The New CervatecTM ELISA
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Cervatec™ ELISA is a novel test for Cervical Cancer Screening. It is intended to be used in addition to the Pap Test for women aged 35 and younger. This is the population of women who present with the highest rates of HR-HPV infection and as well harbour the majority of the high grade cervical disease. They create a clinical dilemma for screening which now can be addressed with Cervatec™.
Cervatec™ is based on the detection of p16, a cellular protein which is specifically up-regulated in the presence of cervical disease. The test provides a quantitative measurement of p16 levels in a patient's sample. The clinician receives either a positive (p16+) or negative (p16-) test result.
Clinical evidence
Cervatec™ is now available as a screening test for Cervical Cancer screening in order to increase significantly the sensitivity of to the Pap test. A large prospective study in Germany with more than 7.500 women (in the age of 35 and younger) and 90 study sites has shown that Cervatec™ alone has a sensitivity of 90% detecting CIN2+ as compared with the Pap Test alone having a sensitivity of 39%. The combination of Cervatec™ and the Pap Test would be expected to identify virtually 100% of the disease based on underlying epidemiology. Together, the two tests found all 62 of the biopsy confirmed CIN2+ cases in the study.
The finding of 62 high grade lesions (0,8% of the study population) correlates perfect with the known findings of true disease of 0,7 -0,8% in normal screening populations.
[click to enlarge]
When used in primary screening for cervical cancer, Cervatec™ increases the detection rate of high-grade cervical lesions. This population of women have both the highest prevalence of HPV infections and are the group where 60-70% of the high grade disease is established.
Cervatec™ ELISA adds significant sensitivity to the conventional PAP smear alone by bringing novel biomarker information from the cells of the cervix. This additional information allows clinicians to identify more women with existing disease which otherwise would have been missed by the Pap smear alone. This in turn allows appropriate treatment to be applied.
Information for the clinician
[click to enlarge]
Cervatec™ in combination with the Pap test adds significant more sensitivity and confidence to your Cervical Cancer screening. With this new test you can provide clear patient management.
PAP negative and p16 negative
Women should return to normal annual screening
PAP positive and p16 positive
Women should be sent to Colposcopy for further examination
PAP positive and p16 negative
In this case the Gynecologist should follow the current available guidelines regarding the PAP test result
PAP negative and p16 positive
These are the women where a majority of the high grade lesions were missed by the Pap test and thus the target for follow-up to find the disease. The clinician has three options to consider:
Conclusion
The high precision of Cervatec™, used in combination with the PAP test, results in a notable increase in the reliability of detecting severe lesions. This means greater certainty for the patient and for the doctor.
Technical information
Cervatec™ is an ELISA (enzyme-linked immunosorbent assay) Test for quantitative proof of the presence of the biomarker p16 INK4a in cervical smear material to improve the sensitivity for the early detection of cervical cancer and its precursors. The over-expression of the biomarker p16 is indicative of an oncogene transformation after persistent infection with high-risk (HR) types of human papilloma viruses
Cervatec™ ELISA is applied to cellular lysate, which can be easily obtained from the cervical smear. In this procedure the p16INK4a biomarker within the cellular lysate is bound by the highly specific antibody E6H4™ and the quantity of p16INK4a in the lysate is then indicated by a subsequent colour reaction using a second antibody to p16INK4a and a sandwich immunoassay design. The intensity of the colour reaction correlates to the quantity of the antigen and thus indicates the degree of oncogene transformation due to HR-HPV types. With this quantitative proof of the presence of p16INK4a, independent of the type of HR-HPV, Cervatec™ can actually indicate the possibility of existing disease instead of just the risk of HR-HPV infection.
Cervatec™ ELISA is based on two monoclonal antibodies for p16, including antibody clone E6H4™, which was specially developed by mtm laboratories and has been validated in more than 50 clinical studies. The Cervatec™ ELISA has been developed and is manufactured in compliance with GMP requirements and is CE labeled for in-vitro diagnostic use.
The ELISA kit includes all necessary ready to use reagents as well a set of standards and control reagents.
Intended Use
In-vitro assay for the quantitative determination of human p16INK4a protein in lysed samples from the cervix uteri. It is indicated to be used in conjunction with conventional Pap cytology testing as an aid to increase the sensitivity for the detection of high-grade cervical intraepithelial neoplasia.
The Cervatec™ p16INK4a ELISA should be used in conjunction with clinical information derived from other diagnostic and screening tests, physical examinations, and full medical history in accordance with appropriate patient management procedures.
Intellectual property
The Cervatec™ ELISA kit is based on technology developed by mtm laboratories AG, Germany and based on European Patents 1 507 148, 1 092 155, 0 665 886 and U.S. Patent 7,306,926 as well as further national patents.
Literature
The literature is quite extensive regarding the performance of p16INK4a across a wide range of clinical challenges in cervical biopsy diagnosis. CINtec® Histology in conjunction with H&E has been shown to increase both the accuracy and inter-observer agreement for diagnosing high grade CIN lesions and cervical cancer.
Cervatec™ ELISA Manual
As a special service mtm AG will send you the Cervatec™ ELISA Manual print out if you wish. Just click here and fill in the order form. mtm laboratories AG will send the print out shortly after receiving your order to the address provided in the order form.
Ordering
The Cervatec™ ELISA kit is available in Germany through mtm's direct operations and orders can be placed directly through this website.
Downloads
Cervatec™ Material Safety Data Sheet ELISA Kit
Cervatec™ Material Safety Data Sheet Sampling Vials
Cervatec™ Instructions for Use ELISA Kit
Cervatec™ Instructions for Use Heating Block
Cervatec™ Instructions for Use Sampling Vials
Cervatec™ is based on the detection of p16, a cellular protein which is specifically up-regulated in the presence of cervical disease. The test provides a quantitative measurement of p16 levels in a patient's sample. The clinician receives either a positive (p16+) or negative (p16-) test result.
