Parc Marcel Boiteux - BP Codolet / France - Tél. 33 (0) CGA-RIACT - PDF

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Décembre 2016 Modèle 22 Cisbio Bioassays Parc Marcel Boiteux - BP Codolet / France - Tél. 33 (0) CHROMOGRANIN A Trousse pour le dosage radioimmunologique de la chromogranine A

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Décembre 2016 Modèle 22 Cisbio Bioassays Parc Marcel Boiteux - BP Codolet / France - Tél. 33 (0) CHROMOGRANIN A Trousse pour le dosage radioimmunologique de la chromogranine A humaine (CGA) dans le sérum ou le plasma Pour diagnostic In Kit for the radioimmunoassay of human chromogranin A in serum or plasma For In diagnostic use Immunoradiometrischer Test zur Bestimmung menschlichen Chromogranin A in Serum oder Plasma Zur In Diagnostik La trousse contient : Kit content: Inhalt des Kits: Tubes revêtus 2 x 50 Coated tubes 2 x 50 Teströhrchen beschichtet 2 x 50 Traceur 407 kbq 1 x 55 ml Tracer 407 kbq 1 x 55 ml Tracer 407 kbq 1 x 55 ml Calibrateurs1-5 5 x qsp 0,5 ml Calibrators x qs 0.5 ml Kalibratoren x qs 0,5 ml Contrôle 1 x qsp 0,5 ml Control 1 x qs 0.5 ml Kontrollserum 1 x qs 0,5 ml Tampon 1 x 60 ml Buffer 1 x 60 ml Puffer 1 x 60 ml Réactif de lavage 1 x 5 comprimés Wash reagent 1 x 5 tablets Waschreagenz 1 x 5 Tabletten Sachet plastique 1 Plastic bag 1 Plastikbeutel 1 Notice d utilisation 1 Instruction for use 1 Gebrauchsinformation 1 Attention : Certains réactifs contiennent de l azoture de sodium Warning: Some reagents contain sodium azide Achtung: Einige Reagenzien enthalten Natriumazid Kit per il dosaggio radioimmunologico della cromogranina A umana (CGA) nel siero o nel plasma Per uso diagnostico In Equipo para la determinación radioinmunológica de la cromogranina A humana (CGA) en suero o plasma Para uso diagnóstico In οκιμασία για τον ραδιοανοσολογικό προσδιορισμό της ανθρώπινης χρωμογρανίνης Α (CGA) στον ορό ή στο πλάσμα Για διαγνωστική χρήση in vitro Contenuto del kit : Contenido del equipo: Περιεχόμενα της τυποποιημένης συσκευασίας: Provette coattate 2 x 50 Tubos recubiertos 2 x 50 Επικαλυμμένοι σωλήνες 2 x 50 Tracciante 407 kbq 1 x 55 ml Trazador 407 kbq 1 x 55 ml Ιχνηθέτης 407 kbq 1 x 55 ml Calibratori x q.b a 0,5 ml Calibradores x csp 0,5 ml Πρότυπα x qs 0,5 ml Siero di controllo 1 x q.b a 0,5 ml Control 1 x csp 0,5 ml Ορός μάρτυς 1 x qs 0,5 ml Tampone 1 x 60 ml Tampón 1 x 60 ml Ρυθμιστικό διάλυμα 1 x 60 ml Reagente di lavaggio 1 x 5 compresse Reactivo de lavado 1 x 5 comprimidos Αντιδραστήριο έκπλυσης 1 x 5 δισκία Sacchetto di plastica 1 Bolsa de plástico 1 Πλαστική θήκη 1 Istruzioni per l uso 1 Instrucciones de uso 1 Οδηγίες χρήσεως 1 Attenzione : Alcuni reagenti contengono sodio azide Precauciones : Algunos reactivos contienen azida sódica Προσοχή: Ορισμένα αντιδραστήρια περιέχουν αζίδιο νατρίου 1 FRA ENG DEU ITA SPA ELL POR SWE POL HUN CES NOR Explication des symboles Explanation of symbols Erläuterung der Sumbole Spiegazione dei simboli Significado de los simbolos Eπεξήγηση των συμβόλων που Significadodos simbolos Symbol förklaring Wyjaśnienie symboli Jelmagyarázat Vysvětlení symbolů Forklaring av symbolene SRP Objašnjenje simbola Conforme aux normes européennes European conformity CE- Konformitätskennzeichnun g Conformita europea Conformidad europea European conformity Conformidad com as normas europeias Förenlig med europeiska normer Zgodne z normami europejskimi Megfelel az európai szabványoknak Evropská shody Europeisk konformitet Evropska usaglašenost T limite de stockage Storage temperature limitation Limitierung der Lagertemperat ur Limiti per la temperatura di conservazione Limites de temperatura de almacenamient o Περιορισμός θερμοκρασίας φύλαξης Limite da temperatura de armazenagem T -gräns vid förvaring Graniczna temperatura przechowywani a Tárolási hőmérséklethatár Mezní teplota skladování Lagertemperatu r begrensning Ograničenje temperature