Warning H317 May cause an allergic skin reaction. P261 Avoid breathing dust/ fume/ gas/ mist/ vapours/ spray. P272 Contaminated work clothing should not be allowed out of the workplace. P280 Wear protective gloves. P333 + P313 If skin irritation or rash occurs: Get medical advice/ attention. P362 + P364 Take off contaminated clothing and wash it before reuse. P501 Dispose of contents/ container to an approved waste disposal plant. Contains: 26172-54-3 2-methyl-2H-isothiazol-3-one hydrochloride 55965-84-9 reaction mass of: 5-chloro-2-methyl-4-isothiazolin-3-one [EC no. 247-500-7] and 2-methyl-2H -isothiazol-3-one [EC no. 220-239-6] (3:1)
Negative Reagent Control 11.5 mL, ready-to-use
DAB Buffered Substrate 31 mL
DAB Chromogen 0.85 mL, 3,3’-diaminobenzidine chromogen solution.
Danger H314 Causes severe skin burns and eye damage. H341 Suspected of causing genetic defects. H350 May cause cancer. P201 Obtain special instructions before use. P280 Wear protective gloves/ protective clothing/ eye protection/ face protection. P303 + P361 + P353 IF ON SKIN (or hair): Take off immediately all contaminated clothing. Rinse skin with water. P304 + P340 + P310 IF INHALED: Remove person to fresh air and keep comfortable for breathing. Immediately call a POISON CENTER/doctor. P305 + P351 + P338 + P310 IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. Immediately call a POISON CENTER/doctor. P308 + P313 IF exposed or concerned: Get medical advice/ attention. Contains 868272-85-9 3,3′-Diaminobenzidine tetrahydrochloride hydrate
Epitope Retrieval Solution 10 x 500 mL, 100 mmol/L Tris buffer pH 9 containing 10 mmol/L EDTA and 15 mmol/L sodium azide (NaN3).
",
"Language": "en",
"Country": "XG",
"Code": "Content"
},
{
"Name": "Background Information",
"Value": "The CINtec® Histology Kit is based on a mouse monoclonal antibody (clone E6H4®) directed against human p16INK4a protein.
The p16INK4a protein is a cyclin-dependent kinase inhibitor which plays a major role in the regulation of the eukaryotic cell cycle. It is part of the retinoblastoma protein (pRB)-mediated control of the G1-S-phase transition, and it triggers cell cycle arrest in the course of cellular differentiation processes. In terminally differentiated epithelial cells, p16INK4a is expressed at levels typically not detectable by immunohistochemistry.
In various tumor entities, the p16INK4a gene was found to be functionally inactivated by gene mutation or promoter hypermethylation. This inactivation of the p16INK4a tumor suppressor gene has been shown to contribute to cell-cycle dysregulation and to loss of control of cell proliferation.
In replication competent cervical epithelial cells however, where high-risk type Human Papillomavirus (HR-HPV) oncoproteins have initiated the cellular transformation process, p16INK4a expression has been shown to be highly up-regulated 1,2. This strong over-expression of p16INK4a has been closely linked at the molecular level to the activity of the E7 oncoproteins from HR-HPV. The p16INK4a over-expression was shown to reflect the E7 oncoprotein-mediated inactivation of the functional complex between pRB and transcription factor E2F, which is one of the key events during the HR-HPV induced cellular transformation3.
There are numerous studies in the published literature reporting that over-expression of the p16INK4a protein was immunohistochemically observed in a very high proportion of cases of high-grade pre-cancerous cervical dysplasia (i.e. 80 – 100% of CIN2 lesions, and virtually all CIN3 lesions) and invasive cancers. Low-grade cervical intra-epithelial lesions (CIN1) have been demonstrated to show p16INK4a over-expression at variable rates, typically within a range of 30 – 60%.1,2, 4-16
Interpretation of the results must take into consideration the fact that p16INK4a is a cellular protein that may be expressed at detectable levels in cervical high-grade dysplastic lesions and cervical cancers as well as in some conditions not associated with cervical dysplasia, albeit at differing levels and with different patterns of expression. Histological tissue preparations have intact tissue morphology to aid in the interpretation of p16INK4a positivity of the cervical lesion. A diffuse staining pattern, i.e. a continuous staining of cells of the basal and parabasal cell layers, with or without staining of cells of superficial cell layers, has been suggested to be rated as a positive test result for p16INK4a over-expression. This staining pattern was shown to provide the highest level of both sensitivity and specificity for high-grade CIN 1,4,5. In contrast, a focal staining pattern (staining of isolated cells or small cell clusters, i.e. non-continuous staining, particularly not of the basal and parabasal cells) as well as lack of any immunoreactivity is regarded as a negative test result for p16INK4a over-expression. 1,4,5
The interpretation of slides stained for p16INK4a using the CINtec® Histology Kit should be performed in conjunction with H&E-stained slides prepared from the same cervical tissue specimen. The additional information provided by the CINtec®-stained slides should be combined with the preliminary morphology-based diagnosis established on the H&E-stained slides in order to create a final diagnosis.
