EnviroLink Forum

SUBJECT: IDEXX Transition to the New SNAP. Beta-lactam Test Kit


Below is the text of a letter received by FDA from Larry Chaney, Ph.D., Dairy
Business Manager, IDEXX Laboratories, Inc.

"Based on FDA's approval of the transition to New SNAP. Beta-lactam test kits,
IDEXX Laboratories, Inc. will manage the inventory of the remaining SNAP
Beta-lactam product based on the customer's demand in an expeditious manner. As
you may be aware, the product is available in both 20 test and 100 test kit
quantities. While we will attempt to completely deplete the inventory of
current product, it may be necessary to sell New SNAP. Beta-lactam based on
customer's test kit quantity demand, creating a limited amount of time that the
two products will be sold.


http://www.cfsan.fda.gov/~ear/mi03-18.html

http://www.aoac.org/testkits/testedmethods.html

No it's not validated for the replacement of the LD50 tests in mice.

Division of Bacteriology, National Institute for Biological Standards and Control, South Mimms, Hertfordshire, UK.

Bacterial neurotoxins are now being used routinely for the treatment of neuromuscular conditions. Alternative assays to replace or to complement in vivo bioassay methods for assessment of the safety and potency of these botulinum neurotoxin-based therapeutic products are urgently needed. Advances made in understanding the mode of action of clostridial neurotoxins have provided the basis for the development of alternative mechanism-based assay methods. Thus, the identification of SNAP-25 (synaptosomal-associated protein of molecular mass 25 kDa) as the intracellular protein target which is selectively cleaved during poisoning by botulinum neurotoxin type A (BoNT/A) has enabled the development of a functional in vitro assay for this toxin. Using recombinant DNA methods, a segment of SNAP-25 (aa residues 134-206) spanning the toxin cleavage site was prepared as a fusion protein to the maltose-binding protein in Escherichia coli. The fusion protein was purified by affinity chromatography and the fragment isolated after cleavage with Factor Xa. Targeted antibodies specific for the N and C termini of SNAP-25, as well as the toxin cleavage site, were prepared and used in an immunoassay to demonstrate BoNT/A endopeptidase activity towards recombinant SNAP-25 substrates. The reaction required low concentrations of reducing agents which were inhibitory at higher concentrations as were metal chelators and some inhibitors of metallopeptidases. The endopeptidase assay has proved to be more sensitive than the mouse bioassay for detection of toxin in therapeutic preparations. A good correlation with results obtained in the in vivo bioassay (r = 0.95, n = 23) was demonstrated. The endopeptidase assay described here may provide a suitable replacement assay for the estimation of the potency of type A toxin in therapeutic preparations.

PMID: 9353935 [PubMed - indexed for MEDLINE]

http://www.ncbi.nlm.nih.gov/entrez/quer ... t=Abstract

I am not sure your debating tactics are designed to discuss rather than "I told you so" and not very healthy.

Is this going to turn into a google search test?
It is easy to select sections of text and find something to contradict it and the posting "copy right" rules helps this.

When faced with a test that works and is an alternative to painfully killing animals then I would expect any decent person would want it used.

Seems I was wrong. some people argue the toss for animal testing for what seems not real reason.

The purpose for the research is to determine whether the test actually WORKS as described, which is generally called validation. I checked the US FDA because you implied that it was developed in the US and as such may already be accepted here. It is not accepted in the US so that line of discussion would be moot.

As for the links to the use of the test for detection of certain antibiotics in milk, that has no relation to testing for potency. I know of several methods which will detect and even identify compounds fairly well but cannot quantify them accurately. Thus, they can be used as a screening or detection method but little else.

Unless and until a proved alternative method is available I could not begin to support a non-animal based test just because of the wishful thinking of people who dislike the use of animals. I have first hand experience with methods developed by a regulatory agency for their own use which when I attempted to duplicate were less reliable than indicated by their reports.

_________________
With friends like Guido, you will not have enemies for long.

“Intellect is invisible to the man who has none”
Arthur Schopenhauer

"The difference between genius and stupidity is that genius has its limits."
Albert Einstein

It has been proved to work and is used in other methods of testing. It is as simple as that. Hardly moot since the test has proved to work and is peer reviewed.

So why is it not validated? Best ask the industry that question.


Like I have said the SNAP test is not validated for replecament of the very popular LD50 yet the SNAP test is used for other forms of testing and has been used to test for food poisoning for years and the SNAP-25 assay was develpoed from these test methods.

Excuses don't cut it.

Are you a scientist?

Which are not the same as in this case. There is a huge difference in being able to detect the any of half a dozen antibiotics that may be present in milk and quantification of the potency of a toxin.



Where is the information on this peer review and proved to work in respect to the use for toxin potency?



It is not the industry that would validate the method but the regulatory agencies.




Detection is far different from quantification and without quantification you cannot have potency determinations. I can put sugar into your drink and have a method to detect that it is present at above a few ppbV, but if you need many ppmV to have a good taste that test will be useless to ensure the good taste. That is the point of potency testing and the difference between potency testing and detection is significant.



