Ultra-sensitive HBsAg IRMA 키트의 민감도 및 변이형 검출능 평가

• 영문명: The Assessment of Ultrasensitive HBsAg kit's Sensitivity level and Performance in Detection of Mutant Forms
• 발행기관: 대한핵의학기술학회
• 저자명: 하동혁(Dong Hyuk Ha) 민경선(Kyung Sun Min) 노경운(Gyeong Woon Noh) 김현주(Hyun Ju Kim)
• 간행물 정보: 『핵의학기술』Vol.15 No.1, 121~125쪽, 전체 5쪽
• 주제분류: 의약학 > 방사선과학
• 파일형태: PDF
• 발행일자: 2011.04.30

영문 초록

Purpose: The DNA-type virus HBV, discovered by D. Dane and others in 1976, is approximately 42nm big and known as the main cause of liver-related diseases around the world. HBsAg has 4 kinds of subtypes including adw, adr, ayw and ayr and besides common antigen factor a, there are d, y, r, w. From the methods of serologically testing HBV, IRMA, EIA and CLIa were developed for testing HBsAg and are being used in examining the surface antigen of HBV. In this study, among the methods for testing HBV, the recently developed RIAKEY Ultrasensitive HBsAg IRMA kit's sensitivity level and performance in detection of mutant forms were measured and compared with CLIA. Materials and methods: Two certified reference materials, which are WHO 1st International Standard 1985(80/549) and WHO 2nd International Standard 2003(00/588. subtype adw2, genotypeA), were used in the examination and the sensitivity level was measured by diluting these materials from 0.08 IU/ml to 0.005 IU/ml. The materials for examining the detection of mutant forms included 9 kinds of subtype 'ad' and one kind of subtype 'ay' purchased from DSI company. Also, with the use of positive and negative samples, they was compared with CLIA. Result: Ultrasensitive HBsAg kit based on IRMA method showed the detection of up to 0.01 IU/ml not only for WHO 1st International Standard 1985(80/549) but also for WHO 2nd International Standard 2003(00/588. subtype adw2, genotypeA) and the sensitivity level was measured as 0.01 IU/ml by WHO standard. In testing the performance for detection of mutant forms, the 9 kinds of subtype 'ad' and one kind of subtype 'ay' mutant materials were detected, demonstrating the capacity of detecting various types of mutant forms. Conclusions: With the clinical importance of sensitivity level and performance in detection of mutant forms increasing in the field of HBsAg diagnosis, the examination of IRMA's effectiveness using RIA method in the aspects of the sensitivity level and performance in detection of mutant forms was carried out and its result is as follows. The sensitivity level was measured as 0.01 IU/ml by WHO standard and it was possible to measure various types of mutant forms with high sensitivity. Thus it is suggested that more speedy and accurate reports could be produced from a nuclear medicine laboratory for clinical practitioners requiring results of various situations.

목차

서론

실험재료 및 방법

결과

고찰

결론

요약

REFERENCES

키워드

WHO Ultra-sensitive HBsAg Mutant form