Creatinine FS*

Order Information 2. High homogentisic acid concentrations in urine samples lead

Cat. No. Kit size
to false results.
1 1711 99 10 021 R1 5 x 20 mL + R2 1 x 25 mL 3. In very rare cases, samples of patients with gammopathy might
1 1711 99 10 026 R1 5 x 80 mL + R2 1 x 100 mL give falsified results [3].
1 1711 99 10 023 R1 1 x 800 mL + R2 1 x 200 mL 4. Eltrombopag medication leads to falsely low or high results in
1 1711 99 10 704 R1 8 x 50 mL + R2 8 x 12.5 mL patient samples.
1 1711 99 10 917 R1 8 x 60 mL + R2 8 x 15 mL 5. In case of product malfunction or altered appearance that could
1 1711 99 90 314 R1 10 x 20 mL + R2 2 x 30 mL affect the performance, contact the manufacturer.
Intended Use 6. Any serious incident related to the product must be reported to
the manufacturer and the competent authority of the Member
Diagnostic reagent for quantitative in vitro determination of State where the user and/or patient is located.
creatinine in human serum, heparin plasma or urine on automated 7. Please refer to the safety data sheets (SDS) and take the
photometric systems. necessary precautions for the use of laboratory reagents. For
diagnostic purposes, the results should always be assessed
Summary with the patient’s medical history, clinical examinations and
Creatinine is a waste product excreted by the kidneys mainly by other findings.
glomerular filtration. The concentration of creatinine in plasma of a 8. For professional use only.
healthy individual is fairly constant, independent from water intake,
exercise and rate of urine production. Therefore, increased plasma Waste Management
creatinine values always indicate decreased excretion, i.e. impaired Refer to local legal requirements for chemical disposal regulations
kidney function. Creatinine clearance is a good indicator for the as stated in the relevant SDS to determine the safe disposal.
glomerular filtration rate (GFR) which allows better detection of Warning: Handle waste as potentially biohazardous material.
kidney diseases and monitoring of renal function. For this purpose, Dispose of waste according to accepted laboratory instructions and
creatinine is measured simultaneously in serum and urine collected procedures.
over a defined time period. [1,2]
Reagent Preparation
Method
The reagents are ready to use.
Kinetic test without deproteinization according to the Jaffé method
Creatinine forms a colored orange-red complex in an alkaline picrate Materials Required
solution. The difference in absorbance at fixed times during General laboratory equipment
conversion is proportional to the concentration of creatinine in the
sample. Specimen
Creatinine + Picric acid ────► Creatinine picrate complex Human serum, heparin plasma or urine
Reagents Only use suitable tubes or collection containers for specimen
Components and Concentrations collection and preparation.
R1: Sodium hydroxide 0.2 mol/L When using primary tubes, follow the manufacturer's instructions.
R2: Picric acid 20 mmol/L
Stability in serum/plasma [4]:
Storage and Stability 7 days at 4 – 25°C
Reagents are stable up to the date of expiry indicated on the kit, if 3 months at –20°C
stored at 2 - 25°C and contamination is avoided. Do not freeze and
protect from light. Stability in urine [4]:
2 days at 20 – 25°C
The in-use stability of the reagent is 18 months.
6 days at 4 – 8°C
6 months at –20°C
Warnings and Precautions
1. Components contained in Creatinine FS are classified Dilute urine 1 + 49 with dist. water; multiply the result by 50.
according to EC regulation 1272//2008 (CLP) as follows: TruLab Urine controls must be prediluted the same way as patient
samples.
Reagent 1: Warning. H290 May be corrosive to
metals. H315 Causes skin irritation. H319 Causes Only freeze once. Discard contaminated specimens.
serious eye irritation. P234 Keep only in original
packaging. P264 Wash hands and face thoroughly Assay Procedure
after handling. P280 Wear protective Basic settings for BioMajesty® JCA-BM6010/C
gloves/protective clothing/eye protection. Wavelength 505/571 nm
P302+P352 IF ON SKIN: Wash with plenty of Temperature 37°C
water/soap. P305+P351+P338 IF IN EYES: Rinse Measurement Kinetic
cautiously with water for several minutes. Remove Sample/Calibrator 5.0 µL
contact lenses, if present and easy to do. Continue Reagent 1 80 µL
rinsing. P332+P313 If skin irritation occurs: Get Reagent 2 20 µL
medical advice/attention. P337+P313 If eye irritation Addition reagent 2 Cycle 19 (286 s)
persists: Get medical advice/attention. P390 Absorb Absorbance Cycle 24/32 (354 s/464 s)
spillage to prevent material damage Calibration Linear
Reagent 2: Warning. H290 May be corrosive to
metals. P234 Keep only in original packaging. P280
Wear protective gloves/protective clothing/eye
protection. P390 Absorb spillage to prevent material
damage.

