HBsAg Serum Test Strip
HBsAg Serum Test Strip (乙肝表面抗原诊断试纸条) 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 Hepatitis-B Surface antigen in human Serum specimen.
IFU, CE and EC Design Certificate
Please refer to the Instruction for Use (IFU), related CE and EC Design Certificates for HBsAg Serum Test Strip as follow:
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 HBsAg Serum Test Strip
- General and Technical information of this HBsAg test kit;
- Packing specification of this HBsAg 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 Hepatitis B Test Kit.
Main technical information of this HBsAg test kit is listed in the following table:
|Catalog No.:||HBV 211|
|Description:||HBsAg Serum Test Strip|
|No. of Step:||One Step|
|Reading Time:||10 Minutes|
|Cut Off:||2 ng/ml|
|Quan. or Qual.:||Qualitative|
|Assay Principle:||Colloidal Gold Chromatographic Immuno Double Antibody Sandwich|
The standard kit size of this Hepatitis B 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 HBsAg Serum Test Strip, 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.
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 HBsAg Serum Test Strip to detect the Hepatitis-B Surface antigen in human Serum 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.