Février 2019 – Modèle 014 Cisbio Bioassays Parc Marcel Boiteux – BP 84175 – 30200 Codolet / France - Tél. 33 (0)4.66.79.67.00 ANTI-INSULIN AAI ANTIBODIES Trousse pour le dosage radioimmunologique Kit for radioimmunoassay for determination Kit zur radioimmunologischen Bestimmung des anticorps anti-insuline libres et totaux of free and total anti-insulin antibodies in von freien und totalen Anti-Insulin dans le sérum humain human serum Antikörpern in Humanserum La trousse contient : Kit content : Inhalt des Kits : Traceur ≤ 52 kBq 2 x 5 mL Tracer ≤ 52 kBq 2 x 5 mL Tracer ≤ 52 kBq 2 x 5 mL Solution précipitante 1 x 100 mL Precipitating solution 1 x 100 mL Präzipitationslösung 1 x 100 mL Réactif d’extraction 1 x 10 mL Extraction reagent 1 x 10 mL Extraktionsreagenz 1 x 10 mL Tampon de neutralisation 1 x 10 mL Neutralization buffer 1 x 10 mL Neutralisationspuffer 1 x 10 mL Contrôle négatif (C1) 1 x qsp 1 mL Negative control 1 x qs 1 mL Negativkontrolle 1 x qs 1 mL Contrôle positif (C2) 1 x qsp 1 mL Positive control 1 x qs 1 mL Positivkontrolle 1 x qs 1 mL Mode d’emploi 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 degli Equipo radioinmunológica para la Δοκιμασία για τον ραδιοανοσολογικό anticorpi anti-insulina liberi e totali nel siero determinación de los anticuerpos anti- προσδιορισμό των ελεύθερων και συνολικών umano insulina libres y totales en suero humano αντισωμάτων έναντι της ινσουλίνης στον ανθρώπινο ορό . Contenuto del kit : Contenido del equipo : Περιεχόμενα της τυποποιημένης συσκευασίας : Tracciante ≤ 52 kBq 2 x 5 mL Trazador ≤ 52 kBq 2 x 5 mL Ιχνηθέτης ≤ 52 kBq 2 x 5 mL Reagente immunoprecipitante 1 x 100 mL Solución precipitante 1 x 100 mL Διάλυμα κατακρήμνισης 1 x 100 mL Reagente di estrazione 1 x 10 mL Reactivo de extracción 1 x 10 mL Αντιδραστήριο εκχύλισης 1 x 10 mL Ρυθμιστικό διάλυμα Tampone di neutralizzazione 1 x 10 mL Tampón de neutralización 1 x 10 mL εξουδετέρωσης 1 x 10 mL Controllo negativo (C1) 1x q.b a 1 mL Control negativo (C1) 1 x csp 1 mL Αρνητικός μάρτυρας (C1) 1 x sq 1 mL Controllo positivo (C2) 1x q.b a 1 mL Control positivo (C2) 1 x csp 1 mL Θετικός μάρτυρας (C2) 1 x sq 1 mL Istruzioni per l’uso 1 Instrucciones de uso 1 Οδηγίες χρήσης 1 Attenzione : Alcuni reagenti contengono sodio azide Precauciones : Algunos reactivos contienen azida sódica Προσοχή : Ορισμένα αντιδραστήρια περιέχουν αζίδιο του νατρίου . FRA ENG DEU ITA SPA ELL CES TUR SRB Explication des Erläuterung der Spiegazione Significado de Eπεξήγηση Vysv ětlení Sembollerin Explanation of symbol ů açıklaması Objašnjenje symboles symbols Sumbole dei simboli los simbolos των simbola συμβόλων Conforme aux Σύμφωνο προς τα CE-Konformitäts- Conformità Conformidad Evropská shody Avrupa'ya uyum normes ευρωπαϊκά Evropska European conformity kennzeichnung europea europea européennes πρότυπα usaglašenost Limiti per la Limites de Όριο Depolama Ograni čenje T° limite de Storage temperature Grenzwerte der Mezní teplota temperatura di temperatura de θερμοκρασίας sıcaklı ğı temperature za stockage limitation Lagertemperatur skladování conservazione almacenamiento αποθήκευσης sınırlaması čuvanje N° de lot Chargencode codice lotto Código de lote Αριθμός παρτίδας Č. šarže Batch code Parti kodu Šifra serije Ημερομηνία Son kullanım Utiliser jusqu’au Use by Verwendbar bis utilizzare entro Consumir antes de Použitelné do Upotrebiti do λήξης tarihi Consultar las consultare le Συμβουλευτείτε Consulter la notice Im Handbuch instrucciones de Přečtěte si návod İş letim Pogledajte Consult operating istruzioni per τις οδηγίες d’utilisation nachschlagen manejo o k použití talimatlarına uputstvo za instructions l‘USO χρήσης funcionamiento danı şın upotrebu In Vitro- Dispositivo Ure đaj za In Vitro Diagnostic Dispositivo de Διαγνωστική Diagnostika in In Vitro Tanılama Diagnostic In Vitro Diagnostische Diagnostico In dijagnostiku in device diagnóstico In Vitro συσκευή In Vitro vitro cihazı Anwendung Vitro vitro Κατασκευάζεται Fabriqué par Hergestellt von Fabricado por Vyrobil Manufactured by Prodotto da από την Üretici Proizveo Αριθμός Katalog Référence Catalogue number Katalog Nr. N. catalogo Número de catálogo Reference Kataloški broj καταλόγου numarası Number of Anzahl der Numero di Número de Αριθμός Nombre de tubes Po čet zkumavek Saptama sayısı Broj odre đivanja determinations Bestimmungen determinazioni determinaciones προσδιορισμών Ραδιενεργός Traceur radioactif Radioaktiver Tracer Tracciante Trazador radiactivo Radioaktivni Radioactive tracer ιχνηθέτης Tracer Radyoaktif radioattivo izleyici indikator Reagente Διάλυμα precipita ční roztok presipitasyon Precipitiraju ći RIP Solution précipitante Precipitating solution Präzipitationslösung Solución