YAKHAK HOEJI (약학회지)

The Pharmaceutical Society of Korea (대한약학회)
권호 표지

Comparison of LAL Test with Pyrogen Test

발열성 물질시험과 세균 내독소 시험의 비교 연구

  • 이유경 (식품의약품안전청 생물학평가부 세균제제과) ;
  • 강윤숙 (식품의약품안전청 식품평가부 식품미생물과) ;
  • 백선영 (식품의약품안전청 생물학평가부 세균제제과) ;
  • 김용관 (식품의약품안전청 생물학평가부 세균제제과) ;
  • 신광훈 (식품의약품안전청 생물학평가부 혈액제제과) ;
  • 민홍기 (식품의약품안전청 생물학평가부 세균제제과)
  • Published : 1999.10.01
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Abstract

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 dinetic-chromogenically and kinetic-turbidimetrically. Both methods equally showed broad detection range (5.0~0.005 EU/ml), excellent sensitivity ($\geq$ 0.005 EU/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 75$^{\circ}C$ for 15 min, 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 standard (1.33 EU/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 ($\geq$0.005 EU/ml), these results seemed to depend on nonspecific reaction. Considering its sensitivity and reproducibility, we could assure that LAL test is proper to detecting pyrogenic with good sensitivity.

Keywords

References

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