Nor does ignorance of the reality of the situation



Yes, I specialize in environmental testing for air pollutants.

_________________
With friends like Guido, you will not have enemies for long.

“Intellect is invisible to the man who has none”
Arthur Schopenhauer

"The difference between genius and stupidity is that genius has its limits."
Albert Einstein

I guess you will have to read what I linked then go do some more research

The clue is the word SNAP. I am not interested in opinion. Come back when you are interested.

good place for you to start.

http://iccvam.niehs.nih.gov/methods/bio ... peptid.pdf



I guess that qualifies in the field of toxicology drug testing then?

So I suppose you're a toxicologist?

_________________
"Yes like I said it all boils down to morals. What you think is right doesn't make a person wrong because they think different " X-Black

No but the man sat next to me is a cancer research scientist

And you?



http://www.sarconline.co.uk/drjoe/

You can visit his site and discuss anything on it if you want to flex your hunting intellect

I would think that a reputable "Dr." would list his name. But then again you're not interested in opinion.

_________________
We do what we must because we can,for the good of all of us....except the ones that are dead.

His name is Joe. Not hard to trace since he lists his qualifications and Uni

What is you point?
Sorry on call got to go and the day was coming on well.

Doesn't matter. I'm not the one that claims you have to be a toxocologist to know what you're talking about. If you get your information from someone else, why can't Wayne or I do the same? Why do you have to claim to work with someone?

Oh, you posted a link. I bet you two are real good buddies. Maybe if I post his link, I can be Dr. Joe's friend too!

_________________
"Yes like I said it all boils down to morals. What you think is right doesn't make a person wrong because they think different " X-Black

I rely very heavily on both the LD50 and the LC 50 charts.

I can't honestly see how that without testing various poisons and chemicals on animals that the results would be accurate. Without animal testing it would be just guesswork.

_________________
We do what we must because we can,for the good of all of us....except the ones that are dead.

I did and the closest thing was the last abstract from 1997 that stated this in the last sentence, which you seem to have ignored.

The endopeptidase assay described here may provide a suitable replacement assay for the estimation of the potency of type A toxin in therapeutic preparations



You are not interested in opposing opinion but you will take any opinion with which you agree as fact? You propose this to be THE better method while submitting articles which are inconclusive or unrelated.



Maybe I' ll just go down the street and ask them. The next facility down the road is a major NIEHS research facility, with a CDC office or an major EPA research facility the next closest in either direction. Of course there are those folks at the two major universities in town too, but they are hard to provide direct references to check.



More so than someone not working in the sciences, especially with chemists and biologists working for me ...

_________________
With friends like Guido, you will not have enemies for long.

“Intellect is invisible to the man who has none”
Arthur Schopenhauer

"The difference between genius and stupidity is that genius has its limits."
Albert Einstein

Is that like, "I stayed in a Holiday Inn Express" or something? (American ad campaign in case you are unaware) I have a few friends and associates who are in oncology treatment and research. Two juvenile cancer researchers were recruited by St. Judes from Duke and when they are in town visiting they stay with us. We have had some very interesting discussions on the subject as well. So, I do understand quite a bit more than just my localized occupation .. The wife of one of my employees is the third highest person in the local CDC office and another friend just retired from the US EPA as an indoor air quality researcher and I regularly converse with both of these people on the subject of risk management.



Cool, I had a woman with PhD in molecular biology working for me once, but I had to let her go due to a problem understanding the training program. I have a man with a PhD in Chemistry doing that job now. Actually, we are supposed to have the largest per capita number of PhDs in the country in our metro area. The guy who lives next door is a molecular biologist but I do not believe he has a PhD in the field though.



Hey, I have not only attended national and international conferences, but I have also presented papers and even chaired sessions within those conferences do I get a special badge or something? I count a dozen "author" and "speaker" badges in the display on my office wall right now.



Sounds like a version of PCRM and their "spin doctoring" to me.



But you are not interested in opinions though are you?

_________________
With friends like Guido, you will not have enemies for long.

“Intellect is invisible to the man who has none”
Arthur Schopenhauer

"The difference between genius and stupidity is that genius has its limits."
Albert Einstein

Actually, the extrapolation to humans from the data IS a bit of educated guess work, but it is based on the largest amount and best quality data available. The risk management aspect is a bit of voodoo science because the only way to know for sure is to perform the tests using human subjects, which did occur in several instances in history, but is not generally acceptable science at this point in time. The charts have a fairly significant conservative fudge factor built into them, but none of us would really like to take any of it for granted.

_________________
With friends like Guido, you will not have enemies for long.

“Intellect is invisible to the man who has none”
Arthur Schopenhauer

"The difference between genius and stupidity is that genius has its limits."
Albert Einstein

I see you feel hurt and under qualified.

I would be interested to read any paper you have published on the subject. Any links?