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BOND
Ready-To-Use Primary Antibody
™
MSH6 (Mismatch Repair Protein) (EP49)
Catalog No: PA0990
Leica Biosystems Newcastle Ltd
Balliol Business Park
Benton Lane
Newcastle Upon Tyne NE12 8EW
United Kingdom
( +44 191 215 4242
Instructions for Use
Please read before using this product.
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Table des Matières
Manuels Connexes pour Leica BOND MSH6
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- Page 1 BOND Ready-To-Use Primary Antibody ™ MSH6 (Mismatch Repair Protein) (EP49) Catalog No: PA0990 Leica Biosystems Newcastle Ltd Balliol Business Park Benton Lane Newcastle Upon Tyne NE12 8EW United Kingdom ( +44 191 215 4242 Instructions for Use Instrukcja obsługi Please read before using this product.
- Page 2 PA0990 Page 1...
- Page 3 MSH6 (Mismatch Repair Protein) (EP49) to the section, and then visualizing this binding using the reagents provided in the detection system. The use of these products, in combination with the automated BOND system (includes Leica BOND-MAX system and Leica BOND-III system), reduces the possibility of human error and inherent variability resulting from individual reagent dilution, manual pipetting and reagent application.
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Page 4: Further Information
Wear disposable gloves when handling reagents. • To obtain a copy of the Material Safety Data Sheet contact your local distributor or regional office of Leica Biosystems, or alternatively, visit the Leica Biosystems’ Web site, www.LeicaBiosystems.com •... -
Page 5: Date Of Issue
Caldes T, et al. Immunohistochemistry and microsatellite instability testing for selecting MLH1, MSH2 and MSH6 mutation carriers in hereditary non-polyposis colorectal cancer. Oncology Reports. 2004; 12: 621-629. Kets CM, et al. Unfavorable pathological characteristics in familial colorectal cancer with low-level microsatellite instability. Modern Pathology. -
Page 6: Anticorps Primaires Prêts À L'emploi Bond
L'utilisation de ces produits avec le système BOND automatisé (qui comprend les systèmes Leica BOND-MAX et Leica BOND-III) réduit la possibilité d'erreur humaine et la variabilité inhérente qui résulte de la dilution de réactifs individuels, du pipetage manuel et de l'application des réactifs. -
Page 7: Précautions
Porter des gants jetables pour la manipulation des réactifs. • Pour obtenir un exemplaire de la Fiche de données de sécurité, contactez votre distributeur local ou le bureau régional de Leica Biosystems. Vous pouvez également consulter le site Internet de Leica Biosystems, www.LeicaBiosystems.com •... -
Page 8: Date De Publication
Shia J, et al. Immunohistochemistry as First-line Screening for Detecting Colorectal Cancer Patients at Risk for Hereditary Nonpolyposis Colorectal Cancer Syndrome: A 2-antibody Panel May be as Predictive as a 4-antibody Panel. The American Journal of Surgical Pathology. 2009; 33: 1639-1645. Berends MJ, et al. - Page 9 Fare riferimento a “Uso dei reagenti BOND” nella documentazione per l’utente di BOND per l’elenco completo dei materiali necessari per il trattamento e la colorazione immunoistochimica dei campioni con il Sistema BOND (che include i sistemi Leica BOND-MAX e Leica BOND-III).
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Page 10: Risoluzione Dei Problemi
Limitazioni specifiche per il prodotto MSH6 (Mismatch Repair Protein) (EP49) è stato ottimizzato da Leica Biosystems per l'uso con il BOND Polymer Refine Detection e con i reagenti ausiliari BOND. Gli utenti che modificano le procedure raccomandate devono assumersi la responsabilità dell’interpretazione dei risultati relativi ai pazienti in tali circostanze. - Page 11 Caldes T, et al. Immunohistochemistry and microsatellite instability testing for selecting MLH1, MSH2 and MSH6 mutation carriers in hereditary non-polyposis colorectal cancer. Oncology Reports. 2004; 12: 621-629. Kets CM, et al. Unfavorable pathological characteristics in familial colorectal cancer with low-level microsatellite instability. Modern Pathology.
