 |
Is the PrivaTest FDA approved? |
The FDA does not "approve" or "disapprove" tests developed by a laboratory.
They do approve test kits developed for sale by medical device manufacturers.
The PrivaTest is a scientifically valid test using approved laboratory industry
methodologies and is performed by a fully licensed CLIA (Clinical Laboratory
Improvement Amendments) certified clinical laboratory.
Back To Top Of Page
|
 |
|
What exactly is the PrivaTest? |
The PrivaTest is a special testing panel developed by Dr. J. Alexander Bralley
who is the chief scientist and founder of MetaMetrix Clinical Laboratory, one
of the premier nutritional testing laboratories in the country since 1984. This
test was designed to provide important information about specific biochemical
pathways, which can then be influenced with targeted nutritional
supplementation. (See PrivaTest
detail on the three biochemical pathways below.)
Back To Top Of Page
|
|
|
Is it true that the PrivaTest can tell me
everything I need? How can a simple urine sample do that? |
The cutting-edge PrivaTest takes nutritional testing to the next step. We don't
just want to know what nutrients happen to be in your blood at any given time.
We want to know if these nutrients are getting into your cells to do their
work. The PrivaTest is not measuring any nutrient level in your urine and
therefore is not intended to provide a nutrient-by-nutrient,
milligram-by-milligram analysis of your nutritional status. However, using a
simple in-home urine collection, backed by hard science, the PrivaTest provides
vital information about how three critical areas of your metabolism are using
the nutrients that you take in. This approach is much more useful clinically
than analyzing for amounts of nutrients that are just circulating around in
your blood. One of the best ways to do that is to look at the end products of
your metabolism. In other words, look for chemical compounds that are coming
out (or NOT coming out) in your urine.
The three areas were selected for testing because research is showing that poor
or altered function in these pathways may be the root cause of many of our
modern health challenges.
No other company offers you the exciting opportunity to gain this kind of
insight into your own unique biochemistry AND the opportunity to have a
customized nutritional supplement created based on your unique biochemical
needs!
Back To Top Of Page
|
|
|
What exactly ARE the three biochemical pathways
examined with the PrivaTest? |
The three areas that are evaluated in the PrivaTest are:
-
Urinary Deoxyguanosine (DOG)–A marker for oxidative damage to your DNA.
-
Urinary Sulfate–A marker for sulfur reserves.
-
Urinary ADMA–A marker for the regulation of nitric oxide.
Back To Top Of Page
|
|
|
What is DOG? |
8-hydroxy, 2-deoxyguanosine (DOG) for short) is a compound that reflects free radical damage to your DNA. When the body's defense systems identify this kind of damage, specialized enzymes "snip out" the damaged area and release it into the urine. It's a direct reflection of how much oxidative damage is happening to your DNA, and therefore how strong your antioxidant blend needs to be.
Back To Top Of Page
|
|
|
What does it mean if my DOG is elevated? |
If your DNA is being attacked and damaged by free radicals, then the body's antioxidant quenching systems are not working up to par. This can result in cell death or cell mutation. High urinary DOG can mean that your lifestyle is putting heavy demands on your antioxidant quenching system; in other words, you are under increased oxidant stress. You need extra antioxidant support.
Back To Top Of Page
|
|
|
What is urinary sulfate? |
Sulfur-containing compounds are used by the liver to turn harmful toxic
substances into neutral compounds and/or water-soluble compounds that can be
eliminated in the urine. The level of sulfate in the urine is a good general
indicator of body sulfur reserves and therefore an indicator of detoxification
ability.
Back To Top Of Page
|
|
|
What does it mean if my urinary sulfate is not in
the desirable range? |
A low level of sulfate in the urine can indicate reduced sulfur reserves in the
body. This can lead to reduced clearance of toxic compounds from the body with
an increased risk of free-radical damage. You need nutritional support with
sulfur containing nutrients and the vitamin and mineral cofactors involved in
the two detoxification phases in the liver.
Back To Top Of Page
|
|
|
What is urinary ADMA? |
Studies have demonstrated that either too much or too little nitric oxide can have its own specific set of effects. Excess is associated with inflammatory processes in the body while inadequate nitric oxide is associated with susceptibility to infection and vascular issues. In the last two decades, research has exploded on nitric oxide and the laboratory methods for measuring its production have been refined. This exciting new measurement, ADMA, is the most recent advance in determining nitric oxide regulation in the body. ADMA levels must be carefully balanced in your body because ADMA is a compound that easily modulates your body's production of nitric oxide.
