Calculations of Results

Plot calibrator concentrations against the corresponding ∆A values using graph paper. The concentration of CRP
(C-reactive protein) in the sample is obtained by reading of a value from the calibration curve. Do not attempt to
extrapolate above or below the range of the calibrators.
Quality Control
Fortress CRP Control (Cat.No:CRP/2 for high level, CRP/1 for low level). Quality control materials are intended for
ISO 13485 accredited company use only to monitor accuracy and precision. The values for these controls should fall within specified limits. If the
CRP( High Sensitivity) control values fall outside these ranges and repetition precedes technical error the following steps should be taken:
1. Check wavelength setting and light source.
2. Ensure that cuvettes are not dirty and that all glassware in use has been cleaned thoroughly.
BXCF383A 3. Check water, contaminants, ie. bacterial growth, may contribute to inaccurate results.
4. Check that assay temperature is accurate.
5. Ensure that reagent pack contents are still within expiry date.
R1: 3 x 20 ml/ R2: 1 x 20 ml Reference Ranges
Serum: 0- 0.6 mg/dl.
STORE AT 2-8oC It is recommended that each laboratory should assign its own normal range as this is dependent upon
geographical location.
FOR IN- VITRO DIAGNOSTICS USE ONLY
Specific Performance Characteristics Linearity
Intended Use The assay is linear up to 32.0 mg/dl. If sample above this
For the in vitro quantitative determination of CRP in serum or plasma samples. concentration should be diluted with 0.9% NaCl and reassay. Multiply the result by dilution factor.
Precision
Clinical Significance:
The CV of the test should be ≤5%
CRP (C-reactive protein) is an acute phase protein whose concentration is seen to increase as a result of the
inflammatory process, most notably in response to pneumococcal (bacterial) infectious, histolytic disease and a
variety of disease states. Originally discovered by Tillet et al. in 1930 in patient sera with acute infection, CRP has now Intra precision
come to be used as a marker or general diagnostic indicator of infections and inflammation, in addition to serving as a N=20 Level 1 Level 2
monitor of patient response to therapy and surgery. Furthermore, regular measurements of CRP in infants can be a
useful aid in the early diagnosis of infectious disease. Mean
(mg/dL) 0.82 2.47
Principle SD 0.01 0.03
When an antigen-antibody reaction occurs between CRP in a sample and anti-CRP antibody which has been sensitized to
latex particles, agglutination results. This agglutination is detected as an absorbance change (570 nm), with the magnitude CV 1.07% 1.28%
of the change being proportional to the quantity of CRP in the sample. The actual concentration is then determined by
interpolation from a calibration curve prepared from calibrators of known concentration.
Sensitivity
Specimen Collection The minimum detectable concentration of CRP with an acceptable level of precision was determined as 0.02 mg/dl.
Serum or plasma sample.
CRP remains stable in serum for at least 3 days at 15-25℃, 6 days at 2-8℃or 6 months at -20℃. Interference
The following analytes were tested up to the levels indicated and found not to interfere:
Reagent Composition Hemoglobin: 500 mg/dl
Reagent 1 Bilirubin: 30 mg/dl
Amino acetic acid buffer Intralipid 1000 mg/dl
Reagent 2
0.20w/v% latex particles of sensitized CRP antibody liquid Correlation
This method (Y) was compared with another commercially available method (X) and the following
Stability And Preparation Of Reagents linear regression equation obtained;
All reagents are ready to use. Y=0.991X-0.036, with a correlation coefficient of 0.998. 110 patient samples were analyzed.
Stable up to the expiry date when stored at 2-8℃. Safety Precautions And Warnings
1. For in vitro diagnostic use only. Do not pipette by mouth. Exercise the normal precautions required for handling
Calibration laboratory reagents.
CRP calibrator (Cat.No: CRP). 2. Reagent contains Sodium Azide. Avoid ingestion or contact with skin or mucous membranes. In case of skin

Fortress Diagnostics Limited, Unit 2C Antrim Technology Park, Antrim, BT41 1QS (United Kingdom)
Tel: +44 (0) 2894 468786 | Fax: +44 (0) 2894 469933 | Website: www.fortressdiagnostics.com
 contact, flush affected area with copious amounts of water. In case of contact with eyes or if ingested, seek -3.3 lower -3.3 lower -3.3 lower -3.3 lower -3.3 lower
immediate medical attention. Prozone check
3. Sodium Azide reacts with lead and copper plumbing, to form potentially explosive azides. When disposing of limit limit limit limit limit
such reagents flush with large volumes of water to prevent azide build up. Exposed metal surfaces should be
cleaned with 10% sodium hydroxide. Calibration Multi-point Multi-point Multi-point Multi-point Multi-point
4. Specimens should be treated as potentially infectious (HIV, Hepatitis B virus, Hepatitis C virus, etc.) and handled method
with appropriate caution.
5. Reagents with different lot numbers should not be interchanged or mixed. Deflection check 3.3 3.3 3.3 3.3 3.3

Discreteness
MONARCH Series Auto-Chemistry analyzers (with barcode reagents) 0.1 0.1 0.1 0.1 0.1
check

Sensitivity check 0.006 0.006 0.006 0.006 0.006

Model Monarch-240 Monarch-400 Monarch-600 Monarch-800 Monarch-Module-1000
Blank horizontal
Item CRP-HS CRP-HS CRP-HS CRP-HS CRP-HS -3.3~3.3 -3.3~3.3 -3.3~3.3 -3.3~3.3 -3.3~3.3
check
Unit mg/dl mg/dl mg/dl mg/dl mg/dl
Linearity range 0 ~ 32 0 ~ 32 0 ~ 32 0 ~ 32 0 ~ 32
2 point 2 point 2 point 2 point 2 point
Method end end end end end

Time 20 10 10 10 9
Photometric
20~31 20~31 20~31 20~31 20~31
point

Main
570 570 570 570 570
wavelength

Sub wavelength 800 800 800 800 800

Reagent R1/T1 150 150 150 150 150

R2/T2 50 -- 50 -- 50

R3/T3 -- 50 -- 50 --

R4/T4 -- -- -- -- --

Normal volume
2 2 2 2 2
of serum sample

Absorbance limit 2 2 2 2 2

Positive Positive Positive Positive Positive

Reaction type
reaction reaction reaction reaction reaction

Fortress Diagnostics Limited, Unit 2C Antrim Technology Park, Antrim, BT41 1QS (United Kingdom)
Tel: +44 (0) 2894 468786 | Fax: +44 (0) 2894 469933 | Website: www.fortressdiagnostics.com