INTENDED USE

The neisseria gonorrhoeae antigen test card 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 use as an aid in the diagnosis of neisseria gonorrhoeae infection.

PRINCIPLE

The neisseria gonorrhoeae antigen test kit is designed 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 region (T) and related antibodies on the control region(C).

During testing, the specimen is added to the sample region (S) and reacts with anti-gonococcus antibodies conjugated to colored particles and precoated onto the sample pad of the test. Then, the mixture migrates through the membrane by capillary action and interacts with reagents on the membrane. If there is sufficient gonococcus antigens in the specimen, a colored band will form at the test region (T) of the membrane. The presence of this colored band indicates a positive result, while its absence indicates a negative result. The appearance of 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.

INTRODUCTION

N. Gonorrhoeae is one of the most common sexually transmitted disease which caused by the bacterium nersseria gonorrhoeae

Symptoms of infection with N. gonorrhoeae differ depending on the site of infection. Note also that 10% of infected males and 80% of infected females are asymptomatic.

Infection of the genitals can result in a purulent (or pus-like) discharge from the genitals which may be foul smelling. Symptoms may include inflammation, redness, swelling, and dysuria N. gonorrhoeae can also cause conjunctivitis, pharyngitis, proctitis or urethritis, prostatitis and orchitis.

Infection of the genitals in females with N. gonorrhoeae can result in pelvic inflammatory disease if left untreated, which can result in infertility. Infertility is caused by inflammation and scarring of the fallopian tube. Infertility is a risk to 10 to 20% of the females infected with N. gonorrhoeae. Thus. It is significant for early diagnosis and treatment for N.gonorrhoeae

N.gonorrhoeae could be detected by many methods based on difference technologies such as culture, microscopic examination, DNA examination and immunoassays. And this kit belongs to immunoassay.

PERFORMANCE CHARACTERISTICS

1.Positive Coincidence Rate:100%

2.Negative Coincidence Rate:100%

3.Analytical Sensitive:The Detection value of gonococcal antigens  should be higher than 5x104  in each specimen.

4.Analytical Specificity: Compared with difference kinds infection factors and the test result are negative.

5.Intra Batch Discrepancy: The test results are same in one batch

6.Inter Batch Discrepancy: The test results are same in difference batch