Rapid Diagnostic Tests (RDTs): Principle, Schematic 3D Diagram, Parts|Lateral Flow Assay|IVD KITS!!!

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Rapid Diagnostic Tests (RDTs): Principle, Schematic 3D Diagram, Parts|Lateral Flow Assay|IVD KITS!!!@ivdmanufacturing7208

RDTs are lateral flow immuno-chromatographic antigen-detection tests, which rely on the capture of dye-labelled antibodies to produce a visible band on a strip of nitro-cellulose, often encased in plastic housing, referred to as cassettes. With malaria RDTs, the dye-labelled antibody first binds to a parasite antigen, and the resultant complex is captured on the strip by a band of bound antibody, forming a visible line (T - test line) in the results window. A control line (C- control line) gives information on the integrity of the antibody-dye conjugate, but does not confirm the ability to detect parasite antigen

Inside the cassette is a strip made of filter paper and nitrocellulose. Typically, a drop of blood is added to the RDT through one hole (A; sample well), and then a number of drops of buffer usually through another hole (B; buffer well). Buffer carries the blood along the length of the RDT.

Mode of action of common malaria RDT format
 1. The first step of the test procedure involves mixing the patient’s blood with a lysing agent in a test strip or well. This ruptures the red blood cells, releasing more parasite protein.
2. Dye-labelled antibody, specific for target antigen, is present on the lower end of nitrocellulose strip or in a plastic well provided with the strip. Antibody, also specific for the target antigen, is bound to the strip in a thin (test) line, and either antibody specific for the labelled antibody, or antigen, is bound at the control line
 3. Blood and buffer, which have been placed on strip or in the well, are mixed with labelled antibody and are drawn up the strip across the lines of bound antibody.
4. If antigen is present, some labelled antibody-antigen complex will be trapped and accumulate on the test line. Excess-labelled antibody is trapped and accumulates on the control line. A visible control line indicates that labelled antibody has traversed the full length of the strip, past the test line, and that at least some free antibody remains conjugated to the dye and that some of the capturing properties of the antibodies remain intact.
 5. The intensity of the test band will vary with the amount of antigen present, at least at low parasite densities (antigen concentration), as this will determine the amount of dye particles which will accumulate on the line. The control band intensity may decrease at higher parasite densities, as much of the labelled antibody will have been captured by the test band before reaching the control.

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