Back To Top Of Page
|
|
|
What does it mean if my level of urinary ADMA
is out of range? |
If ADMA levels are too high, significant effects can occur. In humans, high ADMA has caused increased vascular resistance, decreased blood flow in the brain, increased sodium retention, and decreased heart output, among many other effects. In fact, high ADMA has been associated with everything from poor control of blood pressure, to pregnancy and fertility issues, to accelerated aging, to erectile dysfunction — just to name a few health challenges related to altered NO production. Gene researchers have identified 979 genes that change expression when exposed to high levels of ADMA. If your ADMA level is outside the balanced range, you need extra support with targeted nutrients that impact the nitric oxide production pathways and these will be added to your Custom Essentials. In addition, even if your oxidative stress level is within the desirable range as measured by the DOG level in your PrivaTest, a high ADMA level requires additional antioxidant nutrients to help modulate the effects of excessive ADMA.
Back To Top Of Page
|
|
|
|
Has the PrivaTest been scientifically validated? |
The methodology for these tests has been widely recognized in the scientific
community as valid and reliable. The Trump Network's laboratory, Metametrix, uses
the most advanced laboratory equipment and methods that science has to offer.
This lab has been using these tests reliably for years, primarily for
nutritionally-oriented physicians who have sought nutritional and metabolic
information in diagnosing problems, enhancing performance or taking preventive
measures.
Back To Top Of Page
|
|
|
How accurate are the PrivaTest results? |
The Trump Network Laboratory, Metametrix Clinical Laboratory, has been a fully
licensed clinical laboratory since 1984. Clinical labs perform testing for the
medical profession. They are required by state and federal laws to undergo
rigorous annual inspections by regulating agencies to insure quality and
accuracy of the test results they report. There are established procedures for
insuring quality control and assurance, which each lab must follow to retain
licensure. Metametrix is regularly inspected by the Department of Health and
Human Services for CLIA (Clinical Laboratory Improvement Amendments) licensure
and by the Georgia Department of Human Resources for its Clinical Laboratory
License.
Clinical chemistry is the science of analyzing body chemistry as it relates to
health and disease. In this discipline, there are standard validation methods
for quantifying accuracy and sensitivity of a particular test in regards to the
procedure and equipment used to obtain a result. Reproducibility is gauged by
how closely a lab can duplicate a result from a single sample repeated many
times or from several samples from the same person repeated over several runs.
In general, an acceptable error is a variation of 5-10% or less. This is called
a coefficient of variance or CV. Measurement of certain life-sustaining
substances such as glucose or electrolytes in blood must have a very low CV, as
these measures are critical to patient care. Cholesterol typically has a CV of
5% or less. That means if you measure the same sample of blood for its
cholesterol level 100 times, you should get numbers that will vary around the
"true" value by 5% or less. So, for example, a blood cholesterol test result
that says 200 may actually be 190-210. This range of variance is typical for
clinical labs and is an acceptable criterion for licensing requirements.
Obviously all labs attempt to get CVs as low as possible. The Trump Network test
results that you receive have CVs that are under constant monitoring for
reproducibility and average below 6.75%.
Back To Top Of Page
|
|
|
How does this urinalysis compare to a blood
nutrient test? |
There are several different blood tests for nutrients, which are usually quite
expensive. Most blood tests just measure the level of these nutrients found in
the blood at a given time. While this is useful for some purposes, it does not
provide any information about the utilization of these nutrients by the cells
of the body.
The urinalysis in the PrivaTest studies the by-products of cellular function of
three biochemical pathways. This tells the scientist how well these systems are
using the nutrients available to them or whether those nutrients are even
available to the cells. With that information and other pertinent data,
individual needs in these three areas can be determined.
Back To Top Of Page
|
|
|
How does this urinalysis compare to a hair
analysis? |
Hair analysis is most useful in detecting the presence of heavy metals and
certain minerals in your body. It can also be effective in detecting drug
metabolites. But hair analysis is somewhat limited for evaluating metabolic
function in the three pathways that we evaluate in the PrivaTest. In addition,
a relatively large amount of hair must be taken in long strips from close to
the scalp. Hair dyes can also alter hair analysis results.
Back To Top Of Page
|
|
|
Do your tests look at sensitivity or specificity? |
Most clinical healthcare practitioners have been trained to assess laboratory
results in terms of disease or absence thereof. In fact, the terms
"specificity" and "sensitivity" are defined as such, with "specificity" being
those persons deemed free of disease as identified by a test and "sensitivity"
being those persons having a disease as identified by a test.
However, when it comes to metabolic and nutritional medicine, we cannot apply
the same black-and-white terminology to nutritional laboratory evaluation
because we are not diagnosing disease; we are evaluating function.