Creatinine FS – Page 1 844 1711 10 02 42 December 2021/2

Calculation Performance Characteristics
With calibrator Data evaluated on BioMajesty® JCA-BM6010/C
Serum/Plasma Exemplary data mentioned below may slightly differ in case of
deviating measurement conditions.
ΔA Sample
Creatinine [mg/dL] = x Conc. Cal. [mg/dL]
ΔA Cal. Measuring range up to 14 mg/dL.
Urine When values exceed this range samples should be diluted
1 + 1 with NaCl solution (9 g/L) and the result multiplied by 2.
ΔA Sample Limit of detection** 0.1 mg/dL
Creatinine [mg/dL] = x Conc. Cal. [mg/dL] x 50
ΔA Cal.
Interfering substance Interferences
Creatinine Clearance [mL/min/1.73 m2] [5] ≤ 10% up to
Ascorbic acid 30 mg/dL
mg Creatinine/ 100 mL Urine x mL Urine
= Bilirubin (conjugated) 3 mg/dL
mg Creatinine/ 100 mL Serum x min Urine collection time
Bilirubin (unconjugated) 1.5 mg/dL
The calculated creatinine clearance refers to the average body
surface of an adult (1.73 m2). Hemoglobin 600 mg/dL
Conversion Factor Lipemia (triglycerides) 1800 mg/dL
Creatinine [mg/dL] x 88.4 = Creatinine [µmol/L] For further information on interfering substances, refer to the literature [8-
Creatinine [mg/dL] x 0.0884 = Creatinine [mmol/L] 10].

Precision (Serum/Plasma)
Calibrators and Controls Within run (n=20) Sample 1 Sample 2 Sample 3
DiaSys TruCal U is recommended for calibration. Calibrator values
for the compensated method have been made traceable to the NIST Mean [mg/dL] 0.66 1.52 4.70
(National Institute for Standardization) Standard Reference Material CV [%] 1.49 1.26 0.70
SRM 967 using level 1 and 2 and, therefore, to GC-IDMS (gas Between day (n=20) Sample 1 Sample 2 Sample 3
chromatography - isotope dilution mass spectrometry). Creatinine
Mean [mg/dL] 0.64 1.50 4.65
Standard FS may be used alternatively for calibration. Use DiaSys
TruLab N and P or TruLab Urine Level 1 and Level 2 controls for CV [%] 3.07 2.05 0.94
internal quality control. Quality control must be performed after
Method comparison (Serum/Plasma; n=98)
calibration. Control intervals and limits have to be adapted to the
individual requirements of each laboratory. Results must be within Test x DiaSys Creatinine FS
the defined ranges. Follow the relevant legal requirements and Test y Competitor Creatinine
guidelines. Each laboratory should establish corrective action in
case of deviations in control recovery. Slope 1.03
Cat. No. Kit size Intercept 0.029 mg/dL
TruCal U 5 9100 99 10 063 20 x 3 mL Coefficient of correlation 0.999
5 9100 99 10 064 6 x 3 mL
TruLab N 5 9000 99 10 062 20 x 5 mL Precision (Urine)
5 9000 99 10 061 6 x 5 mL Within run (n=20) Sample 1 Sample 2 Sample 3
TruLab P 5 9050 99 10 062 20 x 5 mL Mean [mg/dL] 27.8 58.3 107
5 9050 99 10 061 6 x 5 mL
TruLab Urine Level 1 5 9170 99 10 062 20 x 5 mL CV [%] 1.03 0.63 0.67
5 9170 99 10 061 6 x 5 mL Between day (n=20) Sample 1 Sample 2 Sample 3
TruLab Urine Level 2 5 9180 99 10 062 20 x 5 mL Mean [mg/dL] 35.4 60.5 123
5 9180 99 10 061 6 x 5 mL
CV [%] 2.74 2.13 1.81
Creatinine 1 1700 99 10 030 6 x 3 mL
Standard FS Method comparison (Urine; n=99)
Test x DiaSys Creatinine FS
Compensated Method
Test y Competitor Creatinine
Picric acid which forms the colored complex reacts unspecifically
with interfering serum components, so-called pseudo-creatinines. Slope 0.957
This leads to falsely elevated creatinine values in serum and plasma Intercept 0.113 mg/dL
samples especially in the low measuring range. To compensate
these interferences, the calibrator value for the compensated Coefficient of correlation 0.999
method indicated in the value sheet of TruCal U has to be used for ** lowest measurable concentration which can be distinguished from zero;
calculation. Additionally, 0.3 mg/dL has to be subtracted from the mean + 3 SD (n = 20) of an analyte free specimen.
calculated creatinine value [6,7]. For use of the compensated
method, calibration with the calibrator TruCal U is strictly
recommended. The method is applicable only for serum and plasma
samples. The compensated method is traceable to GC-IDMS.

