Instructions for Use
Contents
1. DRG HYBR DeXL BH Instructions for Use CRP VD CE HYC 5319 Y 80 tests Ml Manufacturer Distributed by i en DRG DRG Instruments GmbH De Division of DRG International Inc Frauenbergstr 18 D 35039 Marburg Telefon 49 0 6421 17000 Fax 49 0 6421 1700 50 Internet www drg diagnostics de E mail drg drg diagnostics de DRG HYBRID XL CRP HYC 5319 Contents Inhaltsverzeichnis Contenuti Contenido Contenu 1 INTRODUCTION ae eee 3 2 PRINCIPLE OP THE TEST WEE 3 3 WARNINGS AND PRECAUTIONS eener 3 4 REAGENT Soi oE aE A A EA 3 5 SPECIMEN COLLECTION AND PREPARATION 4 6 ASSAY PROCEDURE ecncciarsvicenstsnad teatnemssanvindscauteenrcseedastets 4 7 QUALITY CONTROL 2G eee ees 4 8 EXPECTED NORMAL VALUES oooccccccncnnnnnocccncnnnnnnnonnnnnnnos 5 9 IMITATIONS OR USE Saaai oani unean onae deeg 5 10 PERFORMANCE CHARACTERISTICS ccc 5 11 METHOD COMPARISON AAA 5 12 LEGAL ASPE E 6 13 REFERENCES LITERATURE EN 6 USED SYMBOLS 0d 7 Vers 2 0 2015 02 rl vk 2 DRG HYBRID XL CRP HYC 5319 English 1 INTRODUCTION 1 1 Intended Use The DRG HYBRiD XL CRP is an immunoturbidimetric assay for the quantitative in vitro diagnostic measurement of C reactive protein CRP in serum and plasma heparin and citrate Only for use with the DRG HYBRID XL Analyzer 1 2 Summary and Explanation Concentration of acute phase proteins increase in blood as a response to inflammatory disorders acute phase r2. Be sure that everything is clear and understood 4 Do not remove exchange discard or damage any of the barcode labels provided with each kit and its components All barcodes build an integral system for the kit lot 5 Respect the general safety measures for use of laboratory reagents 6 All reagents of this test kit which contain human serum or plasma have been tested and confirmed negative for HIV III HBsAg and HCV by FDA approved procedures All reagents however should be treated as potential biohazards in use and for disposal 7 Never pipet by mouth and avoid contact of reagents and specimens with skin and mucous membranes 8 Do not smoke eat drink or apply cosmetics in areas where specimens or kit reagents are handled 9 Wear appropriate disposable gloves when handling specimens and reagents Microbial contamination of reagents or specimens may cause false results 10 Handling should be done in accordance with the procedures defined by an appropriate national biohazard safety guideline or regulation 11 Do not use reagents beyond expiry date as shown on the kit labels 12 Unused reagent cartridges must be stored at 2 C to 8 C in the sealed foil pouch with desiccant provided 13 Optimal test results are only obtained when using calibrated pipettes 14 Do not mix or use components from kits with different lot numbers It is advised not to interchange reagent cartridges of different kits even of the same lot Th
3. General needed laboratory equipment Ultra pure water DRG recommends to use Clinical Laboratory Reagent Water CLRW according to CLSI guideline 3C A4 with the following specifications Resistivity at 25 C MQ cm gt 10 Conductivity at 25 C uS cm lt 0 1 Total Organic Carbon p p b ug L lt 50 Colloids ug mL lt 0 05 REF HYB 5252 DRG HYBRID XL Analyzer REF HYI 5392 System Solution 5L 5000 mL Instrument Feed Water according to CLSI guideline 3C A4 with the following specification can also be used Resistivity at 25 C MQ cm gt 1 Conductivity at 25 C uS cm 1 lt 1 Total Organic Carbon p p b ug L lt 200 Colloids ug mL lt 0 1 REF HYI 5394 Wash Buffer 40x concentrate 25 mL REF HYI 5395 Needle Cleaning Solution 30 mL Cleaning solution for the pipetting needle daily and weekly maintenance see also user manual REF HYI 5387 Cuvettes 2 x 360 pieces NaCl solution 9 g L for sample dilution if necessary For use of the Secondary Sample Holder for secondary tubes the following tubes are required HYI 5391 Sample Tubes Secondary 2500 pcs 43 Storage Conditions When stored at 2 C to 8 C unopened reagents will retain reactivity until expiration date Do not use reagents beyond this date Opened reagents and the reagent cartridges must be stored at 2 C to 8 C Once the foil bag has been opened care should be taken to tightly close it
