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HIV Rapid Tests

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HIV Rapid Tests

A rapid test for the diagnosis of Human Immunodeficiency Virus to detect antibodies to HIV type 1, type 2 and Subtype O qualitatively in whole blood, serum or plasma.

For professional in vitro diagnostic use only.


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SUMMARY

HIV 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 and Subtype O.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. Although rarely compared to HIV-1 and HIV-2,infections caused by Subtype O have so far been identified in Africa (Cameroon),France and Germany.HIV-2 has been isolated from West African AIDS patients and from seropositive asymptomatic individuals.2 HIV-1,HIV-2,and Subtype O all elicit immune responses.3 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.4 Despite the differences in their biological characters,serological activities and genome sequences, HIV-1,HIV-2,and Subtype O show strong antigenic cross-reactivity.5,6 Most HIV-2 positive sera can be identified by using HIV-1 based serological tests.

The HIV 1/2/O Rapid Test Device (Whole Blood/Serum/Plasma) is a rapid test to qualitatively detect the presence of antibodies to HIV-1,HIV-2,and/or Subtype O in whole blood,serum or plasma specimen.

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CLINICAL SENSITIVITY,SPECIFICITY AND ACCURACY

The HIV 1/2/O Rapid Test Device (Whole Blood/Serum/Plasma) was evaluated in a multi-center field study, a blood donation center as well as an in-house clinical study.The multi-center study included 1,640 specimens from different countries.There were 1,000 specimens from the blood donation center,and the in-house clinical study included 687 specimens and an HIV Performance Panel that was purchased from a commercial source.

The HIV 1/2/O Rapid Test Device (Whole Blood/Serum/Plasma) was compared to leading commercial ELISA HIV tests and/or Western Blot. Of the 3,327 total specimens,872 were found positive and 2,455 specimens were found negative by ELISA and/or Western Blot.The HIV 1/2/O Rapid Test Device (Whole Blood/Serum/Plasma) showed 99.9% relative sensitivity,and 99.8% relative specificity compared to ELISA and/or Western Blot.


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