B형 간염 바이러스 표면 항원 검색을 위한 Latex agglutination법에 대한 고찰

Abstract

[한글]

1984년 12월부터 1985년 4월 사이에 연세의대부속 영동병원에 HBs항원 집사가 의뢰된 환자의 혈청 중에서 ELISA법으로 양성결과를 보인 151명의 환자혈청과 음성결과를 보인 56명의 환자혈청을 대상으로

RPHA법과 최근 개발된 Latex agglutination법을 원법(LA-A)과

변법 (LA-B ; 가검혈청과 latex입자 현탁액을 원법의 1/2량인 25μl로 감량하여 혼합한 뒤에 원법과 동일한 방법으로 시행한다)으로 구분하여 HBs항원 검사를 시행하였다.

상기의 검사방법에 의하여 나타난 성적에 대하여 예측도등을 비교 검토한 바 다음과 같은 성적을 얻었다.

1.ELISA법에서 HBs항원 양성으로 나타난 환자혈청 151명중에서 RPHA법 140명(72.7%), LA-A법 134명(88.7%) 및 LA-B법 135명(89.4%)이 양성으로 나타났다(P> 0.05).

2.ELISA법으로 확인된 HBs항원 음성환자 56명중에서 RPHA법 55명(98.2%), LA-A법 53명 (94.6%) 및 LA-B번 52명(92.9%)이 음성으로 나타났다 (P> 0.05).

3.ELISA 법으로 HBs항원 강양성 (O.D> 2.0)으로 나타난 환자 142명에 대한 결과는 RPHA법 139명 (97.9%), LA-A법 133명(93.7%) 그리고 LA-B법 133명 (93.7%)이 양성결과를 보였다(P> 0.05).

HBs항원 약양성 (O.D<2.0)으로 나타난 환자 9명에 대한 결과는 RPHA법과 LA-A법에서 각각 1명(11.1%)이 나타났고 LA-B법에서 2명( 22.2%)이 나타났다( P> 0.05).

4. LA법을 비교했을 때 원법 (LA-A)과 변법( LA-B)은 예측도가 각각 97.7%, 97.1%로서 차이는 없었으며 경제적인 효과를 기대할 수 있었다 (P> 0.05).

이상의 결과에서 LA-A법 및 LA-B법은 RPHA법에 못지 않은 유사한 예측도를 보인 점으로 볼 때 대량선별검사, 의원급의 통상검사 및 혈액은행의 응급검사에 특히 유용하리라고 생각되며, 변법 ( LA-B)에서 97.1%의 예측도를 보인 것은 경제적인 효과도 아울러 기대할

수 있을 것으로 생각된다.

Evaluation of Latex Agglutination Tests for the Detection of HBsAg

Hyang Suk Rur

Graduate School of Public Health and Management Yonsei University

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

The study subjects consisted of positive blood serum samples from 151 patients

and negative blood serum samples from 56 patients referred for HBsAg test by ELISA

in Yonsei University Yeong Dong Hospital during 5 month' period from December, 1984

to April,1985.

HBsAg was tested by latex agglutination, using the original(LA-A) method and the

recently developed, modified(LA-B) method separately as well as RPHA.

The results were as follows :

1. Of the 151 HBsAg positive samples confirmed by ELISA, 140 (92.7%) were

confirmed positive by RPHA, 134 (88.7%) by LA-A and 135 (89.4%) by LA-B (P>0.05).

2. Of the 56 HBsAg negative samples confirmed by ELISA, 55(98.2%) were shown

negative by RPHA,53 (94.6%) by LA-A and 52 (92.9%) by LA-B (P>0.05).

3. Of the 142 moderate to strongly reactive samples (O.D>2.0) confirmed by ELISA,

139(97.9%) were confirmed positive by RPHA, 133 (93.7%) by LA-B (P>0.05).

Of the 9 weakly reactive samples (O.D< 2.0) reported by ELISA, 1(11.1%) each was

shown positive by RPHA and LA-A and 2 (22.2%) by LA-B (P>0.05).

4. Comparison of the original latex agglutination (LA-A) and the modified latex

agglutination (LA-B) methods showed their predictability levels were 97.7% by LA-A

and 97.1% by LA-B.

There baa no significant statistical difference between the LA-A and LA-B methods

(P > 0.05) and a further advantage of the modified method is its economical use of

reagents.

On the basis mentioned above, we considered these techniques very useful

detection methods because beth LA-A and LA-B appear to be equivalent about

predictability. Also they can be applied for mass screening of HBsAg, and as

routine fiesta for private clinics and emergency testing of HBsAg in blood banks.

[영문]

The study subjects consisted of positive blood serum samples from 151 patients and negative blood serum samples from 56 patients referred for HBsAg test by ELISA in Yonsei University Yeong Dong Hospital during 5 month' period from December, 1984 to April,1985.

HBsAg was tested by latex agglutination, using the original(LA-A) method and the recently developed, modified(LA-B) method separately as well as RPHA.

The results were as follows :

1. Of the 151 HBsAg positive samples confirmed by ELISA, 140 (92.7%) were confirmed positive by RPHA, 134 (88.7%) by LA-A and 135 (89.4%) by LA-B (P>0.05).

2. Of the 56 HBsAg negative samples confirmed by ELISA, 55(98.2%) were shown negative by RPHA,53 (94.6%) by LA-A and 52 (92.9%) by LA-B (P>0.05).

3. Of the 142 moderate to strongly reactive samples (O.D>2.0) confirmed by ELISA, 139(97.9%) were confirmed positive by RPHA, 133 (93.7%) by LA-B (P>0.05).

Of the 9 weakly reactive samples (O.D< 2.0) reported by ELISA, 1(11.1%) each was shown positive by RPHA and LA-A and 2 (22.2%) by LA-B (P>0.05).

4. Comparison of the original latex agglutination (LA-A) and the modified latex agglutination (LA-B) methods showed their predictability levels were 97.7% by LA-A and 97.1% by LA-B.

There baa no significant statistical difference between the LA-A and LA-B methods (P > 0.05) and a further advantage of the modified method is its economical use of reagents.

On the basis mentioned above, we considered these techniques very useful detection methods because beth LA-A and LA-B appear to be equivalent about predictability. Also they can be applied for mass screening of HBsAg, and as routine fiesta for private clinics and emergency testing of HBsAg in blood banks.