Individual private package Gonorrhea Home Testing kits, High Accuracy, detecting private disease at home

Product Name: Gonorrhea Home Testing kits

Accessories:

Summary and Explanation:

The Gonorrhea Rapid Screen Test is a qualitative test for the detection of the gonorrhea antigen in urogential specimen. Gonorrhea is a common sexually transmitted disease caused by the bacterium Neisseria gonorrhoeae. The bacterium can grow in warm moist areas of the reproductive tract, and also in the anus, throat, eyes and mouth. Most women and some men with gonorrhea do not have any symptoms. Possible symptoms include: burning sensation during urination, coloured (green, yellow, white) discharge from the penis or vagina, and pain or swelling of testicles. If left untreated, gonorrhea may lead to permanent damage of the reproductive organs and infertility, and spread to blood and joints and become life-threatening.

PRECAUTION:

1. Do not use the test kit beyond the expiration date.
2. Do not use the kit if the pouch is punctured or not well sealed.
3. For in vitro use only. Do not swallow.
4. Do not mix the covers of Buffer A and Buffer B.
5. All specimens from the body should be treated as potentially infectious.
6. Contaminated swabs may give incorrect test results.
7. Discard after first use. The test cannot be used more than once.
8. DISPOSAL: The used-device has the risk of infection. Please dispose all used contents properly.

Collecting the specimen:

1. Start up by adding 300ul (about 8-9 drops) of buffer A to the attached mixing tube. Then use a swab to collect specimen in the following suggested method:

a) For male patient: Insert the swab into the urethra of the penis. Gently rotate with sufficient pressure to dislodge the epithelial cells. Allow the swab to remain inserted for a few seconds after rotation. Carefully remove the swab avoiding contact with any external surfaces.

b) For female patient: Use swab number 1 to remove discharges from the vaginal track opening. Then insert swab number 2 into vaginal track for half a minute and retrieve swab. Carefully remove the swab avoiding contact with any external surfaces.

1. Place swab into the tube and mix well with buffer A so that discharges are well suspended in the buffer A. Discard swab into disinfectant container.
2. Add 300 ul (about 8-9 drops) of buffer B to the tube, cap the tube and mix well.

TEST PROCEDURE

1. Use the dropper, draw 0.1ml (about 4 drops) sample into the pipette, and dispense it into the sample well on the cassette.
2. Wait 10 –15 minutes and read results. Do not read results after 30 minutes.

Caution: The above interpreting time is based on room temperature range of 15-30℃. If your room temperature is significantly lower than 15℃, then the interpreting time should be properly increased to 30 minutes.

INTERPRETATION OF RESULTS

Positive:

Two red lines are visible in the result window. The intensity of the test line may be

weaker or darker than that of the control line. This still means a positive result.

Negative:

The control line appears in the result window, but the test line is not visible.

Invalid:

If the control line does not appear in the result window, the test results are INVALID regardless of the presence or absence of the line in the test region.

LIMITATION:

1. The Gonorrhea Rapid Test Cassette (Swab) is for in vitro diagnostic use only. This test should be used for the detection of Gonorrhea antigen from female cervical swab and male urethral swab specimens. Neither the quantitative value nor the rate of increase in Gonorrhea antigen concentration can be determined by this qualitative test.
2. This test will only indicate the presence of Gonorrhea antigen in specimens from both viable and non-viable Neisseria gonorrhoeae. Performance with specimens other than female cervical swabs and male urethral swabs has not been assessed.
3. Detection of gonococcus is dependent on the number of organisms present in the specimen. This can be affected by specimen collection methods and patient factors such as age, history of Sexually Transmitted Diseases (STDs), presence of symptoms, etc. The minimum detection level of this test may vary according to serovar. Therefore, the test results should be interpreted in conjunction with other laboratory and clinical data available to the physician.
4. Therapeutic failure or success cannot be determined as antigen may persist following appropriate antimicrobial therapy.
5. Excessive blood on the swab may cause false positive results.
6. Endocervical samples from female patients should not be collected during menstrual period.