4. beachten per luso Instrucciones instructions d utilisation In vitro diagnostic de Per uso Diagnostica in Para uso Diagn stico Usage Diagnostic VD SC In vitro Diagnostik SE be medical device vitro in vitro in vitro UO For research use onl Mur tar Solo a scopo di ricerca AOPA Uan Seulementdans IE y Forschungszwecke H investigaci n cadre de recherches REE Catalogue number Bestellnummer No di Cat N mero de cat logo R f rence LOT Batch code Chargenbezeichnung N mero de lote No de lot Sufficient for Ausreichendtir Contenuto sufficiente Contenido suficiente Contenu suffisant pour Yo per n saggi para lt n gt ensayos n tests Temperature Temperatur Temperatura di Temperatura de Temp rature de Limitation begrenzung conservazione conservacion conservation PO Verwendbar bis Data di scadenza Fecha de caducidad Date limite d utilisation Ww Mamatacturer Hersteller Fabbricante Fabricante Fabricant Control Control Kontrolle Control Contr le Enzyme Conjugate Enzyme Conjugate Enzymkonjugat Conjugado enzimatico Conjugu enzymatique Substrate Solution Substrate Solution Substratl sung Soluzione di substrato Soluci n de sustrato Solution substrat Probenverd nnungs ae Soluci n para diluci n Solution pour dilution Sample Diluent Sample Diluent medium Diluente dei campioni 4 12 muestra de l chantillon Wash Buffer Wash Buffer Waschpuffer E System Solution System Solution Systeml sung Needle Cle
5. results If primary tubes for sample collection are used please follow the instructions of the manufacturer Do not use haemolytic icteric or lipaemic specimens Samples containing precipitates have to be centrifuged prior to the test run Do not use heat inactivated samples Do not use standards or external controls stabilized with azide 5 1 Specimen Collection Serum Collect blood by venipuncture e g Sarstedt Monovette for serum allow to clot and separate serum by centrifugation at room temperature Do not centrifuge before complete clotting has occurred Patients receiving anticoagulant therapy may require increased clotting time Plasma Whole blood should be collected into centrifuge tubes containing anti coagulant e g Sarstedt Monovette with the appropriate plasma preparation and centrifuged immediately after collection 5 2 Specimen Storage and Preparation Specimens should be capped and may be stored for up to 1 day at 2 C to 8 C prior to performing the assay Specimens stored for a longer time up to two months should be frozen only once at 20 C prior to the assay Thawed samples should be inverted several times prior to testing 5 3 Specimen Dilution 5 3 1 Manual Sample Dilution If in an initial assay a specimen is found to contain more than the highest standard the specimens can be diluted with 0 9 NaCl solution and reassayed as described in Assay Procedure For the calculat
6. again Opened kits retain activity for two months if stored as described above 4 4 Reagent Preparation Bring all reagents such as controls and re calibrators to room temperature 20 C to 25 C prior to use Reagent Cartridges can be used directly after storage in the refrigerator DRG HYBRID XL CRP HYC 5319 Wash Buffer not included in the kit For Wash Buffer 1x dilute 25 mL of Wash Buffer 40x with 975 mL ultra pure water to a final volume of 1000 mL The diluted Wash Buffer 1x is stable for 2 weeks at room temperature 45 Disposal of the Kit The disposal of the kit and all used materials reagents must be performed according to the national regulations Special information for this product is given in the Safety Data Sheet 4 6 Damaged Test Kits In case of any damage to the test kit or components DRG must be informed in writing at the latest one week after receiving the kit Damaged single components should not be used for a test run They have to be stored until a final solution has been found After this they should be disposed of according to the official regulations 5 SPECIMEN COLLECTION AND PREPARATION Serum or plasma Heparin or citrate plasma can be used in this assay Attention This test was not verified with blood collection tubes of all available manufacturers Sample Collection Systems of some manufacturers may contain different materials which in isolated cases could affect the test
7. aning Needle Cleaning Nadel Solution Solution Reinigungsl sung Vers 2 0 2015 02 rl vk