- Page 12 Präparat mit nachfolgender Darstellung dieser Bindung mithilfe der im Detektionssystem enthaltenen Reagenzien. Die Verwendung dieser Produkte in Kombination mit dem automatisierten BOND-System (bestehend aus dem Leica BOND-MAX-System und dem Leica BOND-III-System) reduziert die Gefahr vom Menschen verursachter Fehler und einer inhärenten Variabilität aufgrund einer individuellen Reagenzienverdünnung, einer manuellen Pipettierung und einer Reagenzienanwendung.
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Page 13: Fehlersuche Und -Behebung
Histopathologie unter Verwendung nicht-immunologischer histochemischer Färbemittel empfohlen. Produktspezifische Beschränkungen MSH6 (Mismatch Repair Protein) (EP49) wurde von Leica Biosystems für die Verwendung mit BOND Polymer Refine Detection und den BOND-Zusatzreagenzien optimiert. Anwender, die von den empfohlenen Testverfahren abweichen, müssen die Verantwortung für eine Auswertung der Patientenergebnisse unter diesen Umständen übernehmen. - Page 14 Shia J, et al. Immunohistochemistry as First-line Screening for Detecting Colorectal Cancer Patients at Risk for Hereditary Nonpolyposis Colorectal Cancer Syndrome: A 2-antibody Panel May be as Predictive as a 4-antibody Panel. The American Journal of Surgical Pathology. 2009; 33: 1639-1645. Berends MJ, et al.
- Page 15 El uso de estos productos, en combinación con el sistema automatizado BOND (incluye los sistemas Leica BOND-MAX y Leica BOND-III), reduce la posibilidad de error humano y la variabilidad inherente derivada de la dilución de reactivos, el pipeteado manual y la aplicación de reactivos.
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Page 16: Solución De Problemas
Limitaciones específicas del producto El MSH6 (Mismatch Repair Protein) (EP49) se ha optimizado en Leica Biosystems para su uso con BOND Polymer Refine Detection y reactivos auxiliares BOND. Los usuarios que no sigan los procedimientos de prueba recomendados deben aceptar la responsabilidad de la interpretación de los resultados de pacientes en esas circunstancias. -
Page 17: Fecha De Publicación
Shia J, et al. Immunohistochemistry as First-line Screening for Detecting Colorectal Cancer Patients at Risk for Hereditary Nonpolyposis Colorectal Cancer Syndrome: A 2-antibody Panel May be as Predictive as a 4-antibody Panel. The American Journal of Surgical Pathology. 2009; 33: 1639-1645. Berends MJ, et al. -
Page 18: Refª. De Catálogo: Pa0990
A utilização destes produtos, em combinação com o sistema BOND automático (inclui o sistema Leica BOND-MAX e o sistema Leica BOND-III), reduz a possibilidade de erro humano e a variabilidade inerente resultante da diluição do reagente individual, da pipetagem manual e da aplicação do reagente. - Page 19 Utilizar luvas descartáveis quando manusear o produto. • Para obter uma cópia da Ficha de dados de segurança do material, contacte o seu distribuidor local, gabinete regional da Leica Biosystems ou, em alternativa, visite o site da Leica Biosystems www.LeicaBiosystems.com/pt/ •...
- Page 20 Caldes T, et al. Immunohistochemistry and microsatellite instability testing for selecting MLH1, MSH2 and MSH6 mutation carriers in hereditary non-polyposis colorectal cancer. Oncology Reports. 2004; 12: 621-629. Kets CM, et al. Unfavorable pathological characteristics in familial colorectal cancer with low-level microsatellite instability. Modern Pathology.
- Page 21 Om du använder dessa produkter i kombination med det automatiska BOND-systemet (som innefattar systemen Leica BOND-MAX och Leica BOND-III) minskar du risken för mänskliga misstag och de oundvikliga variationer som blir resultatet av individuell reagensutspädning och manuell pipettering och reagensanvändning.
- Page 22 ögonen, slemhinnorna och övre luftvägarna. Bär engångshandskar vid hantering av reagens. • Du kan få en kopia av materialsäkerhetsdatabladet genom att kontakta en lokal distributör eller Leica Biosystems regionkontor eller också på Leica Biosystems webbplats, www.LeicaBiosystems.com •...
