B(Ortho)(P>0.05).
3) Of the 130 HBsAg negative samples tr RIA, 11 (8.4%) by Cellognost (Behring),
6(4.6%) by Serodia (Fujizoki) and 4(3.1%) by Raphadex B(Ortho) were positive (p>0.05).
4) Seropositive rates for HBsAg in 205 voluntary blood donors were 5.2% by CIEP
and 16.4% to 20.4% by different kits for RPHA (p<0.05).
The RPHA appears to he a very sensitive, rapid, and simple method for detecting
HBsAg, However, false positive results occurring with sore sera needs confirmation tr
specific inhibition or by testing with another methods.
In terms of sensitivity and specificity, ELISA appeals to be a satisfactory method
which can be used in clinical laboratory. Also it can circumvents the high cost and
problems inherent in RIA systems.
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