HIV 1/2 Total Antibody Home Test
HIV 1/2 Total Antibody Home Test (艾滋病毒1/2总抗体全血自测试纸卡) is a one-step qualitative lateral flow rapid diagnostic test kit, based on the Colloidal Gold Chromatographic Immuno Double Antigen Sandwich principle, which is used to detect HIV 1/2 Total Antibody in human Whole blood specimen.
Supplementary information of HIV 1/2 Total Antibody Home Test
- General and Technical information of this HIV AB test kit;
- Packing specification of this HIV AB Cassette 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 HIV Total Antibody Test Kit.
Main technical information of this HIV AB test kit is listed in the following table:
| Former Cat. No.: | HIV 318 |
|---|---|
| Description: | HIV 1/2 Total Antibody Home Test |
| Category: | Sexually Transmitted Disease |
| Style: | Cassette |
| Unit: | PCS |
| Specimen: | Whole blood |
| No. of Step: | One Step |
| Reading Time: | 5-20 minutes |
| Cut Off: | |
| Specification: | 4.0 mm |
| Quan. or Qual.: | Qualitative |
| Sensitivity: | 98.2% |
| Specificity: | 100% |
| Assay Principle: | Colloidal Gold Chromatographic Immuno Double Antigen Sandwich |
The standard kit size of this HIV Total Antibody Cassette test kit is 1 tests per box; 400 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: | 1 Tests |
|---|---|
| Dimension of Kit Box: | 18.5 * 6.0 * 1.5 CM |
| Boxes per Carton: | 400 Kits |
| Tests per Carton (BULK): | 1200 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
- HCG Urine Test Midstream in single foil pouch;
- Disposable Urine Cup (optional);
- Instruction For Use (IFU).
To carry out the assay with a HIV 1/2 Total Antibody Home Test, Whole blood 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.
Blood Collection With Venipuncture
Collect the whole blood into the collection tube (containing EDTA, citrate or heparin) by venipuncture.
Blood Collection With Lancet
Clean the area to be lanced with an alcohol swab. Squeeze the end of the fingertip and pierce with a sterile lancet.
Wipe away the first drop of blood with sterile gauze or cotton. Take a dropper provided, while gently squeezing the dropper tube, immerse the open end in the blood drop and then gently release the pressure to draw blood into the dropper.
Whole Blood Storage Condition
It is preferable to test the specimen immediately after blood collection.
If specimens can’t be tested immediately but can be tested within three days, they should be refrigerated at 2 ~ 8°C. For storage periods longer than three days, freezing is recommended.
Before testing, they should be brought to room temperature prior to use.
Storing the specimen for more than three days may lead to non-specific reaction, thus affect the specificity of the testing results.
Colloidal Gold Chromatographic Immuno Double Antigen Sandwich method is used in this HIV 1/2 Total Antibody Home Test to detect the HIV 1/2 Total Antibody in human Whole blood specifically. The introduction of this Colloidal Gold Chromatographic Immuno Double Antigen Sandwich testing principle is given blow.
Double antigen sandwich technology is commonly used to detect total antibody, which include IgM, IgG and IgA antibodies, which all can react and bound to specific antigen. In the lateral flow double antigen sandwich chromatographic rapid test, recombinant or purified antigens are used to capture and detect the total antibodies specifically.
In the test band region, purified or recombinant antigens or proteins are immobilized. In the end of the membrane strip where the samples are supposed to be added, another antigen 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 antigen conjugate particles resolve into the specimen, where the antigen conjugate will react and bound to the target antibodies, if present.
This antibody-antigen conjugate complex then moves along the strip to the testing band region, under capillary effect. Where the immobilized antigen captures the complex, and the antigen-antibody-antigen-colloidal gold 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 antibody in the specimen, the colloidal gold particles will not congregate on the test band region, and no color will develop, indicating a negative result.
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