INTENDED USE
The
StrongStep® HPV 16/18 Antigen Rapid Test Device is a rapid visual
immunoassay for the qualitative presumptive detection of HPV
16/18 E6&E7 oncoproteins in female cervical swab specimens.
This kit is intended to be used as an aid in the diagnosis of
Cervical Pre-cancer and Cancer.
INTRODUCTION
In
developing countries, cervical cancer is a leading cause of
cancer related death of women, due to the lack of implementation
of screening tests for cervical pre-cancer and cancer. A
screening test for low resource settings should be simple, rapid,
and cost effective. Ideally, such a test would be informative
regarding HPV oncogenic activity. Expression of both HPV E6 and
E7 oncoproteins is essential for cervical cell transformation to
occur. Some research results demonstrated a correlation of E6
&E7 oncoprotein positivity with both severity of cervical
histopathology and risk for progression. Hence, E6&E7
oncoprotein promises to be an appropriate biomarker of
HPV-mediated oncogenic activity.
PRINCIPLE
The
StrongStep® HPV 16/18 Antigen Rapid Test Device has been designed
to detect HPV 16/18 E6&E7 Oncoproteins through visual
interpretation of color development in the internal strip. The
membrane was immobilized with monoclonal anti-HPV 16/18 E6&E7
antibodies on the test region. During the test, the specimen is
allowed to react with colored monoclonal anti-HPV 16/18 E6&E7
antibodies colored particals conjugates, which were precoated on
the sample pad of the test. The mixture then moves on the
membrane by capillary action, and interact with reagents on the
membrane. If there were enough HPV 16/18 E6&E7 oncoproteins
in specimens, a colored band will form at the test region of the
membrane. Presence of this colored band indicates a positive
result, while its absence indicates a negative result. Appearance
of a colored band at the control region serves as a procedural
control. This indicates that proper volume of specimen has been
added and membrane wicking has occurred.
SPECIMEN COLLECTION AND STORAGE
■ The
quality of specimen obtained is of extreme importance. As much
as cervical
epithelial cell should be collected by the swab.
For
cervical specimens:
■ Use
only Dacron or Rayon tipped sterile swabs with plastic shafts. It
is recommend
to use the swab supplied by the kits manufacturer(The swab
are not
contained in this kit, for the ordering information, please
contact the manufacture
or local distributor, the cataloge number is 207000).
Swabs from
other suppliers have not been validated. Swabs with cotton tips
or wooden
shafts are not recommended.
■
Before specimen collection, remove excess mucus from the
endocervical area with a
separate swab or cotton ball and discard. insert the swab into
the cervix
until only the bottommost fibers are exposed. Firmly rotate the
swab for
15-20 seconds in one direction. Pull the swab out
carefully!
■ Do
not place the swab in any transport device containing medium
since transport
medium interferes with the assay and viability of the organisms
is not
required for the assay. Put the swab to the extraction tube, if
the test may be
run immediately. If immediate testing is not possible, the
patient samples
should be placed in a dry transport tube for storage or
transport. The swabs
may be stored for 24 hours at room temperature (15-30°C) or 1
week at 4°C
or no more than 6 month at -20°C. All specimens should be
allowed to
reach a room temperature of 15-30°C before testing.