HIV

HIV (Human Immunodeficiency Virus) is a single-stranded, enveloped RNA virus that attacks the body’s immune sys- tem, especially the CD4+ white blood cells (CD4 expressing T lymphocytes). Despite the homology in conserved regions, there are two main types of human immunodeficiency virus: HIV-1 and HIV-2. HIV-1 virus is divided into four groups: M, N, O, and P. The most widespread group, M, is also classified into nine subtypes; A, B, C, D, F, G, H, J, and K.

It is not possible to cure the disease once a person is infect- ed. However, with the current medical therapies, controlling the infection and preventing the progression of the disease is possible.

For most infected people, flu-like symptoms last for a few days longer. However, due to a high number of asympto- matic patients, the only way to ensure having an HIV infec- tion is to get tested.

Anti-HIV 1/2 Test

Anti-HIV 1/2 Test is a rapid qualitative immunoassay for the detection of antibodies to Human Immunodeficiency Virus Type 1 (HIV-1) and Type 2 (HIV-2) in human whole blood, serum or plasma.

The device’ outer designs are given in the following pages. The device is also sampled in the following pages. The device is packed into a foil pouch.

All devices are packed in carton boxes of forty together with an instruction for use and pipettes. Labeling is done according to EN ISO 18113. Information provided with the device conforms EN ISO 15223, EN ISO 18113 and Annex 1.8 of the Directive.