precipitante immunoprecipitante κατακρήμνισης solüsyonu rastvor Contrôle Kontrolle Control Ορός ελέγχου Kontrola Kontrol Control Controllo Kontrola Reagente di Reactivo de Αντιδραστήριο extrak ční ekstraksiyon Ekstrakcioni EXTRACT Réactif d’extraction Extraction reagent Extraktionsreagenz estrazione extracción εκχύλισης reagencie reaktifi reagens Tampon de Tampone di Tampón de neutraliza ční pufr nötralizasyon Neutralizacioni BUF Neutralization buffer Neutralisationspuffer εξουδετέρωσης neutralisation neutralizzazione neutralización tamponu pufer MISE A JOUR / UPDATING AAI Cisbio Bioassays - Février 201 9 - Modèle 01 4 FRA Modifications par rapport à la version précédente : Mise à jour code langue Serbe. ENG Changes from the previous version: Updated Serbian language code. DEU Änderungen gegenüber der Vorgängerversion: Serbischer Sprachcode aktualisiert. ITA Modifiche rispetto alla versione precedente: Aggiornato il codice della lingua serba. SPA Cambios desde la versión anterior: Código de idioma serbio actualizado. ELL Αλλαγές από την προηγούμενη έκδοση : Ενημερώθηκε κώδικας σερβικής γλώσσας . CES Zm ěny od p ředchozí verze: Aktualizovaný srbský kód jazyka. TUR Bir önceki sürüm üzerinde yapılan de ğişiklikler: Sırp dil kodu güncellendi. Promene od prethodne verzije: SR B Ažurirana šifra srpskog jezika ENG AAI Cisbio Bioassays - February 2019 - Model 014 1. NAME AND INTENDED USE ANTI-INSULIN RIA is a radioimmunometric assay for determination of free and total anti-insulin antibodies in human serum. The kit is intended for professional use. 2. INTRODUCTION The ANTI-INSULIN RIA kit allows to measure: - anti-insulin antibodies induced during a treatment by human or porcine insulin. - anti-insulin autoantibodies , present in prediabetes, before any treatment by insulin. 3. PRINCIPLE The principle of anti-insulin antibody (AIA) detection is based on the demonstration of a specific binding with iodine 125-labeled insulin. Two determinations can be performed with the kit: 1) Determination of free anti-insulin antibodies (free AIA) The free AIA are antibodies not complexed with circulating insulin. They are determined by a radioimmunoprecipitation assay in liquid phase: - serum containing anti-insulin antibodies incubates with iodine 125-labeled insulin. - the 125 I-insulin bound to AIA fraction is separated from the free 125 I-insulin fraction by precipitation with polyethylene glycol (PEG). - after centrifuging, radioactivity counting of the pellets (bound fraction) allows the calculation of the binding percentage of 125 I-insulin. 2) Determination of total anti-insulin antibodies (total AIA) The total AIA are the free AIA plus the antibodies complexed with serum insulin. They are determined by the same protocol as the free AIA after dissociation of immune complexes in acid medium, insulin adsorption by active charcoal, neutralization then centrifuging. The detection of free anti-insulin antibodies (AIA) and/or total AIA is carried out within 2 hours. This incubation time provides sufficient sensitivity for the monitoring of AIA induced by insulin treatment. 4. REAGENTS Each kit contains enough reagents for 100 tubes. The expiry date is marked on the external label. REAGENTS SYMBOLS QUANTITY STORAGE Human INSULIN 125 I: ready for use. Human insulin iodinated on A14 and purified by HPLC, in 2 vials TRIS buffer containing phenol red. Contains 0.1% sodium TRACER of 2-8°C until the expiry date. azide (NaN 3). The 2 vials contain approximately 52 kBq (1.4 5 mL µCi) 125 I-insulin with specific activity close to 300 µCi/µg (11.1 Mbq/µg) on the labeling day. PRECIPITATING SOLUTION, blue: ready for use. 1 vial Polyethylene glycol solution in phosphate buffer. RIP of 2-8°C until the expiry date. Contains 0.1% sodium azide (NaN 3). 100 mL EXTRACTION REAGENT, black: ready for use. 1 vial Solution containing charcoal-dextran in glycine buffer at an EXTRACT of 2-8°C until the expiry date. acid pH. Contains 0.1% sodium azide (NaN 3). This reagent 10 mL should be dispensed under shaking. 1 vial NEUTRALIZATION BUFFER, colorless : ready for use. 2-8°C until the expiry date. BUF of 10 mL Barbital buffer. Contains 0.1 % sodium azide (NaN 3). NEGATIVE CONTROL (C1) : lyophilized. Normal human serum containing 0.1% sodium azide (NaN 3). CONTROL - 1 vial 2-8°C until the expiry date. Reconstitute with 1 mL demineralized or distilled water. qsp After reconstitution: the C1 and C2 Gently homogenize after complete dissolution. Avoid the 1 mL controls should be promptly divided into formation of foam. aliquots and frozen at – 20°C. Under these POSITIVE CONTROL (C2) : lyophilized. (*) conditions, the controls are stable for at Human specimen containing a