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Introduction:
The Vianalyse™ panty liner is the only non-intrusive method of assessing
the cause of an abnormal vaginal discharge. The product is useful for
both professionals and lay persons. It allows women to evaluate quickly
whether an abnormal vaginal discharge is due to either a simple Candida
(yeast) infection or a bacterial / parasitic infection. This is important
because most women will assume that Candida is the cause and just purchase
a treatment from their local pharmacy when Candida only accounts for around
30% of infections. This means that most women will put up with discharge
and infection for longer than necessary and usually go to their doctor
only after several days.
The
real advantage of using Vianalyse™ is that it will help fast-track women
to the correct use of an OTC treatment or to their doctor for the necessary
prescription. Prompt and effective treatment is important for general
well being but has several important health benefits - research suggests
that vaginal infections are an important factor in infertility, they can
cause early miscarriage, and they increase the risk of transmission of
sexually transmitted diseases.
Technology:
The Vianalyse™ product conveniently evaluates the cause of abnormal vaginal
discharge whilst a woman goes about her normal daily routine. After about
6 hours or as soon as any discharge is felt the woman simply removes an
indicator strip from the panty liner and checks for a change in colour.
If a blue-green colour is seen then a bacterial or parasitic infection
may be present and the woman should consult her doctor for further advice.
If the test strip stays yellow then a yeast infection or temporary irritation
may be the cause and the purchase of an OTC treatment will be all that
is required.
The Vianalyse™ test works by changing colour upon contact with vaginal
discharge that is abnormal and has a higher pH than normal. The Vianalyse™
panty liner membrane is specific to abnormal vaginal discharge and even
if contaminated with relatively alkaline urine, in the pH range 5.5-7.5,
will not give false positive results. This is an important point because
existing pH based tests to assess the cause of vaginal discharge are not
very reliable because they are affected by the presence of urine or recent
douching etc. Vianalyse™ is not affected by urine because the panty liner
strip contains novel polymers that give a reversible colour reaction with
urine after 10 minutes. This means that if a woman does have a urine leak
whilst using Vianalyse™ it will not affect the results. Vianalyse™ is
also better than other tests because it is non-invasive and monitors continually,
whereas spot tests can give false negative results.
Clinical
Study:
In a clinical study involving 109 women, aged 18-60 years, at two hospitals,
entering the clinic for investigation of an abnormal vaginal discharge.
Each woman was given a single panty liner to use during the waiting period
and the results obtained were compared to the clinicians conclusion.
Of these 109 women studied, 52 were shown to have a bacterial or parasitic
infection and 57 women had either a Candida infection or temporary irritation.
Vianalyse™ correctly identified 90% of the bacterial/parasitic infection
cases and 84% of the Candida or temporary irritation cases. Overall Vianalyse™
showed a positive predictive value of 84% and negative predictive value
of 91%.
Conclusions:
This clinical study supports the use of Vianalyse™ as a reliable and non-intrusive
method of identifying the cause of an abnormal vaginal discharge. The
use of the test in clinics or at home is likely to fast-track women to
the correct treatment and subsequent relief from symptoms. The clinical
performance of Vianalyse™ is significantly better than other tests, particularly
pH tests, largely because of the fact that urine does not interfere with
the test. Other tests available are also invasive and difficult to read.
Existing diagnostic methods are known to provide accurate diagnosis at
first visit in only 55-60% of cases. With an estimated 4 million plus
visits to GP's each year the Vianalyse™ test represent a significant advance
in diagnosis and therefore proper treatment for these women.
Since Vianalyse™ detects pH changes in vaginal mucus it may also be a
useful aid for women having difficulty in conceiving or perhaps having
recurrent miscarriage. Research suggest that undiagnosed infection is
an important cause of failure to conceive and also a factor in early miscarriage.
Positive results would indicate the need for treatment.
The test
is a Class 1 Medical Device and is sold CE marked and compliant with the
EU Medical Device Directive.
Copyright
Med-Direct International Ltd
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