Product Description
This test kit is a lateral flow chromatographic immunoassay for the qualitative detection HPV 16/18 E7 Protein in female cervical swab specimens. It is intended to be used as an aid in the diagnosis of cervical pre-cancer or cancer including HPV types 16 and 18 (E7). The test only provides preliminary screening results but not critical diagnosis criteria. Any reactive specimen with the HPV 16/18 E7 Antigen Rapid Test Kit must be analyzed and confirmed with alternative testing
method(s) and clinical findings. The test is intended for healthcare professional use.
Principle
The HPV 16/18 E7 Antigen Rapid Test Kit is a qualitative membrane-based immunoassay for the detection of HPV 16/18 E7 Protein in female cervical swab specimens. The membrane is precoated with anti-HPV 16/18 E7 monoclonal antibodies and anti-HPV 16/18 E7 monoclonal antibodies on the test line region (T). During testing, the specimen reacts with the particle coated with anti-HPV 16/18 E7 monoclonal antibodies. The mixture migrates upward on the membrane chromatographi-cally by capillary action to react with anti-HPV 16/18 E7 monoclonal antibodies on the membrane and generate a colored line. The presence of this colored line in the test line region (T) indicates a positive result, while its absence indicates a negative result. An internal quality control is included in the test, in the form of a colored line appearing in the control line region (C), indicating that the test is functional, and proper and sufficient volume of specimen has been applied to enable migration through the test and control line, regardless of whether there is a test line or not. If the control line (C) does not appear within the testing time, test result is invalid and the test should be repeated with a new test device.
Storage and Stability
1. The test kit should be stored either at room temperature or refrigerated (2-30°C), away from direct sunlight. Do not freeze the kit or expose the kit to temperatures over 30°C.
2. The shelf life of the kit is as indicated on the outer package (24 months from date of manufacture).
3. This test kit is stable until the expiration date marked on the outer package.Ensure all test components are at room temperature(15-30°C) before use.
4. Perform the test immediately after taking out the test device from the foil pouch.
