Diagenics Limited,
South House 3,
Bond Avenue,
Bletchley,
Milton Keynes,
MK1 1SW

Registered in England
No. 2905701

Registered Office:
3 Warren Yard,
Warren Park,
Stratford Road,
Milton Keynes,
MK12 5NW

Human Diabetes

Description Insulin ELISA Iso-Insulin ELISA Ultrasensitive Insulin ELISA
Code No. 10-1113-01
10-1113-10
10-1128-01 10-1132-01
No. of tests 96/10x96 96 96
Measured antigen human insulin human insulin insulin lispro human insulin
Standards mU/l 0, 3, 10, 30,100, 200 0, 3, 10, 30,100 0, 0.15, 1, 3, 10, 20
Calibration 1st IRP 66/304 1st IRP 66/304 1st IRP 66/304
Incubations (mins) 60+15 60+15 60+30
Sample/sample volume serum/plasma 25ul serum/plasma 25ul serum/plasma 25ul
Sensitivity <1 mU/L <6 pmol/L 1 mU/L 6 pmol/L <0.07 mU/L
<0.42 pmol/L
Precision intra/inter cv% <4%, <4% <4%, <4% <6%, <4%
Hook 30000mU/L
180nmol/L
2000 mU/L
12 nmol/L
800000 mU/l
4800 nmol/l
Cross-reactions
  • C-peptide <0.01%
  • proinsulin <0.01%
  • insulin lispro <0.006%
  • h-proinsulin des (64-65) 98%
  • h-proinsulin split (65-66) 56%
  • h-proinsulin des (31-32) <0.5%
  • h-proinsulin split (32-33) <0.5%
  • C-peptide <0.1%
  • proinsulin 54%
  • insulin lispro 100%
  • h-proinsulin des (64-65) 66%
  • h-proinsulin split (65-66) 78%
  • h-proinsulin des (31-32) 58%
  • h-proinsulin split (32-33) 56%
  • C-peptide <0.01%
  • proinsulin <0.01%
  • insulin lispro <0.006%
  • h-proinsulin des (64-65) 98%
  • h-proinsulin split (65-66) 56%
  • h-proinsulin des (31-32) <0.5%
  • h-proinsulin split (32-33) <0.5%

Description C-peptide ELISA specific Ultrasensitive C-peptide ELISA Proinsulin ELISA
Code No. 10-1136-01 10-1141-01 10-1118-01
No. of tests 96 96 96
Measured antigen human C-peptide human C-peptide human proinsulin
Standards p/mol/L 0, 100, 330, 1300, 2500, 4000 0, 5, 16, 60, 120, 230 0, 3.3, 11, 44, 132
Calibration IRR 84/510 IRR 84/510 IRR 84/611
Incubations (mins) 60+60+15 60+60+30 60+60+15
Sample/sample volume serum/plasma/urine 25ul serum/plasma/urine 25ul serum/plasma 50ul
Sensitivity ≤15pmol/L
≤0.045ug/L
<1.5 pmol/L
≤0.0045ug/L
≤0.5 pmol/L
≤0.0045ug/L
Precision intra/inter cv% <5%, <5% <4%, <6% <5%, <6%
Hook 1750 nmol/L 36.6 nmol/L 80 nmol/lq
Cross-reactions
  • Insulin <0.0006%
  • proinsulin <1.8%
  • h-proinsulin des (64-65) 74%
  • h-proinsulin split (65-66) 10%
  • h-proinsulin des (31-32) 3%
  • h-proinsulin split (32-33) 2%
  • Insulin <0.0006%
  • proinsulin 3%
  • h-proinsulin des (64-65) 74%
  • h-proinsulin split (65-66) 10%
  • h-proinsulin des (31-32) 3%
  • h-proinsulin split (32-33) 2%
  • Insulin <0.03%
  • C-peptide <0.006%
  • h-proinsulin des (64-65) 84%
  • h-proinsulin split (65-66) 90%
  • h-proinsulin des (31-32) 95%
  • h-proinsulin split (32-33) 95%

