발열성 물질시험과 세균 내독소 시험의 비교 연구

• 영문명: Comparison of LAL Test with Pyrogen Test
• 발행기관: 대한약학회
• 저자명: 이유경(Yoo Kyoung Lee) 강윤숙(Yoon Sook Kang) 백선영(Sun Young Baek) 김용관(Yong Kwan Kim) 신광훈(Kwang Hoon Shin) 민홍기(Hong Ki Min)
• 간행물 정보: 『약학회지』제43권 제5호 (1999년), 606~613쪽, 전체 8쪽
• 주제분류: 의약학 > 기타의약학
• 파일형태: PDF
• 발행일자: 1999.10.28

영문 초록

To survey the possibility of replacing the pyrogen test with Limulus Amebocyte Lysate (LAL) test and to find out a standard methods suitable to our blood products made in Korea, 100 samples of 20% human serum albumin were tested by commercial LAL test kits and results of those were compared with rabbit pyrogen test. The LAL test is used both kinetic-chromogenically and kinetic- turbidimetrically. Both methods equally showed broad detection range (5.0~0.005EU/ml), excellent sensitivity (>/-0.005EU/ml) and predominant recovery rate within valid dilution range, but kinetic-turbidimetric method seemed to be more reproducible than kinetic-chromogenic method(kinetic-chromogenic method : S.D.=15.88, kinetic-turbidimetric method : S.D.=8.12). After heating the sample at 75oC for 15min, the results showed a little elevated recovery rate with both methods. After performing the test on 100 albumin samples with both kits, the results were analysed using the USP stadard (1.33EU/ml). 7% of samples in kinetic-chromogenic methods and 1% of samples in kinetic-turbidimetric method exceeded the limit of endotoxin levels regulated for blood products in USA. Because this phenomenon was not observed in both methods at the same time and both methods have high sensitivity (>/-0.005EU/ml), these results seemed to depend on non-specific reaction. Considering its sensitivity and reproducibility, we could assure that LAL test is proper to detecting pyrogenic with good sensitivity.

키워드

Limulus Amebocyte Lysate(LAL) test rabbit pyrogen test kinetic-chromogenic method kinetic-turbidimetric method.