Program / Abstract Book - KMU WWW3 Server for Education ...

No. 15 (PC 15)
Preparation of multi-purpose matrix-based material for laboratory service and
investigation
Sumiyoshi Naito 1 , Kazumi Akasaska 3 , Shuichi Kino 3 , Yutaka Tomoda 3 , Tadashi Matsubayashi 4 ,
Nobuyuki Kubota 2 , Junichi Ando 5 , Shigemi Hosogaya 6 , Yoshihisa Itoh 1 .
Asahikawa Medical University 1 , Eiken Chemical Co., Ltd. 2 , Asahikawa Medical University Hospital 3 ,
Nissui Pharmaceutical Co., Ltd. 4 , SRL, Inc. 5 , Kagawa Prefectural University of Health Sciences 6 , Japan
Aim Reference material is a key in setting reference measurement system. If it is serum-matrix base
and analytes contained are closely similar, it can be used for many other clinically relevant purposes.
We have newly developed the multi-purpose serum-matrix base reference material.
Materials and Methods The material was prepared in a similar manner as ERM-DA470, an
international reference material of serum proteins, IRMM. In short it is lyophilized after processing
normal pooled sera (Shima Laboratories, Japan), reconstituted with hepes buffer, and spiked with CRP,
cystatin C, and beta-2-microglobulin.
Results We have successfully prepared the material with high safety, short-term stability, and
long-term stability. Tests are negative for HBV, HCV, and HIV. After reconstituting with 1 ml of water
the value was unchanged at 4ºC and room temperature until 12 hours. We confirmed the stability for
one year. Storage at 4ºC and -80ºC gave a good result. These include CRP, cystatin C, beta
2-microoglobulin, pepsinogen I, II, and others. No inter-vial differences are noted. 31 different serum
proteins and cytokine value was initially set by participation of immunoassay systems. The value in
each analyte was generally 2/3 of that of normal adult, which may be caused by amount of distilled
water added. Some minute discrepancy was found in the reaction of cystatin C and beta2-microglobulin
between the material and patient’s sera.
Comments The present prepared material definitely play a unique role for standardization for
immunoassay of different kinds of analytes, especially non-standardized controls for everyday’s
laboratory services, and references of a given analyte for experimental purpose.
- 68 -