C-REACTIVE PROTEIN

CRP (Quantitative Test) 1 × 50 ml

Quantitative determination of C-reactive protein (CRP) in Serum by means of lipaemic sera and turbid frozen serum samples must be cleared with a delipidating
particle-enhanced turbidimetric immunoassay. agent. Delipidation of samples do not affect the results of CRP in serum samples.
The cleared patient serum sample must be used on the same day, as turbidity may
Only for in vitro use in clinical laboratory (IVD). reoccur.
Clinical Significance Procedure
C- reactive protein (CRP) is one of the acute phase proteins being synthesised by
hepatocytes. The serum concentration of CRP increases during acute stages of 1. Bring the working reagent and the photometer (cuvette holder) to 37ºC.
diverse diseases associated with inflammation and tissue injury. Elevated CRP has 2. Assay conditions:
been demonstrated in nearly all bacterial and fungal infections. In addition, it has Wavelength: . . . . . . . . . . . . . . . . . .540 nm (530-550)
been shown to be increased in other diseases as neoplasia, and rheumatic diseases Temperature: . . . . . . . . . . . . . . . . . . . . . . . . . . 37ºC
as well as in major surgery. Cuvette light path: . . . . . . . . . . . . . . . . . . . . . . .1 cm
The diagnosis usefulness of CRP is based on the velocity and on the magnitude of 3. Adjust the instrument to zero with distilled water.
its increase. Serum concentrations are raised within hours of disease onset and the 4. Pipette into a cuvette:
increase can be as much 2000-fold. A rapid fall of CRP levels indicates recovery. Working Reagent (μL) - 500
Principle Calibrator or sample (μL) - 5
This CRP test is based upon the reactions between C reactive protein (CRP) and 5. Mix and read the absorbance immediately (A1) and after 2 minutes (A2) of the sample
latex-covalently bound antibodies against human CRP. CRP values are determined addition.
photometrically.
Reagents Calculation
Each CRP kit contains: Plot the calibration curve and the sample concentration is obtained by interpolation
A.- Buffer - 45 mL of TRIS buffer, pH: 6.5, and 0.09 % sodium azide as preservative. the sample absorbance (A2-A1) in the calibration curve.
B.- Latex reagent – 5 mL of Polystyrene particles (0.5%) coated with antibodies anti- If is an one point calibration:
human-CRP serum in a glycine buffer (0.1 M, pH: 8.2), containing NaCL (0.15 M) (A2 - A1)Sample – (A2 - A1)Blank
and bovine serum albumin (0.5%). Preservative: Sodium azide 0.075% _____________________________ x Calibrator Concentration
C.- Calibrator – 1 mL. Human - based reference fluid. Preservative: sodium azide, (A2 - A1)Calibrator – (A2 - A1)Blank
0.075 %. All raw materials of human origin used in the manufacture of this product
showed no reactivity when tested for HBsAg, anti-HIV-1/2 and HCV with Reference Values
commercially available test methods. However, this product should be handled as Adults : Upto 6 mg/L
though capable of transmitting infectious diseases New borns up to 3 weeks: <4.1 mg/L
Reagent Preparation Infants and Children : <2.8 mg/L
Working Reagent is prepared with 1 part of Latex Reagent and 9 parts of Buffer Each laboratory should establish an expected range for the geographical area in
Reagent. Prepare a fresh WR based on its workload. Shake gently the reagents which it is located.
before pipetting. Reagent Performance
Stability Linearity
Reagents in the original vial is stable to the expiration date on the vial label when The range interval for the multipoint calibration method is from 0 to 90 mg/L.
capped and stored at +2 - +8ºC. Immediately following the completion of an assay With this method you can use the one point calibration procedure using a
run, the reagent vial should be capped until next use in order to maximize curve calibrator with dilutions. One point calibration is linear at least up to 75 mg/L.
stability. Once opened the reagent can be used within 1 month if stored tightly closed When values exceed the range the samples should be diluted with saline solution
at +2 - +8ºC after use. Do not freeze reagents. and the result should be multiplied by the appropriated factor.
The CRP latex reagent should have a white, turbid appearance free of granular Sensitivity
particulate. Visible agglutination or precipitation may be a sign of deterioration, and Calculating the mean plus 3SD of twenty replicates of zero standard resulted in a
the reagent should be discarted. lower limit of detection less than 2 mg/L.
