발열성 물질시험과 세균 내독소 시험의 비교 연구

Comparison of LAL Test with Pyrogen Test

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.