• Incidence Testing
• Rapid Test Platform
• Oral Fluid Sampling System
• Molecular Diagnostics

RAPID TEST PLATFORM

Lateral-flow immunoassays are tests that take advantage of the specific binding of antibodies to antigens. One of the main characteristics of such immunological techniques is the appropriate labeling of the antibody to the antigen enabling visualization of the specific binding action. This label aids to create a signal that correlates with the immunoreaction and allows the detection of the analyte of interest. In a lateral-flow immunoassay system, the antibody-antigen reaction is shown chromatographically as colored lines on the membrane.

The lateral-flow test strip is comprised of a sandwich of overlapping materials which are made into a card and cut into strips which are then tested. The card is usually comprised of an adhesive backing card, sample pad or conjugate pad (or both), a membrane and an absorbent pad. The backing card is used as a “backbone” for the subsequent overlapping materials to adhere to. The sample pad is often impregnated with a buffering solution which, when rehydrated, can aid in blocking non-specific binding of excess reactants to the membrane. The conjugate pad is impregnated with a detector reagent often called a “conjugate”. The conjugate has two linked components: (1) a colored entity (e.g. colloidal gold) to allow the reaction to be observed and (2) a reactive protein (e.g. Protein A) that will allow the reaction to take place. The membrane material (often nitrocellulose) is “striped” with two different reagents in separate parallel lines. One line is striped with the control reagent and will demonstrate that the test ran properly. The other line is striped with a test reagent and will differentiate reactive (color present) from non-reactive (color absent) test specimens. Finally, at the end of the strip is an absorbent pad (wick material) which aides to draw or “wick” the combined specimen/buffer up the strip.

Calypte’s Aware™ HIV-1/2 family of lateral flow tests are qualitative, visually read, in vitro immunoassays for the detection of antibodies to Human Immunodeficiency Virus Type 1 (HIV-1) and Type 2 (HIV-2) in human oral mucosal transudate specimens (Aware™ HIV-1/2 OMT), whole blood, serum or plasma (Aware™ HIV-1/2 BSP) and urine specimens (Aware™ HIV-1/2 U).

Biological Principles Of The Calypte Aware™ HIV-1/2 tests

The Aware™ HIV-1/2 lateral flow tests utilize a lateral flow immunoassay system as described above. In the Aware™ HIV-1/2 tests, the materials are prepared using a proprietary formulation and components that provide a matrix for optimal immunochromatography and exquisite sensitivity, even in the most demanding samples such as oral fluid and urine. In the Aware™ HIV-1/2 OMT and Aware™ HIV-1/2 U tests, the assay test strip contains recombinant proteins representing the immunodominant regions of the HIV-1 gp41 and HIV-2 gp36 transmembrane proteins and a goat anti-human IgG F(ab´)2 fragment antibody-capture procedural control immobilized onto the nitrocellulose membrane in the Test Zone and the Control Zone, respectively.

The Aware™ HIV-1/2 BSP assay test strip is similar to the Aware™ HIV-1/2 OMT and U tests but utilizes synthetic peptides instead of recombinant proteins to represent the immunodominant regions of the HIV-1 gp41 and HIV-2 gp36 transmembrane proteins and a Protein A antibody-capture procedural control immobilized onto the nitrocellulose membrane in the Test Zone and the Control Zone, respectively.