HCG Urine/Serum Test Strip

HCG Urine/Serum Test Strip (早早孕血清检测试纸条) 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 or Serum specimen.

Detailed information of HCG Urine/Serum Test Strip

  1. General and Technical information of this HCG test kit;
  2. Packing specification of this HCG Dipstick style test kit (gross weight in full kit package and in bulk packing);
  3. Specimen used to carry out the assay, and the requirements on specimen collection, storage and processing; and,
  4. 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 115
Description:one-step HCG Urine/Serum Test Strip
Category:Fetility & Eugenics
Style:Dipstick
Unit:PCS
Specimen:Urine, Serum
No. of Step:One Step
Reading Time:5 Minutes
Cut Off:25 mIu/ml
Specification:3.0 mm
Quan. or Qual.:Qualitative
Sensitivity:99.5%
Specificity:98.5%
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

Materials Provided

  • Lateral Flow immunochromatographic assay (GICA) Strip;
  • Instruction leaflet;
  • Disposable urine cup (optional).

To carry out the assay with a HCG Urine/Serum Test Strip, Urine or Serum 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.

Urine Collection

A urine specimen must be collected in a clean and dry container.

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.

Serum Collection

Collect blood specimen into a red top blood collection tube by vein puncture, which contains no anticoagulants.

Allow the blood to clot, or separate the serum by centrifugation.

Carefully withdraw the serum into a new pre-labeled tube.

Urine, Serum Storage Condition

The specimens should be tested as soon as possible after collection.

The serum specimens can be stored up to 3 days at 2-8°C. For longer time storage, the specimens should be frozen at -20°C.

Urine specimens may be stored at 2-8°C for up to 48 hours. For long-term storage, specimens may be frozen and stored below -20°C.

Don’t freeze and thaw the specimens repeatedly.

Prior to testing, bring frozen specimens to room temperature slowly and mix gently.

Specimens containing visible particulate matter should be clarified by centrifugation before testing.

Do not use samples demonstrating gross lipemia, gross hemolysis or turbidity in order to avoid interference on result interpretation.

Colloidal Gold Chromatographic Immuno Double Antibody Sandwich method is used in this HCG Urine/Serum Test Strip to detect the Human Chorionic Gonadotropin in human Urine or Serum specifically. The introduction of this Colloidal Gold Chromatographic Immuno Double Antibody Sandwich testing principle is given blow.

GICA Double Antibody Sandwich Method Illustration

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.