|
Q: |
"We were wondering about the use of alcohol based hand sanitizer
which we use countless times per day and the effect on EtG. We
tried to research it on the Internet, and it says that it is
absorbed by the body, however it stated that studies on those in
recovery have not been performed. Could you please let me know
your thoughts on this? Thank you for your time." |
|
Q: |
Looking at superimposed graphs of blood alcohol levels from one
drink in a men and one drink in a women, the women will have a
higher blood alcohol level. Is this true also with the ETG
levels? Theoretically, a women would have higher blood alcohol
levels with incidental use also, and therefore higher ETG
results. If this is true, shouldn't the cut-off levels be
different for male and female? |
|
Q: |
We've had a few instances of positive urine alcohol (low levels)
and negative ETG. We are suspecting perhaps our lab cut off for
urine is lower and more specific, than the cut off for ETG. What
do you think? |
|
Q: |
Does warm weather during shipment cause a more rapid breakdown
of EtG in urine? |
|
Q: |
Questions concerning the AWOL vaporizer: |
|
Q: |
What about incidental alcohol use, such as in food, mouthwash,
communion wine, etc? |
|
Q: |
Is EtG dependable enough to rely on a
positive determination to take legal action, such as revoking a
license or probation? |
|
Q: |
Should an EtG always be performed to confirm
a positive urine alcohol test? |
|
Q: |
Is EtG waived for CLIA? |
|
Q: |
Why are cutoff values different from
different labs? |
|
Q: |
Is EtG heat labile? (ie Does a positive EtG
and a negative alcohol suggest cooking with alcohol as a source
or just a lower level of exposure?) |
|
Q: |
Are there any meds that would give a positive
EtG? |
|
Q: |
What about polyethylene glycol? Can it cause
a positive EtG? |
|
Q: |
If further research has shown some
individuals producing higher quantities of ETG with incidental
use, and the difficulty having a percise exact cut-off, will
this change the current cut-off levels? How can it be assured
the positive value of >100 or >250 (as currenty used)is from
actual beverage alcohol intake? Is it possible the cut-off
levels will change considering this new finding? |
| Q: |
Please clarify for me the units of measured
urine EtG levels. In the discussion of incidental exposure, you
refer to 100-500 micrograms/liter as being possible incidental
exposure but that it would unlikely be incidental at > 500
micrograms/liter. Then in a later discussion regarding
laboratory cutoffs you refer to 100 mg/liter. Since the
difference here is huge, I ask that you please clarify. In
other points in your presented literature and discussions you
also refer to nanograms/ml which would be equal to to
micrograms/liter. The use of different unit values makes it
very hard to draw conclusions. Thank you for the opportunity to
read all the information presented in your web site. |
|
Q: |
"We were wondering about the use of alcohol based hand sanitizer
which we use countless times per day and the effect on EtG. We
tried to research it on the Internet, and it says that it is
absorbed by the body, however it stated that studies on those in
recovery have not been performed. Could you please let me know
your thoughts on this? Thank you for your time." |
|
A: |
Yes, We were concerned to evaluate Purrell Gel that has a high
content of ethanol (>70%) and is commonly used in hospitals and
elsewhere. To tentatively evaluate this we have had individuals
used large amounts of the product and to date have had none show
up with a positive EtG in urine. We have not evaluated this with
pathologic skin conditions, however, we doubt if enough is
absorbed through the skin to yield a positive EtG test.
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|
Q: |
Looking at superimposed graphs of blood alcohol levels from one
drink in a men and one drink in a women, the women will have a
higher blood alcohol level. Is this true also with the ETG
levels? Theoretically, a women would have higher blood alcohol
levels with incidental use also, and therefore higher ETG
results. If this is true, shouldn't the cut-off levels be
different for male and female? |
|
A: |
Probably not, however, this has not been specifically examined.
