Gonorrhea Antigen Rapid Test

• Customization: Available
• Type: Detection Card
• Syringe: None
• Model NO.: HNG025G
• Blood Sampling Needle: None
• Breathing Pattern: None
• Animal Anesthesia Machine Control Method: None
• Assay Time: 5-10 Minutes
• Delivery Time: 3~5days After Get Payment
• Payment: T/T, Western Union, Paypal
• Customized: Accpet
• Transport Package: Carton
• Specification: 10Tests/Kit
• Trademark: PETX
• Origin: Hangzhou
• HS Code: 38220010
• Production Capacity: 5000000PCS/Year

Product Description

INTENDED USE
Gonorrhea Antigen Rapid Test is a rapid chromatographic immunoassay for the qualitative detection of Neisseria gonorrhoeae antigen in female cervical swab and male urethral swab specimen. The test results are intended to aid in the diagnosis of Gonorrhea infection in people.  
MATERIALS
Materials Provided

Individually packed test devices	Extraction Tubes
Disposable sampling swabs (Female Cervical)	Dropper Tips
Extraction Reagent 1 (0.2M NaOH)	Workstation
Extraction Reagent 2 (0.2 M HCI)	Package insert

Materials Required but Not provided

Disposable Sampling Swabs

Timer

 

PROCEDURE

Allow the test, reagents, swab specimen, and/or controls to reach room temperature (15-30°C) prior to testing.

1. Remove the test cassette from the foil pouch and use it within one hour. Best results will be obtained if the test is performed immediately after opening the foil pouch.
2. Extract the Chlamydia antigen according to the specimen type.

• For Female Cervical or Male Urethral Swab Specimen:
. Hold the reagent 1 bottle vertically and add 5 drops of reagent 1 (approx. 300ul) to the extraction tube. Reagent 1 is colorless. Immediately insert the swab, compress the bottom of tube and rotate swab 15 times. Let stand for2 minutes.
. Hold the reagent 2 bottle vertically add 6 drops of reagent 2 (approx. 250ul) to the extraction tube. The solution would turn turbid. Compress the bottle of tube and rotate the swab 15 times until the solution turn clear with a slight green or blue tint. If the swab is bloody, the color will turn yellow or brown. Let stand 1 minute.
. Press the swab against the side of tube and withdraw the swab while squeezing the tube. Keep as much liquid in the tube as possible. Fit the dropper tip on top of extraction tube.

1. Place the test cassette on a clean and level surface. Add 3 full drops of the extracted solution (approx. 100ul) to each specimen wells of the test cassette, then start the timer. Avoid trapping air bubbles in the specimen well.
2. Wait for the colored line(s) to appear. Read the result at 10 minutes; do not interpret the result after 20 minutes.

PERFORMANCE CHARACTERIST

The Gonorrhea Antigen Rapid Test has been evaluated with specimens obtained from patients of STD clinics. Culture is used as the reference method. The results show that Gonorrhea Antigen Rapid Test has a high sensitivity and specificity relative to the reference method.
Table: Gonorrhea Antigen Rapid Test vs. Culture  

Method		Culture		Total Results
Gonorrhea Antigen Rapid Test	Results	Positive	Negative
	Positive	152	3	155
	Negative	9	266	275
Total Result		161	269	430

Relative Sensitivity: 94.41% (95%CI: 89.58%~97.17%)  
Relative Specificity: 98.88% (95%CI:96.62%~99.78%) 
Accuracy: 97.21% (95%CI:95.13%~98.45%)
Cross-Reactivity
Cross reactivity of Gonorrhea Antigen Rapid Test with other organisms has been studied using suspensions of 10⁷ org/test. The following organisms were found negative when tested with the Gonorrhea Antigen Rapid Test and did not produce any positive result either for Gonorrhea:

Acinetobacter calcoaceticus	Klebsiella pneumoniae	Proteus mirabilis
Salmonella choleraesius	Neisseria meningitides	Neisseria gonnorhea
Pseudomona aeruginosa	Enterococcus faecium	Candida albicans
Group B/C Streptococcus	Staphylococcus aureus	Proteus vulgaris
Branhamella catarrhalis	Hemophilus influenzae	Neisseria gonnorhea
Enterococcus faecalis	Gardnerella vaginalis