LAL Test에서 위양성을 나타내는 원인들에 대한 고찰

• 영문명: Consideration About the Bacterial Endotoxin Test Showing False Positive Test Result When Performing LAL Test
• 발행기관: 대한핵의학기술학회
• 저자명: 황기영(Ki Young Hwang) 조용현(Yong Hyun Cho) 이용석(Hyung Woo Kim) 김형우(Hyung Woo Kim) 이홍재(Hong Jae Lee) 김현주(Hyun Ju Kim)
• 간행물 정보: 『핵의학기술』Vol.13 No.2, 156~158쪽, 전체 3쪽
• 주제분류: 의약학 > 방사선과학
• 파일형태: PDF
• 발행일자: 2009.10.30

영문 초록

Purpose: Since radiopharmaceuticals are intended for human administration, it is imperative that we should undergo quality control very strictly. Now almost all the PET laboratories have adopted Bacterial Endotoxin Test as the stand quality control method to monitor whether pyrogen is free or not in the product vial containing crude solution. The aim of this study is to find out the reason why false positive result is observed when using commercially available test vial. Materials and Methods: For this experiment, we used commercially available single test kit (Associates of Cape Code. Inc. USA) and we made pH samples by mixing each buffer whose pH ranges are 1.0 to 12.0. Otherwise we made Ethanol samples diluted with distilled water. After making test samples, it added 0.2 mL to the test vial. Assay mixture in the test vial was incubated in a water bath (Chang Shin Co. KOR) for 60 min at 35±2℃. Results: After incubation period (60±1℃), we inverted the test vial about 180。 To know what pH and how many percentage of Ethanol (Fisher Scientific Korea. Ltd) will affect the reaction. With pH buffer, false positive result was observed at pH 1.0 to 5.0 and 7.7 to 12.6 but at pH 5.2 to.7.5, the test results show negative. It’s very strange that we couldn’t observe negative test result with Tris buffer at pH 8.4, 8.6, 8.8, 9.0. in other case Ethanol, the test result was seen with 5 to 10% Ethanol. But to my surprise we could see very thick gel formation with 100% Ethanol. Conclusions: In this study, we could notice that pH which is too much acidic or alkalic or high concentrated Ethanol would affect Bacterial Endotoxin Test result. As you know, LAL test is sensitive and very reliable method. Therefore, we are needed to elicit the accurate test result as possible as we can.

목차

Introduction

Materials and Methods

Result

Conclusion

요약

REFERENCES

키워드

Bacterial Endotoxin Test LAL test Pyrogen Radiophamaceutical