There appears to be much variation in how much EtG one
individual produces compared to another (due to polymorphism of
the enzyme systems), which is probably a more significant factor
than between men and women. Also, because less than 0.1% of
alcohol is metabolized into EtG, and because of urine
concentration/dilution factors, time frame, etc, It is doubtful
that it will be possible to have exacting precise cutoffs. In
other words, the cutoff levels will need to be fairly high
anyway and will probably not be greatly affected by slight
changes in serum alcohol levels. However, time will tell, as
more research is performed.
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|
Q: |
We've had a few instances of positive urine alcohol (low levels)
and negative ETG. We are suspecting perhaps our lab cut off for
urine is lower and more specific, than the cut off for ETG. What
do you think? |
|
A: |
Urine EtG is actually more "specific" than urine alcohol since
you can have alcohol in urine without drinking (if it ferments
there) but the only way you can have EtG in the urine is if
alcohol is in your body. So there are really only three reasons
you can have a positive urine alcohol and negative urine EtG. 1.
The alcohol fermented "in-vitro" in the urine, 2. The urine was
obtained within one hour after drinking, since it takes EtG a
little longer to appear in urine than alcohol, or 3. The cutoff
value for EtG is too high.
In the case of #1 there is evidence that not only can yeast
ferment alcohol but also some bacteria and the amount of glucose
necessary can be small. So it's not just in diabetics with yeast
in the urine that fermentation occurs. In the case of #2 it
doesn't make much sense that someone would drink and then give a
urine sample within 1 hour. In case #3 some labs are setting the
cutoff for EtG high to avoid positive EtGs from "incidental
alcohol use" and this is making EtG less sensitive.
In conclusion, we are using a 100 ng/ml cutoff and if the urine
is positive for alcohol but negative for EtG we are assuming it
was probably in-vitro fermentation (ie a false positive test).
Nevertheless we still confront the participant and ask them if
they've been drinking but we drop it there if they say no. We've
not yet had one of this type who've admitted drinking.
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|
Q: |
Does warm weather during shipment cause a more rapid breakdown
of EtG in urine? |
|
A: |
Recent experiments show that heating urine to 100 C (boiling
point of H2O) actually increased the stability of EtG. The data
are showing that at room temperature, in some individuals with
nitrites and/or blood in urine, that EtG can deteriorate over a
week. We are surmising that esterases associated with infection
may be causing breakdown of EtG. Heating seems to prevent
breakdown, possibly due to neutralizing the bacteria. So, the
fact is that heat doesn't cause breakdown of EtG, it actually
increases stability.
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|
Q: |
Questions concerning the AWOL vaporizer: |
|
A: |
We have recently become
aware of a “new” method of alcohol abuse known as Alcohol
Without Liquid (AWOL) vaporizer.
One of the web sites:
www.awolmachine.com
We were concerned that
AWOL would invalidate EtG urine testing and asked a forensic lab
for an opinion. Following is the response from Dr. Ed Barbieri
from National Medical Services, Willow Grove PA:
”We
have looked into the AWOL machine from the website. Alcohol may
enter the bloodstream in the manner that is described on the web
site. For ethanol to get to the brain it MUST enter the
bloodstream. If ethanol enters the bloodstream, it will be
distributed to other tissues throughout the body including the
liver and, therefore, will be metabolized. Once metabolized,
ethylglucuronide can be formed and will be eliminated (along
with some ethanol) into the urine. In summary, if someone is
choosing to take in ethanol in this manner, it will still be
metabolized through traditional pathways that may result in
positive EtG findings. The EtG results would be dependent upon
the time from exposure, amount etc., all of the same things that
would need to be considered if alcohol was ingested in a liquid
form through drinking."
