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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.
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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.)
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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.
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For instance, some researchers estimate that as much as 90% of cancers can be
linked to poor clearance of environmental toxins from the body. Detoxification
function is one of the three areas examined in the PrivaTest.
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Additionally, free radical damage has been identified as a causative factor in
many diseases, particularly heart disease. Once again, the PrivaTest looks at
markers for how well your antioxidant system is working.
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Finally, the 1998 Nobel Prize in Medicine was given for research in nitric
oxide regulation and its impact on vital metabolic functions. The PrivaTest
measures a physiological marker for nitric oxide production in the body.
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!
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What exactly ARE the three biochemical pathways
examined with the PrivaTest? |
The three areas that are evaluated in the PrivaTest are:
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Urinary Lipid Peroxides–A marker for oxidative stress.
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Urinary Sulfate–A marker for sulfur reserves.
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Urinary Nitrate–A marker for the regulation of nitric oxide.
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What are lipid peroxides? |
Lipid peroxides are oxygen fragments that are generated as a by-product of
free-radical production and the measurement of their level in the urine is a
well-documented method for estimating antioxidant sufficiency.
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What does it mean if my lipid peroxides are high? |
Most cells in your body are surrounded by a fat (lipid) layer. It is this layer
that is attacked and damaged by free radicals when the body's antioxidant
quenching systems are not working up to par. This can result in cell death or
cell mutation. High lipid peroxides in the urine 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.
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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.
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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.
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What is urinary nitrate? |
If a person follows a low-nitrate diet for 24 hours (as instructed in the
PrivaTest kit) the level of nitrate found in the urine is a good general
indicator of the production of nitric oxide, a special molecule that is
involved in the regulation of many systems in the body.
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What does it mean if my level of urinary nitrate
is out of range? |
Studies have demonstrated that either the up-regulation of nitric oxide or the
down-regulation of nitric oxide can have its own specific set of problems.
Up-regulation is associated with inflammatory processes in the body and down
regulation is associated with susceptibility to infection. If your level is
outside the balanced range, you need nutrient support with nutrients that
impact the production pathways.
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Are these three areas in the PrivaTest really
indicators of nutritional status? |
These lab tests are indicators of nutritional status in so far as they are
markers of biochemical function related to nutritional usage or repletion, and
thus can also be controlled (more accurately, influenced) by the sufficiency or
insufficiency of essential nutrients. Our three tests indicate nutritional
status as follows:
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Urinary lipid peroxides can reflect the state of oxidative stress by measuring
the level of harmful compounds (peroxides) that have, simply put, escaped the
“trap” of a person’s antioxidant-quenching system and thus are showing up in
the urine. Oxidation of fat cells produces residues called ThioBarbituric Acid
Reactive Substances (TBARS), such as malondialdehyde. The measurement of TBARS
is a research tool used by those who are doing antioxidant and physiological
research and who are publishing in peer-reviewed journals such as the Journal
of Applied Physiology, Medicine and Science in Sports and Exercise, and Free
Radial Biology & Medicine. The test is not intended to provide direct
measurement of the amount of vitamin E or other antioxidants in the person’s
body, but it does provide a strong marker of how effectively those antioxidants
are functioning by measuring how much lipid peroxide “escapes” into the urine.
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The urinary sulfate level is a marker for the level of sulfur reserves, one of
the key compounds used by the liver for changing toxic substances into
water-soluble compounds, which are then cleared from the body by the kidneys.
Dietary deficiencies of sulfur-containing amino acids can reduce liver
sulfation systems. If you are showing a higher level of sulfate in the urine,
this generally correlates with a good sulfur reserve for liver detoxification
processes. Conversely, a lowered sulfate level can indicate the body’s attempt
to conserve its sulfur because (1) it is running low on supply or (2) reserves
are being rapidly used for increased detoxification demands. Again, this is not
a direct measurement of liver detoxification, but a marker for nutrient
function.
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The research on nitric oxide has exploded in the last few years, providing new
insight into this molecule, which appears to be an important regulatory
molecule in many systems in the body, particularly in the immune and vascular
systems. The nitrate level measured in the urine (following a period of
dietary-nitrate restriction, as directed in our testing instructions) has been
recognized as a marker for endogenously produced (made inside the body) nitric
oxide. Once again, this is not a direct measurement of nitric oxide, but a
marker for the up- or down-regulation of its production.
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Has the PrivaTest been scientifically validated? |
The methodology for these tests has been widely recognized in the scientific
community as valid and reliable. Ideal Health'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.
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How accurate are the PrivaTest results? |
The Ideal Health 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 Ideal Health test
results that you receive have CV's that are under constant monitoring for
reproducibility and average below 6.75%.
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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.
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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.
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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.
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What period of time do the substances analyzed
reflect in terms of past metabolic history?
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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.
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Can supplementation really affect these pathways? |
Yes. For instance:
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In a study done on 21 males, it was found that urinary lipid peroxide excretion
levels were significantly decreased in the vitamin-E supplemented group
compared to the unsupplemented group after an eccentric exercise session at 75%
of their maximum heart rate (exercise being a known oxidative-damage inducer).
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Studies on failure-to-thrive children with leaky gut show low urinary sulfate
levels and an "increased requirement for dietary sulphur amino acids . . . for
hepatic detoxification of xenobiotics (toxins) . . ."
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Researchers have found that " . . .abundant in vitro and in vivo data
demonstrate that availability of arginine for NOS (nitric oxide synthase) can
control the synthesis of nitric oxide with major physiological and in many
cases pathological consequences."
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What in particular are the effects of this
supplementation in "healthy" people? |
Even the way this question is framed admits to the fact (by the use of
quotation marks around the word "healthy") that it is often difficult to
define. 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.
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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.
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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 Ideal Health'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.
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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 KidKaps product, MultiTerm. This
high quality, multivitamin/mineral provides excellent general nutritional
support.
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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.
Also, Custom Essentials is designed for your biochemistry, which may not match
that of your baby's, and while it is in no way harmful, it might not supply all
the needs of a growing fetus. Therefore, if you are considering pregnancy or
are pregnant now, we recommend that you begin using a multivitamin/mineral that
is specifically designed for this special purpose. Check with your
obstetrician.
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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 priced in the $330 range
(and Ideal Health is able to reduce the price to $99.95 for the PrivaTest,
through its technological strategic alliances), it is necessary to package the
two.
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What if I'm already supplementing when I take the
test? |
You should not take supplements for the 24 hours prior to collecting your
morning urine specimen. For example, if you are collecting on Monday morning,
you should not take supplements from Sunday morning to Monday morning. Full
instructions are included in the PrivaTest kit.
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.
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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 one of the 48 formulas
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.
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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 Ideal Health. 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 48 formulas.
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What questions on the questionnaire are used to
create my Custom Essentials? |
All the questions on the questionnaire are used.
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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 for only $99.95
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