- Page 23 Caldes T, et al. Immunohistochemistry and microsatellite instability testing for selecting MLH1, MSH2 and MSH6 mutation carriers in hereditary non-polyposis colorectal cancer. Oncology Reports. 2004; 12: 621-629. Kets CM, et al. Unfavorable pathological characteristics in familial colorectal cancer with low-level microsatellite instability. Modern Pathology.
- Page 24 Αραίωση και ανάμειξη Το πρωτογενές αντίσωμα MSH6 (Mismatch Repair Protein) (EP49) έχει αραιωθεί ιδανικά για χρήση στο σύστημα BOND (περιλαμβάνει το σύστημα Leica BOND-MAX και το σύστημα Leica BOND-III). Δεν απαιτείται ανασύσταση, ανάμειξη, αραίωση ή τιτλοποίηση αυτού του αντιδραστηρίου. Υλικά που απαιτούνται αλλά δεν παρέχονται...
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Page 25: Αντιμετώπιση Προβλημάτων
Το πρωτογενές αντίσωμα MSH6 (Mismatch Repair Protein) (EP49) αναπτύχθηκε για χρήση στο αυτοματοποιημένο σύστημα BOND (περιλαμβάνει το σύστημα Leica BOND-MAX και το σύστημα Leica BOND-III) σε συνδυασμό με το σύστημα ανίχνευσης BOND Polymer Refine Detection. Το συνιστώμενο πρωτόκολλο χρώσης για το πρωτογενές αντίσωμα MSH6 (Mismatch Repair Protein) (EP49) είναι το... - Page 26 Offit K. MSH6 Mutations in Hereditary Nonpolyposis Colon Cancer: Another Slice of the Pie. Journal of Clinical Oncology. 2004; 22: 4449-4451. Shia J, et al. Value of Immunohistochemical Detection of DNA Mismatch Repair Proteins in Predicting Germline Mutation in Hereditary Colorectal Neoplasms. The American Journal of Surgical Pathology. 2005; 29: 96-104. Shia J, et al.
- Page 27 Større end eller lig med 1,41 mg/l som angivet af ELISA. Fortynding og blanding MSH6 (Mismatch Repair Protein) (EP49) primære antistof er optimalt fortyndet til anvendelse med BOND-systemet (herunder Leica BOND- MAX-systemet og Leica BOND-III-systemet). Genopløsning, blanding, fortynding eller titrering af dette reagens er ikke nødvendig.
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Page 28: Fejlfinding
øjne, slimhinder og øvre luftveje. Brug engangshandsker ved håndtering af reagenser. • Hvis du ønsker et eksemplar af sikkerhedsdatabladet, kan du kontakte din lokale forhandler eller regionskontoret til Leica Biosystems, eller du kan besøge Leica Biosystems’ hjemmeside på www.LeicaBiosystems.com •... - Page 29 Caldes T, et al. Immunohistochemistry and microsatellite instability testing for selecting MLH1, MSH2 and MSH6 mutation carriers in hereditary non-polyposis colorectal cancer. Oncology Reports. 2004; 12: 621-629. Kets CM, et al. Unfavorable pathological characteristics in familial colorectal cancer with low-level microsatellite instability. Modern Pathology.
- Page 30 Groter dan of gelijk aan 1,41 mg/l zoals bepaald door ELISA. Verdunnen en mengen MSH6 (Mismatch Repair Protein) (EP49) primair antilichaam is optimaal verdund voor gebruik op het BOND-systeem (waaronder het Leica BOND-MAX-systeem en het Leica BOND-III-systeem). Reconstitutie, menging, verdunning of titratie van dit reagens is niet nodig.
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Page 31: Probleemoplossing
Draag wegwerphandschoenen bij het hanteren van reagentia. • Een kopie van het veiligheidsinformatieblad kunt u verkrijgen bij uw lokale distributeur of het regionale kantoor van Leica Biosystems of via de website van Leica Biosystems op www.LeicaBiosystems.com •... - Page 32 Shia J, et al. Immunohistochemistry as First-line Screening for Detecting Colorectal Cancer Patients at Risk for Hereditary Nonpolyposis Colorectal Cancer Syndrome: A 2-antibody Panel May be as Predictive as a 4-antibody Panel. The American Journal of Surgical Pathology. 2009; 33: 1639-1645. Berends MJ, et al.
