Abstract:

Objective　To improve tacrolimus (FK506) internal quality control material, and remedy the monitoring blind of commercial ones. Methods　The results of FK506 were observed in 1 year,and the feasibility of self-made low-level quality control material was evaluated. By self-made internal quality control materialof low level (ZCON-L) and self-made internal quality control material of middle level (ZCON-M), the intra-day and inter-day relative standard deviations (RSD%) were determined. The differences between low-level and middle-level commercial internal quality control materials (Level 1 and Level 2) and self-made ones were compared. The internal quality control chart was drawn,the ZCON-M and Level 2 were analyzed statistically,and the difference of self-made internal quality control material and commercial ones was analyzed. The ZCON-L and ZCON-M were put at 4,25 and 37 ℃ and monitored for 7 d, and the influence of temperature was observed. The self-made internal quality control material were subpackaged biocleanly and stored at -30 ℃, someone was took out every week, after thawing, it was monitered following the routine works, and stored at 4 ℃. Monitoring for 10 months, the stability was observed and analyzed. Results　Among 9 975 determinations of FK506 in 1 year, there was about 28.4% in the monitoring blind. The intra-day RSD and inter-day RSD of ZCON-L and ZCON-M were 4.5％,5.3％and 7.06%, 5.37% respectively,conforming to the performance indicators of ARCHITECT i1000 automatic immunoassay analyzer and the requirement of RSD<15％ of biological sample analysis method in the Chinese Pharmacopoeia. The correlations between ZCON-L,ZCON-M and Level 1, Level 2 were good (r²=0.835 2 and 0.818 5), and their trends were consistent in the internal quality control chart. ZCON-M and Level 2 had no statistical significance by t test (P>0.05). The temperatures (4,25 and 37 ℃) in 7 d had less effect to the self-made internal quality control material. The total RSD of ZCON-L and ZCON-M in 10 months were 7.56％ and 4.97％. Conclusions　The stability of self-made FK506 internal quality control material is good,it has no difference with commercial ones,it can be used in the clinical determination, so it can remedy the monitoring blind of commercial internal quality control materials and make up the internal quality control.

Key words: Self-made internal quality control material, Internal quality control, Tacrolimus