For example, in the PrivaTest, the decision point of concern for urinary
sulfate (a marker for sulfur reserves) is 180 mg/liter. (We have established
that decision point based on several factors including peer-reviewed literature
studies and clinical observations, as well as reference range comparisons from
other metabolic laboratories.) Below this point, we reasonably suspect that
body sulfur reserves are being compromised for some reason. Now, the corollary
to that supposition is that, with low sulfur reserves, Phase II detoxification
ability may also be compromised due to the important roles that
sulfur-containing compounds play in detoxification.
Suppose that 1000 individuals take the urinary sulfate test. Out of that 1000,
let's say there are 200 people below 180 mg/liter. In other words, based on our
criteria, there are 200 "positives." Are we able to say with precision that all
200 people with less than 180 mg of urinary sulfate are experiencing
compromised detoxification ability? No. We are simply saying that a marker for
sulfur reserves is showing that possibility.
Because these clinical markers can sometimes be affected long before clinical
symptoms appear AND because our therapies are based on low to moderate doses of
nutritional substances, we are willing to accept more false positives.
In other words, in nutritional medicine, is it more important to have
sensitivity than specificity. We will assume that everyone with a certain set
of markers is heading down the road to eventual overt clinical symptomatology,
even though all of them might not be. We would prefer to offer all "suspect"
individuals a safe, "nutritional insurance" package now, rather than wait for a
definitive differentiation through future clinical diagnosis after function is
compromised to the extent that disease has developed.
According to Dr. Richard Lord of Metametrix Laboratory, this question is at the
very heart of what metabolic testing labs do and is exactly what differentiates
them from traditional reference laboratories. We are examining functional
biochemical markers and using nutritional therapy to support, improve or even
correct pathway function.
Back To Top Of Page
|
|
|
What period of time do the substances analyzed
reflect in terms of past metabolic history?
|
The substances that are analyzed in the urinalysis reflect ongoing processes.
You can have fluctuations from day to day, however, your particular trend
should remain stable over time unless something changes in your lifestyle.
These substances can also be influenced by nutritional intervention and it
requires at least 90 days of faithful supplementation to accurately evaluate
the impact of this intervention.
Back To Top Of Page
|
|
|
|
What in particular are the effects of this
supplementation in healthy people? |
This is a dilemma facing all laboratories doing nutritional testing.
The standard in the laboratory industry is to derive reference ranges from all
pooled patient data (including sick and healthy persons). This method, by
and large, provides a satisfactory reference range against which an individual
result may be compared to the general population and is useful in combination
with other patient data.
However, this average may not necessarily be ideal. For instance, the
laboratory reference range for cholesterol used to be considerably higher,
because the average cholesterol value for the average American was inching
upward each year. Is this a healthy trend and could you feel good if you fell
into the middle of this reference range? Based on the number of cardiac
incidents in people whose cholesterols were in this normal range, no. But
this was accepted as the gold standard for years. In fact, it wasn't until
after several long-term outcome studies which plotted cholesterol levels
against cardiac events that the cholesterol reference range was changed to
between 120 and 200. Now all laboratories use this reference range or something
very close to it.
Unfortunately, in the world of nutritional medicine, time and expense are the
barriers to these sorely needed outcome studies. The best that researchers can
do now to acquire a healthy comparison in a study is to use control groups of
age- and sex-matched persons who exhibit no overt disease. This is the
challenge that we have to continually examine and incorporate into our
recommendations regarding what is more ideal (based on patient outcomes
studies and user feedback) despite what may be acceptable in the industry as
average. This requires constant study and analysis of the current body of
published literature by our staff of research Ph.D.'s and critical analyses of
our own laboratory data.
You may rest assured that our tests and products will constantly be evolving as
scientific research dictates. No other nutritional company offers the consumer
the on-going opportunity to be on the cutting-edge of nutritional advancement
AND to have instant access to premier nutritional products based on these
advancements.
Back To Top Of Page
|
|
|
So what are your analyses showing about the
PrivaTest and Custom Essentials? |
Although not done as formal controlled studies, our retest data analyses
consistently show that around 66% of the test results (and remember each person
gets 3 test results) will stay in a desirable range, if they started out that
way (either naturally or from other supplementation), or they improve, if they
started out in a less desirable place. Considering the lack of control over
lifestyle impact and the fact that our only information about compliance is in
their order patterns, we consider that 66% a gratifying number. However, the
33% of results that do not improve, due to genetic makeup or something in the
lifestyle, are the ones in which we are most interested. Using some of this
information, we have created two specialized booster products to address these
situations. Future analyses will tell us more and lead to increased
customization.
