iCare Test Principle

Test Type

The iCare Test Kit represents a type of Test known as the “Rapid Test” or “Rapid Screen Test”, because of its ability to give rapid results, in as little as 15 minutes, compared to other types of STD testing which require days for the patient specimen to be sent to a lab for testing. Rapid tests are based on similar technology as EIA tests (EIA: Enzyme Immuno Assay), which are equivalently called ELISA tests (ELISA: Enzyme-Linked Immunosorbent Assay). However the term “ELISA test” is often used in STD testing to refer to the traditional, non-rapid application of ELISA tests, leading to confusion.

The iCare test is a simple, visual qualitative test that detects antibodies in human whole blood, serum or plasma. The test is based on immunochromatography and can give a result within 15 minutes.

 

Test Principle

The assay starts with a diluent prepared sample applied to the sample well. The viral antigen -colloidal gold conjugate embedded in the sample pad reacts with the viral antibody present in blood, serum or plasma sample forming a conjugate/viral antibody complex. As the mixture is allowed to migrate along the test strip, the conjugate/viral antibody complex is captured by a second antibody immobilized on a membrane forming a colored test band in the test region.

A negative sample does not produce a test band due to the absence of colloidal gold conjugate/viral antibody complexes. The antigens used in the conjugate test are recombinant proteins that correspond to highly immunoreactive regions of the virus. A colored control band in the control region appears at the end of test procedure regardless of test result. This control band is the result of the colloidal gold conjugate binding to the anti-virus antibody immobilized on the membrane. The control band indicates that the colloidal gold conjugate is functional.

 

Test Accuracy

The accuracy of disease testing kits on the market are commonly given in terms of “sensitivity” and “specificity”. The exact definitions of “sensitivity” and “specificity” are given below (numbers are for illustration only):

 

Our iCare HIV Test Kits (blood sample type) have been demonstrated by clinical trials to have a sensitivity of >99.8% and specificity of >99.8%.