Creatinine FS – Page 2 844 1711 10 02 42 December 2021/2

Reference Range Literature
Serum/Plasma, Jaffé-method not compensated 1. Newman DJ, Price CP. Renal function and nitrogen
metabolites. In: Burtis CA, Ashwood ER, editors. Tietz
mg/dL µmol/L
Textbook of Clinical Chemistry. 3rd ed. Philadelphia: W.B
Adults [1]
Saunders Company; 1999. p. 1204-1270.
Women 0.6 – 1.1 53 – 97
2. Thomas L. Clinical Laboratory Diagnostics. 1st ed. Frankfurt:
Men 0.7 – 1.3 62 – 115
TH-Books Verlagsgesellschaft; 1998. p. 366-74.
Children [2,11]
3. Bakker AJ, Mücke M. Gammopathy interference in clinical
Neonate 0.5 – 1.2 44 – 106
chemistry assays: mechanisms, detection and prevention.
Infant 0.4 – 0.7 35 – 62
ClinChemLabMed 2007;45(9):1240-1243.
Child 0.5 – 1.2 44 – 106
4. Guder WG, Zawta B. Recommendations of the Working group
Serum/Plasma, Jaffé-method compensated on Preanalytical Quality of the German Society for Clinical
Chemistry and the German Society for Laboratory Medicine:
mg/dL µmol/L
The Quality of Diagnostic Samples. 1st ed Darmstadt: GIT
Adults [6]
Verlag 2001; p. 24-5,50-1.
Women 0.5 – 0.9 44 – 80
5. Junge W, Wilke B, Halabi A, Klein G. Determination of
Men 0.7 – 1.2 62 – 106
reference intervals for serum creatinine, creatinine excretion
Children [12]
and creatinine clearance with an enzymatic and a modified
Neonate 0.24 – 1.04 21 – 92
Jaffé method. Clin Chim Acta 2004; 344: 137-148.
Infant 0.17 – 0.42 15 – 37
6. Mazzachi BC, Peake MJ, Ehrhardt V. Reference Range and
Child 0.24 – 0.87 21 – 77
Method Comparison Studies for Enzymatic and Jaffé Creatine
24h urine [1] Assays in Plasma and Serum and Early Morning Urine. Clin.
Women 11 – 20 mg/kg/24h 97 – 177 µmol/kg/24h Lab. 2000; 46: 53-55.
Men 14 – 26 mg/kg/24h 124 – 230 µmol/kg/24h 7. Swanson AF, Swartzentruber M, Nolen PA et al. Multicenter
Evaluation of the Boehringer Mannheim Compensated, Rate-
Albumin/creatinine ratio (early morning urine) [13]:
Blanked Creatinine/Jaffe Application on BM/Hitachi Systems.
< 30 mg/g Creatinine
Advances in Clinical Diagnostics. 1993. Boehringer Mannheim
Creatinine clearance [2] Corporation.
Women 95 – 160 mL/min/1.73 m2 8. Young DS. Effects of Drugs on Clinical Laboratory Tests. 5th
Men 98 – 156 mL/min/1.73 m2 ed. Vol. 1 and 2. Washington, DC: The American Association
Each laboratory should check if the reference ranges are for Clinical Chemistry Press 2000.
transferable to its own patient population and determine own 9. Young DS. Effects on Clinical Laboratory Tests - Drugs
reference ranges if necessary. Disease, Herbs & Natural Products,
https://clinfx.wiley.com/aaccweb/aacc/, accessed in January
2021. Published by AACC Press and John Wiley and Sons,
Inc.
10. Sonntag O, Scholer A. Drug interference in clinical chemistry:
recommendation of drugs and their concentrations to be used
in drug interference studies. Ann Clin Biochem. 2001
Jul;38:376-85.
11. Soldin SJ, Brugnara C, Wong EC, eds. Pediatric Reference
Intervals. 6th ed. AACC Press, 2007: p. 77-78.
12. Schlebusch H, Liappis N, Klein G. Ultrasensitive CRP and
Creatinine: Reference intervals from infancy to childhood. Clin
Chem Lab Med. 2001; 39 Special supplement pp S1-S448;
May 2001. PO-T042.
13. Dati F, Metzmann E. Proteins-Laboratory testing and clinical
use. 1st ed. Holzheim: DiaSys Diagnostic Systems; 2005: p.
93.
Additions and/or changes in the document are highlighted in grey.
For deletions, please refer to the customer information for the
corresponding edition number of the package inserts.
DiaSys Diagnostic Systems GmbH
Alte Strasse 9 65558 Holzheim
Germany
www.diasys-diagnostics.com

* Fluid Stable

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