8. bject to the liability of the manufacturer For further information please refer to the User Manual of the DRG HYBRiD XL analyser specific application sheets product information and package inserts of all necessary components 13 REFERENCES LITERATURE 1 Agrwal A Kilpatrick JM Volanakis JE Structure and function of human C reactive protein In Mackiewicz A Kushner Baumann H eds Acute phase proteins London CRC Press 1993 79 92 2 Whicher JT Rifai N Biasucci LM Markers of the acute phase response in cardiovascular disease an update Clin Chem Lab Med 2001 39 85 88 3 Thomson D Whitcher JT Banks RE Acute phase reactions in predicting disease outcome In Emery P ed Management of early inflammatory arthritis Balliere s Clinical Rheumatology London Balliere Tyndall 1992 393 404 4 Chamers RE Stross P Barry RE Whicher JT Serum amyloid A protein compared with C reactive protein alpha 1 anti chymotrypsin and alpha 1 acid glycoprotein a monitor of inflammatory bowel disease Eur J Clin Invest 1987 17 460 467 5 Clyne B Olshaker Js The C Reactive Protein The Journal of Emergency Medicine 1999 17 1019 1025 Vers 2 0 2015 02 rl vk 6 DRG HYBRID XL CRP HYC 5319 USED SYMBOLS European Conformity TE Conformit europea Conformidad europea Ge SE ennzeichnung europ ennes Consult instructions for Gebrauchsanweisung Consultare le istruzioni Consulte las Consulter les use
9. e assay is between 1 0 mg L 250 mg L 10 2 Specificity of Antibodies Cross Reactivity Due to its antibodies the DRG CRP Test is a specific immunoassay for human CRP 10 3 Sensitivity The sensitivity study was designed according to CLSI guideline EP17 A2 The Limit of Blank LoB is 1 0 mg L The Limit of Detection LoD is 2 5 mg L The Limit of Quantification LoQ is 7 0 mg L 10 4 Precision Performance The precision study was designed according to CLSI guideline EP5 A2 10 4 1 Within Run Intra Assay Samples were analysed 2 times daily in duplicates for 20 days n 80 CV is given as mean of 40 duplicate CVs The within run variability is shown below a pol es 29 2 ol w er ps fal ss s a fof so 64 10 4 2 Total Precision Inter Assay Samples were analysed 2 times daily in duplicates for 20 days n 80 The total precision is shown below sek n Mean mar o a Jof es a 2 fo ss on e feof w2 an a er Vers 2 0 2015 02 rl vk 5 10 4 3 Inter Lot The between lots variation was determined by 6 measurements of 4 samples with 3 different kit lots ov 10 5 Recovery Recovery was determined by adding four increasing concentrations of the analyte to four different patient samples containing different amounts of endogenous analyte Each sample non spiked and spiked was assayed and analyte concentrations of the samples were calculated from the Master Curve The percentag
10. e kits may have been shipped or stored under different conditions and the binding characteristics of the wells in the reagent cartridges may differ slightly 15 Some reagents contain Proclin 300 BND and or MIT as preservatives In case of contact with eyes or skin flush immediately with water 16 Chemicals and prepared or used reagents have to be treated as hazardous waste according to the national biohazard safety guidelines or regulations Vers 2 0 2015 02 rl vk 3 17 For information on hazardous substances included in the kit please refer to Safety Data Sheets For professional users the Safety Data Sheet for this product is available upon request directly from DRG 4 REAGENTS 4 1 Reagents provided 4 1 1 Reagent Cartridges 80 pieces containing the following Reagent 1 260 uL TRIS pH 7 5 100 mmol L Polyethylenglycol PEG detergents and stabilizers Reagent 2 100 uL TRIS pH 8 0 100 mmol L Anti human CRP antibodies goat with stabilizers 4 1 2 Re Calibrator 1 amp 2 2 vials 0 5 mL each ready to use For re calibration of the quantitative DRG HYBRiD XL CRP test Concentrations are lot specific Contain non mercury preservative 4 1 3 Control 1 amp 2 2 vials 1 0 mL each ready to use For control values and ranges please refer to the bar code on vial label or to the QC Datasheet See Reagent Preparation Contain non mercury preservative 4 2 Materials required but not provided
11. e recoveries were determined by comparing expected and measured values of the samples fom Range of Recovery 10 6 Linearity Four samples containing different amounts of analyte were serially diluted with 0 9 NaCl solution The percentage recovery was calculated by comparing the expected and measured values for the analyte 1 2 3 4 194 0 Average Recovery 10 7 Interfering Substances Haemoglobin up to 1 mg mL Bilirubin up to 0 12 mg mL and Triglyceride up to 7 5 mg mL have no influence on the assay results Until today no substances drugs are known to us which have an influence to the measurement of CRP in a sample 10 8 High Dose Hook Effect No hook effect was observed in this test up to 1000 mg L of CRP 11 METHOD COMPARISON A comparison of DRG HYBRiD XL ELISA CRP Test HYC 5319 y and DRG ELISA ElA 1952 x using clinical samples gave the following correlation n 40 r 0 900 y 0 8121x 2 2501 A gt O 00 o CH CH CH CH DRG HYBRiD XL mg L N O 0 20 40 60 80 100 120 Reference Method mg L DRG HYBRID XL CRP HYC 5319 12 LEGAL ASPECTS 12 1 Reliability of Results The test must be performed exactly as per the manufacturer s instructions for use Moreover the user must strictly adhere to the rules of GLP Good Laboratory Practice or other applicable national standards and or laws This is especially relevant for the use of control reag