Description Leptin ELISA Insulin Pre-Transplantation ELISA
Code No. 10-1199-01 10-1222-01
No. of tests 96 96
Measured antigen human leptin human insulin
Standards 0, 0.10, 0.25, 0.65, 1.50, 5.0 ng/ml 0, 3.0, 10.0, 30.0, 100.0, 200.0, mU/l
Calibration 1st IS NIBSC Code 97/594 1st IRP 66/304
Incubation (mins) 120+15 15+15
Sample/sample volume serum/plasma diluted 1/21 serum/plasma
Sensitivity 0.05 ng/ml 1.5 mU/l
Precision intra/inter cv% <3% <5.2% <3% <4.5%
Hook >100,000 ng/ml  
Cross-reactions
  • CNTF ≤0.05%
  • G-CSF ≤0.0004%
  • IL-6 ≤0.0002%
  • IL-11 ≤0.0008%
  • IL-12 ≤0.0004%
  • LIF ≤0.002%
  • Oncostatin ≤0.0002%
  • Rat Leptin 0.02%
  • Mouse Leptin ≤0.001%
  • Sheep Leptin 0.003%
  • C-peptide <0.01%
  • Proinsulin <0.01%
  • Proinsulin des (64-65) 98%
  • Proinsulin split (65-66) 56%
  • Proinsulin des (31-32) <0.5%
  • Proinsulin split (32-33) <0.5%
  • Insulin Lispro (Humalog®, Eli Lilly) <0.006%
  • Insulin aspart <0.006%
  • IGF-I <0.02%
  • IGF-II <0.02%
  • Rat insulin 0.7%
  • Mouse insulin 0.3%
  • Porcine insulin 374%
  • Sheep insulin 48%
  • Bovine insulin 31%

Description Glucagon ELISA Glicentin ELISA GLP-1 NL-ELISA
Code No. 10-1271-01 10-1273-01 10-1278-01
No. of tests 96 96 96
Measured antigen Human Glucagon Human Glicentin Amidated GLP-1
Measuring range 1.5—120 pmol/l 3—300 pmol/l 0.9 -940 pmol/l (2.8 - 2900 pg/ml)
Calibration WHO 1st IRP 69/194 in-house Against a highly purified, fully validated commercial preparation
Incubation (mins) overnight+15 60+60+15 120+15
Sample/sample volume Serum/plasma/cell culture 25ul Serum/plasma/cell culture 25ul 25ul
Sensitivity 1 pmol/l 3 pmol/l 0.65 pmol/l
Precision Total 7.5—9.5% Total 6—12.2% 2.5—11
Hook >8 umol/l >100 nmol/l >18.8 nmol/L
Cross-reactions
  • Oxyntomodulin 4.4%
  • Mini-Glucagon <0.1%
  • GLP-1 <0.3%
  • GLP-2 <0.3%
  • Glicentin 0.8%
  • Oxyntomodulin ND
  • Mini-Glucagon ND
  • GLP-1 ND
  • GLP-2 ND
  • Mouse Glicentin ND
  • Glucagon ND
  • Rat Glicentin 0.9%
  • GLP-1 (1-36) amide 88%
  • GLP-1 (7-36) amide 93%
  • GLP-1 (9-36) amide 100%
  • others - see Directions for use

Description Lispro NL_ELISA ELISA
Code No. 10-1291-01
No. of tests 96
Measured antigen Insulin Lispro
Measuring range 1 - 500 mU/l
Calibration EuPh Ref: Insulin Lispro CRS4
Incubation (mins) 60 + 60 + 10
Sample/sample volume Serum/plasma 10ul
C of D/LLOQ 0.36 mU/l  1.0 mU/l
Precision Total 3.0—7.7%
Hook None up to 10,000 mU/l
Cross-reactions

The following were not dectected:

  • Native human insulin
  • Native human proinsulin
  • Glargine
  • Glargine M1
  • Glargine M2
  • Degludec
  • Detemir
  • Insulin NPH
  • Aspart
  • Glulisine
  • Native Porcine insulin
  • Native Porcine proinsulin