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HIV 1+2 Antibody Rapid Test Kits

One step anti-HIV rapid test kits are intended to be used for blood screening as an aid for the diagnosis of HIV-1 and/or HIV-2 infection.

HIV Test strip and Cassette

One-step anti-HIV Rapid Test

CE2265 markOne step anti-HIV 1+2 test strip and test cassette are direct binding screening testing devices for the presence of antibodies to HIV-1 and HIV-2 viruses in human serum, plasma and/or whole blood specimens. These HIV rapid tests are based on the principle of double antigen sandwich immunoassay. anti-HIV rapid test kits can be used for screening of blood donors or as an aid for the diagnosis of clinical conditions related to infection with HIV-1 and/or HIV-2. Our anti-HIV 1/2 antibody rapid serum test kit is CE2265 marked.

It is intended for professional use as an aid in diagnosis of HIV infections. This assay provides only a preliminary result, and all positive specimens should be confirmed with other qualified assays.

HIV-1 and HIV-2 Differentiation

Serological studies have determined that HIV-1 and HIV-2 have multiple common epitopes in core antigens but much less so in the envelope antigens. This clinical diagnostic issues related to HIV are the detection of antibodies to HIV1/2 in human plasma or serum by immunoassay.

HIV and AIDS

The human immunodeficiency virus (HIV) is a lentivirus that causes acquired immunodeficiency syndrome (AIDS). HIV attacks the immune system, resulting in a chronic, progressive illness and leading to life-threatening opportunistic infections.
There are two types of HIV: HIV-1 and HIV-2. HIV-1 has been isolated from patients with AIDS and AIDS related complex, and from healthy persons with high potential risk of developing AIDS. Patients with HIV-2 are found primarily in parts of West Africa.

Treatment with anti-retrovirals increases the life expectancy of people infected with HIV.

HIV 1/2 Test Kits: Principle, Packing...

Cat. No. Description (& Details) Specimen PCS/Box Quan. per CTN Quantity (Tests)
HIV 311 Anti-HIV 1/2 Test Strip serum 100 Bulk: 6000 PCS
Boxed: 48 Boxes
HIV 312 Anti-HIV 1/2 Test Cassette serum 25 Bulk: 1600 PCS
Boxed: 40 Boxes
HIV 313 Anti-HIV WB Test Cassette serum/WB 25 Bulk: 1600 PCS
Boxed: 40 Boxes
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HIV Rapid Test kit

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Anti-HIV 1/2 Test Strip

General Information

(IVD Kit »-» Sexually Transmitted Disease -» One Step Lateral Flow Immunochromatographic Assay)

Catalog No.:HIV 311
Description:Anti-HIV 1/2 Test Strip
Category:Sexually Transmitted Disease
Style:Strip
Unit:PCS
Specimen:serum
No. of Step:One Step
Reading Time:10-15 Minutes
Cut Off:
Specification:3.0 mm
Quan. or Qual.:Qualitative
Sensitivity:98%
Specificity:98.2%
Method:Lateral Flow Double Antigen Sandwich

Packing Specification

Tests per Kit:100 Tests
Box Dimension:21.0 * 12.5 * 5.5 CM
Kits per CTN:48 Kits
Carton Dimension:53 * 45 * 36 CM
Tests per CTN (BULK):6000 Tests
Carton Volume:0.085 CBM
GW per CTN (Boxed):15.0 KG
GW per CTN (Bulk):16.0 KG

Materials Provided in the Test Kit

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

Specimen

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.

Testing Principle of Lateral Flow Double Antigen Sandwich

GICA Double Antigen Sandwich Method Illustration

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.

Information | Packing | Specimen | Principle

Anti-HIV 1/2 Test Cassette

General Information

(IVD Kit »-» Sexually Transmitted Disease -» One Step Lateral Flow Immunochromatographic Assay)

Catalog No.:HIV 312
Description:Anti-HIV 1/2 Test Cassette
Category:Sexually Transmitted Disease
Style:Card
Unit:PCS
Specimen:serum
No. of Step:One Step
Reading Time:10-15 Minutes
Cut Off:
Specification:4.0 mm
Quan. or Qual.:Qualitative
Sensitivity:98%
Specificity:98.2%
Method:Lateral Flow Double Antigen Sandwich

Packing Specification

Tests per Kit:25 Tests
Box Dimension:21.0 * 12.5 * 6.5 CM
Kits per CTN:40 Kits
Carton Dimension:53 * 45 * 36 CM
Tests per CTN (BULK):1600 Tests
Carton Volume:0.085 CBM
GW per CTN (Boxed):14.0 KG
GW per CTN (Bulk):16.5 KG

Materials Provided in the Test Kit

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

Specimen

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.

Testing Principle of Lateral Flow Double Antigen Sandwich

GICA Double Antigen Sandwich Method Illustration

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.

Information | Packing | Specimen | Principle

Anti-HIV WB Test Cassette

General Information

(IVD Kit »-» Sexually Transmitted Disease -» One Step Lateral Flow Immunochromatographic Assay)

Catalog No.:HIV 313
Description:Anti-HIV WB Test Cassette
Category:Sexually Transmitted Disease
Style:Card
Unit:PCS
Specimen:serum/WB
No. of Step:One Step
Reading Time:5-20 minutes
Cut Off:
Specification:4.0 mm
Quan. or Qual.:Qualitative
Sensitivity:98.5%
Specificity:98.6%
Method:Lateral Flow Double Antigen Sandwich

Packing Specification

Tests per Kit:25 Tests
Box Dimension:21.0 * 12.5 * 6.5 CM
Kits per CTN:40 Kits
Carton Dimension:53 * 45 * 36 CM
Tests per CTN (BULK):1600 Tests
Carton Volume:0.085 CBM
GW per CTN (Boxed):14.0 KG
GW per CTN (Bulk):16.5 KG

Materials Provided in the Test Kit

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

Specimen

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.

Whole Blood Collection

Whole blood can be collected with blood collection tube with venipuncture into blood collection tube (containing EDTA, citrate or heparin).

Or, by lancet lancing. 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.

serum/WB Storage Condition

Test specimens as soon as possible after collecting.

The specimens can be stored up to 3 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.

Testing Principle of Lateral Flow Double Antigen Sandwich

GICA Double Antigen Sandwich Method Illustration

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.

Information | Packing | Specimen | Principle