BXC0382A BXC0382B BXC0382C For In Vitro Diagnostics Use Only

R1 1x40ml R1 2x40ml R1 4x40ml Lot Number

R2 1x10ml R2 2x10ml R2 4x10ml Catalogue Number
R4 1x1ml R4 1x1ml R4 1x1ml Storage Temperature

STORE AT 2-8°C Expiry Date (Year / Month)

CRP Warning, Read Enclosed Documents
PRODUCT CODE: BXC0382 INSTRUCTIONS FOR USE Instructions For Use
Manufactured By
FOR IN-VITRO DIAGNOSTIC USE ONLY

Precision:
CRP Mix well before first use and once weekly. Mean
Intra Assay – Within run
SD CV
TURBIDIMETRIC (WITH CALIBRATOR) Unopened kit components: Up to the expiration date at +2°C to +8°C Sample
Mg/l Mg/l %
Human Serum 9.42 0.235 2.55
Kit Contents: BXC0382A BXC0382B BXC0382C Sample: Human Serum 50.4 0.22 0.44
R1 Assay Buffer 1 x 40 ml 2 x 40 ml 4 x 40 ml Serum
R2 Antibody Reagent 1 x 10 ml 2 x 10 ml 4 x 10ml Serum stable for 7 days at 2-8oC. Inter Assay – Between Run
R4 Calibrator 1 x 1 ml 1 x 1 ml 1 x 1 ml Haemolysed or lipaemic samples are not suitable for testing. Mean SD CV
Sample
Intended Use: Centrifuge samples containing precipitate before performing Mg/l Mg/l %
Turbidimetric assay for the in vitro quantitative determination of CRP in Human Serum 9.149 0.162 1.77
human serum and plasma. Specimen: Human Serum 50.48 0.162 0.32
Collect serum using standard sampling tubes
Summary: Li-/Na- heparin, EDTA- or citrate plasma. Normal Values:
C-reactive protein is the classic acute phase protein to inflammatory Centrifuge samples containing precipitate before performing the
reactions. It is synthesized by the liver and consists of five identical assay.
polypeptide chains forming a five-membered ring of molar mass Up to 6 mg/l (0.6mg/dl)
120 000 daltons. CRP is the most sensitive of the acute phase reactants, These values are supplied as a guideline only.
Stability: 7 days at + 2°C to +8°C 3 months at - 20°C It is recommended that a laboratory establishes its’ own reference
and its concentration increases rapidly during inflammatory processes.
Complexed CRP activates the complement system beginning with Range
C1q. CRP then initiates opsonization and phagocytosis of invading Manual Procedure:
cells, but its main function is to bind and detoxify endogenous toxic Wavelength Temperature Cuvette Measurement Use on Automated Analysers:
substances produced as a result of tissue damage. Against This reagent is suitable for use on a range of automated analysers.
CRP assays are used to detect systematic inflammatory processes 540nm 37oC 1 cm light path Specific instructions for these applications are available on request
distilled water
(apart from certain types of inflammation such as SLE and ulcerative from your local distributor.
colitis). Pipette into cuvette as follows: For automated use we recommend a serum based calibrator to
eliminate any matrix bias which may be observed with the aqueous
Sample/Calibrator 5 μl
Reagent Concentration: standard.
R1(Assay Buffer) 800 μl
Tris/HCI Buffer pH 8.2 20 mmol/l Fortress CRP Calibrator cat. No BXC0324A
R2 (Latex Reagent) 200 μl
R1 Assay Buffer Detergent 0.1 %
Mix, read absorbance A1 immediately, incubate for 2 minutes at Quality Control:
Sodium Azide 0.95 g/l 37oC and read absorbance A2
Glycine Buffer pH pH 10.0 It is recommended that a laboratory uses normal and abnormal
R2 Antibody Latex particles coated with reference control sera to verify the performance of the procedure,
Calculation: both performance of the reagent and any instrumentation employed
Reagent Anti Human CRP ∆A = [(A2 – A1)] sample or calibrator in the determination. Results obtained should fall within the specified
Sodium Azide 0.95 g/l ∆A Sample x Calibrator concentration = CRP Conc. (mg/l) ranges.
R4 Calibrator Lot Specific ∆A Calibrator
Fortress CRP Control Level 1 & Level 2 Cat No BXC0326A & B or Fortress
Reagent Handling and Preparation: Linearity: ASO/CRP/RF Control BXC0645A or Fortress Protein Control Level 1 &
R1: Ready to use. The method is linear up to 150 mg/l Level 2 BXC0641A/BXC0642A
R2: Ready to use. Shake gently before use. Sample above this concentration should be diluted with 0.9% NaCl
R4: Ready to use (e.g. 1 + 1). Multiply the result by the appropriate factor (e.g. 2). Fortress QC materials of human source have been tested at donor
level for HbsAg Antigen, HIV1&2 antibodies and HCV antibody and
Sensitivity: found to be negative. However no test can offer complete assurance
The method will accurately measure CRP levels down to 2mg/l

Fortress Diagnostics Limited, Unit 2C Antrim Technology Park, Antrim, BT41 1QS (United Kingdom)
Tel: +44 (0) 2894 487676 | Fax: +44 (0) 2894 469933 | Website: www.fortressdiagnostics.com BXC0382 – CRP| Revision No.14 SEPT/16 | Page 1 of 2
to the absence of infectious diseases so all material should be handled
and disposed of as if it is potentially infectious.

Some common reasons for incorrect results can be:

 Wavelength used for the determination
 Light source
 Temperature
 Cleanliness, e.g of cuvettes used in measurements
 Bacterial contamination of reagent
 Reagent expiry
 Calibration frequency

Health & Safety:

This kit is designed for use by suitably qualified laboratory personnel
only. Exercise the normal precautions required for the handling of
laboratory reagents. Do not ingest the material. Dispose of material
according to local guidelines.

References:
1.Bablok W et al. General Regression Procedure for Method
Transformation. J Clin Chem Biochem 1988; 26:783-790
2.Eda S et al. Development of a new microparticle-enhanced
turbidimetric assay for C-reactive protein with superior features in
sensitivity and dynamic range. J Clin Lab Anal 1998:12:137-144.
3.Greiling H, Gressner AM ed. Lehrbuch der Klinischen Chemie und
Pathobiochemie, 3. Auflage. Stuttgart/New York: Schattauer, 1995:
1159-62

Fortress Diagnostics Limited, Unit 2C Antrim Technology Park, Antrim, BT41 1QS (United Kingdom)
Tel: +44 (0) 2894 487676 | Fax: +44 (0) 2894 469933 | Website: www.fortressdiagnostics.com BXC0382-CRP | Revision No. 14 SEPT/16 | Page 2 of 2