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The Neisseria Gonorrhoeae antigen test kit is a rapid visual immunoassay for the qualitative detection of Neisseria Gonorrhoeae in female endocervical swab and male urethral swab specimens. This kit is intended for an aid in the diagnosis of Neisseria Gonorrhoeae infection.
As one of most common sexually transmitted diseases, Gonorrhoea is caused by its pathogen is Nesseria Gonorrhea. Human body is sole host of N. Gonorrhea which usually adheres to columnar epithelial cells of mucosal surface. Pathogenic materials of N. Gonorrhea mainly contain flagella, membrane protein, protease, lipopolysaccharide, etc, which directly infect urogenital tract, oropharynx and rectal mucosa during sexual intercourse or newborn baby through birth canal to cause simple gonorrhea, pelvic inflammatory disease, oropharyngeal and anorectal disease, gonococcal conjunctivitis and disseminated gonorrhoea in clinical manifestation. Therefore, it is very important for early diagnosis and treatment of N.gonorrhoeae
N.Gonorrhoeae could be detected by many methods based on different technologies such as culture method, microscopic examination, DNA examination and immunoassays. And this kit belongs to immunoassay.
The Neisseria Gonorrhoeae antigen test kit is used to detect N. Gonorrhoeae through visual interpretation of the color development in the internal strip. The membrane was immobilized with gonococcal Antigen-specific polychonal 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 colored 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 immobilized monoclonal antibody on the membrane. If there is sufficient gonococcus antigens in the specimen, a colored band will form at the test well (T) of the membrane. This colored band indicates a positive result, while its absence indicates a negative result. A colored band at the control region serves as a procedural control, indicating that the proper volume of specimen has been added and membrane wicking has occurred.
|Individual packed test devices||Each device contains a strip with colored conjugates and reactive reagents precoated at the corresponding position.||
|Lysis Buffer A||Main Ingredients: NaCl , NaOH, and purified water||
|Lysis Buffer B||
Main Ingredients: NaCl , sodium
Azide , and purified water
|Plastic Extraction Tube||For specimens preparation use||20 pcs|
|Dacron swab||For specimens collection||20 pcs|
|Package Insert||For operation instruction||1 pc|
STORAGE AND VALIDITY
The quality of specimen collected is extremely important. Detection of gonococci requires a rigorous and thorough collection technique which provides viable cellular tissues rather than just secretion. For female endocervical specimens, the specimens are invalid if the swab inserted into endocervical cannal is less than 1/2 deep or contaminated by exocervical or vaginal cells. For male urethral specimens, the specimens are invalid if the patient urinates within 1h or the swab inserted into urethra less than 2 cm deep.
For female endocervical specimens:
For male urethral specimens:
Prepare endocervical or Urethral swab specimens:
INTERPRETATION OF RESULTS
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 colored 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.
LIMITATIONS OF THE TEST
1.Read the entire procedure carefully prior to testing, incorrect performance may lead to incorrect results.
2.The Test Kit is for professional in vitro diagnostic use, and should only be used for the qualitative detection of gonococcal antigens.
3.As with all diagnostic tests, a definitive clinical diagnosis should not be based on the results of a single test, but should only be confirmed by the physician after all clinical and laboratory findings have been evaluated.
4.This kit is intended for an aid in the diagnosis of Neisseria Gonorrhoeae infection
5.Only Dacron or Polyester swab can be used to collect endocervical samples, and the kit is with Dacron swabs
6.Do not interchange or mix reagents from different lots
Contact Person: Ms. Anna Lee