Span Biotech Ltd.

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.

KIT COMPONENTS

MATERIALS REQUIRED BUT NOT PROVIDED

·    Timer

STORAGE AND VALIDITY

·    The kit should be stored at 2-30°C in a cool and dry place, protected from light

·    The validity is 24months

·    Do not freeze.

·    Do not use after the expiration date indicated on the package.

SPECIMEN COLLECTION

The quality of specimen obtained is extreme important. Detection of Gonococci requires a rigorous and thorough collection technique which provides active cellular rather than just tissues. For female endocervical specimens, the specimens are invalid if the swab inserted into endocervical cannal is less than 1/2 deep or contamination with exocervical or vaginal cells. For male urethral specimens, the specimens are invalid if the patient urinated within 1 hours 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 manufacture. 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 contamination 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.

PROCEDURE

·    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 level surface

·    Extract gonococcal antigens according to difference specimens

1.         Prepare endocervical or Urethral swab specimens:

·     Added 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 15 times. Then keep the swab into the extraction tube for 2 minutes.

·    Added 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 15 times. Then keep the swab into the extraction tube in one minute. The solution will be brown if the swab with blood. Squeeze and discard the swab. Finally, cover the extraction tube with dropper.

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

3.         Read the result within 10-15 minutes.  Positive result shall be read within 10 minutes, negative result shall be read within 15 minutes. Do not interpret the result after 15 minutes

INTERPRETATION OF RESULTS

POSITIVE RESULT: Two colored bands appear on the membrane. One band appears in the control region (C) and another band appears in the test region (T). Positive result indicates the specimen with gonococcal antigens.

NEGATIVE RESULT: Only one colored band appears in the control region (C). No apparent colored band appears in the test region (T).Negative result indicates the specimen without testing concentration gonococcal antigens

 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 region (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 shall be regarded as positive.

LIMITATIONS OF THE TEST

1.         Read the entire procedure carefully prior to testing, incorrect performance will 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 made by the physician after all clinical and laboratory findings have been evaluated.

4.         This kit is intended for use as 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 difference lots

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

PRECAUTIONS

·    For single use only

·    For professional in vitro diagnostic use only.

·    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.

·    Do not use the devices when the package damaged

·    Do not interchange or mix reagents from difference lots

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

·    Do not touch  membrane before performance

·    When the assay procedure is competed ,dispose the test kit and tube

·    carefully after autoclaving them at 121°C for at least 30\0mintues. Or treated them with 5% sodium hypochloride for 40-60 minutes, or burn them.