Gonorrhea Sexually Transmited Disease Rapid Test with ISO and CE

• Customization: Available
• Type: IVD Reagent
• Certificate: CE, ISO
• Model NO.: EC-Gonorrhea
• Method: Colloidal Gold Rapid Test
• Warranty: 3 Years
• Material: Medical Grade ABS Plastic
• Package: Bottle + Carton
• Function: Early Detection
• Display: Screening
• Format: Strip+Bottle
• Name: Gonorrhea Test Kit
• Equipment: by Eye or Machine
• Reaction Time: 5-10 Seconds
• Accuracy: 99.7%
• Delivery Time: 3-5 Days
• Temperature: 4-30 Degree
• Storage: Room Temperature
• Transport Package: Carton
• Specification: 64*50*44 cm
• Trademark: evancare or OEM
• Origin: China
• HS Code: 3002150090
• Production Capacity: 100000PCS/Day

Product Description

 

Product Description

EVANCARE Diagnostic Gonorrhea Rapid Test Kits


For professional and in vitro diagnostic use only.

 

[INTENDED USE]

The Gonorrhea Rapid Test Device(Swab)is used for qualitative detection of the presence

of Gonorrhea in female cervix and male urethra, and the clinical auxiliary diagnosis

of Gonorrhea infection, and test results also need to be further confirmed by the clinician in

connection with symptoms, signs and other test results.

 

 

 

[PRINCIPLE]

 

The Gonorrhea Rapid Test Device(Swab)uses highly specific antigen-antibody reaction

and immune chromatography analysis techniques for the qualitative detection of whether

clinical specimens contain Gonorrhea trachomatis antigen, and the kit contains Gonorrhea

trachomatis antigen-specific antibodies,which are pre-fixed on the test area (T) on the membrane,and the corresponding antibodies on the quality control area (C). During the detection,the pyrolysis-off specimens on the cotton swab are titrated into the sampling

wells (S) of the kit, and the specimens make a specific antibody reaction with the

Gonorrhea trachomatis antigen of the pre-coated gold particles.Then, the mixture followed up with upward chromatography under capillary effect. If it is positive , gold-labeled Gonorrhea will first bind with Gonorrhea trachomatis antigen in the specimens in the

chromatography process, then the bonder will be combined by specific antibody of Gonorrhea trachomatis antigen, which is fixed on the membrane, and within the test

area (T) there will appear a red band. If it is negative, there will no red band within the test

area (T). Regardless of whether the Gonorrhea trachomatis antigen exists in clinical

samples, there will be a red band within the quality control area (C). The red band

within the quality control area (C) is to determine whether there is sufficient sample,

and whether the process of chromatography is in line with the normal standards, and at the

same time it is used as the internal control standards of the agent.
 

 

 

 

 

 

 

 

 

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Detailed Photos

  

Positive: *Two lines appear. One colored line should be in the control

region (C), and another apparent colored line adjacent should be in the test

region (T).

Negative: One colored line appears in the control region (C). No line

appears in the test region (T).

Invalid: Control line fails to appear. Insufficient specimen volume or

incorrect procedural techniques are the most likely reasons for control line

failure. Review the procedure and repeat the test using a new test cassette.

If the problem persists, discontinue using the lot immediately and contact

your local distributor.

 

Item No.	EVANCARE Diagnostic Gonorrhea Rapid Test Kits
Contents	Each bag:1 test cassette and 1 desiccant(cassette)                  25 cassettes+1 Buffer  /box antigen test      We can put instruction as your requirement
Format / Size	Cassette:2.5mm 3.0mm 4.0mm
Methodology	Sandwich Colloidal Gold
Assay Type	Qualitative Detection
Specimen	Antigen  (Swab),
Indicator	Gonorrhea Test Cassette
Storage Temperature	4-30 degree centigrade

Expiry date	3  years
Certificate	CE,ISO,FREE SALE,FDA...
Detection Limits	Home or Professional Use
Accuracy	> 99.99%
Reaction Time	3-5 min
Delivery	5-7 days
OEM Service	Available
Shipping Method	by air  or sea or international express

Company Profile

 

Certifications

 

Product Procedure

 

 

Activity Exhibition

FAQ