KISSH Monkeypox Virus Antigen Rapid Test Kit
【Intended Use】
The product is a lateral flow chromatographic immunoassay for the
qualitative detection of monkeypox virus antigen in human whole
blood, serum, plasma , rash exudate or nasal swab.
【Principle】
This product use double antibody sandwich method. During the test,
a specimen is dropped into the hole, and then the specimen is
superimposed under the capillary effffect. If the specimen contains
monkeypox virus, A color band appears in the test area ( T)
indicate a positive result for monkeypox virus. If the specimen
does not contain the corresponding substance to be tested, there
will
be no color bands in the test area ( T), and the result will be
negative. A color band appears in the quality control area ( C)
regardless of whether the corresponding substance to be tested is
present in the specimen. The color band in the quality control area
(C) is the standard to determine whether there are enough specimens
and whether the chromatographic process is normal, and
also serves as the internal control standard of the test.
【Specification】
20 Tests/Kit
【Components】
- Individually packed test cassette *20
- Droppers/ Swab *20
- Specimens dilution tube/extraction tube with buffer *20
- Package insert (IFU) *1
【Interpretation of Results】
Positive: * A color band in the quality control area (C) and a color band in
the T area.
* Note: The color bands in the test area (T) may appear in
different shades of color.
However, within the specified observation time, no matter the color
of the color
band is dark or light, even if there is only a very weak color
band, it should be
judged as a positive result.
Negative: only one color band appears in quality control area (C), no color
band
appears in test area (T). Negative results indicated that no
substance under test
could be tested in the specimen.
Invalid: no color stripe appears in the quality control area (C), the
result is
considered invalid. Some causes of invalid results are because of
not following the
directions correctly or the test may have deteriorated beyond the
expiration date. In
any case, it should be retested. If the problem persists, stop
using this lot number
immediately and contact with your local supplier.