The CRP buffer reagent should be clear and colourless. Any turbidity may be sign of Specificity
deterioration and reagent should be discarted. The assay is specific for CRP determination. There is no significant interference
It is recommended that each Laboratory prepares a fresh Working Reagent by bilirrubin, haemoglobin, or rheumatoid factor or Intralipid (up to 0.5 %). Other
based on its workload. substances can interfere. For a comprehensive review of interfering substances,
refer to the publication by Young.
Calibration Curve and Controls Prozone Effect
* One Point Calibration by diluting high level calibrator with saline by 1+1 The system did not show prozone phenomenon at least up to 430 mg/L.
Analytical Range up to 90 mg/L. Assay Precision
Intra-assay coefficients of variation (CV) for three samples (CRP values ranging
Calibrator 1 100 µl of CRP Calibrator* from 8 to 33 mg/L) were between 2.8 and 4.2 %. Inter-assay CVs were between
Calibrator 2 100 µl of Calibrator 1 + 100 µl of Saline Solution 3.9 and 4.6 %.
Calibrator 3 100 µl of Calibrator 2 + 100 µl of Saline Solution Method Comparison
Calibrator 4 100 µl of Calibrator 3 + 100 µl of Saline Solution 25 samples were correlated with a nephelometric commercial procedure. When
Calibrator 5 100 µl of Saline Solution comparing the results by lineal regression the result was: y = 1.08 x – 3.4 and
(*) See values on the label or on the insert. Multiply by the r=0,9916
appropriate factor.
Analytical characteristics have been obtained in a single experiment in a
For quality control use a suitable control material. The control intervals and limits conventional spectrophotometer. Therefore, the data expressed in the present
must be adapted to the individual laboratory requirements. Values obtained should document should be interpreted as a guide example.
fall within established limits. Each laboratory should establish corrective measures to Test Parameters
be taken if values fall outside the limits. Control must be assayed and evaluated as Mode Fixed Time Kinetic
for patient samples. Wavelength (nm) 540
Precautions Sample Volume (µl) 5
For in vitro diagnostic use only. Do not pipette by mouth. Reagents containing Working Reagent Volume (µl) 500
sodium azide must be handled with precaution. Sodium azide can form explosive Lag Time (A1) (Sec.) 5
azides with lead and copper plumbing. Since absence of infectious agents cannot be Measuring Time (A2) (Sec.) 120
proven, all specimens and reagents obtained from human blood should always be Calibrator Conc. (IU/mL) As on vial
handled with precaution using established good laboratory practices. Disposal of all Reaction temperature (° C) 37
waste material should be in accordance with local guidelines. As with other Reaction Direction Increasing
diagnostic tests, results should be interpreted considering all other test results and Normal Low 0
the clinical situation of the patient. Normal High 6
Specimens Blank with Distilled Water
Fresh or deep frozen serum. CRP remain stable for 8 days at +2 to +8ºC. If the test Units mg/L
should be performed later, it is recommended to freeze the serum. Avoid successive Linearity Limit Upto 90 (Multipoint calibration)
freezing and thawing. Discard haemolysed or contaminated samples. Heavily Upto 75 (One point calibration)
Literatures
Hokama Y, Nakamura RM. C-Reactive protein: current status and future perspectives. J Clin Lab
Anal 1987; 1: 15-27
Hessian PA, Palmer DG. The presence and possible significance of C-Reactive protein in
rheumatoid inflammation. J Rheumatol 1985 1985; 12:871-5.
Okamura JM, Miyagi JM, Terada K, Hokama Y. Potential clinical applications of C -reactive protein. Manufactured by: Peerless Biotech Pvt. Ltd.,
J Clin Lab Anal 1990; 4:231-5. Marketed By: Euro Diagnostic Systems Pvt. Ltd.,
Müller M, Mierau R, Wohltmann D. Interference of IgM rheumatoid factor with nephelometric
Creactive # 99 & 100, Nehru Nagar Industrial Estate, 2nd Link Street,
protein determinations. J Immunol Methods 1985; 80: 77-90. Kottivakkam, Chennai -600041 Phone:+91-44-24541688Email:
Young DS. Effects of Drugs on Clinical Laboratory Test. 5th Edition, AACC Press, 2000. admin@peerlessbio.com, www.peerlessbio.com
Passing H, Bablok W. A new biometrical procedure for testing the equality of measurements from
two analytical methods.
Application of linear regression procedures for method comparison studies. Part I. J Clin Chem Clin
Biochem 1983; 21:709-20.
Sonderdruck aus DG Klinische Chemie Mitteilungen 1995; 26: 207 – 224

