The cintec plus cytology test is an objective triage solution for managing hpvpositive or abnormal pap cytology primary screening results and helps address some of the limitations of traditional pap cytology. The cintec plus cytology test is a powerful technology in the fight against cervical disease and is an important component of the roche cervical cancer prevention portfolio, said ann costello, head, roche tissue diagnostics. Request pdf clinical utility of cintec plus triage in equivocal cervical cytology and hpv primary screening objectives. In the nilm group tested with cintec plus n 59, one sample was tested positive for cintec plus and 3 samples were invalid. Switzerlandbased roche has gained approval from the china food and drug administration for its cintec plus cytology test, intended to enhance the detection of human papillomavirus. A ground breaking concept developed by cintec international comprises a range of self inflating, waterfilled structures which are capable of providing a high level of protection to people and property against a range of terrorist devices, including those containing chemical, biological and radiological agents. Pdf role of p16ki67 dual immunostaining in detection of.
Paratec parapet wall strengthening cintec anchors are an effective method for strengthening parapet walls from stress and impact. Evaluation of p16ki67 dualstained cytology as triage test for high. Introduction the optimal methods for screening hivinfected women, especially for those living in subsaharan africa, for cervical precancer and early cancer has yet to be established. Cintec international brochure by cintec international issuu. Cytojournal immunocytochemical expression of ki67p16 in.
With each project and application, from highrise buildings to historical structures, the blastec system provides an innovative, costeffective solution to total building protection. A deep awareness of emerging market trends, an ongoing commitment to research and development, a continuing quest for quality, a shared sense of community with our customers, a dedication to service these are the principles that have guided cintecsince its foundation. The diagnosis of glandular lesions of the cervix uteri is often difficult 1 because of inflammatory or hyperplastic changes that may mimic neoplasia. At the end of your monthly term, you will be automatically renewed at the promotional monthly subscription rate until the end of the promo period, unless you elect to change or. Cintec sock anchors the cintec anchor system is a versatile method of structural reinforcement tailored to meet the specific strengthening and repair requirements, without the.
Roche will seek us fda premarket approval pma based on. Usefulness of cintec plus p16 ink4a ki67 doublestaining. Email article add to my reading list export citation create citation alert cited by in scopus. Clinical utility of cintec plus triage in equivocal cervical cytology. Clinical utility of cintec plus triage in equivocal. The sensitivity of cintec plus for u or s hg cin was 91% in the asc group and 100% in the lsil group, while the corresponding specificities were 61 and 43%, respectively. However, these solutions are not always the most aesthetically pleasing. Methods and analysis a convenience sample of 5000 rwandan women, ages 3054 years and living with hiv infection, is being consented and enroled into a crosssectional study of cervical cancer screening. Of the neoplastic samples, 7 were excluded because of insufficient residual cellularity or loss of neoplastic cells. The cintec plus cytology kit is approved for use in europe to identify p16 and ki67 proteins in cervical pap test samples. The cobas hpv test was positive for all cin and cancer samples except two cin3. Cintec rail digital brochure by cintec international issuu. The cintec plus cytology kit roche mtm laboratories ag, mannheim, germany was used according to the instructions of the manufacturer. Dualstaining for p16ki67 was performed at a central laboratory roche mtm laboratories using the cintec plus cytology kit roche mtm laboratories ag, mannheim, germany according to the instructions of the manufacturer.
P16ki67 dual staining cintec plus test researchgate. Our innovative anchors provide a seamless solution for historic. Prevent cervical cancer roche cervical cancer screening. Cintec plus triage alone and combined with hpv 1618 genotyping was performed on. This system can be used on a variety of buildings and structures. Jun 27, 2011 the cintec plus system is an immunohistochemical cocktail composed of antibodies against p16 ink4a surrogate of hpv infection and ki. All samples were stained with cintec plus p16ki67 double stain. Our portfolio helps identify highrisk genotypes together with individual results for the most aggressive hpv genotypes 1618, identify those with transforming lesions p16ki67 positive who need colposcopy, and. Cintec sock anchors the cintec anchor system is a versatile method of structural reinforcement tailored to meet the specific strengthening and repair requirements, without the need for external and internal steel bracing. The cintec plus system is an immunohistochemical cocktail composed of antibodies against p16ink4a surrogate of hpv infection and ki67 proliferation marker meant to improve the sensitivity and specificity for detecting highgrade dysplasia hgd.
