HPV E7(16&18) Oncoprotein Test

Intended use

The test kit is used to qualitatively test E7 oncoprotein expressed by HPV-16and/or HPV-18 in female cervical exfoliated cells. lt could be for self-testing inhome use or in medical  institutions for professional use. lf the test is positive, it isrecommended to go to a professional medical institution for further diagnosis.This product is used for the auxiliary diagnosis of cervical diseasesin women, andcannot be used as a basis for diagnosis alone.

Test principle

The product adopts the double antibody-sandwich method to detect antigens.

Materials and Components

（1）Test device

（2）Sample collection tube with extraction reagent

（3）Sampling kit (Optional)

（4）Instruction

（5）Timer

Product Information

Specimen requirements

1. This kit is only suitable for the detection of E7 oncoprotein expressed by HPV-16 and (or) HPV-18 in female cervical exuded cells. lt is only used for in vitro diagnosis and should not be used for the detection of other body fluids.

2. In the process of specimen collection, pay attention in strict accordance with the sampling requirements to prevent wrong detection results caused by the small number of sample cells collected.

3. When there is a large amount of visible mucus and bleeding in the specimen,the detection will be affected, resulting in wrong detection results. Therefore, it is recommended that patients avoid the period of menstruation and ovulation for sampling.

4. vaginal drugs and vaginal lubricants will affect the test, resulting in false test results. Therefore, no sexual and vaginal medication is required with in the first three days of sampling.

5. after the first collection, if you need to collect again, please collect a week later,and use new test kits.

Test Procedure

Carefully read the reagent instruction before using the test kit and bstrictly operate according to the instruction to ensure reliable results. Bring test device, extraction reagent andspecimens were restored to room temperature 15-30℃(59-86℉).

(Note: These diagrams only show self-test operation, if professional use, please refer tothe manual)

1. Testing

（1）Place the sampling device on the patient's cervical transformation area and turn it six times clockwise.

（2）Unscrew the cap of the sample collection tube counter clockwise.

（4）After the swab head comes into contact with the bottom of the sample collection tube, invert it10 times to allow the extraction reagent inside the tube to fully release the sample inside the extraction reagent.

（5）Place on a dry, clean and level surface and allow to stand at room temperature for 10minutes ± 5 minutes.

（6）Take out the test device from sealed foil pouch and place on a dry, clean and level surface.

（7）Unscrew the cap of the sample collection tube, hold the sample collection tube vertically. Add 2-3 full drops of the sample without air bubbles into the specimen well (S) of the test device.

（8）Start the timer. Wait for the colored line(s) to appear. Read the results at 10 minutes.Do not read the result after 15 minutes.

2.Test Results