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