Back To Top Of Page
|
|
|
What if I have a medical condition and I go to my
doctor and he/she doesn't believe in or know about this kind of testing or
supplementation? |
It is not The Trump Network's place to convince anyone of the value of our
programs and products. We can only present our products and offer information
but the decision is ultimately the consumer's. The best course of action is to
provide information to your healthcare professional and let them make an
informed decision with you. Bear in mind that most conventional clinicians have
barely enough time to keep up with the literature in their own specialty, and
very few will have read the medical research literature in nutritional and
metabolic medicine. Some clinicians will initially question the validity of
nutritional and metabolic testing because they are not familiar with the
related science. The monographs written by Dr. Bralley are intended to provide
a summary of the relevant literature for those clinicians unfamiliar with the
research. The best information can come from the list of Custom Essentials
ingredients labels on the PrivaTest report, and the scientific monographs by
Dr. Bralley. The final decision to use any of our programs or products must
ultimately be a decision between you and your healthcare professional.
Back To Top Of Page
|
|
|
How old must you be before taking the PrivaTest? |
Because of the data used to create our laboratory decision points, you must be
12 years old to take the PrivaTest and to use Custom Essentials. Children who
are younger than 12 can benefit from taking the KidKaps product, or Prime Essentials. This
high quality, multivitamin/mineral supplements provide excellent general nutritional
support.
Back To Top Of Page
|
|
|
I'm pregnant (or trying to get pregnant). Should I
take the PrivaTest? |
Custom Essentials is not designed specifically as a prenatal multivitamin
mineral. It does not contain extra amounts of certain nutrients, such as folic
acid and iron, which can be needed in prescription amounts during pregnancy. Therefore, if you are considering pregnancy or
are pregnant now, check with your obstetrician to see whether they want you to use
Custom Essentials (with some additional pregnancy-specific nutrients like iron
and folate taken separately), or whether they prefer you take a pre-natal vitamin
instead. It's up to you and your obstetrician to decide.
Back To Top Of Page
|
|
|
Can the testing be completed separate from
purchase of products? |
The PrivaTest is specifically designed to provide information for the
formulation of custom products. Since these tests are normally priced in the $330 range
(and The Trump Network is able to reduce the price for the PrivaTest,
through its technological strategic alliances), it is necessary to package the
two.
Back To Top Of Page
|
|
|
What if I'm already supplementing when I take the
test? |
Just continue as normal. There are no restrictions on the use of supplements, nor are any dietary changes required before you take the PrivaTest.
The questionnaire asks about your supplementation routine. Please complete it
as accurately as you can. This will allow the lab to interpret the results of
the test and make adjustments to your formulation where appropriate.
Back To Top Of Page
|
|
|
I think the lab needs to know something about me
and/or my health conditions and/or medications to create my custom formula. Can
I write this information on the questionnaire? |
Please don't. The questionnaire asks you everything that we need to know in
order to formulate your supplement. Because of the way our sophisticated system
has been created to handle the high volume of test specimens, the only
information that the lab can use is the information asked for on the
questionnaire. Lab personnel will not see any written comment. The results are
electronically transmitted to our fulfillment center and automatically analyzed
through a sophisticated computer algorithm that selects the appropriate formula
based on that analysis.
We do not need to know if you have any specific health condition in order to
create your Custom Essentials because we are looking at biochemical pathways,
not disease.
Back To Top Of Page
|
|
|
What if I have allergies or sensitivities to
certain nutrients? Can I tell the lab not to include them in my formula? |
If you are concerned about a specific nutrient being included in your
formulation because of an allergy to that nutrient, you need to check the list
of possible Custom Essential ingredients BEFORE YOU TAKE THIS TEST. This list
is available from the person who introduced you to The Trump Network. You may also
get the list from Customer Care at 800-768-7667.
If your suspected allergen is on the list, please be aware that we are unable
to delete specific nutrients from any of our formulas.
Back To Top Of Page
|
|
|
What questions on the questionnaire are used to
create my Custom Essentials? |
The 5 questions on the Test Request Form are used to create your Custom Essentials.
Back To Top Of Page
|
|
|
When should I retest? |
You need to be on Custom Essentials for at least 3 full months before you
retest. However, 9 months is the commonly recommended time. During those 9
months, you've been receiving the very finest in nutritional support from your
special blend. If you wish to continue with the unsurpassed individualized
nutritional support found in your present Custom Essentials formula, please be
assured that you may do so with complete confidence. Many people find upon
retesting that their current formula continues to be the perfect formula for
them.
However, if you have made any major changes in your lifestyle or dietary habits
and you would like to evaluate the impact from those changes, we want you to
know that the retest is available to you.
Back To Top Of Page
|