12. ents It is important to always include within the test procedure a sufficient number of controls for validating the accuracy and precision of the test The test results are valid only if all controls are within the specified ranges and if all other test parameters are also within the given assay specifications In case of any doubt or concern please contact DRG 12 2 Therapeutic Consequences Therapeutic consequences should never be based on laboratory results alone even if all test results are in agreement with the items as stated under point 12 1 Any laboratory result is only a part of the total clinical picture of a patient Only in cases where the laboratory results are in acceptable agreement with the overall clinical picture of the patient should therapeutic consequences be derived The test result itself should never be the sole determinant for deriving any therapeutic consequences 12 3 Liability Any modification of the test kit and or exchange or mixture of any components of different kit lots could negatively affect the intended results and validity of the overall test Such modification and or exchanges invalidate any claim for replacement Claims submitted due to customer misinterpretation of laboratory results subject to point 12 2 are also invalid Regardless in the event of any claim the manufacturer s liability is not to exceed the value of the test kit Any damage caused to the test kit during transportation is not su
13. esponse 1 2 C reactive protein CRP the best known member of this group is present only at low concentration in blood of healthy individuals lt 5 mg L but is elevated up to 500 mg L in the acute phase response caused by inflammatory processes associated with bacterial infections post operative conditions or tissue damage CRP concentration increases already after 6 hours reaching a peak after 48 hours The measurement of CRP represents a useful laboratory test for detection of acute infection as well as for monitoring inflammatory processes in acute rheumatic 3 and gastrointestinal 4 diseases CRP testing shows various advantages in comparison to the erythrocyte sedimentation rate ESR and the leukocyte count In fact CRP is more sensitive shows earlier response and returns to reference range more rapidly after healing 2 PRINCIPLE OF THE TEST The DRG HYBRID XL CRP Kit is a immunoturbidimetric assay It is based on an endpoint determination of the CRP concentration by photometric measurement of the antigen antibody reaction between antibodies against human CRP and CRP that is present in the sample 3 WARNINGS AND PRECAUTIONS 1 This kit is for in vitro diagnostic use only For professional use only 2 This kit can only be used in combination with the DRG HYBRID XL Analyzer 3 Before starting the assay read the instructions completely and carefully Use the valid version of the package insert provided with the kit
14. hese bar codes It is recommended to tap the bottom of the Cartridge Segments containing the reagent cartridges once on the bench before placing them on the rotor This is to avoid foam and adhering of the liquid on the sealing of the reagent cartridge Place reagent cartridges on the rotor of the unit The heating to 37 C incubation temperature is performed automatically in the unit 6 3 Calibration Traceability This method was standardized against the DRG CRP ELISA EIA 1952 Each DRG HYBRID XL reagent contains a barcode with the specific information for re calibration of the reagent lot The Master Curve is printed as a 2 D barcode on the outer label of the kit package and on the QC Datasheet and has to be scanned with the external barcode scanner prior to the first use of the respective kit lot Re calibration is recommended if one or both assay controls are found outside the specified range after 4 weeks of use of the same reagent kit on the unit 6 4 Calculation of Results The analyte concentrations are calculated automatically by the DRG HYBRID XL s system software 7 QUALITY CONTROL It is recommended to use control samples according to state and federal regulations The use of control samples is advised to assure the day to day validity of results It is also recommended to participate in national or international Quality Assessment programs in order to ensure the accuracy of the results A
