AFP Serum Rapid Test Cassette

AFP Serum Rapid Test Cassette (甲胎蛋白血清诊断试纸卡) 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 Alpha Fetoprotein in human Serum specimen.

Please refer to the Instruction for Use (IFU) of the AFP Serum Rapid Test Cassette.

Detailed information of AFP Serum Rapid Test Cassette

  1. General and Technical information of this AFP test kit;
  2. Packing specification of this AFP Card 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 Alpha Feto-Protein Test Kit.

Main technical information of this AFP test kit is listed in the following table:

Catalog No.:AFP 512
Description:AFP Serum Rapid Test Cassette
Category:Tumor Marker
Style:Card
Unit:PCS
Specimen:Serum
No. of Step:One Step
Reading Time:15-20 Minutes
Cut Off:25 ng/ml
Specification:4.0 mm
Quan. or Qual.:Qualitative
Sensitivity:99%
Specificity:99.5%
Assay Principle:Colloidal Gold Chromatographic Immuno Double Antibody Sandwich

The standard kit size of this Alpha Feto-Protein Card test kit is 25 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:25 Tests
Dimension of Kit Box:21.0 * 12.5 * 6.5 CM
Boxes per Carton:40 Kits
Tests per Carton (BULK):1600 Tests
G.W. per Carton (Boxed):14.0 KG
G.W. per Carton (Bulk):16.5 KG
Carton Dimension:53 * 45 * 36 CM
Carton Volume:0.085 CBM

Materials Provided

  • Test cassette in single foil pouch with desiccant;
  • Disposable sample dropper;
  • Specimen Diluents;
  • Instruction leaflet.

To carry out the assay with a AFP Serum Rapid Test Cassette, 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.

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.

Serum Storage Condition

Test specimens as soon as possible after collecting. The specimens can be stored up to 5 days at 2-8°C if not tested immediately. The specimens should be frozen at -20°C for longer time storage. Don’t freeze and thaw the specimens for many times. 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 AFP Serum Rapid Test Cassette to detect the Alpha Fetoprotein in human 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.