za čuvanje N de lot Batch code Chargencode codice lotto Código de lote Κωδικός παρτίδας Lote Lotnr. Numer partii Gyártási szám Č. šarže Porsjoner kode Šifra serije Utiliser jusqu au Consulter la notice d utilisation Diagnostic In Use by Consult operating instructions In Diagnostic device Verwendbar bis Das Handbuch zu Rate ziehen In- Diagnosti sche Anwendung utilizzare entro consultare le istruzioni per l USO Dispositivo Diagnostico In Consumir antes de Consultar las instrucciones de manejo o funcionamiento Dispositivo de diagnóstico In Ημερομ. λήξης Utilizado por Används senast Ανατρέξτε στις οδηγίες λειτουργίας διαγνωστική συσκευή In Consulte o manual de operações Dispositivo de diagnostico In Läs bruksanvisnin gen In vitrodiagnos Zużyć do Patrz dołączona ulotka Diagnostyka In Felhasználható az alábbi dátumig : Olvassa el a használati utasítást In vitro diagnosztika Použitelné do Přečtěte si návod k použití Diagnostika in vitro Bruk ved Konsulter driftsinstrukser In Diagnose innretning Upotrebiti do Pogledajte uputstvo za upotrebu Uređaj za dijagnostiku in vitro Fabriqué par Manufactured by Hergestellt von Prodotto da Fabricado por Κατασκευάζεται από την Fabricado por Tillverkad av Wyprodukowan e przez Gyártja: Vyrobil Produsere ved Proizveo Référence Catalogue number Katalog Nr. N. catalogo Número de catálogo Αριθμός καταλόγου Número do catalogo Referens Wzorzec Referenciakészít mény Reference Katalogiser antall Kataloški broj Nombre de tubes Number of determinations Anzahl der Bestimmunge n Numero di determinazioni Número de determinacione s Αριθμός προσδιορισμών Número de determinações Antal rör Liczba probówek A kémcsövek száma Počet zkumavek Antall determinations Broj određivanja Tubes revêtus Coated tubes beschichtete Röhrchen Provette coattate Tubos recubiertos Επιστρωμένα σωληνάρια Tubos adsorvidos Belagda rör Probówki powlekane Bevont kémcsövek potažené zkumavky Belagt rør Obložene epruvete Traceur radioactif Radioactive tracer Radioactiver Tracer Tracciante radioattivo Trazador radiactivo Ραδιενεργός ιχνηθέτης Marcador radioativo Radioaktiv tracer Znacznik radioaktywny Nyomjelző izotóp Tracer Radioaktiv tracer Radioaktivni indikator Calibrateur Calibrator Kalibrator Calibratore Calibrador Βαθμονομητής Calibrador Kalibrator Kalibrator Kalibrátor Kalibrátor Calibrator Kalibrator BUF Contrôle Tampon Control Buffer Kontrolle Puffer Controllo Tampone Control Ορός ελέγχου Controle Tampon Ρυθμιστικό διάλυμα Tampão Kontroll Kontrola Kontroll Kontrola Buffert Bufor Puffer pufr Styring Buffer Kontrola Pufer WASH Solution de lavage Wash solution Waschlotion Soluzione di lavaggio Solución de lavado ιάλυμα πλύσης Solução de lavagem Tvättlösning Roztwór płuczący MOSÓREAGENS promývací reagencie Vaskløsning Rastvor za pranje 2 MISE A JOUR / UPDATING Cisbio Bioassays - Décembre Modèle 22 FRA Modifications par rapport à la version précédente : 1.Ajout de La trousse est destinée à un usage professionnel / 7.1 Enlever précision (±1%) / 7.2 ajout de l'information sur les essais en double ENG Changes from the previous version: 1.The kit is intended for professional use adding / 7.1 Remove ±1% precision / 7.2 information on assays in duplicate added DEU Änderungen gegenüber der Vorgängerversion: 1. Das Kit ist für den professionellen Gebrauch vorgesehen hinzufügen / 7.1 zu entfernen ± 1% (Präzision) / 7.2 Informationen zu Tests in Doppelbestimmungen hinzugefügt ITA Modifiche rispetto alla versione precedente: 1. Aggiunto Il kit è destinato all'uso professionale / 7.1 rimuovere ± 1% (precisione) / 7.2 Aggiunta informazione sui dosaggi in doppio SPA Cambios desde la versión anterior: 1. Se ha añadido El kit está destinado a uso profesional / 7.1 quitar ± 1% (precisión) / 7.2 Se ha añadido información sobre los ensayos por duplicado ELL Αλλαγές από την προηγούμενη έκδοση: 1. Προσθήκη Το κιτ προορίζεται για επαγγελματική χρήση / 7.1 αφαίρεση ± 1% (ακρίβεια) / 7.2 Προσθήκη πληροφοριών σχετικά με τις δοκιμασίες εις διπλούν POR Alterações em relação à versão anterior: 1. O kit destina-se a utilização profissional adicionando / 7.1 remova a ± 1% (precisão) / 7.2 Recomenda-se executar o ensaio em duplicado para calibradores, para controlo SWE Ändringar från föregående utgåva: 1. Setet är avsett för yrkesmässigt bruk läggs till / 7.1 avlägsna ±1% (precision) / 7.2 Det rekommenderas att analysen körs i duplikat när det gäller kalibratorer och kontrollen. POL Zmiany w stosunku do poprzedniej wersji: 1. Dodanie Zestaw jest przeznaczony do zastosowania profesjonalnego / 7.1 usunąć z precyzją+- 1% / 7.2 Dodano informacje na temat oznaczeń w dwóch powtórzeniach HUN Változások az előző verzióhoz képest: 1. A kit professzionális használatra készült hozzáadva /7.1 távolítsa pontosságú ± 1% / 7.2 a kétszeres assay-kre vonatkozó információ hozzáadva CES Změny od předchozí verze: 1. Přidání Souprava je určena pro profesionální použití / 7.1 odstranění ±1 % (přesnost) / 7.2 Je doporučeno, aby měření probíhalo v duplikátech pro kalibrátory a kontroly. NOR Endringer fra forrige versjon: 1. Kitet er beregnet på profesjonell bruk» / 7.1 Fjern ± 1% presisjon / 7.2 Vi anbefaler at assayet utføres i duplikat for kalibratorgruppene og kontrollene». SRP Promene od prethodne verzije: 1. Dodavanje Kit je namenjen za profesionalnu upotrebu 7.1 ukloniti ± 1% (preciznost) / 7.2 dodate informacije o dvostrukim testovima 3 ENG Cisbio Bioassays - December Model NAME AND INTENDED USE is a kit for the radioimmunoassay of human chromogranin A in serum or plasma. The kit is intended for professional use. 2. INTRODUCTION CGA is an acidic, hydrophilic protein of 439 aa (49 kd), present in chromaffin granules of the neuroendocrine cells. It is a member of the granin family. CGA acts as a pro-hormone. Its proteolysis constitutes a key element of its physiology. This degradation releases biologically active peptides (vasostatins, chromostatin, pancreastatin, parastatin ) which have different paracrine and autocrine functions. The proteolysis is tissue-specific, and the protein s fragmentation differs depending on its location. It takes place mainly in the cell, inside the chromaffin granules. In immunohistochemistry, the presence of CGA in tumoral cells can be related to the neuroendocrine origin of the tumor. Circulating CGA exists in healthy subjects and the values obtained are independent of age and sex. The interest of seric CGA assay was first shown in pheochromocytoma, then rapidly extended to other endocrine cancers with particularly significant high levels in intestinal cancers and endocrine tumors of the pancreas. Recent studies have shown that the levels of circulating CGA are associated with a neuroendocrine differentiation and are linked to the tumor mass, without however substituting for more specific secretions such as NSE in small-cell lung cancer. Some authors have also shown that the presence of CGA in prostate cancers may be the sign of an unfavorable evolution of the disease. It has been demonstrated that these pathological levels are associated with a lowered survival rate, independently of the patient's stage. 3. PRINCIPLE is a solid-phase two site immunoradiometric assay. Two monoclonal antibodies were prepared against sterically remote sites on the CGA molecule. The first one is coated on the solid phase (coated tube), while the second, radiolabeled with iodine 125, is used as a tracer. CGA (molecules or fragments) present in the calibrators or the samples to be tested are sandwiched between the two antibodies. Following the formation of the coated antibody/antigen/iodinated antibody sandwich, the unbound tracer is easily removed by a washing step. The radioactivity bound to the tube is proportional to the concentration of CGA present in the sample. 