1. Klaes R, Friedrich T, Spitkovsky D, Ridder R, Rudy W, Petry U, Dallenbach-Hellweg G, Schmidt D, and von Knebel Doeberitz M. Overexpression of p 16INK4a as a specific marker for dysplasia and neoplastic epithelial cells of the cervix uteri. Int J Cancer 2001, 92(2):276-84 2. Sano T, Oyama T, Kashiwabara K, Fukuda T, and Nakajima T. Expression status of p16 protein is associated with human papillomavirus oncogenic potential in cervical and genital lesions. Am J Pathol 1998, 153(6):1741-8 3. von Knebel Doeberitz M. New markers for cervical dysplasia to visualise the genomic chaos created by aberrant oncogenic papillomavirus infections. Eur J Cancer 2002, 38(17):2229-42 4. Klaes R, Benner A, Friedrich T, Ridder R, Herrington S, Jenkins D, Kurman RJ, Schmidt D, Stoler M, and von Knebel Doeberitz M. p16INK4a immunohistochemistry improves interobserver agreement in the diagnosis of cervical intraepithelial neoplasia. Am J Surgical Pathol 2002, 26(11):1389-99 5. Wang SS, Trunk M, Schiffman M, Herrero R, Sherman ME, Burk RD Hildesheim A, Concepcion Bratti M, Wright TC, Rodriguez AC, Chen S, Reichert A, von Knebel Doeberitz C, Ridder R, and von Knebel Doeberitz M. Validation of p16INK4a as a marker of oncogenic human papillomavirus infection in cervical biopsies from a population-based cohort in Costa Rica. Cancer Epidemiol Biomarkers Prev 2004, 13(8):1355-60 6. Agoff SN, Lin P, Morihara J, Mao C, Kiviat NB, and Koutsky LA. p16INK4a expression correlates with degree of cervical neoplasia: a comparison with Ki-67 expression and detection of high-risk HPV types. Modern Pathol 2003, 16(7):665-73 7. Negri G, Egarter-Vigl E, Kasal A, Romano F, Haitel A, and Mian C. p16INK4a is a useful marker for the diagnosis of adenocarcinoma of the cervix uteri and its precursors: an immunohistochemical study with immuncytochemical correlations. Am J Surg Pathol 2003, 27(2):187-93 8. Negri G, Vittadello F, Romano F, Kasal A, Rivasi F, Girlando S, Mian C, and Egarter-Vigl E. p16INK4a expression and progression risk of low-grade intraepithelial neoplasia of the cervix uteri. Virchows Arch 2004, 445(6):616-20 9. Schorge JO, Lea JS, Elias KJ, Rajanbabu R, Coleman RL, Miller DS, and Ashfaq R. p16INK4a as molecular biomarker of cervical adenocarcinoma. Am J Obstet Gynecol 2004, 190(3):668-73 10. Christal JL, and Valente PT. The utility of p16 immunohistochemistry in the diagnosis of cervical intraepithelial neoplasia. Pathol Case Rev 2006, 11(3):117-20 11. Kong CS, Balzer BL, Troxell ML, Patterson BK, and Longacre TA. p16INK4a Immunohistochemistry is Superior to HPV In Situ Hybridization for the Detection of High-risk HPV in Atypical Squamous Metaplasia. Am J Surg Pathol 2007, 31(1):33-43 12. Nucci MR, and Crum CP. Redefining Early Cervical Neoplasia: Recent Progress. Adv Anat Pathol 2007, 14(1):1-10 13. Ishikawa M, Fujii T, Saito M, Nindl I, Ono A, Kubushiro K, Tsukazaki K, Mukai M, and Nozawa S. Overexpression of p16INK4a as an indicator for human papillomavirus oncogenic activity in cervical squamous neoplasia. Int J Gynecol Cancer 2006, 16(1):347-53 14. Kalof AN, Evans MF, Simmons-Arnold L, Beatty BG, and Cooper K. p16INK4a Immunoexpression and HPV In Situ Hybridization Signal Patterns Potential Markers of High-Grade Cervical Intraepithelial Neoplasia. Am J Surg Pathol 2005, 29(5):674-9 15. Ansari-Lari MA, Staebler A, Zaino RJ, Shah KV, and Ronnett BM. Distinction of Endocervical and Endometrial Adenocarcinomas: Immunohistochemical p16 Expression Correlated With HumanPapillomavirus (HPV) DNA Detection. Am J Surg Pathol 2004, 28(2):160-7 16. Regauer S, and Reich O. CK17 and p16 expression patterns distinguish (atypical) immature squamous metaplasia from high-grade cervical intraepithelial neoplasia (CIN III). Histopathology 2007, 50(5):629-35",
"Language": "en",
"Country": "XG",
"Code": "Background Information"
},
{
"Name": "Intended Use",
"Value": "Pour utilisation en diagnostic in vitro.