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|
Q: |
What about incidental alcohol use, such as in food, mouthwash,
communion wine, etc? |
|
A: |
This is an important question and an important issue to
understand. Ethanol, unlike other drugs, is fairly ubiquitous in
our environment. It's in food (ie vanilla extract). It's used as
solvent in "over-the-counter" meds. It's used in ceremonies
(i.e. communion, etc). It is recommended that anyone being
tested (i.e. those in monitoring following alcohol problems) be
advised that they should not consume food containing alcohol,
avoid OTC meds containing alcohol, mouthwash with alcohol,
and/or communion wine or anything else containing alcohol. It is
possible in some circumstances that the urine EtG level could
exceed the cutoff levels by this type of "non-beverage alcohol"
exposure. However, it is very unlikely that an EtG level >500
ug/L could be obtained through incidental, non-beverage, alcohol
intake. Therefore, between the cutoff level of 100 ug/L and 500
ug/L it is possible that the alcohol consumption was incidental.
An EtG level greater than 500 ug/L is highly likely to be due to
beverage alcohol consumption. One way to think of this is that
EtG testing is similar to opioid testing where dietary use of
poppy seeds can lead to a true positive morphine level but only
up to about 2000 ng/ml beyond which it is very unlikely to be
due to poppy seeds. Likewise it's important to encourage
individuals in monitoring to avoid poppy seeds.
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|
Q: |
Is EtG dependable enough to rely on a positive determination to
take legal action, such as revoking a license or probation? |
|
A: |
EtG appears to be highly specific, similar to testing for other
drugs. It is a direct metabolite and is only present in urine
following alcohol consumption. However, no forensic toxicology
test is 100% reliable. Therefore, we strongly recommend that for
all urine tests found to be positive that the individual be
referred for in-depth clinical evaluation. It is important with
any laboratory test to obtain clinical correlation!
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|
Q: |
Should an EtG always be performed to confirm a positive urine
alcohol test? |
|
A: |
Here's our thinking on the issue: Urine alcohol can have false
positives primarily due to in vitro fermentation. It's a good
idea whenever there's a positive urine alcohol to do a urine
glucose and look for yeast. In some labs this is routine. The
problem is that if there is glucose and yeast it still doesn't
mean that the individual did not drink alcohol, it just makes it
more likely that it could have been a false positive. In
addition to false positives from fermentation, there's also been
a question of positive urine alcohol tests due to non-beverage
alcohol consumed (mouthwash, food, otc meds, etc) at just the
right time prior to urine testing. (not really false positive
but not representing alcohol consumption).
Okay, now we have EtG testing. What a great test. At the
thresholds we are have established it has a very smaller chance
of being a false positive. Less than 1% of alcohol is
metabolized via the EtG pathway. You therefore have to drink
significantly more for it to show up. Also, in vitro
fermentation does not cause a positive EtG, which is only formed
in the liver.. Smaller amounts of alcohol consumed in mouthwash
or food, etc, would also not produce enough EtG to get over the
threshold as readily. The flip side for EtG is that there is a
chance, with small amounts of alcohol consumption, of having a
false negative (just like urine alcohol, which can frequently be
negative after drinking). The EtG needs a significant amount of
alcohol consumed to be positive.
So here's what to do. For a positive urine alcohol, confront
the individual regarding the positive test. See what they say.
If they admit to drinking alcohol, of course you don't need to
test further. If they deny use then you have a couple options:
1. You can advise them that there's a new test that can help
corroborate their contention that they did not drink. They would
be wise to let you run the test (on the same urine specimen) to
clarify the positive urine. Everyone I've done this with thusfar
has readily agreed. If they refuse inform them that it will
certainly appear that they are avoiding clarifying the issue and
appear more likely that the urine alcohol is a true positive.
and/or 2. You can run the EtG anyway (since you certainly have
the agreement for forensic testing). You can charge them or pay
from your program (depending on how you want to do it). If they
complain you can tell them you did it for their benefit because
of a positive urine test. I've done it both ways. Usually the
last thing they are worried about when this comes up is $65
dollars.
Okay, if the EtG is negative I would consider the urine
alcohol a false positive and drop it. (This doesn't actually
prove it is a false positive, however, it substantially
increases the likelihood.) It's my opinion that it is far better
to miss a true positive (because you can catch them later, and
you surely will). The worst thing would be a false positives
which wrongly incriminates them and it destroys trust and
wrongly diagnoses them and, of course, the consequences can be
harsh.
