CRP Kit Mea AutoQuant in i lite zs ceneaqeor | Buller oo catbrator Reagent Packsize | 2xa0m1 210m adel INTENDED USE ‘Autouant CRP Kits intended for the quantitative determination of Reactive protein in human serum by turbidimetric immunoassay fon AutoQuant 400i/ 400 Supremus/ 400 automated nical chemistry analyzer iTropucTiON reactive protein (CRP) is an acute phase _ protein synthesized in the liver Its rate of synthesis increases within hours of acute injury or the onset of inflammation and may reach as high as 20 times the normal levels, A rapid fll of CRP indicates recovery. ‘The degree of elevation of CAP level directy reflects the mass of activity of inflamed tissue. Its ability to fall to normal levels on resolution of the condition renders quantified CRP values to be a ‘good indicator to allow rapid selection of appropriate antiinflammatory therapy in several rheumatic cseases which are Clinically dificult to assess. Apart from indicating inflammatory disorders, CRP levels helps in differential diagnosis, in the ‘management of neonatal septicemia and meningitis where standard ‘lcrobioiogical investigations are cicult. CRF levels se invariably after major surgery, but fall to normal within 7-30 days. Absence of this fall is indicative of septic or inflammatory postoperative ‘complications, Serum CRP concentration provides useful information in patients with myocardial infarction there being an ‘excellent correlation between peak levels of CRP and creatine phosphokinase, PRINCIPLE OF THE TEST ‘AutoQuant CRP is @turbidimetri assay for determination of ‘Greactive protein In human serum and is based on the principle of, agglutination reaction, When the activation buffer mixed with sample is allowed to react with the AutoCuant CRP reagent, an Inzoluble complexis formed inthe presence of CRP imparting turbiulty whl cere Le viceaureu at 240 rn, The concentration of ‘CRP is dependent on the intensity of turbidity. KIT COMPONENTS Composition Ri - Buffer : Phosphate buffered saline (pH 7.43), Polyethylene lycol (40 g/l), Sodium azide (0.09 %) R2.- Ant serum Reagent : Phosphate buffered saline (pH 7.43), Polyclonal goat anti-human CRP (variable), Sodium azide (0.09 %) 3 - Calibrator : Dilution of human plasma and pleural fluid containing high levels of CRP with phosphate buffered saline, liquid and stablized, Contains 0,09 % sodium aide, Concentration Is lot specific, see vial label, [MATERIALS REQUIRED BUT NOT PROVIDED 41. 0.9% Saline 2, Instrumentation: fully auto analyzer SPECIMEN: Fresh Serum Sample STORAGE OF TEST KIT Unopened test kts snoutd be stored at 2-8 °C upun etept The teat kit may be used throughout the expiration date on the kit (18, Months from the date of manufacture). Do not freeze. Diagnostics PRECAUTIONS AND WARNINGS 4. For in vito use only. 7 2,This pack insert must be completely underst0o ‘operation. Do not modify the test procedure or substitute reagents from other manufacturers or other lots unless the reagent Is stipulated as interchangeable. It Is recommended to handle carefully by entitled and professionally educated person, 3, Do not pipette by mouth, Use disposable gloves while performing the assay, Wash hands thoroughly when finished. 4. Follow good laboratory practice to avoid microbial contamination of reagents 4s Uns may reduce the lie ut he product and cause erroneous results. Ensure that the assay Is incubated at the mentioned ‘temperature in the protocol Do not use reagents beyond the expiry date. Incase of skin contact with any of the reagents, wash thoroughly, with running water. 8, Shake the RZ: Antiserum reagent well before use to Improve test performance. 