1. High sensitivity and specificity
2. Precision and accuracy
3. Simple operation, read in shortly
4. Home use Gonorrhea rapid test kit
5. sexually transmitted disease rapid test kits
The Neisseria Gonorrhoeae antigen test kit is a rapid visual immunoassay for the qualitative detection of Neisseria Gonorrhoeae in the female endocervical swab and male urethral swab specimens. This package is intended as the aid in the diagnosis of Neisseria Gonorrhoea infection.
The Neisseria Gonorrhoeae antigen test kit is used to detect N. Gonorrhoeae through visual interpretation of the colour development in the internal strip. The membrane was immobilised with the gonococcal Antigen-specific polyclonal antibody on the test position (T) and related antibodies on the control position(C).
During testing, the specimen is added to the sample well (S) and reacts with anti-gonococcus monoclonal antibody conjugated to coloured Polystyrene latex microsphere and precoated onto the sample pad of the test. Then, the mixture migrates through the membrane by capillary effect and interacts with the immobilized monoclonal antibody on the membrane. If there are sufficient gonococcus antigens in the specimen, a coloured band will form at the test well (T) of the membrane. This coloured band indicates a positive result, while its absence indicates a negative result. A coloured band at the control region serves as a procedural control, pointing out that the proper volume of specimen has been added and membrane wicking has occurred.
Main Ingredients: NaCl, NaOH, NaCl ,and purified water
|Individually packed test devices||Each device contains a strip with coloured conjugates and reactive reagents precoated at the corresponding position.||
|Lysis Buffer A||7ml*1 bottle|
|Lysis Buffer B||Main Ingredients: sodium
Azide , and purified water
|PlaNaCl,extraction Tube||For specimens preparation use||1 Pc|
|Dacron swab||For specimens collection||1 pc|
|Package Insert||For operation instruction||1 pc|
1.Read the entire procedure carefully prior to testing. Bring tests, specimen and buffer to room temperature (15-30°C) before use.
2.Do not open the foil pouch until ready to perform the test
3.Place the tests on a clean and flat surface
4.Extract gonococcal antigens according to different specimens
A.Prepare endocervical or Urethral swab specimens:
1.Add 5 drops of Lysis buffer A into the extraction tube vertically. Immerse the specimen swab into the extraction tube. Squeeze the tube and twirl the swab for 15 times. Then keep the swab into the extraction tube for 2 minutes.
2.Add 5 drops of Lysis buffer B into the same extraction tube. Deposit may be produced in the mixture. Squeeze the tube and twirl the swab for 15 times. Then keep the swab into the extraction tube for one minute. The solution will be brown if the swab with blood. Squeeze and discard the swab. Finally, cover the extraction tube with dropper.
B.Add 2 drops of extracted samples from extraction tube to the sample well(S) on the test cassette
C.Read the result within 10-15 minutes. Positive result may be read within 10 minutes, negative result may be read within 15 minutes. Do not interpret the result after 15 minutes
INTERPRETATION OF RESULTTS
POSITIVE RESULT:Two colored bands appear on the membrane. One band appears in the control well (C) and another band appears in the test well (T). Positive result indicates the specimen with gonococcal antigens.
NEGATIVE RESULT: Only one colored band appears in the control well (C). No apparent coloured band appears in the test well (T).Negative result indicates the concentration of gonococcal antigens in the specimen does not suffice testing.
INVALID RESULT: Control band fails to appear. Results from any test which has not produced a control band at the specified reading time must be discarded. Please review the procedure and repeat with a new test. If the problem persists, discontinue using the kit immediately and contact your local distributor.
The intensity of the color in test well (T) may vary depending on the concentration of aimed substances present in the specimen. But in the valid time, even the color band is very week, the result should be regarded as positive.