Physicians
Elevate patient care with the most accurate cervical test available on the worldwide market
Laboratories
Learn how to become validated to process the innovative OncoE6™ Cervical Test
HPV & Cervical Cancer
In regions where women do not have access to regular check-ups, cervical cancer is a leading cause of death. In many places, the Pap test is used to detect cervical cancer; this outdated method was introduced in the 1940s, and because of its low accuracy it is now often replaced by HPV testing. Nearly all cervical cancers are caused by HPV infection, but only a very small number of women who have HPV will develop cervical cancer. For example, in the US, more than 20% of women have HPV, but less than 0.5% will develop cervical cancer. A positive HPV test alone can therefore lead to unnecessary anxiety, and to unnecessary treatments. Identifying which high-risk HPV infections will lead to cancer has historically been a diagnostic challenge. It is now known that HPV produces two oncoproteins, E6 and E7, without which cancer does not occur.
Detection of HPV DNA or RNA simply identifies infection. Detection of the E6 and/or E7 oncoproteins, however, provides a means of identifying the transition from infection toward cancer. Arbor Vita’s OncoE6™ Cervical Test offers a solution to this problem: the OncoE6™ Cervical Test directly detects the cancer-causing E6 oncoprotein molecule, made by those few HPV infections that will cause cervical cancer with a high likelihood.
Arbor Vita’s OncoE6™ product line identifies patients that are not only infected with HPV but are also producing E6 oncoproteins, indicating the presence of cervical pre-cancerous or cancerous lesions.
With its dipstick-like format, OncoE6™ is simple, quick, non-invasive, and requires no refrigeration. The test is compatible with specimens collected from either a regular Pap smear or liquid Thinprep© (see OncoE6™ Liquid Specimen Preparation Kit).
OncoE6™ Cervical Test – CE-IVD
The OncoE6™ Cervical Test is a rapid and easy-to-use lateral flow assay based on the detection of E6 oncoproteins. The OncoE6™ Cervical Test is available in the US, as a service through our CLIA-certified laboratory.
OncoE6™ Cervical Test Starter Kit – CE-IVD
The Starter Kit contains accessories to help with smooth running of the OncoE6™ Cervical Test, including simple reference guides.
PROTOCOLS AND RESOURCES
Clike the following link for guide and instruction LBL2000050_OncoE6-Cervical-Test-Instructions-for-Use_RevN
Product Description
Arbor Vita Corporation has developed the OncoE6™ Cervical Test, a rapid, easy to use lateral flow assay based on the detection of E6 oncoproteins to assess the likelihood that cervical malignancy is present. The OncoE6™ Cervical test demonstrates outstanding clinical performance with high specificity and high positive predictive value and thus can be used to triage patients with high risk HPV and other abnormal screening results to avoid unnecessary treatment procedures. This qualitative test is used to analyze cells extracted from cervical cytology swab specimens. The assay is based upon the capture and detection of E6 oncoproteins from high risk HPV types 16 and 18 using highly specific monoclonal antibodies (mAbs) in a lateral-flow (LF) assay format. This test detects down to a thousand abnormal cells with a simple line read by eye. The test is room temperature stable and requires no complex equipment.
Advantages
• Easy to use “dipstick” (lateral flow) format
• Predictive cancer biomarker screen with high specificity for cervical cancer and pre-cancerous lesions caused by high risk HPV strains 16 and 18
• Detects strains that account for 70-80% of cervical cancer worldwide (84% in China, 92% in India)
• No complex equipment or refrigeration required
• Minimal laboratory training required
• Low startup and test cost
• Test results available in ~ 2 ½ hours
• Low false positive rate
• Low false negative rate
Kit Components
The OncoE6™ Cervical Test Specimen Collection Kit (part #2001000) contains material for collection and storage of 24 specimens:
• 24 swabs for Specimen Collection – polyester tipped, sterile
• 24 tubes for Specimen Storage
The OncoE6™ Cervical Test Specimen Processing Kit (part #2000000) contains material and reagents for 24 tests:
• 1 bottle of Lysis Solution A
• 1 vial of Conditioning Solution B
• 24 vials of Detector Reagent C
• 1 vial of Wash Solution D
• 1 bottle of Developing Solution E
• 8 Test Units – 3 test strips each
• 1 vial of Positive Control
• 24 tubes for Lysis
• 24 vials for Wash
• 24 tubes for Development
• 1 Instructions For Use
Equipment required but not supplied
• Microcentrifuge, 1.5 to 2.0 mL tubes, >10,000 x g
• Micropipettes
• Tube rotator (end-to-end rotation), 8 RPM
• Timer
• Thermometer
Product Reference
If you have questions about this product, please use Part Number #2000000 or Part Number #2001000 as a Product References.
Product Certification
CE-IVD (In Vitro Diagnostics) marked
Legal and Disclaimers
The buyer/user has a non-exclusive licence to use OncoE6™ Cervical Test. The OncoE6™ Cervical Test is available in the US, as a service through our CLIA-certified laboratory.
References
Chen W., et al. (2009) Human papillomavirus type-distribution in cervical cancer in China: the importance of HPV 16 and 18. Canc. Causes. Contr. 20(9):1705–1713.
Schweizer, J., et al. (2010) Feasibility Study of a Human Papillomavirus E6 Oncoprotein Test for Diagnosis of Cervical Precancer and Cancer. J. Clin. Microbiol. 48(12):4646–4648.
Zhao, F. H, Jeronimo, J, Qiao, Y. L, et al. (2013) An Evaluation of Novel, Lower-Cost Molecular Screening Tests for Human Papillomavirus in Rural China. Cancer Prev. Res. 6(9):938–948.
Kit Components
• 1 Solution Stand
• 2 Test Platforms
• 2 Reading Guides
• 1 Quick Guide
Product Reference
Do you have any question about this product? Do you need a quote? To ensure a quick and relevant answer, please use Part Number #2000031 as a Product Reference.
Product Certification
CE-IVD (In Vitro Diagnostics) marked
Legal and Disclaimers
The buyer/user has a non-exclusive licence to use OncoE6™ Cervical Test Starter Kit.