CRP Calibrator (C Reactive Protein Calibrator)

Intended use
The CRP calibrator is used for making the calibration curve.
Summary
Contains 1 liquid calibrator. This product has been standardized against the CRM 470 international standard.
Reagent: contents and concentrations
Reactive components: C reactive protein (human).
Additives: stabilizers, preservatives.
This product is supplied in vials with 1 ml. The concentration is lot-specific.
Precautions and warnings
For in vitro diagnostic use.
This product has been prepared exclusively from the blood of donors tested individually and found by FDA approved methods
to be free from HbsAg and antibodies to HIV and HCV. However, as no testing method can rule out the risk of potential
infection with certainty, the product must be handles just as carefully as patient specimens. In the event of exposure the
directives of the responsible health authorities should be followed.
Handling
Ready for use.
Stability
Store at +2…+8ºC.
Stability: unopened, up to the stated expiration date.
Testing procedure
Materials provided: Calibrator
Additional materials: Reagents and analysers, general laboratory equipment and solution saline.
Assay
Follow the instructions of the operator’s manual to calibration.

Lot Expiry Date Concentration Units

mg/L

Significados de los símbolos indicados en las etiquetas.Explanation of symbols used on labelling. Explication des symbols figurant sur les etiquettes. Spiegazione dei simboli utilizzati sull’eticheta. Significado dos símbolos indicados nas etiquetas.
Erläuterung der symbole auf den etiketten.

LOT IVD REF REAG CAL Buffer LYOPH Conc. Control H / Control L
Temperatura de almacén Control Alto / Control Bajo
Fecha de Caducidad Número de Lote Para Diagnóstico In Vitro Número de catálogo Conformidad Europea Fabricado por Fecha de Fabricación Reactivo Calibrador Tampón Liofilizado Concentración
Storage Temperature Control High / Control Low
Expirate Date Lot Number For In Vitro Diagnostic Catalog Number European Conformity Manufactured by Manufactured Date Reagent Calibrator Buffer Lyophilised Concentration
Temperature de Conservation Contrôle élevè / Contrôle Bas
Date de Péremption Número de Lot Usage In Vitro Numéro de catalogue Conformité aux normes européennes Fabriqué par Réactif Calibrateur Tampon Lyophilisé Concentration
Temperatura de Controllo Alto / Controllo Basso
Data di Scadenza Numero di Lotto Per Uso Diagnostico In Vitro Numero di catalogo Conformità europea Fabbricato da Reagenti Calibradore Tampone Liofilo Concentrazione
Conservazione Controlo Alto / Controlo Baixo
Data Expiração Número de Lote Utilizar em Diagnostico In Vitro Número de catálogo Comformidade com as normas europeias Fabricado por Reagente Calibrador Buffer Liofilizado Concentraçao
Temperatura de Conservação Kontrolle Hoch / Kontrolle
Verwendbar bis Chargen-Nr In Vitro Diagnosticum Katalognummer CE-Konformitätskennzeichnung Hergestellt Reagenz Kalibrator Puffer Lyophilisiert Koncentration
Lagertemperatur Niegrid

2017/04