Gonorrhea Antigen Test Strip
Gonorrhea Antigen Test Strip (淋病病毒抗原快速检测试纸条) is a one-step qualitative lateral flow rapid diagnostic test kit, based on the Colloidal Gold Chromatographic Immuno Double Antibody Sandwich principle, which is used to detect Neisseria Gonorrhea Antigen in human Urogenital Swab specimen.
Please refer to the Instruction for Use (IFU) of the Gonorrhea Antigen Test Strip.
Detailed information of Gonorrhea Antigen Test Strip
- General and Technical information of this NGH test kit;
- Packing specification of this NGH Dipstick style test kit (gross weight in full kit package and in bulk packing);
- Specimen used to carry out the assay, and the requirements on specimen collection, storage and processing; and,
- Specific immuno assay principle used in this Gonorrhea Test Kit.
Main technical information of this Gonorrhea AG test kit is listed in the following table:
|Catalog No.:||NGH 321|
|Description:||Gonorrhea Antigen Test Strip|
|Category:||Sexually Transmitted Disease|
|No. of Step:||One Step|
|Reading Time:||10-20 Minutes|
|Cut Off:||100 bacterium/ul|
|Quan. or Qual.:||Qualitative|
|Assay Principle:||Colloidal Gold Chromatographic Immuno Double Antibody Sandwich|
The standard kit size of this Gonorrhea Dipstick test kit is 100 tests per box; 40 boxes per carton.
To save freight cost, sometimes bulk packing is used, meaning test strip, cassette or multi-test panel is packed in single aluminum pouch; 50 or 100 pouches in one plastic bag; and then plastic bags are packed in cartons along with the unfolded boxes for the test kits. In this way, the customers can easily pack the tests into test kits after receiving the bulk packed goods.
|Tests per Kit:||100 Tests|
|Dimension of Kit Box:||21.0 * 12.5 * 5.5 CM|
|Boxes per Carton:||40 Kits|
|Tests per Carton (BULK):||5500 Tests|
|G.W. per Carton (Boxed):||14.5 KG|
|G.W. per Carton (Bulk):||16.0 KG|
|Carton Dimension:||53 * 45 * 36 CM|
|Carton Volume:||0.085 CBM|
- Gonorrhea Antigen Test strip in single pouch with desiccant;
- Specimen Diluents 1;
- Specimen Diluents 2;
- Instruction leaflet for use.
To carry out the assay with a Gonorrhea Antigen Test Strip, Urogenital Swab should be collected according to the instructions given in the Instruction For Use included in the test kit. After collecting, it is preferable to perform the testing as early as possible; if not viable, the specimen should be stored properly. A general introduction about the collection, and storage of the specimens is given below.
Female Endocervical Specimen
Before specimen collection, use a swab or cotton ball to remove excess mucus from the endocervical area and discard.
Use the swab provided along the kit or any shafted swabs with rayon or Dacron tips. The swab should be inserted into the endocervical canal past the squamocolumnar junction, until most of the tip is no longer visible. This will permit acquisition of columnar or cuboidal epithelial cells which are the main reservoir of the organism to detect. Firmly rotate the swab for 15-20 seconds and withdraw without contamination of extra-cervical or vaginal cells.
Alternatively, endocervical specimens can be collected with a cytology brush (Not provided. Caution: do not use cytology brushes with pregnant patients). Insert the cytology brush into the endocervical canal past the squamocolumnar junction. Leave the brush still for two to three seconds. Rotate the cytology brush two full turns, and withdraw the brush without touching any vaginal surface.
Place the swab in the extraction tube, and carry out the test immediately.
Male Urethral Specimen
Use standard wire-shafted fiber-tipped swabs for urethral specimen collection. Instruct the patients not to urinate at least one hour prior to specimen collection.
Insert the swab into the urethra about 2-4cm, rotate for 3-5 seconds and withdraw it.
Place the swab to the extraction tube, and carry out the test immediately.
Urogenital Swab Storage Condition
If immediate testing is not possible, the patient sample should be placed in a dry transport tube for storage or transport. The swabs may be stored for 4 hours at room temperature (15-30℃) or 24 hours at refrigerated (2-8℃). Do not freeze.
All specimens should be allowed to reach a room temperature of 15-30℃ before testing.
Colloidal Gold Chromatographic Immuno Double Antibody Sandwich method is used in this Gonorrhea Antigen Test Strip to detect the Neisseria Gonorrhea Antigen in human Urogenital Swab specifically. The introduction of this Colloidal Gold Chromatographic Immuno Double Antibody Sandwich testing principle is given blow.
In the double antibody sandwich lateral flow chromatographic rapid test, two antibodies are used to detect viral protein or antigen.
In the test band region, antibody specific to the target antigen or protein is immobilized. In the end of the membrane strip where the samples are added, another antibody conjugated with colloidal gold particles is embedded.
During the testing process, specimen from the patient is added to the end of the membrane strip. The antibody conjugate particles will resolve into the specimen, where the antibody conjugate will react and bound to the target protein or viral antigen, if present.
This antigen-antibody conjugate complex then moves along the strip to the testing band region, under capillary effect. The immobilized antibody in the test line region then bound to another binding site on the antigen complex, and the antibody-antigen-antibody complex is fixed on test band region.
When the complex congregates, the highly concentrated colloidal gold particles will develop some red or pink color, indicate a positive result.
If there is no target protein or antigen in the specimen, the colloidal gold particles will not congregate and no color will develop, indicating a negative result.