4. REAGENTS Each kit contains enough reagents for 100 tubes. The expiry date is marked on the external label. REAGENTS SYMBOLS QUANTITY STORAGE COATED TUBES: ready for use. Anti-CGA monoclonal antibody coated on the bottom of the tube. ANTI CGA125 I: ready for use. 125I anti CGA monoclonal antibody, buffer, bovine serum, sodium azide, red dye, nonimmunized mouse immuno-globulins, EDTA. 407 kbq ( 11 µci). CALIBRATORS: lyophilized.* Recombinant human CGA, human serum, EDTA, preservative ng/ml Reconstitute with 0.5 ml of distilled water. CONTROL: lyophilized **. Recombinant human CGA, human serum, preservative. 180 ng/ml Reconstitute with 0.5 ml of distilled water. BUFFER: ready for use. Used as dilution buffer, diluent and 0 calibrator. Buffer, bovine serum, sodium azide, EDTA. WASH REAGENT: tablets. Dilute 1 tablet / 100 ml of distilled water. Shake gently. CT TRACER CAL CONTROL BUF WASH 2 packs of 50 tubes 1 55 ml vial 5 vials qsp 0.5 ml 1 vial qsp 0.5 ml 1 60 ml vial 5 tablets under blister PLASTIC BAG 1 * The values shown are target values only; the true value of each calibrator is shown on its label. ** The acceptance range true values are printed on the vial label. Unused coated tubes removed from their pack must be stored in the plastic bag supplied with the kit. After reconstitution, do not keep more than 1 hour at room temperature. Store frozen in aliquots at - 20 C for 6 weeks. After reconstitution, do not keep more than 1 hour at room temperature. Store frozen in aliquots at - 20 C for 6 weeks. After dilution, store in a capped container for a maximum of 15 days. 4 ENG Cisbio Bioassays - December Model PRECAUTIONS FOR USE 5.1. Safety measures Raw materials of human origin contained in the reagents of this kit have been tested with licensed kits and found negative for the anti- HIV 1, anti-hiv 2, anti-hcv antibodies and the HBs antigen. However as it is impossible to strictly guarantee that such products will not transmit hepatitis, the HIV virus, or any other viral infection, all raw materials of human origin including the samples to be assayed must be treated as potentially infectious. Do not pipette by mouth. Do not smoke, eat or drink in areas in which specimens or kit reagents are handled. Wear disposable gloves while handling kit reagents or specimens and wash hands thoroughly afterwards. Avoid splashing. Decontaminate and dispose of specimens and all potentially contaminated materials as if they contained infectious agents. The recommended method of doing this is autoclaving for a minimum of one hour at C. Sodium azide may react with lead or copper piping to form highly explosive metal azides. During waste disposal, flush the drains thoroughly to prevent a build-up of these products Radioprotection rules This radioactive product may only be received, purchased, stored or used by persons so authorized, and by laboratories covered by such authorization. The solution should under no circumstances be administered to humans or to animals. The purchase, storage, use or exchange of radioactive products are subject to the laws in force in the user's country. Enforcement of the basic radioprotection rules will ensure adequate safety. A summary of these is given below: Radioactive products must be stored in their original containers in a suitable area. A record of the reception and storage of radioactive products must be kept up to date. Handling of radioactive products should take place in a suitably-equipped area with restricted access (controlled zone). Do not eat, drink, smoke or apply cosmetics in a controlled zone. Do not mouth-pipette radioactive solutions. Avoid any direct contact with all radioactive products by using laboratory coats and protective gloves. Contaminated laboratory equipment and glassware must be disposed of immediately after contamination to prevent cross-contamination of different isotopes. Any contamination or radioactive substance loss should be dealt with in accordance with the established procedures. All radioactive waste disposal must be carried out according to the regulations in force Handling precautions Do not use kit components beyond their expiry date. Do not mix reagents from different batches. Do not test more than 100 tubes at the same time. Avoid any microbial contamination of the reagents or of the water. Fully respect the incubation times and the washing instructions indicated. 