Audited Supplier
EC-Gonorrhea
IVD Reagent
CE, ISO
Colloidal Gold Rapid Test
3 Years
Medical Grade ABS Plastic
Bottle + Carton
Early Detection
Screening
Strip+Bottle
Gonorrhea Test Kit
by Eye or Machine
5-10 Seconds
99.7%
3-5 Days
4-30 Degree
Room Temperature
evancare or OEM
Carton
64*50*44 cm
China
3002150090
Product Description
EVANCARE Diagnostic Gonorrhea Rapid Test Kits
For professional and in vitro diagnostic use only.
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 bandwithin 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.
.
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)
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 |
