The Dengue Ag NS1-IgM/ IgG rapid test is a lateral flow immunoassay
for the simultaneous detection and differentiation of IgG anti–
dengue virus, IgM anti-dengue virus and dengue antigen (Dengue Ag) in human
serum, plasma or whole blood. It is intended to be used by
professionals as a screening test and as an aid in the diagnosis of infection with dengue virus. Any
reactive specimen with the Dengue Ag NS1-IgM/ IgG rapid test must
be confirmed with alternative testing method(s).
PRECAUTIONS
1) For in vitro diagnostic use and professional use only.
2) Read the package insert instruction before use the kit.
3) Do not use beyond the expiration date which appears on the
package label.
4) Do not open the sealed pouch, unless ready to conduct the assay.
5) Bring all reagents to room temperature (15°C-30°C) before use.
6) Do not use the components in any other type of test kit as a
substitute for the components in this kit.
7) Haemolized blood may be used for the testing, but do not take
precipitants.
8) Wear protective clothing and disposable gloves while assaying
samples. Wash hands thoroughly after performing the test.
9) Handle all specimens as if they contain infectious agents. When
the assay procedure is completed, dispose of specimens carefully
after autoclaving them for at least one hour. Alternatively, they
can be treated with 0.5 to 1% solution of sodium hypochlorite for
one hour before disposal.
10) Do not smoke, drink, or eat in areas where specimens or kit
reagents are being handled.
11) Wear protective clothing and disposable gloves while assaying
samples. Wash hands thoroughly after performing the test.
12) Handle all specimens as if they contain infectious agents. When
the assay procedure is completed, dispose of specimens carefully
after autoclaving them for at least one hour. Alternatively, they
can be treated with 0.5 to 1% solution of sodium hypochlorite for
one hour before disposal.
13) Do not smoke, drink, or eat in areas where specimens or kit
reagents are being handled.
11) Read result after 30 minutes may give erroneous results.
12) Do not perform the test in a room with strong air flow, ie. an
electric fan or strong air- conditioning.
13) As with all diagnostic tests, a definitive clinical diagnosis
should not be based on the results of a single test, but should
only be made by the physician after all clinical and laboratory
findings have been evaluated.
14) Excess sample volume (>5µL) can give false positives.
