HBs항원검출을 위한 Third generataion test에 관한 비교 연구

Abstract

[한글]

1965년 Blumberg등에 의하여 최초로 발견된 Australia antigen이 B형 간염 바이러스의 표식자임이 알려진 후 좀 더 예민하고 신빙도 높은 방법으로 검출하려는 노력이 계속되어 왔다.

RIA, ELISA 및 RPHA의 세 검사방법은 예민도가 가장 높으며 모두 third generation test로 분류하고 있다. 그러나 통상검사로서는 결과의 예민도와 특이성뿐만 아니라 검사소요시간, 복잡성 및 비용 등도 고려되어야하나 우리의 여건에서 이러한 종합적인 검토가 된

바는 없는 것 같다.

이에 저자는 최근에 개발되고 있는 ELISA와 RPHA법에 관한 것을 검토하기 위하여 이 연구를 하였다. 즉 1980년 7월부터 12월 사이에 만 6개월간 혈액 내의 HBs항원검사가 의뢰된 235명의 연세의료원 입원환자와 혈액은행 공혈자 206명을 대상으로 실험하여 다음과

같은 결과를 얻었다.

1. 혈액 내의 HBs항원검사가 의뢰된 235명의 환자중 RIA법으로는 86명(36.6%), ELISA법으로는 85명(36.2%)이 양성결과를 보였다(P>0.05).

2. RIA법으로 HBs항원 양성인 59예에 대한 RPHA 양성은 Cellognost(Behring)로는 57예(96.6%), Serodia(Fujizoki)로는 58예(98.3%), Raphadex B(Ortho)로는 54예(91.5%)이었다(P>0.05).

3. RIA법으로 HBs항원 음성인 130예에 대한 RPHA법 양성은 Cellognost로는 11예(8.4%),

Serodia로는 6예(4.6%), Raphadex B로는 4예(3.1%)이었다(P>0.05).

4. 혈액은행 공혈자 206명의 HBs항원 양성율은 CIEP로는 5.2%, RPHA법으로는 제조원에 따라 16.4∼20.4%이었다(P<0.05).

이상의 결과에서 HBs항원을 검출하는데 있어서 ELISA법은 RIA법과 거의 유사한 예민도를 보이며 실용성이 높아 환자진단을 위한 검사로서 적당하다고 인정되었다. 또한 RPHA법은 제조원에 따라 다소 예민도의 차이가 있으나 방법이 간편하여 공혈자의 screening에

적당한 방법으로 생각되었다.

A comparative Study on the Third Generation Tests for the Detection of HBsAg

Dong HEE Cho

Department of Medical Science The Graduate School Yonsei University

(Directed by Prof. Samuel Y.Lee, M.D)

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 suitable for routine use. Because radioimmunoassay(RIA) is generally

accepted as being the most sensitive method currently available, sensitivity and

specificity of other third generation tests 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 cases 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

CeIlognost(Behring), 58(98.3%) by Serodia(Fujizoki), and 54(91.5%) by Raphadex

B(0rtho) (P>0.05).

3. Of the 13O HBsAg negative samples by RIA. 11(8.4%) by Cellognost(Behring),

6(4.6%) by Serodia(Fujizoki) and 4(3.1%) by Raphndex B(Ortho) were

positive(P>0.05).

4. Seropositive rates for HBsAg in 206 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 be a very sensitive, rapid, and simple method for detecting

HBsAg. However, false positive results occurring with some sera needs confirmation

by specific inhibition or by testing with another methods.

In terms of sensitivity and specificity, ELISA appears 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.

[영문]

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 suitable for routine use. Because radioimmunoassay(RIA) is generally

accepted as being the most sensitive method currently available, sensitivity and specificity of other third generation tests 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 cases 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 CeIlognost(Behring), 58(98.3%) by Serodia(Fujizoki), and 54(91.5%) by Raphadex B(0rtho) (P>0.05).

3. Of the 13O HBsAg negative samples by RIA. 11(8.4%) by Cellognost(Behring), 6(4.6%) by Serodia(Fujizoki) and 4(3.1%) by Raphndex B(Ortho) were positive(P>0.05).

4. Seropositive rates for HBsAg in 206 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 be a very sensitive, rapid, and simple method for detecting HBsAg. However, false positive results occurring with some sera needs confirmation by specific inhibition or by testing with another methods.

In terms of sensitivity and specificity, ELISA appears 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.