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Neisseria Gonorrhoeae Antigen Rapid Test Kit(Immunochromatographic Assay)

INTENDED USE:The Neisseria gonorrhoeae antigen rapid test kit is suitable for the in vitro qualitative detection of Neisseria gonorrhoeae antigen in male urethral swab samples and female cervical swab samples for the auxiliary diagnosis of gonococcal infection.
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  • ICA2220

  • BioTeke

Warm Warning: This product is not available for US market.


A.Intended Use:
The Neisseria gonorrhoeae antigen rapid test kit is suitable for the in vitro qualitative detection of Neisseria gonorrhoeae antigen in male urethral swab samples and female cervical swab samples for the auxiliary diagnosis of gonococcal infection. This kit is intended for use by qualified and trained clinical laboratory personnel specifically instructed and trained in the techniques of in vitro diagnostic procedures.
B.Product details :
a. Test Specimen :Vaginal Swab ; Urethral Swab
b. Sensitivity :95.79%
c. Accuracy : 97.97%
d. Specificity:99.50%
e. Reading Time : 15-20 min


C.Materials Provided :
Components: Test Card , Extraction Buffer A , Extraction Buffer B , Sample Extraction Tube , Waste Bag.


D.Advantages :
a. Sampling is convenient and hygienic, bidding farewell to traditional urine testing and not limited to usage scenarios;
b. Higher sensitivity, pregnancy can be detected as early as 4 days before the next physiological period;
c. The results are clear and easy to understand, with a short detection time, and a positive result can be detected as soon as 20
seconds;
d.High accuracy of results.



E.Test Procedure

1. Put the tube into the kit box holder. 

2. Add all of extraction buffer A vertically to the sample extraction tube and immediately insert the swab after sampling, squeeze the villi part of the swab in the tube through the outer wall of the tube by finger 15 times to dissolve the potential antigen into solution from swab as much as possible, leave to stand for 2 minutes. 

3. After the sample has stood for 2 minutes, Add all of extraction buffer B vertically to the sample extraction tube, squeeze and swirl the swab 15 times, then remove and discard the swab. 

4. Cover the dropper lid on the sample extraction tube. 

5. Remove the test card by opening the aluminum foil pouch from tear notch and lay it flat. 

6. Add approximately 80uL(3 drops) of the treated specimen into the sample well of the test card. 

7. Please read the chromogenic results in the detection zone between 15~20 minutes to ensure proper test performance.



F. Product qualifications(By Nov.1st ,2023)

a. CE Certification - AEMPS Registration Letter

b.CE Certification - AEMPS Registration Prove
c. CE Certification - EC Declaration Of Conformity
d. CE Certification - EAR Certificate Of Notification
e. ISO 13485 Certificate
f.  ISO 9001 Certificate
g.  ISO 45001 Certificate
h.  ISO 14001 Certificate
i.   IMPS Certificate




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