症例は31歳, 男性.意識障害, 失禁を主訴に来院, 血糖29mg/dlより低血糖による意識障害と診断し, ブドウ糖静注にて症状改善した. 低血糖の原因としてインスリノーマが疑われたが, IRI<10μU/ml, IRI/血糖<0.5といずれも低値であり, 腹部エコー, CT, MRIにて膵に異常を認めなかった. しかしプロインスリンは893pmol/lと著明高値を認めた. 経皮経肝門脈採血下に腹腔動脈へのCa負荷後, 門脈-脾静脈合流部において著明な|R|の上昇反応を認め, さらに選択的腹腔動脈造影にて膵鉤部に直径約1cmの腫瘍像を認めたことよりインスリノーマと診断した. 腫瘍核出術が施行され, 術後プロインスリンは6.4pmol/lと正常化を認め低血糖発作も消失した. IRI低値, プロインスリン高値のインスリノーマの症例は稀であり報告する.選択的動脈内Ca負荷も診断に有用であった.

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The allowable limits of error against 36 clinical biochemical analytes to establish the analytical quality specifications were investigated. These quality specifications were based on the analyses of physiological and biological variations with normal data in 9 studies published after 1990. These studies were performed against Japanese healthy volunteers and biochemical data were collected more than 10 weeks.
Desirable quality specifications for imprecision and bias were estimated using the following formulae, which was proposed by Fraser & Harris: Imprecision one-half of the average within-subject biological variation: 1/2CV_I. Bias one-quarter of the group (within-plus between-subject) biological variation: 1/4 (CV_G²+CV_I) ^1/2.
The results of quality specification were obtained very similar to those of Fraser's (Fraser CG, 1992) and Ricós' (Ricós C, 1999). These quality specifications are met with international requirement, and it will be possible to accept in laboratory medicine.
The quality specifications for imprecision can be used as the criteria of internal quality control, and those for bias can be also used as criteria of measurement values of control materials and the external quality assessment schemes.

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