국가 표준물질을 이용한 B형 간염 검사 시약 간의 결과 비교

• 영문명: The Comparison of Results Among Hepatitis B Test Reagents Using National Standard Substance
• 발행기관: 대한핵의학기술학회
• 저자명: 이영지(Young Ji Lee) 심성재(Seong Jae Sim) 백송란(Song Ran Back) 서미혜(Mee Hye Seo) 유선희(Seon Hee Yoo) 조시만(Shee Man Cho)
• 간행물 정보: 『핵의학기술』Vol.14 No.2, 203~207쪽, 전체 5쪽
• 주제분류: 의약학 > 방사선과학
• 파일형태: PDF
• 발행일자: 2010.10.30

영문 초록

Purpose: Hepatitis B is infection caused by Hepatitis B virus (HBV). Currently, there are several methods, Kits and equipments for conducting Hepatitis B test. Due to ununiformed methods, it would cause some differences. To manage these differences, it needs process evaluating function of test system and reagent using particular standard substance. The aim of this study is to investigate tendency of RIA method’s reagent used in Asan Medical Center through comparing several other test reagents using national standard substance. Materials and Methods: The standard substance in National Institute of Food and Drug Safety Evaluation’s biology medicine consists of 5 things, 4 antigens and 1 antibody. We tested reagents using A, B company’s Kits according to each test method. All tests are measured repeatedly to obtain accurate results. Results: Test result of “HBs Ag Mixed titer Performance panel” is obtained match rate compared S/CO unit standard with RIA method and EIA 3 reagents, CIA 2 reagents is that company A’s reagent is 94.4% (17/18), 83.3% (15/18), B is 88.9% (16/18), 77.8% (14/18). Test result of “HBs Ag Low titer Performance panel” is obtain that EIA 2 reagents is shown 7 posive results , CIA 3 reagents is 11, and RIA method’s company A’s reagent is 3, B is 2 of 13 in low panel. “HBV surface antigen 86.76 IU/vial” tested dilution. A is obtain positive results to 600 times(0.14 IU/mL), B is 300 times (0.29 IU/mL). Case of “HBV human immunoglobulin 95.45 IU/vial”, A is shown positive result to 10,000 times (9.5 mIU/mL) and B is 4,000 times (24 mIU/mL). Test result of “HBs Ag Working Standards 0.02~11.52 IU/mL” is shown that Company A’s kit concentration level was 0.38IU/mL, company B was 2.23 IU/mL and higher level of concentration was positive results. Conclusion: When comparing various test reagents and RIA method according to National Standard substances for Hepatitis B test, we recognized that there were no significant trends between reagents. For hepatitis B virus antigen-antibody titers even in parts of the test up to 600 times the antigen, antibodies to 10,000 times the maximum positive results could be obtained. Therefore, we confirmed that results from Asan Medical Center are performed smoothly by reagents and system for hepatitis B virus test.

목차

서론

실험대상 및 방법

결과

고찰 및 결론

요약

REFERENCES

키워드

Hepatitis B virus RIA EIA CIA National standard substances