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HIV 1/2/O
Tri-line
Human Immunodeficiency Virus Rapid Test Device
(Whole Blood)
type 1, type 2, and
Subtype O in whole blood, serum or plasma.
For professional in
vitro diagnostic use only.
INTENDED USE
The HIV 1/2/O
Tri-line Human Immunodeficiency Virus Rapid Test
Device (Whole Blood) is a rapid chromatographic
immunoassay for the qualitative detection
of antibodies to
HIV-1, HIV-2, and Subtype O in whole blood, serum or
plasma to aid in the diagnosis of HIV infection.
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
Tri-line Human Immunodeficiency Virus 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.
TEST
PROCEDURE
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