Inverness Medical has announced its Determine HIV 1/2 Ag/Ab Combo rapid HIV diagnostic test has received CE marking, making it available for use in a range of healthcare settings.
Determine HIV 1/2 Ag/Ab Combo enables simultaneous and separate detection of HIV p24 antigen (Ag) and antibodies (Ab) for HIV-1 and HIV-2 in human serum, plasma or whole blood.
This increases the ability to detect and diagnose primary HIV infection.
This test can detect HIV infection 2-20 days earlier than HIV antibody tests only (with a mean average of five days).
During HIV infection, the p24 antigen is produced during the first few weeks and is detectable seven-nine days earlier than the appearance of HIV antibodies.
As a result, the p24 antigen is an ideal marker in aiding early HIV diagnosis.
Fourth-generation HIV-screening assays represent the latest advancements in HIV serological tests.
These assays can detect HIV antibody and HIV-1 p24 antigen simultaneously and were developed to detect acute, as well as latent infections using a time and cost-saving strategy.
Most fourth-generation diagnostics are laboratory-based tests (for example Elisas) and are not appropriate for point-of-care applications or for use in challenging environments, such as remote developing-world settings.
The first test of its kind for acute HIV infection, Determine HIV 1/2 Ag/Ab Combo provides clear visual results in 20 minutes.
The easy to use, robust format of Determine does not require electricity, water or the use of bulky laboratory equipment and can be performed in point-of-care settings and remote locations in developing countries where laboratory facilities are limited.
This gives significant advantages over lab-based EIA and Elisa fourth-generation HIV testing.
Determine HIV 1/2 Ag/Ab Combo provides clear and accurate results.
It has excellent sensitivity of 100 per cent for patients at a chronic stage of infection and a specificity of 99.23 per cent and 99.66 per cent for HIV antibodies and HIV-1 p24 antigen respectively.
The Determine HIV 1/2 Ag/Ab Combo test helps to diagnose and screen for early HIV infection.
The ability of this test to enhance diagnosis of those with acute HIV infection will provide additional benefits in HIV prevention programmes and ultimately contribute to a reduction in the spread of HIV.
