This test is a single use, rapid device intended for qualitative detection of antibodies to Human Immunodeficiency Viruses or HIV 1+2 in serum and whole blood. It is intended for use in medical institution as an aid for the diagnosis and management of patients related to infection with HIV.
HIV (Human Immunodeficiency Virus) is the etiologic agent of Acquired Immune Deficiency Syndrome (AIDS). The virion is surrounded by a lipid envelope that is derived from the host cell membrane.
Several viral glycoproteins are on the envelope. Each virus contains two copies of positive-sense genomic RNAs. HIV-1 has been isolated from patients with AIDS and AIDS-related complex, and from healthy people with high potential risk for developing AIDS.1 HIV-1 consists of Subtype M. Highly divergent strains of HIV-1 were first recognized in 1990 and grouped provisionally as Subtype O as this variation has similar glycoprotein markers to HIV-1 but a slight variation to the protein marker. HIV-2 has been isolated from West African AIDS patients and from seropositive asymptomatic individuals.
Detection of HIV antibodies in serum, plasma or whole blood is the most efficient and common way to determine whether an individual has been exposed to HIV and to screen blood and blood products for HIV. Despite the differences in their biological characters, serological activities and genome sequences, HIV-1, HIV-2 show strong antigenic cross-reactivity.
Most HIV-2 positive sera can be identified by using HIV-1 based serological tests. The HIV 1.2 Rapid Test Cassette (Whole Blood/Serum/Plasma) is a rapid test to qualitatively detect the presence of antibodies to HIV type 1 and type 2, in whole blood, serum or plasma specimen.
We supply OEM: Private label test kits for pharmaceutical and laboratory groups that want to create their own brand.
Having successfully completed the CE marking, available for use in Europe (CE).
Manufacturing company with CE, issued as OEM, in compliance with Directive 98/79EC of the European Parliament and of the council of in vitro diagnostic Medical devices, according to Annex II, List A.
ISO 13485 certification.
Qualitative results within 10-20 minutes.
This test is available in strip and cassette format. The procedure is simple and requires no additional instrumentation to read the results. The HIV Test is an easy and effective aid for the screening and diagnosis of HIV infection.