Clinical evidence
Cervatec™ is now available as a screening test for Cervical Cancer screening in order to increase significantly the sensitivity of to the Pap test. A large prospective study in Germany with more than 7.500 women (in the age of 35 and younger) and 90 study sites has shown that Cervatec™ alone has a sensitivity of 90% detecting CIN2+ as compared with the Pap Test alone having a sensitivity of 39%. The combination of Cervatec™ and the Pap Test would be expected to identify virtually 100% of the disease based on underlying epidemiology. Together, the two tests found all 62 of the biopsy confirmed CIN2+ cases in the study.
The finding of 62 high grade lesions (0,8% of the study population) correlates perfect with the known findings of true disease of 0,7 -0,8% in normal screening populations.
[click to enlarge]
When used in primary screening for cervical cancer, Cervatec™ increases the detection rate of high-grade cervical lesions. This population of women have both the highest prevalence of HPV infections and are the group where 60-70% of the high grade disease is established.
Cervatec™ ELISA adds significant sensitivity to the conventional PAP smear alone by bringing novel biomarker information from the cells of the cervix. This additional information allows clinicians to identify more women with existing disease which otherwise would have been missed by the Pap smear alone. This in turn allows appropriate treatment to be applied.
Information for the clinician
[click to enlarge]
Cervatec™ in combination with the Pap test adds significant more sensitivity and confidence to your Cervical Cancer screening. With this new test you can provide clear patient management.
PAP negative and p16 negative
Women should return to normal annual screening
PAP positive and p16 positive
Women should be sent to Colposcopy for further examination
PAP positive and p16 negative
In this case the Gynecologist should follow the current available guidelines regarding the PAP test result
PAP negative and p16 positive
These are the women where a majority of the high grade lesions were missed by the Pap test and thus the target for follow-up to find the disease. The clinician has three options to consider:
- 1. Direct to Colposcopy
This will be the best way to identify those women being positive for p16 and having a high grade lesion. - 2. Repeat testing in 3-6 months and if positive then Colposcopy
This option keeps women in a normal procedure for the Gynecologist as in the case of a positive PAP result for a repeat visit and testing - 3. HR-HPV Test
This option is to test the p16+ women for HR-HPV. In the case of a p16+ / HR-HPV +, the woman would be sent to colposcopy. In the case of a p16+ / HR-HPV -, the woman would return to routine screening.
Conclusion
The high precision of Cervatec™, used in combination with the PAP test, results in a notable increase in the reliability of detecting severe lesions. This means greater certainty for the patient and for the doctor.
Technical information
Cervatec™ is an ELISA (enzyme-linked immunosorbent assay) Test for quantitative proof of the presence of the biomarker p16 INK4a in cervical smear material to improve the sensitivity for the early detection of cervical cancer and its precursors. The over-expression of the biomarker p16 is indicative of an oncogene transformation after persistent infection with high-risk (HR) types of human papilloma viruses
Cervatec™ ELISA is applied to cellular lysate, which can be easily obtained from the cervical smear. In this procedure the p16INK4a biomarker within the cellular lysate is bound by the highly specific antibody E6H4™ and the quantity of p16INK4a in the lysate is then indicated by a subsequent colour reaction using a second antibody to p16INK4a and a sandwich immunoassay design. The intensity of the colour reaction correlates to the quantity of the antigen and thus indicates the degree of oncogene transformation due to HR-HPV types. With this quantitative proof of the presence of p16INK4a, independent of the type of HR-HPV, Cervatec™ can actually indicate the possibility of existing disease instead of just the risk of HR-HPV infection.
Cervatec™ ELISA is based on two monoclonal antibodies for p16, including antibody clone E6H4™, which was specially developed by mtm laboratories and has been validated in more than 50 clinical studies. The Cervatec™ ELISA has been developed and is manufactured in compliance with GMP requirements and is CE labeled for in-vitro diagnostic use.
The ELISA kit includes all necessary ready to use reagents as well a set of standards and control reagents.
Intended Use
In-vitro assay for the quantitative determination of human p16INK4a protein in lysed samples from the cervix uteri. It is indicated to be used in conjunction with conventional Pap cytology testing as an aid to increase the sensitivity for the detection of high-grade cervical intraepithelial neoplasia.
The Cervatec™ p16INK4a ELISA should be used in conjunction with clinical information derived from other diagnostic and screening tests, physical examinations, and full medical history in accordance with appropriate patient management procedures.
Intellectual property
The Cervatec™ ELISA kit is based on technology developed by mtm laboratories AG, Germany and based on European Patents 1 507 148, 1 092 155, 0 665 886 and U.S. Patent 7,306,926 as well as further national patents.
Literature
The literature is quite extensive regarding the performance of p16INK4a across a wide range of clinical challenges in cervical biopsy diagnosis. CINtec® Histology in conjunction with H&E has been shown to increase both the accuracy and inter-observer agreement for diagnosing high grade CIN lesions and cervical cancer.
Cervatec™ ELISA Manual
As a special service mtm AG will send you the Cervatec™ ELISA Manual print out if you wish. Just click here and fill in the order form. mtm laboratories AG will send the print out shortly after receiving your order to the address provided in the order form.
Ordering
The Cervatec™ ELISA kit is available in Germany through mtm's direct operations and orders can be placed directly through this website.
Downloads
Cervatec™ Material Safety Data Sheet ELISA Kit
Cervatec™ Material Safety Data Sheet Sampling Vials
Cervatec™ Instructions for Use ELISA Kit
Cervatec™ Instructions for Use Heating Block
Cervatec™ Instructions for Use Sampling Vials
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