Intended Use
The
rapid test for HIV (1+2) antibody from KHB is an in vitro, visually read test
for the qualitative determination of antibodies against HIV‐1 and HIV‐2 in
human serum, plasma or whole blood. This product is intended for use as an aid
to detect antibodies against HIV (1+2) from individuals.
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| The Inno Scientific HIV RTK pack comes with diluent, sterile lancet, pipette, alcohol pad, instruction leaflet and KHB HIV Diagnostic Kit (HIV1+2) |
Principle of the Procedure
The
rapid test of HIV (1+2) antibody from KHB adopts the solid phase colloidal gold
immunochromatographic
technology for the qualitative detection of antibodies against HIV‐1/HIV‐2. The
gold HIV‐1 gp160(2) conjugate and the
gold HIV‐2 gp36(3) conjugate are coated
to the conjugate pad in advance. The test line (gp36 and gp41 antigens) and the
control line (monoclonal antibody against gp160) are pre‐coated on the surface
of Nitrocellulose (NC)
membrane. When the
sample is added
to the sample
pad, it migrates
through the conjugate
pad, reconstitutes and mixes with the colloidal gold‐antigen complex and
moves on till the end of the strip. A reddish‐purple test line will be visible
in the strip if there are enough antibodies against HIV‐1/HIV‐2 in the sample.
If the specific antibodies are absent, or present at a very low level, no color
change will occur in the test line(4, 5).
Materials Provided
• HIV
(1+2) antibody test cassette
• Sample
diluent
• Instructions
for
use
• Pipette
• Sterile
lancet
• Alcohol
pad
Safety Precautions
• Wear
gloves during the entire testing process.
• Do not
pipette by mouth.
• Do not
eat or smoke while handling samples.
• Clean
and
disinfect all the areas that may be
contaminated by spills of samples or
reagents with
appropriate disinfectant.
• Decontaminate
and
dispose of all samples, reagents, and other potentially contaminated material
as if they were infectious wastes, in a bio-hazard container.
Handling Precautions
• Do
not mix and interchange different samples.
• Do not
use sample diluent from different batches in one
single test.
• Use of
hemolytic samples, rheumatoid factors‐contained
samples and lipidemic,
icteric samples may lead to
impairing the test result.
• Pooled
samples
or samples other than specified (i.e.
saliva, urine) are strictly forbidden to
be tested.
• Ensure
the
sample is added correctly prior the addition of
sample diluent.
Warning
• For
in vitro diagnosis of the infection of HIV only, other diseases cannot be
diagnosed with any
composition of this kit.
• The cassette,
individually enclosed in a foil pouch and packed every 50 in a kit, is only for
"single
use".
• Do not
use the test cassette if the pouch is damaged or the seal is broken. Contact
the supplier
when it happens.
• The sample
diluent in this kit contains Sodium Azide as the preservative, be cautious while
in
operation with the kit.
• Care should
be taken to avoid the contact between the sample area of the cassette and the
diluent
bottle to avoid the contamination of the diluent.
Storage Requirements
• The
test cassettes and the sample diluent must be stored
at 4~30℃ until expiration
date.
• Do not
use expired devices.
• Kit components
are stable until expiration date when handled and stored as this instructions
for
use required.
• Test cassette
should be used immediately upon unpacking the pouch.
Sample Collection and Storage
Requirements
• Human
serum,
plasma, and whole blood samples should be collected through venipuncture (or
whole blood through fingerstick).
• Whole
blood
and plasma sample can be prepared with EDTA, heparin or sodium citrate as
anticoagulant. The use of other anticoagulants may affect the results of the
test.
Test Procedure
Equilibrate all samples and the device to
room temperature
before testing.
Sample diluent from different batches
cannot be mixed.
1. Take
out a
test cassette from the foil pouch, and place it on a horizontal surface.
2. Use
the sample of either serum/plasma or whole blood: Add 40μl of sample to the sample area
firstly (Figure 1), then
slowly add 1 drop of sample diluent to
the
same area (Figure 2). Please
avoid direct contact of the diluent bottle with the sample area.
3. Wait
a
minimum of 15 minutes (up to 30 minutes) and read result.
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Positive Result (Figure 3)
Clear visible reddish‐purple bands appear both
at the control line (C‐line) and the test line (T‐line) of the cassette.
The
test result is valid even the band of the control line (C‐line) appears much
lighter or darker than the band of test
line (T‐line).
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Negative Result (Figure 4)
A reddish‐purple band appears only at the
control line (C‐line) of the cassette (Figure 4).
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Invalid Result 1 (Figure 5)
Reddish‐purple band
appears at neither the control line nor the test line of the cassette (Figure
5). Repeat the test of
the sample. If the result remains the same, then the
result is invalid and contact KHB supplier.
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