Neisseria Gonorrhea Antigen Rapid Test Kit (Colloidal Gold)

For professional in vitro diagnostic use only

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.

• Timer
• The kit should be stored at 2-30°C in a cool and dry place, protected from light
• The validity duration is 24 months
• Do not freeze.
• Do not use after the expiration date indicated on the package.

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:

• Use only dacron or polyester tipped sterile swabs. It is recommended to use the swab supplied by the kits manufacturer. Swabs with cotton tips are not recommended
• Before specimen collection, remove excess mucus from the endocervical area with a separate swab or cotton ball and discard .The swab should be inserted into the endocervical cannal, past the squamocolumnar junction, until most of the tip is no longer visible. This will permit acquisition of columnar or cubical epithelial cells which are the main reservoir of gonorrhea organisms. Firmly rotate (clockwise or anticlockwise) the swab in a circle and stay for 10 seconds without being contaminated with exocervical or vaginal cells

For male urethral specimens:

• Standard Dacron tipped sterile swabs should be used for urethral specimen collection. Instruct the patients not to urinate at least one hour prior to specimen collection
• Insert the swab into the urethra about 2-4cm; firmly rotate (clockwise or anticlockwise) a circle and stay for 10 seconds , withdraw it, and place it into the extraction tube, if the swab may be tested immediately. If not, place the specimen into a dry transport tube for transport and storage. The swabs maybe stored for 4-6 hours at room temperature (15-30°C) or 24-72 hours at 2-8°C, freeze is forbidden. It is strongly recommended that test the specimen immediately after collection.
• All specimens should be brought back into room temperature of 15-30°C before testing
• Read the entire procedure carefully prior to testing. Bring tests, specimen and buffer to room temperature (15-30°C) before use.
• Do not open the foil pouch until ready to perform the test
• Place the tests on a clean and flat surface
• Extract gonococcal antigens according to different specimens

1. Prepare endocervical or Urethral swab specimens:

• 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.
• 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.

1. Add 2 drops of extracted samples from extraction tube to the sample well(S) on the test cassette
2. 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

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.

NOTE:

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.

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

1. Positive Coincidence Rate:100%
2. Negative Coincidence Rate:100% Analytical Sensitivity:The detection value of gonococcal antigens should be higher than 5x10⁴ in each specimen.
3. Analytical Specificity: Compared with difference kinds infection factors and the test result are negative.
4. Intra-batch Discrepancy: The test results are the same in one batch
5. Inter-batch Discrepancy: The test results are the same in different batch

l For disposable use only

l For professional in vitro diagnostic use only.

l The specimen dilution buffer contains sodium azide which may react with lead or copper plumbing to form potentially explosive metal azides. Do not drink or smell it.

l Do not use the devices when the package is damaged

l Do not interchange or mix reagents from different lots

l Do not use after the expiration date indicated on the package

l Do not touch membrane before performance

l When the assay procedure is completed ,dispose the test kit and tube

carefully after autoclaving them at 121°C for at least 30 mintues. Or treat them with 5% sodium hypochloride for 40-60 minutes, or burn them.

1. Beggs M,Novotny M, Sampedro S,et al.A self-performing Chromatographic immunoassay for the qualitative determination of human chorionic gonadotrophic(HCG) in urine and serum ClinChem ,1990,36:1084

2. Valkirs G.E,Barton R, immunoconcentration A new format for solid-phase immunoassay Clinchem .,1985 31:1427

3. Knapp,J.S et al. Neisseria gonorrhoeae, Manual of Clinical Microbiology, Sixth Edition, ASM press, Washington DC.,324-325(1995)

4. Centers for Disease Control and Prevention, Sexually Transmitted Diseases Treatment Guidelines 2002 Morbidity and Mortality Weekly Report(2002),51(rr-6)

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