Le CINtec® Histology Kit est un test d’immunohistochimie permettant la détection qualitative de l’antigène p16INK4a dans des coupes de tissus préparées à partir de biopsies cervicales fixées au formol et incluses en paraffine.
Il est destiné à être utilisé en conjonction avec des lames colorées en H&E, issues des mêmes échantillons de tissus cervicaux. Il est une aide pour améliorer la précision diagnostique et la concordance inter-observateurs dans les néoplasies intraépithéliales cervicales de haut grade.
Ce test est destiné à une utilisation manuelle ou à une utilisation sur les instruments Autostainer.
Ce test doit être interprété par un anatomopathologiste qualifié à la lumière des examens histologiques, des informations cliniques pertinentes et des contrôles appropriés.",
"Language": "fr",
"Country": "XG",
"Code": "Intended Use"
},
{
"Name": "Principle",
"Value": "The CINtec® Histology Kit contains a set of reagents for the immunohistochemical detection of the p16INK4a antigen. The Kit is designed to perform a two-step immunohistochemical staining procedure for formalin-fixed, paraffin-embedded tissue specimens obtained from cervical biopsies. For the detection of the antigen, a primary monoclonal mouse antibody clone E6H4® directed to human p16INK4a protein is used.
A ready-to-use visualization reagent comprising a polymer reagent conjugated with horseradish peroxidase and goat anti-mouse Fab’ antibody fragments is used. The Visualization Reagent has been subjected to solid-phase absorption to eliminate cross reactivity with human immunoglobulins. The chromogen reaction is based on horseradish peroxidase-mediated conversion of a DAB chromogen to a visible reaction product at the antigen site. After counterstaining, the specimen may be cover-slipped and the results may be evaluated by light microscopy inspection.",
"Language": "en",
"Country": "XG",
"Code": "Principle"
},
{
"Name": "Product Purpose",
"Value": "Pour utilisation en diagnostic in vitro.
Le CINtec® Histology Kit est un test d’immunohistochimie permettant la détection qualitative de l’antigène p16INK4a dans des coupes de tissus préparées à partir de biopsies cervicales fixées au formol et incluses en paraffine.
Il est destiné à être utilisé en conjonction avec des lames colorées en H&E, issues des mêmes échantillons de tissus cervicaux. Il est une aide pour améliorer la précision diagnostique et la concordance inter-observateurs dans les néoplasies intraépithéliales cervicales de haut grade.
Ce test est destiné à une utilisation manuelle ou à une utilisation sur les instruments Autostainer.
Ce test doit être interprété par un anatomopathologiste qualifié à la lumière des examens histologiques, des informations cliniques pertinentes et des contrôles appropriés.",
"Language": "fr",
"Country": "XG",
"Code": "Product Purpose"
}
]
}
}
]
}
CINtec® Histology Kit
CE
IVDFor in vitro diagnostic use.
Description
Detailed Specifications
Référence produit
Compatible Instruments
...
...
Documents techniques
Accéder aux documents disponibles dans votre pays
Vous êtes actuellement sur le site Web mondial. Modifiez la localisation pour afficher les options de langues ou accédez à eLabDoc, le référentiel des documents des produits.
