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BIONORTM
HIV-1&2
is a rapid magnetic particle based Enzyme Immuno Assay detecting
antibodies against HIV-1, HIV-1 group 0 and HIV-2. The test is ideal
for use in small blood
collection centres, and laboratories performing between 5 to 100
tests per day.
The test kit contains
250 tests, and includes all necessary consumables, ready-to-use
reagents in dropper vials and an easy-to-follow protocol. The test
can use serum, plasma
and whole blood as sample, and results are read visually.
The test requires
a compact test station which includes these functions: tilting,
magnetic
rack, pump and lamp, for standardised reading of results. The unit
can be used on 220V
and on a 12V car battery.
The test is also
suitable for use at small and medium-sized laboratories/hospitals.
Since it can be performed at ambient temperature, the test is also
ideal for use in
Africa, South East Asia and Latin America.
The BIONOR HIV-1&2 test kit has been evaluated by WHO with excellent
results,
100% sensitivity and 98,8% specificity. WHO, Report no. 11 of the
Operational
characteristics of commercially available assays to detect antibodies
to HIV-1
and/or HIV-2 in human sera.
(Ref: Beelaert
G., Vercauteren G., Fransen K., Mangelschots M., De Rooy M., Garcia-Ribas
S., van der Groen G.,
Comparative evaluation of eight commercial enzyme linked immunosorbent
assays and 14 simple assays for detection
of antibodies to HIV. J. Virol. Methods 105 (2002) 197-206.
Example
of test results
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the top)
BIONOR™
HIV-1&2 Confirmatory
A NEW PEPTIDE-BASED MAGNETIC PARTICLE EIA for individual detection
of IgG
antibodies against recombinant p24 (CORE), synthetic peptides to
gp41 (TM1), synthetic
peptides to gp120/recombinant gp41 (ENV) and synthetic peptides
to gp36 (TM2)
Reagents:
Everything needed for performing the assay is included in the kit.
The reagents are
supplied “ready to use” in droppers. Very robust reagents. 12 months
shelf life.
No reduction in shelf life after opening the kit. No temperature
critical steps
Testing
station:
The testing station to be used with the Bionor™ HIV-1&2 Confirmatory
Test, consists
of a rocking platform with magnets, aspirator, lamp and waste container
and is self-contained.
It can be operated on 230 V, optionally 115 V or 12 V. Very robust
device which needs
minimum maintenance.
Interpretation of results:
Reading of results is simple and clear cut. Positive results give
a clear and distinct red colour.
Since each of the four antigen/antibody reactions can be read
separately, the interpretation of
results is very easy. Following the ASTPHLD/CDC criteria for interpretation
of results, studies
have shown that the number of indeterminate can be significantly
reduced compared to western
blot assays. Examples of test results are shown below.
Ref: Sommerfelt M.A., Ohlsson I., Flolid I., Thorstensson R.,
Sørensen B. (2003). A Simple Semi-rapid HIV-1&2 Confirmatory
Immunoassay Using Magnetic Particles. J. Virol. Methods. In press
Example of test results
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Assay
Principle
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the top)
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