- Page 33 MSH6 (Mismatch Repair Protein) (EP49) binde seg til snittet, for deretter å visualisere bindingsprosessen ved hjelp av reagensene som brukes i deteksjonssystemet. Ved å bruke disse produktene i kombinasjon med det automatiserte BOND-systemet (herunder Leica BOND-MAX-systemet og Leica BOND-III-systemet) reduseres muligheten for menneskelig feil og iboende variabilitet som følge av individuell reagensfortynning, manuell pipettering og reagenspåføring.
- Page 34 Produktspesifikke begrensninger MSH6 (Mismatch Repair Protein) (EP49) har blitt optimalisert hos Leica Biosystems til bruk med BOND Polymer Refine Detection og BOND-hjelpereagenser. Brukere som avviker fra de anbefalte testprosedyrene, må ta ansvaret for tolkningen av pasientresultatene under disse forholdene.
- Page 35 Caldes T, et al. Immunohistochemistry and microsatellite instability testing for selecting MLH1, MSH2 and MSH6 mutation carriers in hereditary non-polyposis colorectal cancer. Oncology Reports. 2004; 12: 621-629. Kets CM, et al. Unfavorable pathological characteristics in familial colorectal cancer with low-level microsatellite instability. Modern Pathology.
- Page 36 Repair Protein Panel) (EP49) seksiyona bağlanmasının beklenmesi, ardından teşhis sisteminde sağlanan reaktifler yardımıyla bu bağlanmanın görüntülenmesiyle elde edilir. Bu ürünlerin otomatik BOND sistemi (Leica BOND-MAX sistemi ve Leica BOND-III sistemi) ile birlikte kullanılması bağımsız reaktif seyreltme, manüel pipetleme ve reaktif uygulama işlemlerinde meydana gelebilecek insan hataları...
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Page 37: Sorun Giderme
Kullanım Talimatları MSH6 (Mismatch Repair Protein) (EP49) primer antikoru BOND Polymer Refine Detection ile birlikte otomatik BOND sisteminde (Leica BOND-MAX sistemi ve Leica BOND-III sistemini içerir) kullanılmak üzere geliştirilmiştir. MSH6 (Mismatch Repair Protein) (EP49) primer antikor için önerilen boyama protokolü IHC Protocol F’tir. BOND Epitope Retrieval Solution 2 ile 20 dakika ısı indüklü epitop alımı önerilir. - Page 38 Caldes T, et al. Immunohistochemistry and microsatellite instability testing for selecting MLH1, MSH2 and MSH6 mutation carriers in hereditary non-polyposis colorectal cancer. Oncology Reports. 2004; 12: 621-629. Kets CM, et al. Unfavorable pathological characteristics in familial colorectal cancer with low-level microsatellite instability. Modern Pathology.
- Page 39 с участъка, след което това свързване се визуализира, като се използват реагентите, предоставени в системата за откриване. Употребата на тези продукти заедно с автоматизираната система BOND (включва системите Leica BOND-MAX и Leica BOND-III) намалява възможността от човешка грешка и присъщата изменчивост в резултат на отделно разреждане на реактиви, ръчно...
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Page 40: Допълнителна Информация
конвенционалната хистопатология с използване на неимунологични хистохимични оцветявания. Специфични ограничения на продукта Продуктът MSH6 (Mismatch Repair Protein) (EP49) е оптимизиран от Leica Biosystems за употреба с BOND Polymer Refine Detection и спомагателните реагенти BOND. Потребителите, които се отклоняват от препоръчаните процедури за тестване, трябва... - Page 41 Offit K. MSH6 Mutations in Hereditary Nonpolyposis Colon Cancer: Another Slice of the Pie. Journal of Clinical Oncology. 2004; 22: 4449-4451. Shia J, et al. Value of Immunohistochemical Detection of DNA Mismatch Repair Proteins in Predicting Germline Mutation in Hereditary Colorectal Neoplasms. The American Journal of Surgical Pathology. 2005; 29: 96-104. Shia J, et al.
- Page 42 Ha ezeket a termékeket automata BOND rendszerrel együtt használják (így a Leica BOND-MAX rendszerrel vagy a Leica BOND-III rendszerrel), csökken az emberi hibák lehetősége, és mérsékelhetők az egyes reagensek hígításából, a manuális pipettázásból és a reagensek alkalmazásából származó eredendő eltérések.