Cintec plus triage alone and combined with hpv 1618 genotyping was. Cintec plus showed modest sensitivity 64% and specificity 53% in identifying the presence of hgd at surgical biopsy. Verification of doubtful pap smear results of women. Placement and internship, seminars and workshops, student activities.
Roche roche acquires mtm laboratories ag, expanding. Triaging hpvpositive women with p16ki67 dualstained cytology. The kit contains a readytouse antibody cocktail lot no. Cintec plus cytology test provides improved diagnostic and early intervention of precancerous cervical diseases. Cervical cancer prevention from roches fdaapproved cytology test. Cintec plus immunocytochemistry as a tool for the cytologic. Roche wins cfda approval for cintec plus cytology test. Cintec approved installers the cintec anchor system is a versatile method of structural reinforcement bespoke to the specific strengthening and structural repair requirements of individual projects. In the us, cintec plus is available for research use only.
Apr 05, 2017 patients for followup or intervention. Roche wins cfda approval for cintec plus cytology test 2016. Oct 22, 2019 each woman provided both cervical and vaginal specimens that were tested for highrisk human papillomavirus hrhpv dna using the xpert hpv test cepheid at point of care. Positive and negative predictive values for hgd were 28% and 83%, respectively. Evaluation of cintec plus testing as an adjunctive test in. References to cintec in this document are to the companies cintec international ltd uk, cintec america inc. Psychosocial interventions for anxiety and depression in adult. When inserting the anchor ensure that the injection tube is towards the top of the borehole never force or twist the anchor into the hole. Structural reinforcement anchoring systems cintec worldwide. Vehicle weight to 40 tomes plus hb or special loading. To evaluate the cintec plus assay mtm laboratories, a new immunocytochemical method for the simultaneous detection of p16 ink4a and ki67, in liquidbased cervicovaginal cytology, investigating the association of the dual staining with hpv infection and genotyping as well as cytological and histological abnormalities. Improving consistency in the diagnosis of cervical pre.
Evaluation of p16ki67 dualstain cytology performed on. The blastec system is a complete analysis, design and installation process that enables structures to withstand the adverse effects of blast loads. The study confirmed that the cintec plus cytology test had significantly higher specificity and was more effective overall than the hc2 hpv test in identifying women with precancerous lesions. Evaluation of cintec plus testing as an adjunctive test. A subset of paired cervical and vaginal specimens n 243 were selected to undergo cintec plus roche p16ki67 dualstain cytology and liquidbased cytology lbc. Cintec plus immunocytochemistry effective triage tool for. Evaluation of p16ki67 dualstain cytology performed on self. While cervical cytology is accepted triage for human papillomavirus. Thinprep t2000 processors hologic were used for slide preparation. Cintec plus immunocytochemistry as a tool for the cytologic diagnosis of glandular lesions of the cervix uteri article in american journal of clinical pathology 85. Roche has secured fda approval for its cintec plus cytology test that provides information for hpvpositive women risk of developing. In the presence of dysplasia, a red chromogen marks ki.
Old, historic and listed buildings and monuments often require structural repairs, having deteriorated over time. Pdf the dual immunostaining of cervical cytology p16ki67 which combines a high sensitivity with. F07342f07348, with mouse monoclonal antibody directed to human p16ink4a protein and rabbit monoclonal antibody directed against human ki67 protein. Cintec approved installers protectahome over 38 years. When compared with pap smear, the cintec plus cytology test is significantly more effective in detecting cervical precancer. With each project and application, from highrise buildings to historical structures, the blastec system provides an. This subset n 243 pairs comprised cervical and vaginal specimen pairs that were concordant hrhpvpositive n 98, 40. Usefulness of cintec plus p16 ink4a ki67 doublestaining in cytological screening of cervical cancer article in acta cytologica 555. Cytology test is a qualitative immunocytochemical assay intended for the simultaneous detection of the p16. Cytojournal immunocytochemical expression of ki67p16. Results fiftyfive pairs 22% were excluded from further analysis because the smears were not assessable. Get adobe acrobat pdf pack at the reduced monthly subscription price of mo plus applicable taxesvatgst through the adobe store. Cintec sock anchors anderton structural repair services. The object of this training course is to give the installer a complete knowledge of the cintec anchoring system.