9. The calibration curve must be validated periodically with known controls, (rorinwwo degree vo Preparation of calibration curve The concentration of R3: Calibrator is as mentioned on the vial Iobel Dilute the calibrator serially as mentioned below for preparation of calibration curve. ‘The above five dilutions ofthe calibrator including the highest (D1) and lowest (D6) concentrations of measuring range must be used for the preparation of the calibration curve. Tet Tube]i [2 ]3 ]4 ]5 |e No. Callbrator [01 [02 [os [oa | ps | 06 dilution No. (0.9%Saline | | 100, | 100, | 100 _| 100_ | 100 sama tome cama — ts So Oe othe Ne P| "The ealration eurve so obtained is valid only for the same lot of reagents. PERFORMANCE CHARCTERISTICS 3. Unearity “The measuring ange I 0 to 32 mel. 2, Senstivity/ Limit of detection (LOD) “The limit of detection Is 0.08 me/dl 3. Accuracy Control ‘Assigned Measured (me/al) (mesa) eta 2.63 (2.1-3.16) 25 larg 5.26 (421-634) 5.02 Levels 7.15 (5,728.58) 7.05; Precision Intraassay/ Within run precision 20 | Mean 30 ow (rg/at)_| _trng/ay (, sample | 0.68 0.02, 3.25 sample2 | 5.62 0.03 057 tual ert eons Pt, Sz on, DD, Me Pa Sure, ES 8 74, eran Mr, Chea, Vph9t6 india, T+9'-260:3052100, F +91-260-0062125, W wirmmsife.com ltome} Obets sa, Bd General Wanss 83, 1060, Busses, Belgum. T-+(G2) 2732-595, F +(32) 2 732-60-03, E mal@obéis.not GujaratInter-assay/Run to run precision Programme Parameter for AutoQuart400 n=29 | Mean 2 w “estitem CRP (mefay_ | (mgsay_| (0 Decimal dt 3 sample [O71 0.08 325 Wait maga sample? [5.51 oz zit Assay 2 Pont End 5. Hook Effect 5 fete as Hook effect is > 100 ma/d re eg 2 REFERENCE VALUES ‘Second wavelength 700) “The reference values of CRP in normal population are between 0-1 | Normal volume ef sample iG mefd. The reference values vary with regards to the time of [absorbance lit 33 collection of the serum sample. Each laboratory should establish ts esate = ‘own reference value. ene a0 BIBLIOGRAPHY R2 0 1. MB.Pepys, G.MHirschfeld, reactive protein: acrtcal update, RS 30 the journal of CnicalInvestigstion, volume 121, 2003 Position . 2. L.Wu, THan, Xan eta, Serum C-reactive protein asa possible [Calibration method Logi Toes marker to predict delayed hemorrhage aftr colonoscople Point . polypectomy, Med Sci Monit 18(8): CR480-485, 2012, Galbration soltion 1106 + (ealibrator value) 3. Kseo, Lee, Lahn etal, active protein as an indicator of Sse dati inflammatory respanses to experimentally induced cyettsin dogs Vet Sei, 13(2):79-185, 2013, 4, Yl, 2M. Y.Mia eta, Serum C-reactive protein (CRP) 2s a simple and independent Prognostic Factor in Exranodal Natural Killer/-Cell ymphorra, Nasal Type, PLOS ONE, volume 8, issue 5, 264158,2013. 5. Sd.Semple, reactive protein: biological functions, cardiovascular disease and physical exercise, SAJSM, vol 18 No. 1, 2006. 6. Data on file: Merl Diagnostics. Ipu/cRPAQao1/01 22-07-2019 ‘Sols ved on Mel Diagnosto lbs EVEnRg A — Aten Se stn or Use Balch No {ta} into bogrostes Sxpiy0ae EAM) Conat tason bx Use Monvcer — Stage Tongans Kp Ory AS aap Any tom Sung Mandactwing Dato @) Do nal sei package is damaged (ETRE) viz Exogean Raveseraiva inthe Exopcn Comiy Programme Parameter for AutoQuant 400i/ 400 Supremus ._ BASIC PARAMETER: Method End Point Primary Fiter 340 Secondary Fer NO Unit mg/dl Decimal z RLVolume: 200 Ri Position * Incubation Time 1 (Sec) 0 2 Volume 50 Incubation THe 2 (See) 20 ‘Sample Volume 16 Reading Time (Sec) 36 Linearity 2 2.__ REFERENCE RANGE Normal Low o Normal High a 3,_ CALIBRATION: No: of Calibration é Calibration Rule Polynomial Calibration Cup z * User defined jr lsenaelined = eel Bar Code i valid for AutoCuvant 400 400 Supremus analyzer.