- Page 43 A MSH6 (Mismatch Repair Protein) (EP49) elsődleges antitest automata BOND rendszerrel (így a Leica BOND-MAX rendszerrel vagy a Leica BOND-III rendszerrel) és a BOND Polymer Refine Detection kittel való együttes használatra lett kifejlesztve. A MSH6 (Mismatch Repair Protein) (EP49) elsődleges antitesthez javasolt festési protokoll az IHC Protocol F. A hőindukált epitópfeltáráshoz BOND Epitope Retrieval Solution 2 oldat 20 percig tartó...
- Page 44 Caldes T, et al. Immunohistochemistry and microsatellite instability testing for selecting MLH1, MSH2 and MSH6 mutation carriers in hereditary non-polyposis colorectal cancer. Oncology Reports. 2004; 12: 621-629. Kets CM, et al. Unfavorable pathological characteristics in familial colorectal cancer with low-level microsatellite instability. Modern Pathology.
- Page 45 în sistemul de detecție. Utilizarea acestor produse, în combinație cu sistemul automat BOND (care include sistemul Leica BOND-MAX și sistemul Leica BOND-III), reduce posibilitatea producerii erorii umane și variabilitatea inerentă care rezultă din diluția individuală a reactivului, pipetarea manuală și aplicarea reactivului.
- Page 46 Restricții specifice produsului MSH6 (Mismatch Repair Protein) (EP49) a fost optimizat la Leica Biosystems pentru utilizarea cu BOND Polymer Refine Detection și cu reactivii auxiliari BOND. Utilizatorii care se abat de la procedurile de testare recomandate trebuie să accepte responsabilitatea pentru interpretarea rezultatelor pacientului în aceste circumstanțe.
- Page 47 Caldes T, et al. Immunohistochemistry and microsatellite instability testing for selecting MLH1, MSH2 and MSH6 mutation carriers in hereditary non-polyposis colorectal cancer. Oncology Reports. 2004; 12: 621-629. Kets CM, et al. Unfavorable pathological characteristics in familial colorectal cancer with low-level microsatellite instability. Modern Pathology.
- Page 48 Разведение и смешивание Первичное антитело MSH6 (Mismatch Repair Protein) (EP49) имеет оптимальное разведение для применения в системе BOND (включающей системы BOND-MAX и BOND-III компании Leica). Этот реактив не нуждается в восстановлении, смешивании, разведении или титровании. Необходимые материалы, не входящие в комплект поставки...
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Page 49: Меры Предосторожности
Инструкция по применению Первичное антитело MSH6 (Mismatch Repair Protein) (EP49) было разработано для использования в автоматизированной системе BOND (включающей системы BOND-MAX и BOND-III компании Leica) в сочетании с BOND Polymer Refine Detection. Рекомендуемым протоколом иммуногистохимического окрашивания с использованием MSH6 (Mismatch Repair Protein) (EP49) является... - Page 50 Bibliography Clinical Laboratory Improvement Amendments of 1988, Final Rule 57 FR 7163 February 28, 1992. Villanova PA. National Committee for Clinical Laboratory Standards (NCCLS). Protection of laboratory workers from infectious diseases transmitted by blood and tissue; proposed guideline. 1991; 7(9). Order code M29-P. Bancroft JD and Stevens A.
- Page 51 Rozcieńczanie i mieszanie. Przeciwciało pierwszorzędowe MSH6 (Mismatch Repair Protein) (EP49) jest optymalnie rozcieńczone pod kątem użycia w systemie BOND (w tym systemów Leica BOND-MAX i Leica BOND-III). W przypadku tego odczynnika nie jest konieczne dodawanie wody, mieszanie, rozcieńczanie ani miareczkowanie.
