Infection Disease AIDS HIV1/2 Rapid Test Device

For professional in vitro diagnostic use only

INTENDED USE

The HIV 1/2 Rapid Test Strip (Whole Blood/Serum/Plasma) is a rapid visual immunoassay for the qualitative presumptive detection of antibodies to HIV-1/HIV-2 in human whole blood, serum, or plasma specimens. This kit is intended to be used as an aid in the diagnosis of HIV infection.

INTRODUCTION

HIV is the etiologic agent of Acquired Immune Deficiency Syndrome (AIDS). The virion is surrounded by a lipid envelope that is derived from 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. HIV-2 has been isolated from West African AIDS patients and from seropositive asymptomatic individuals. Both HIV-1 and HIV-2 elicit immune response. 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 of the differences in their biological characters, serological activities and genome sequences, HIV-1 and HIV-2 show strong antigenic cross-reactivity. Most HIV-2 positive sera can be identified by using HIV-1 based serological tests.

PRINCIPLE

The HIV 1/2 Rapid Test Strip (Whole Blood/Serum/Plasma) has been designed to detect antibodies to HIV-1/HIV-2 through visual interpretation of color development in the internal strip. The membrane was immobilized with recombinant HIV antigens on the test region. During the test, the specimen is allowed to react with colored HIV antigens colloidal gold conjugates, which were precoated on the sample pad of the test. The mixture then moves on the membrane by a capillary action, and interact with reagents on the membrane. If there were enough HIV-1/HIV-2 antibodies in specimens, a colored band will from at the test region of the membrane. Presence of this colored band indicates a positive result, while its absence indicates a negative result. Appearance of a colored band at the control region serves as a procedural control. This indicates that proper volume of specimen has been added and membrane wicking has occurred.

Hangzhou Aichek Medical Technology Co.,Ltd

Hangzhou Aichek Medical Technology Co.,Ltd is a high-tech company specialises in manufacturing rapid diagnostic and healthcare products.

With five product lines of fertility, infectious diseases, cardiac marker, tumor marker and drug of abuse, our research and development team continues to grow.

Based in Hangzhou, the company has long-term cooperation with various R&D institutions in greater China, the United States and Europe, offering the strongest technical support for the development of the company.

We are also a certified ISO and CE organization. By employing strict quality control system, our management team assures exceptional customer service and high quality products.