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             One Step Gonorrhea  Swab/Urine Test

INTENDED USE

Medical Healthcare One Step Chlamydia-Gonorrhea Swab/Urine Test Cassette is a rapid test for the visual detection of Chlamydia and Gonorrhea antigen, in the secretory specimen and urine from urogenital system, as an aid in the diagnosis of chlamydia and gonococcus infection.

For in vitro diagnostic use only. For professional use only.

SUMMARY

Gonorrhea is one of the common sexually transmitted diseases (STD) in the whole world. Incidence of a disease is increasing year after year .It is the key approach to early and fast diagnosis for early treatment and shutting infection off. Nowadays Neisseria Gonorrhea is the major pathogenic bacteria for many developing countries. Neisseria Gonorrhea is similar to the cell membrane structure of E.Coli.  Its outer membrane is the special structure of  G- bacteria and include three kinds of protein: major outer membrane protein( PI ); secondary outer membrane protein(PⅡ); tertiary outer membrane protein(PⅢ). Among them, PI’s content exceeds 60% in all outer membrane. PI protein has two different subtypes molecular, that is PIA, PIB. These two types of protein can't have a widely antigenic variation, and can induce antibody to answer in organism. So they have strong immunogenicity and play an important role in the process of infection. PI interact with host´s cell membrane at the same time , they are also organismal major immunity .As a result, they are the important antigen sign of serum.

PRINCIPLE

one step Gonorrhea test is based on a sandwich-type colloidal gold immunoassay. High bio-activity and specificity recombinant Gonorrhea outer menbrane protein I antigen, dyed with the colloidal gold, will interact with the Gonorrhea antigen in the swab/urine from the patient.

When the Gonorrhea antigen levels are at or above the target cutoff, Gonorrhea antigen in the specimen binds to the antibody-dye conjugate and are captured by recombinant antigens immobilized in the test region (T) of the device. This produces a colored Test band and indicates a positive result.

When the Gonorrhea antigen levels are zero or below the target cutoff (the detection sensitivity of the test), there is not a visible colored band in the test region (T) of the device. This indicates a negative result.

To serve as a procedure control, a colored line will appear at the control region (C), if the test has been performed properly.

PRECAUTIONS

1.          This kit is for external use only. Do not swallow.

2.          Discard after first use. The test cannot be used more than once.

3.          Do not use test kit beyond expiry date.

4.          Do not use the kit if the pouch is punctured or not well sealed.

5.          Keep out of the reach of children.

6.          Do not mix the covers of Buffer A and Buffer B.

7.          DISPOSAL OF THE DIAGNOSTIC: The used-device has the infectious risk. The process of disposing the diagnostic must follow the local infectious disposal law or laboratory rule.

CONTENT OF THE KIT

1.          One test in one pouch.

2.          One pouch contains a test cassette, a dropper and a desiccant. The desiccant is for storage purposes only, and is not used in the test procedures.

3.          Leaflet with instructions for use.

4.          Buffer A and Buffer B.

STORAGE AND STABILITY

1.     The test kits can be stored at room temperature (4ºC to 30ºC) in the sealed pouch up to the expiration date.

2.      Keep away from sunlight, moisture and heat.

3.    DO NOT FREEZE.

SPECIMEN COLLECTION AND PREPARATION

Test must be in room temperature. (18ºC to 30ºC).

1.    Male patients: Urethral specimens should be collected  ≥1 hour after urination. Using the collection swab insert 2 to 4 centimeters into the urethral lumen and rotate for 3 to 5 seconds. Put the swab into the transport tube.

2.    Female patients: Before collecting a specimen, remove the mucous and secretions from the cervix with a larger cleaning swab and discard. With the collection swab, sample the endocervical canal while rotating the swab for 15-30 seconds. Put the swab into the transport tube.

3.    Urine specimen: Collect 20 to 30ml of first-catch urine in a sterile container. The patient should not have urinated in the hour prior to sample collection.Centrifuge the urine specimen and discard the supernate. Use the precipitate for detection. (Although urine specimen is workable, the swab specimen is more recommended for higher sensitivity.)

TEST PROCEDURE

Test must be in room temperature (18ºC~ 30ºC)

    A. Extraction

1.   Label an extraction tube for each patient and place in a tube holder or rack.

2. Add 6 drops (300ul) of Extraction Buffer A to the extraction tube. Mix liquids by gently swirling the tube. Place the specimen swab in the tube and twirl briefly to mix the reagent Incubate at room temperature (18°C -30°C) for 5 minutes, with the swab in the tube.

3. Add 2 drops (100ul) of Extraction Buffer B to the extraction tube containing the swab.

4.Twirl the swab vigorously for 10 seconds, and then expunge as much liquid as possible from the swab by pressing and rotating the fiber portion against the wall of the tube. Discard the swab. Cap the tube and mix contents by gentle swirling.

B. Immunoassay of the Extract

1. Remove the test device from the sealed pouch.

2. Holding tube vertically, add exactly (100ul) four drops of the extracted specimen to the sample well.

3. Wait for 5 minutes and read results. Do not read results after 15 minutes.

　                 

Note: Do not interpret test results after 15 minutes

　

INTERPRETATION OF RESULTS

Positive (+)

Rose-pink bands are visible in both the control region and the test region. It indicates a positive result for gonorrhea antigen in the specimen.

Negative (-)

A rose-pink band is visible in the control region. No color band appears in the test region.  It indicates that the concentration of the gonorrhea antige of the specimen is zero or below the detection limit of the test.

Invalid

No visible band at all, or there is a visible band only in the test region and not in the control region. Repeat with a new test kit. If test still fails, please contact the distributor or the store, where you bought the product, with the lot number.

 

Note: There is no meaning attributed to line color intensity or width.

QUALITY CONTROL

Though there is an internal procedural control line in the test device of control region, the use of external controls is strongly recommended as good laboratory testing practice to confirm the test procedure and to verify proper test performance. Positive and negative control should give the expected results. When testing the positive and negative control, the same assay procedure should be adopted.

LIMITATIONS OF PROCEDURE

1.    This test has been developed for testing swab/urine samples only. The performance of this test using other specimens has not

       been substantiated.

2.    This test is a qualitative screening assay. It is not designed to determine the quantitative concentration of gonorrhea antigen.

PERFORMANCE CHARACTERISTICS

A.  Sensitivity and Specificity

Collect 200 samples from the outpatients. All of them have the urogenital discomfort syndromes. The test result between ELISA and kit is shown below:

Table 1: comparative results between kit and ELISA:

	Positive （n=32）	Negative （n=168）	Total（n=200）	Sensitivity	Specificity
Gonorrhea-a test kit	+30/32	－164/168	194/200	93.8%	97.6%
ELISA	＋31/32	－166/168	197/200	96.9%	98.8%

 

 

 

 

 

B.   Precision

1.  Within run precision was determined by using 10 replicates of four different specimens containing different concentration s of antibody. The negative and positive values were correctly identified 100% of the time.

2.  Between run precision was determined by using the four different specimens containing different concentrations of antibody in 3 different lots of test devices. Again negative and positive results were correctly identified 100% of the time.