내독소 검사에서 자동합성장치에 따른 간섭요인 극복에 대한 연구

Study on Overcoming Interference Factor by Automatic Synthesizer in Endotoxin Test

Purpose : Samsung medical ceter shall find a cause of the interference factor and suggest a solution for it. Materials and Methods : A sample of 18F-FDG, radioactive pharmaceuticals produced by TRACERlab MX and FASTlab synthesizer. Gel-clot method uses Positive control tube and single test tube. Kinetic chromogenic method uses ENDOSAFE-PTS produced by Charles River. Results : According to Gel clot method of Endotoxin Tests at FASTlab, both turbidity and viscosity increased at 40-fold dilution and Gel clot was detected. In case of TRACERlab MX, Gel clot was detected in most of samples but intermittently not in a few of them. When using ENDOSAFE-PTS, sample CV (Coefficient of Variation) of FASTlab is 0% at all dilution rates whereas spike CV is 0% at 1-fold dilution, 0~35% at 10-fold, 3.6~12.9% at 20-fold, 5.2~7.1% at 30-fold, 1.1~17.4% at 40-fold, spike recovery; 0% at one-fold, 25 ~ 58% at 10-fold, 50 ~ 86% at 20-fold, 70~92% at 30-fold, and 75~120% at 40-fold. Sample CV of TRACERlab MX, is 0% at all dilution rates whereas spike CV is 1.4~4.8% at one-fold dilution, 0.6~19.9% at 10-fold, spike recovery; 35~72% at one-fold dilution and 77~107% at 10-fold. Conclusion : Gel clot does not seem to occur probably to H3PO4 which engages in bonding with Mg2+ion contributing gelation inside PCT. Dilution which is identical to reducing the amount of H3PO4, could remove interfering effects accordingly. Spike recovery was obtained within 70~150% - recommended values of supplier - at 40-fold dilution even in kinetic chromogenic method.