More than 500,000 new cases of cervical cancer are diagnosed each year worldwide. The cintec plus cytology kit roche is an immunocytochemical dual color method for cell markers p16 and ki67. The clinical performance of cintec plus triage alone and combined with hpv 1618 genotyping and its potential to reduce immediate colposcopy referrals were evaluated. Cintec, a structural masonry expert headquartered in newport, wales, has undertaken vital restoration work on one of the worlds most prestigious government buildings, the. Clinical value of roches cintec plus cytology test. Cintec plus cytology is powered by dualstain biomarker technology that detects the simultaneous presence within a single cell of two biomarkers. Listed below are blastec blast protection and blast mitigation for masonry structures contact list. Pdf role of p16ki67 dual immunostaining in detection. Unique dualbiomarker technology makes you certain about the presence of transforming hpv infection. The approval was based on a study that demonstrated greater overall performance of combined sensitivity and specificity of the cintec plus cytology test in determining which women are more susceptible to. In older women, combining the cintec plus test with hpv dna testing would make a lot of sense. These were installed through the cracks to reconnect the inner reinforced brickwork to the original.
Cintec news updates on the latest events and seminars in. A triage tool for cervical pap smears with atypical squamous cells of undetermined significance and low grade squamous intraepithelial lesion asc. Cintec audio visual audio visual lighting control data. The detection rate of cintec plus was 100% for all valid cin and cancer cases two invalid samples. Performance of a dna methylation marker panel using liquidbased. The cintec histology test is used to confirm the presence or absence of highgrade cervical disease in women who have had a tissue biopsy. Roche wins cfda approval for cintec plus cytology test march 8, 2016 switzerlandbased roche has gained approval from the china food and drug administration for its cintec plus cytology test, intended to enhance the detection of human papillomavirus. The sensitivity and specificity of cintec plus for u or s hg cin in both groups combined were 97 and 53%, respectively. The cintec plus cytology test was developed to help identify those hpv infections that may lead to cancer and distinguish them from those that will not. Cintec plus roche diagnostics, mannheim, germany, which detects the two biomarkers p16 and ki67 simultaneously by. Cintec supplied 108 stud and rebar stitching anchors ranging in length from 1 to 10 metres.
Cintec plus test could be very useful to identify those women with clinically significant precancers who may be missed by the lower sensitivity pap test. The cintec plus cytology test is not available as an in vitro diagnostic test in the united states. Offer starts on jan 8, 2020 and expires on sept 30, 2020. Roche improving consistency in the diagnosis of cervical. Each woman provided both cervical and vaginal specimens that were tested for highrisk human papillomavirus hrhpv dna using the xpert hpv test cepheid at point of care. Traditionally pattress type plates and tie bars were used to stabilise these structures, and repair the cracks in the walls. Cintec histology p16 immuno staining increases the accuracy and reliability of the diagnosis of high grade precancerous disease. Germany in vitro diagnostics market industry share 2023.
Merging creative thinking with solid engineering principles, our reinforcement anchoring systems have solved thousands of client problems worldwide. Clinical utility of cintec plus triage in equivocal cervical. Cintec plus is a helpful adjunct in identifying u or s hg cin when applied to surepath pap smears with asc or lsil. Repeat cytology, hrhpv testing, hpv genotyping, and cintec plus for all women.
Cintec plus was more specific than hr hpv testing and ki. A limited number of cintec plus cytology kits roche mtm laboratories, heidelberg, germany was available for this evaluation. The cintec histology test uses the p16 biomarker for a more. The accuracy of p16ki67 and hpv test in the detection of cin23. The cintec plus system is an immunohistochemical cocktail composed of antibodies against p16 ink4a surrogate of hpv infection and ki. At the end of your monthly term, you will be automatically renewed at the promotional monthly subscription rate until the end of the promo period, unless you elect to.
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