HCG Urine Test Strip
HCG Urine Test Strip (早早孕尿液检测试纸条) 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 Human Chorionic Gonadotropin in human Urine specimen.
IFU, CE and ISO
Please refer to the Instruction for Use (IFU), related CE and ISO13485 certificates for HCG Urine Test Strip as follow:
- US.FDA 510K Letter
- IFU of HCG Urine Test Strip
- CE Self-Declaration of Conformity
- TUV CE Certificate
- ISO13485:2006 Certificate
All the documents and certificates provided here on the website are subjected to changes without prewarning. Please check with your sales manager for the latest version for practical uses, such as product registration; before carrying out an assay, reading the Instruction for Use included in the test kit is always a good practice.
Detailed information of HCG Urine Test Strip
- General and Technical information of this HCG test kit;
- Packing specification of this HCG 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 Human Chorionic Gonadotropin Test Kit.
Main technical information of this HCG test kit is listed in the following table:
|Catalog No.:||HCG 112|
|Description:||one-step HCG Urine Test Strip|
|Category:||Fetility & Eugenics|
|No. of Step:||One Step|
|Reading Time:||5 Minutes|
|Cut Off:||25 mIu/ml|
|Quan. or Qual.:||Qualitative|
|Assay Principle:||Colloidal Gold Chromatographic Immuno Double Antibody Sandwich|
The standard kit size of this Human Chorionic Gonadotropin Dipstick test kit is 100 tests per box; 48 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:||48 Kits|
|Tests per Carton (BULK):||6000 Tests|
|G.W. per Carton (Boxed):||15.0 KG|
|G.W. per Carton (Bulk):||16.0 KG|
|Carton Dimension:||53 * 45 * 36 CM|
|Carton Volume:||0.085 CBM|
- Lateral Flow immunochromatographic assay (GICA) Strip;
- Instruction leaflet;
- Disposable urine cup (optional).
To carry out the assay with a HCG Urine Test Strip, Urine 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.
A urine specimen must be collected in a clean and dry container.
For hormone test such as HCG prenancy test, the first urine specimen in the morning is preferred since it generally contains the highest concentration of hormone, although urine specimens collected at any time of the day may be used.
Urine specimens exhibiting visible particles should be centrifuged, filtered, or allowed to settle to obtain clear specimen for testing.
Urine Storage Condition
Urine specimens may be stored at 2-8°C for up to 48 hours prior to testing. For long-term storage, specimens may be frozen and stored below -20°C.
Frozen specimens should be thawed and mixed before testing.
Colloidal Gold Chromatographic Immuno Double Antibody Sandwich method is used in this HCG Urine Test Strip to detect the Human Chorionic Gonadotropin in human Urine 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.