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One step HCV test
Card
INTRODUCTION
One
Step Cassette Style ANTI-HCV Test is a rapid direct binding
test for the visual detection of hepatitis C
antibodies(ANTI-HCV) in serum as
an aid in the diagnosis of hepatitis C infection. One Step
ANTI-HCV Test is based on the principle of double antigen
sandwich immunoassay for
determination of ANTI-HCV in serum. Purified recombination
antigens were employed to specifically identify ANTI-HCV
with high sensitivity.
This
one step test only takes about 10-20 minutes. Test results
are read visually without any instrument.
SPECIMEN COLLECTION
Collect blood into a container without
anticoagulant. Allow the blood to clot and separate the
serum from the clot. Use the serum for testing. If the specimen cannot be tested on the
day of collection, store the serum specimen in a
refrigerator or freezer. Bring the specimens to normal room temperature before testing. Do not
freeze and thaw the specimen repeatedly.
TEST PROCEDURE
1.When you are ready to
begin testing, open the sealed pouch by tearing along the
notch. Remove the test from the pouch.
2.Draw 0.2ml (about 5
drops)sample into the pipette, and dispense it into the
sample well on the cassette.
3.Wait 10~20 minutes and
read results. Do not read results after 30 minutes.
INTERPRETATION OF RESULTS
*Negative:Only one
colored band appears on the control region. No apparent band
on the test region.
*Positive:In
addition to a pink colored band, a distinct pink colored
band will also appear in the test region.
*Invalid:A
total absence of color
in
both regions is an indication of
procedure error and/or that test reagent deterioration has
occurred.
STORAGE AND STABILITY
The test cassette can be stored
at room temperature(18 to 30℃)in
the sealed pouch for duration of shelf life. The test
cassette should be kept away from
direct sunlight, moisture and heat.
PRECAUTION
*For in vitro diagnostic
use only.
*Do not use test cassette
beyond expiry date.
*The test cassette should
not be reused.