15. ion of the concentrations this dilution factor has to be taken into account Example a dilution 1 10 10 uL sample 90 uL 0 9 NaCl solution mix thoroughly b dilution 1 100 10 uL dilution a 1 10 0 9 NaCl solution mix thoroughly 6 ASSAY PROCEDURE 6 1 General Remarks All reagents such as controls and re calibrators and specimens must be allowed to come to room temperature 20 C to 25 C before use All reagents and samples must be mixed without foaming Reagent Cartridges can be used directly after storage in the refrigerator Once the test has been started all steps should be completed without interruption Vers 2 0 2015 02 rl vk 4 Samples controls and re calibrators should be measured within 2 hours in order to avoid possible evaporation effects The Secondary Sample Holder HY 5437 for secondary tubes has the capacity for a maximum of 20 samples including controls and re calibrators They all have to be pipetted into the secondary tubes and the respective barcodes of control re calibrator vials and if available the sample barcodes have to be read with the external barcode scanner 6 2 Test Procedure To ensure proper operation of the test the instructions in the user manual for the DRG HYBRiD XL should strictly be followed All test specific information required for the correct operation is included in the respective barcodes of the reagents Take care not to damage t
16. pply appropriate statistical methods for analysing control values and trends If the results of the assay do not agree with the established acceptable ranges of control materials patient results should be considered invalid In this case please check the following expiration dates and storage conditions of reagents operational reliability of the analyser In addition it is indicated to perform a Re calibration In case of further questions please contact your local distributor or DRG directly 7 1 Internal Controls For Quality Control it is necessary to use the two internal controls provided with each kit Acceptance ranges for both internal controls Control 1 amp 2 were established by the manufacturer and are summarized in the QC Datasheet added to the kit Note that the expected values and acceptance ranges stated in the QC Datasheet always refer to the current kit lot Internal controls should be run in single determination ona routine basis e g once per 24 h if re calibration is required if one or both internal controls are out of range if anew kit lot is used in order to avoid any negative impact on the kit performance by improper transport or to detect improper storage during transport DRG HYBRID XL CRP HYC 5319 7 2 External Controls Use controls at both normal and pathological levels The control intervals and control ranges for external controls should be adapted to the individual requirement
17. s of each laboratory All results must be within the defined limits Each laboratory should establish corrective measures to be taken if values of external controls are not found in the acceptance range 8 EXPECTED NORMAL VALUES It is strongly recommended that each laboratory should determine its own normal and pathological values Normal concentration in healthy human serum is usually lower than 5 mg L slightly increasing with aging Higher levels are found in late pregnant women mild inflammation and viral infections 10 40 mg L active inflammation bacterial infection 40 200 mg L severe bacterial infections and burns A 200 mg L The results alone should not be the only reason for any therapeutic consequences The results should be correlated with other clinical observations and diagnostic tests 9 LIMITATIONS OF USE Reliable and reproducible results will be obtained when the assay procedure is performed with a complete understanding of the instructions for use and with adherence to good laboratory practice Any improper handling of samples or modification of this test might influence the results 10 PERFORMANCE CHARACTERISTICS 10 1 Assay Dynamic Range The dynamic range of the assay is defined by the limit of blank and the maximum value of the Master Curve Values below the measuring range are indicated as lt 1 0 mg L Values above the measuring range are indicated as gt 250 mg L The range of th
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