6. SPECIMEN COLLECTION AND PREPARATION The assay is performed directly on serum or plasma. If the test is to be carried out within 24 hours, serum and plasma must be refrigerated at 2-8 C. Otherwise, they should be divided into aliquots and deep frozen (-20 C) until needed. If the samplings are carried out with plasma, the values will be systematically higher. Dilutions Should elevated CGA levels be suspected, the buffer diluent found in the kit is used for dilution. It is recommended to carry out the dilutions using disposable plastic tubes. 7. ASSAY PROCEDURE 7.1. Material required Precision micropipettes or similar, with disposable tips, capable of dispensing 50 µl, µl, 1000 µl, and 2000 µl. Their calibration should be checked regularly. Distilled water. Disposable plastic tubes. Vortex-type mixer. Circular horizontal shaker (400 rpm). Gamma scintillation counter calibrated for 125 iodine measurement Protocol All reagents must be brought to room temperature (18-25 C) at least 30 minutes before their use. Dispensing of the reagents into the tubes is carried out at room temperature (18-25 C). The assay requires the following groups of tubes: Calibrator 0 group, for the determination of non specific binding. Calibrator groups, to establish the calibrator curve. Control group for the control. Sx groups, to test serum or plasma samples. It is recommended that the assay be performed in duplicate for the calibrators, the control and for the samples. Strictly observe the order in which reagents are to be added: Dispense L of buffer into each tube. Add 50 L of calibrator, control or sample to be assayed to the corresponding tube. Mix each tube gently with a Vortex-type mixer. Incubate for 18-20h at room temperature (18-25 C). Wash the coated tubes: Aspirate the contents of all tubes as completely as possible. Add 1.0 ml of washing solution to each tube. Aspirate the contents of all tubes. Repeat the process once more. Aspirate the contents of the tubes as completely as possible. There must be no residual volume in the coated tubes after washing. To obtain reliable and reproducible results, the different washing steps have to be performed correctly: the addition of the washing solution must be carried out with sufficient speed to create turbulence in the tubes. Dispense L of 125 l anti CGA monoclonal antibody into each tube, including the 3 total activity tubes. Incubate for 2h 5 min at room temperature (18-25 C) under agitation (400 rpm). Wash the coated tubes as described above. Measure the remaining radioactivity bound to the tubes with a gamma scintillation counter. 5 ENG Cisbio Bioassays - December Model QUALITY CONTROL Good laboratory practices require that quality control samples be used in each series of assays to check the quality of the results obtained. All specimens should be treated identically, and result analysis using the appropriate statistical methods is recommended. 9. RESULTS For each group of tubes, calculate the mean counts after subtracting the background. Draw up the calibrator curve by plotting the calibrators cpm against their concentrations. The curve should be plotted by spline smoothing. Read the sample values directly from the curve, correcting the read value for the dilution factor if necessary. Typical calibrator curve (example only): these
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