Samples with higher values must be diluted and the result multiplied by  Biorex Elevated Human Assayed Control

Control Cat No BXC0312B

the dilution actor. (10x5ml)

Sensitivity: Biorex QC materials of human source have been tested at donor level
Creatinine levels down to 14 µmol/l (0.15 mg/dl) can be accurately for HbsAg Antigen, HIV1&2 antibodies and HCV antibody and found to
measured using this method. be negative. However no test can offer complete assurance to the
absence of infectious diseases so all material should be handled and
Precision: disposed of as if it is potentially infectious.
Intra Assay – Within run

CREATININE
Creatinine conc(µmol/l) n CV% If results fall outside the acceptable range appropriate action as
76.7 20 1.65 determined by the laboratory’s internal quality procedures should be
448 20 0.48 taken. Some common reasons for incorrect results can be:
1. Wavelength used for the determination
PRODUCT CODE: MON0111 Creatinine conc(µmol/l
Inter Assay – Between Run
n CV%
2. Light source
3. Temperature
STORE AT ROOM TEMPERATURE UP TO 25°C 75.9 30 2.9 4. Cleanliness, e.g. of cuvettes used in measurements
454 30 1.6 5. Bacterial contamination of reagent
Interferences: 6. Reagent expiry
JAFFE (WITHOUT DEPROTEINISATION) Bilirubin & Haemoglobin at high levels will interfere with this method. 7. Calibration frequency
Antibiotics containing cephalosporin can give falsely elevated values. Health & Safety:
Kit Contents: MON0111B  Bilirubin: 20mg/dl This kit is designed for use by suitably qualified laboratory personnel
 Haemolysis: 500mg/dl only. Exercise the normal precautions required for the handling of
R1: NaOH 2 x 50 ml  Lipaemia: 2000mg/dl laboratory reagents. Do not ingest the material. Dispose of material
R2: Picric Acid 2 x 50 ml  Ascorbic Acid: 30mg/dl according to local guidelines.

Creatinine Clearance: References:

Intended Use: 1. Bartels, H., Bohmer, M.,(1972) Clin. Chem. Acta 37:193.
This product is intended for quantitative in-vitro determination of o mg creatinine/dl urine X ml urine 24 hrs [ml/min] 2. Schirmeister, J., H Willmann & H. Kiefer. (1964) Dtsch. Med. Wschr.
Creatinine in serum/plasma and urine. mg creatinine/dl serum x 1440 89:1018.
3. Tietz NW, Clincical Guide to Laboratory Tests, 3rd Edition.
Test Principle: Method Comparison: 4. Henry RJ et al Clincial Chemistry – Principles and Techniques.
Creatinine reacts with picric acid in an alkaline medium to form a A comparison of the Biorex Creatinine (y) with a commercial Harper & Row 11th Edition.
deep yellow complex. The amount of complex formed is directly obtainable assay (x) gave the following result:
proportional to the level of creatinine in the sample.  y =0.94x + 1.04; r = 0.999 For In Vitro Diagnostics Use Only

Clinical Significance: Normal Values: Lot Number

Increased creatinine levels usually indicate renal function impairment
Serum / Plasma Urine Catalogue Number
but would not be considered a sensitive indicator of early renal
disease. Plasma concentrations can be more sensitive to changes in Men 53-97 µmol/l (0.6-1.1 8.84-13.3
mg/dl) mmol/24 hrs Storage Temperature
glomerular function where a chronic renal disease state exists.
Urinary creatinine is only useful when performed as part of a creatinine Women 44-80 µmol/l (0.50-0.90
1 – 1.5 g/24 hrs Expiry Date (Year / Month)
clearance test. In these circumstances it is useful verification of the mg/dl)
completeness of a 24 hour urine collection. These values are supplied as a guideline only. It is recommended that
a laboratory establishes its own reference range.
Warning, Read Enclosed Documents
Reagent Concentration: Consult instructions for use
Sodium Hydroxide 0.32 mol/l Use on Automated Analysers:
Picric Acid 35 mmol/l This reagent is suitable for use on Biorex Monarch series and a range of Manufacturer
automated analysers. Specific instructions for these applications are
Reagent Handling and Preparation: available on request from our technical department. For automated CE Marking Conformité
All reagents are supplied ready to use. Stable to expiry date when use we recommend a serum based calibrator to eliminate any matrix
stored at room temperature (15-25°C).
Date of Manufacture
bias which may be observed with the aqueous standard.
 Biorex Calibration Serum cat. No BXC0321K/L/M
Sample:
 Serum, Heparinised Plasma or Urine Quality Control:
 For urine analysis dilute samples 1 + 49 with distilled water It is recommended that a laboratory uses normal and abnormal
reference control sera to verify the performance of the procedure,
both performance of the reagent and any instrumentation employed
Linearity: in the determination. Results obtained should fall within the specified
The method is linear up to a creatinine concentration of 2000 µmol/l ranges.
(22.7 mg/dl) in serum/plasma and 44 mmol/l (500 mg/dl) in urine.  Biorex Normal Human Assayed Control Cat No BXC0312A (10x5ml)

Biorex Diagnostics Limited, 9A Antrim Technology Park, Antrim, BT41 1QS (United Kingdom)
Tel: +44 (0) 2894 487676 | Fax: +44 (0) 2894 469933 | Website: www.Biorexdiagnostics.com MON0111 – CREATININE | Revision No. 16 JAN/23 | Page 1 of 2
CREATININE APPLICATION FOR MONARCH 240

Biorex Diagnostics Limited, 9A Antrim Technology Park, Antrim, BT41 1QS (United Kingdom)
Tel: +44 (0) 2894 487676 | Fax: +44 (0) 2894 469933 | Website: www.Biorexdiagnostics.com MON0111 – CREATININE | Revision No. 16 FEB/23 | Page 2 of 2