Technical Assistance - Siemens IMMULITE 2000 C-Peptide Mode D'emploi

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(PST) = 0.94 (Serum) + 0.45 ng/mL
r = 0.99
n = 43
Means:
5.3 ng/mL (Serum)
5.6 ng/mL (Heparin)
5.4 ng/mL (PST)
(SST) = 0.99 (Plain tubes) + 0.15 ng/mL
r = 0.99
n = 42
Means:
5.1 ng/mL (Serum)
5.2 ng/mL (SST)
Method Comparison–Serum: The assay
was compared to IMMULITE 2000
C-Peptide (L2KPE) procedure on 89
serum samples. (Concentration range:
approximately 1.2 – 6.9 ng/mL. See graph
1.) By linear regression:
(IML 2000 L2KPEP) = 0.94 (IML 2000 L2KPE) –
0.30 ng/mL
r = 0.923
Means:
2.9 ng/mL (IMMULITE 2000 L2KPEP)
3.4 ng/mL (IMMULITE 2000 L2KPE)
Method Comparison–Urine: The assay
was compared to IMMULITE 2000
C-Peptide (L2KPE) procedure on 87 urine
samples. (Concentration range:
approximately 0.6 – 6.9 ng/mL. See graph
2.) By linear regression:
(IML 2000 L2KPEP) = 1.01 (IML 2000 L2KPE) –
0.33 ng/mL
r = 0.969
Means:
3.3 ng/mL (IMMULITE 2000 L2KPEP)
3.6 ng/mL (IMMULITE 2000 L2KPE)
References
1) Beischer W. Proinsulin and C-peptide in
humans. In: Fotherby K, Pal S, editors.
Hormones in Normal and Abnormal Human
Tissues. Vol 3. Berlin: Walter DeGruyter, 1983:
1-43. 2) Beyer J, Krause U, Cordes U. C-
peptide: its biogenesis, structure, determination
and clinical significance. Giornale Ital Chem Clin
1979;4 Suppl 1:9-22. 3) Bonser A, Garcia-Webb
P. C-Peptide measurement: methods and
clinical utility. CRC Crit Rev Clin Lab Sci
1984;19:297-352. 4) Gonen G, Rubenstein AH,
Horwitz DL, Blix PM. Clinical significance of C-
peptide. In: Baba S, Kaneko T, Yanaihara N,
editors. Proinsulin, Insulin, C-Peptide.
Amsterdam: Excerpta Medica, 1979: 246-53.
5) Horwitz D, et al. Proinsulin, insulin and C-
peptide concentrations in human portal and
peripheral blood. J Clin Invest 1975;55:1278-83.
6) Horwitz D, Kuzuya H, Rubenstein AH.
Circulating serum C-peptide. N Engl J Med
6
1976;295:207-9. 7) Polonsky KS, Rubenstein
AH. C-peptide as a measure of the secretion
and hepatic extraction of insulin; pitfalls and
limitations. Diabetes 1984;33:486-93.
8) Rendell M. Expanding clinical use of C-
peptide radioimmunoassay. Acta Diabetol Lat
1983;20:105-13. 9) Rubenstein AH, Kuzuya H,
Horwitz DL. Clinical significance of circulating C-
peptide in diabetes mellitus and hypoglycemic
disorders. Arch Intern Med 1977;137:625-32.
10) Turkington RW, Estkowski A, Link M.
Secretion of insulin or connecting peptide; a
predictor of insulin dependence of obese
diabetics'. Arch Intern Med 1982;142:1102-5.
11) Data on file. 12) National Committee for
Clinical Laboratory Standards. Procedures for
the collection of diagnostic blood specimens by
venipuncture; approved standard. 4th ed.
NCCLS Document H3-A4, Wayne, PA: NCCLS,
1998. 13) CLSI. Protocols for the Determination
of Limits of Detection and Limits of Quantitation;
Approved Guideline. CLSI document EP17-A
Vol. 24 (No. 34). CLSI, 940 West Valley Road,
Suite 1400, Wayne, Pennsylvania 19087-1898,
USA, 2004. 14) Evaluation of Precision
Performance of Quantitative Measurement
Methods; Approved Guideline-Second Edition.
CLSI document EP5-A2. CLSI, 940 West Valley
Road, Suite 1400 Wayne, Pennsylvania 19087-
1898, USA 2004. 15) Centers for Disease
Control. Update: Universal precautions for
prevention of transmission of human
immunodeficiency virus, hepatitis B virus and
other bloodborne pathogens in healthcare
settings. MMWR, 1988;37:377–82, 387–8.
16) Clinical and Laboratory Standards Institute
(formerly NCCLS). Protection of Laboratory
Workers From Occupationally Acquired
Infections; Approved Guideline - Third Edition.
Wayne, PA: Clinical and Laboratory Standards
Institute; 2005. NCCLS Document M29-A3.
17) Federal Occupational Safety and Health
Administration, Bloodborne Pathogens
Standard, 29 CFR 1910.1030.

Technical Assistance

In the United States, contact Siemens
Healthcare Diagnostics Technical
Services department. Tel: 877.229.3711.
Outside the United States, contact your
National Distributor.
www.siemens.com/diagnostics
The Quality System of Siemens Healthcare
Diagnostics Products Ltd. is certified to ISO
13485.
IMMULITE 2000 C-Peptide (PIL2KPEP-9, 2018-03-15)

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