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Page 52: Środki Ostrożności
Przeciwciało pierwszorzędowe MSH6 (Mismatch Repair Protein) (EP49) zostało opracowane z myślą o zastosowaniu w automatycznym systemie BOND (obejmującym systemy Leica BOND-MAX i Leica BOND-III) w połączeniu z BOND Polymer Refine Detection. Zalecany protokół barwienia dla przeciwciała pierwszorzędowego MSH6 (Mismatch Repair Protein) (EP49) to IHC Protocol F. Zaleca się cieplne odmaskowywanie epitopu przy użyciu roztworu BOND Epitope Retrieval Solution 2 przez 20 minut. - Page 53 Shia J, et al. Immunohistochemistry as First-line Screening for Detecting Colorectal Cancer Patients at Risk for Hereditary Nonpolyposis Colorectal Cancer Syndrome: A 2-antibody Panel May be as Predictive as a 4-antibody Panel. The American Journal of Surgical Pathology. 2009; 33: 1639-1645. Berends MJ, et al.
- Page 54 Uporaba teh izdelkov, skupaj z avtomatiziranim sistemom BOND (vključuje sistem Leica BOND-MAX in sistem Leica BOND-III), zniža možnost človeške napake in variabilnosti, ki sama po sebi izhaja iz redčenja posameznega reagenta, ročnega pipetiranja in nanosa reagenta.
- Page 55 Koncentracija konzervansa ProClin™ 950 je 0,35 %. Vsebuje aktivno učinkovino 2-metil-4-izotiazolin-3-on in lahko povzroči draženje kože, oči, sluznice ter zgornjih dihalnih poti. Kadar delate z reagenti, nosite rokavice za enkratno uporabo. • Kopijo varnostnega lista lahko dobite pri lokalnem distributerju ali regionalni pisarni družbe Leica Biosystems ali na spletnem mestu www.LeicaBiosystems.com. •...
- Page 56 Caldes T, et al. Immunohistochemistry and microsatellite instability testing for selecting MLH1, MSH2 and MSH6 mutation carriers in hereditary non-polyposis colorectal cancer. Oncology Reports. 2004; 12: 621-629. Kets CM, et al. Unfavorable pathological characteristics in familial colorectal cancer with low-level microsatellite instability. Modern Pathology.
- Page 57 Potřebný materiál, který není součástí dodávky Úplný seznam materiálů potřebných ke zpracování vzorku a k imunohistochemickému barvení pomocí systému BOND system (včetně systému Leica BOND-MAX system a Leica BOND-III system) je uveden v bodě „Použití reagencií BOND“ v uživatelské dokumentaci BOND.
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Page 58: Řešení Problémů
Primární protilátka MSH6 (Mismatch Repair Protein) (EP49) byla vyvinuta k použití v automatickém systému BOND system (včetně systému Leica BOND-MAX a Leica BOND-III) v kombinaci se soupravou BOND Polymer Refine Detection. Protokol doporučeného barvení primární protilátky MSH6 (Mismatch Repair Protein) (EP49) je IHC Protocol F. Teplem indukované odmaskování epitopu se doporučuje s použitím roztoku BOND Epitope Retrieval Solution 2 po dobu 20 minut. - Page 59 Caldes T, et al. Immunohistochemistry and microsatellite instability testing for selecting MLH1, MSH2 and MSH6 mutation carriers in hereditary non-polyposis colorectal cancer. Oncology Reports. 2004; 12: 621-629. Kets CM, et al. Unfavorable pathological characteristics in familial colorectal cancer with low-level microsatellite instability. Modern Pathology.
- Page 60 Vyššia alebo rovnaká ako 1,41 mg/l podľa ELISA. Riedenie a miešanie Primárna protilátka MSH6 (Mismatch Repair Protein) (EP49) je optimálne zriedená na použitie v systéme BOND (zahŕňa systémy Leica BOND-MAX a Leica BOND-III). Rekonštitúcia, miešanie, riedenie ani titrácia tohto činidla nie sú potrebné.
- Page 61 Špecifické obmedzenia pre tento výrobok MSH6 (Mismatch Repair Protein) (EP49) bol v spoločnosti Leica Biosystems optimalizovaný na použitie so systémom BOND Polymer Refine Detection a pomocnými činidlami BOND. Používatelia, ktorí sa odchýlia od odporúčaných testovacích postupov, musia akceptovať...
- Page 62 Caldes T, et al. Immunohistochemistry and microsatellite instability testing for selecting MLH1, MSH2 and MSH6 mutation carriers in hereditary non-polyposis colorectal cancer. Oncology Reports. 2004; 12: 621-629. Kets CM, et al. Unfavorable pathological characteristics in familial colorectal cancer with low-level microsatellite instability. Modern Pathology.
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