A novel ultra-sensitive enzyme immunoassay for soluble human insulin receptor ectodomain and its measurement in urine from healthy subjects and patients with diabetes mellitus.
OBJECTIVE
For the early identification of patients at risk of developing diabetes mellitus, and to prevent the onset of diabetes by performing dietary counseling and exercise guidance, we have developed an ultra-sensitive immune complex transfer enzyme immunoassay (ICT-EIA) to measure soluble human insulin receptor ectodomain (sIRalpha) in urine which is collected non-invasively.


METHODS
We developed ICT-EIA for sIRalpha and measured urinary sIRalpha from 106 healthy volunteers, 35 obese volunteers and 42 patients with diabetes.


RESULTS
The detection limit of ICT-EIA (0.04 pg/mL), using a urine sample of as little as 100 microL, was a few hundred-fold higher than that of conventional ELISA. Using ICT-EIA, the urinary sIRalpha level in patients with diabetes (9.7+/-20.1 pg/mg creatinine) was significantly higher than those in healthy volunteers (1.4+/-0.9; P<0.001).


CONCLUSIONS
ICT-EIA for sIRalpha may be useful as a good marker for evaluating diabetes risk.
Umehara
Asako
A
Human Life Science, Tokushima Bunri University, Tokushima 770-8514, Japan.
Nishioka
Mamiko
M
Obata
Toshiyuki
T
Ebina
Yousuke
Y
Shiota
Hiroshi
H
Hashida
Seiichi
S
D000293:Adolescent; D000328:Adult; D015703:Antigens, CD / Q000097:blood / Q000276:immunology / Q000652:urine*; D001665:Binding Sites / Q000276:immunology; D001786:Blood Glucose / Q000032:analysis; D002138:Calibration; D002940:Circadian Rhythm; D003920:Diabetes Mellitus / Q000175:diagnosis / Q000652:urine*; D005260:Female; D005951:Glucose Tolerance Test; D006801:Humans; D007124:Immunoenzyme Techniques / Q000379:methods*; D007328:Insulin / Q000652:urine; D020738:Leptin / Q000652:urine; D008297:Male; D008875:Middle Aged; D009765:Obesity / Q000175:diagnosis / Q000652:urine; D011972:Receptor, Insulin / Q000097:blood / Q000276:immunology; D015203:Reproducibility of Results; D052243:Resistin / Q000652:urine; D012680:Sensitivity and Specificity; D055815:Young Adult
D015703:Antigens, CD; D001786:Blood Glucose; D007328:Insulin; D020738:Leptin; D052243:Resistin; C435941:INSR protein, human; D011972:Receptor, Insulin