If the EtG is positive, let them know you now have absolute
proof they consumed alcohol (a positive urine alcohol and
a positive EtG). Do not waver from your confidence and the
chances are, in my experience, if you provide hope fot them
despite their relapse that 90+% will confess and accept help.
The manner of approaching them in this situation matters. I just
say, "we now know you did drink alcohol and it's not the
end of the world, we just want to get you some help.". The more
legalistic the process has been prior to this point, with that
individual, the higher the likelihood they will "lawyer up" and
fight it. What a sad situation that is!
If it goes to court and your program has to defend the test
we will help you. There is enough data now that we believe we
can defend it in court. Especially if there is a positive
urine alcohol and a positive EtG. This is pretty much
a no brainer!
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|
Q: |
Is EtG waived for CLIA? |
|
A: |
CLIA, is an acronym for Clinical Laboratory Improvement
Amendment. This act is about defining "certification" for labs
and not lab tests. Some tests, minor office tests like urine
dipstick, etc, are exempt, such that any medical office can do
them without CLIA certification. EtG testing is not exempt, in
this sense, however, it would not be a consideration, I'm sure,
to run an EtG in a non-CLIA lab (ie an office test).
What they are probably asking about, and asking it wrong, is
about whether or not EtG is FDA approved as a diagnostic test.
The answer is no. Currently it is being performed as a
toxicology test which does not require approval.
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|
Q: |
Why are cutoff values different from different labs? |
|
A: |
Re cutoffs values: What determines the best cutoff level is
complicated. It is a balancing act. The cutoff values should
not be so low that the test picks up extraneous alcohol intake
(food, mouthwash, etc) resulting in "false positives." On the
other hand it is not desirable for the threshold to be too high,
which reduces sensitivity, and would create more false
negatives. Another important issue is purity of the testing
method. Depending on the technique and its accuracy the cutoff
level can be important to reduce intrinsic variations that cause
errors from the test. NWT believes they have developed a
superior method and can substantiate the quality of its
selection of cutoff at 100 ug/L.
Also, we know that very little alcohol (.02-.06%) is metabolized
by non-oxidative glucuronidation. The "standard drink" in the
USA is 14gm (about 1.5oz of vodka, 12oz beer, 5oz wine). Thus
the small fraction of alcohol actually metabolized this route
means that a significant amount of alcohol would have to be
consumed to register positive even with a cutoff of 100 ug/L.
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|
Q: |
Is EtG heat labile? (ie Does a positive EtG and a negative
alcohol suggest cooking with alcohol as a source or just a lower
level of exposure?) |
|
A: |
EtG is formed in the liver of someone when ethanol combines with
activated glucuronide. This is the only way it is formed. When
EtG is detected in the body (usually urine, however, it can be
detected in other body fluids and in hair, etc) it means that
ethanol is in the body. Incidental alcohol exposure, from food,
mouthwash, otc meds, communion wine, or even skin exposure to
alcohol, usually causes a very mild elevation of EtG in the
urine (<100 but almost always <500). Therefore for urine EtG
>500 ng/ml you can usually be almost certain beverage alcohol
has been consumed.
EtG is stable in room temperature for quite a while. Heating
urine can destroy EtG, however, this is easily avoided in the
lab. Cooking has nothing to do with it since EtG is not in food.
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|
Q: |
Are there any meds that would give a positive EtG? |
|
A: |
There have actually been no false-positive tests for EtG to
date. Only ethyl alcohol seems to produce EtG. The issue is
really more where did the alcohol come from? Many medications
include ethanol as a solvent (cough syrup, etc) and therefore
could cause very low level of EtG (usually < 100 ng/ml),
however, no medication causes elevated EtG, that we know of,
it's just the ethanol being used as a solvent with the liquid
medications.
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|
Q: |
What about polyethylene glycol? Can it cause a positive EtG? |
|
A: |
Probably impossible! Polyethylene glycol can be found as an
ingredient in various tablets and OTC meds. There is no evidence
that degradation of this compound produces ethanol, especially
in enough quantity to cause a positive EtG test.
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|
Q: |
If further research has shown some individuals producing higher
quantities of ETG with incidental use, and the difficulty having
a percise exact cut-off, will this change the current cut-off
levels? How can it be assured the positive value of >100 or
>250 (as currenty used)is from actual beverage alcohol intake?
Is it possible the cut-off levels will change considering this
new finding? |
|
A: |
The answer is I hope not but it could happen.
In my experience cutoffs can be for at least two
purposes, 1. To be sure the drug is actually present (ie high
enough over Level of Detection, that background noise,
variability of controls, etc, are satisfied), and 2. To
eliminate incidental environmental exposure (for example,
setting marijuana level high enough such that second hand smoke
exposure can't be claimed as an excuse for a positive.)
Specificity and sensitivity always compete. Setting the
cutoff high sacrifices sensitivity for specificity and two low
the opposite.
A good example of this is to consider what's happened
with morphine/codeine cutoffs historically. For years, the
cutoff was 300 and it was known that positives could be from
poppy seeds. Studies, however, showed that poppy seeds could
rarely cause a level over 2,000 and never over 5,000. This was
valuable info for MROs, so that we could stratify our level of
concern based upon this info and the patients reaction. For
example, if a morphine level came back at 400 we would call the
patient and let them know they'd tested positive for morphine
and ask if they've been taking morphine or codeine. Some
patients would admit diversion explicitly or implicitly by
making up an untenable excuse. Others would act surprised and
say there's no way it could be valid. Sometimes further inquiry
revealed they were exposed to poppy seeds. If they denied using
when the level was less than 2000 we would usually report the
test negative.
This seemed to be a reasonable approach, until
inexperienced or overly reactive individuals received reports
and didn't bother to involve an MRO or whatever the reason,
there were tenacious false-accussations, with borderline levels,
that resulted in much trouble, unhappiness, etc.. One way to
avoid this would be to better train people or involve qualified
MROs, however, the powers that be decided to raise the morphine
cutoff to 2,000. This results in fewer "false positives" and
less work, however, it sacrifices earlier detection.
The same thing may happen with EtG cutoffs, which would
be a shame, since the primary value of EtG testing is the longer
timeframe of detection which would be reduced with increasing
cutoff.
In my opinion the ideal situation is to have a
cutoff that assures ethanol was consumed (i.e. 100) and a second
cutoff that is very unlikely result from casual incidental
contact (500-750). (A problem with this, that we are
discovering, is that "casual incidental exposure" can be a very
large amount of ethanol. In one case a doctor admitted he was
adding an entire bottle of vanilla to his coffee each morning.
This turned out to be 2 standard drinks. Would this be
incidental exposure?) His level was 820. In another case,
communion wine was blamed, which allegedly was consumed almost
daily.
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|
Q: |
Please clarify for me the units of measured urine EtG levels.
In the discussion of incidental exposure, you refer to 100-500
micrograms/liter as being possible incidental exposure but that
it would unlikely be incidental at > 500 micrograms/liter. Then
in a later discussion regarding laboratory cutoffs you refer to
100 mg/liter. Since the difference here is huge, I ask that you
please clarify. In other points in your presented literature
and discussions you also refer to nanograms/ml which would be
equal to to micrograms/liter. The use of different unit values
makes it very hard to draw conclusions. Thank you for the
opportunity to read all the information presented in your web
site. |
| A: |
Yes, the difference is 1,000. Some of the confusion stems from
the fact that the European literature uses lower figures. For
example in the European literature .4 mg/L or = .4 ug/ml and in
the USA the same amount would be expressed as 400 ng/ml or 400
ug/L. We've just got to make it confusing don't we.
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