Below you’ll see a patent for a home parasite test kit, and a report of a clinical lab study on parasites in the US.
I have been in contact with the patent holder in regard to the test kit, hoping that this would be available. (I'm not revealing anything that is already public knowledge on the kit.) I held onto information hoping that the company's project would come into fruition. Since my initial contact, cirumstances have changed.
Last month, I was sent “good news” and this would be available within 6 months. I was told that the kit is better than the original model. Their company had lined up a supplier for the US and Canada. Additionally, they had a meeting with the FDA this month. I received another email a few days ago and received “bad news”. The kit will not be available for another 2 years nor will it be available to consumers. This is a real drag and who knows why the FDA made them change things (but I have my suspicions!) The home kit would have been an empowerment tool for us all to confirm our critters situation. This, unfortunately, puts us back in the hands of poor lab testing and physicians who are clueless. The somewhat good news is that the kit will, hopefully, be available to physicians to do testing in their offices in a couple of years.
In reading the patent information below, it helped me understand why lab tests turn out negative even when obvious critter bits have been added to specimen jar or when we experience definite signs of a parasite problem.
http://www.freepatentsonline.com/6596502.html
United States Patent 6596502
The invention concerns a home kit and a method for detection of the presence of a fecal parasite in a stool.
BACKGROUND OF THE INVENTION
Parasitology is one of the very few remaining tests in clinical medicine which relies on the visual recognition skills of a trained technologist. It involves, in fact, two visual recognition skills. One is the identification of particular morphological features characterizing an organism as belonging to a certain species, and being able to recognize it by name. The other, and much more difficult skill is the ability to recognize old, young, damaged, deformed, or even partially degraded organisms--perhaps occurring only at the edge of a microscopic field--and know that it is a particular parasite. Such being the case, a negative result for a parasitology test only indicates that no parasite was found, and can not be conclusive that a patient is negative for parasites.
The problem of parasite identification for the laboratory is additionally difficult due to the fact that parasite frequency can vary widely, and may not have any relation to severity of disease. Parasite reports are typically graded from rare to many. It is possible, in fact for a person to have a serious parsitological infestation, but to have only infrequent, periodic, or occasional shedding of parasitic organisms. In the case of low frequency of occurrence in the stool, organisms may or may not be present in the particular specimens being examined under the microscope.
The problem of parasite identification for the laboratory is additionally complicated due to the fact that transportation of specimens from the patient to the clinical laboratory is usually delayed and during this delay the parasites may die or be degraded, thus decreasing even further the chances of identification.
Thus, the situation exists where many clinical laboratories fail to detect parasites which, in fact, are present in patient specimens. Clinical laboratory surveys in the United States frequently report a positive prevalence of parasites of 1-3%, and rarely over 5%. Yet various published studies by specialty, or university based laboratories, show that the true positive rate can be as much as 4- or 5-fold higher than
In response to this situation, parasitologists have developed methods of concentrating parasites and staining them with contrasting colors so as to improve recognition ability. Thus, a concentration procedure followed by a trichrome staining procedure has been developed as the standard method of properly performed parasitology analysis. This method, however, is laborious and time consuming. It is, therefore, not done by all labs all the time, in spite of recommendations to that effect. Even when performed, it does not address or solve all the problems mentioned above.
In recognition of this situation diagnostic device companies have developed tests for particular parasites. Notably tests for giardia lamblia, entamoeba histolytica, and cryptosporidium sp. are commercially available. These take two forms, either being an ELISA test (i.e.: Alexon-Trend, Inc), or fluorescent tagging of the organisms followed by direct microscopic examination (ie:Meridian Diagnostics, Inc). The problem with these tests, however, is that they attempt to identify a particular organism, and not all organisms or the overall presence of parasites. Furthermore these tests require laboratory procedures and the intervention of skilled technicians.
The nature of parasite examination, and prevalence in the world, divides the parasites into two large groups: protozoans, and worms and eggs. Protozoans are single celled organisms, and are the most common parasites found in developed countries of the world. They are, also, as a rule, smaller than worms and eggs, and are examined on high power (40.times.) of the microscope. Worms and eggs on the other hand are multi-cellular organisms, and are very common in underdeveloped countries of the world. They are, as a rule, larger than protozoans and are examined at low power (10.times.) of the microscope.
What is needed by medical science and the market, therefore, are two tests--one for protozoans, and one for worms and eggs. It would be sufficient to identify those specimens which are positive and differentiate them from those that are negative. It would be even more advantageous, however, to identify specifically those particular parasites which are present in each specimen.
SUMMARY OF THE INVENTION
The present invention is based on the realization that there is a need for a non-invasive, fast, accurate, and user friendly method for diagnosing the presence of parasites, both protozoan and non-protozoan, in stool. The need is especially evident in view of the high false negative diagnosis of many standard laboratory tests and the high level of skill required to identify, under a microscope the instance and type of the parasite. The present invention is further based on the realization that detection of the presence of parasites in stool is of the type of detections which may be carried out at home, or at a doctor's clinic, without involving an analyzing laboratory, since the patient (or doctor) can easily understand a positive result of such a test, and proceeds to treat the parasite, with consultation with a doctor by the administration of anti-parasitic compounds. Furthermore, there is a great advantage of detecting parasites in fresh stool instead of waiting until the parasite reaches the laboratory resulting many times in non-viable or degraded parasites.
The present invention is further based on the realization that it is possible to develop a kit for such a non-invasive, reliable and home (and practitioner's office) testing.
There is more to this which is rather lengthy. There is also a file to look at the kit.
http://www.freepatentsonline.com/6596502.html
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Below is a study done by Omar Amin in 2000. I know that Wrayc posted a comment about this lab and wasn’t very happy with them. The test showed a negative result, with an entity included in the sample. Therefore, the lab testing done at Mr. Amin’s clinic can be viewed subjectively, knowing that the results may not be wholly accurate. Regardless, the report is extensive with charts and I suggest the reading.
Here’s the beginning of the report and following is a link.
Seasonal Prevalence of Intestinal Parasites in the United States During 2000
Abstract.
One-third of 5,792 fecal specimens from 2,896 patients in 48 states and the District of Columbia tested positive for intestinal parasites during the year 2000. Multiple infections with 2 – 4 parasitic species constituted 10% of 916 infected cases. Blastocystis hominis infected 662 patients (23% or 72% of the 916 cases). Its prevalence appears to be increasing in recent years. Eighteen other species of intestinal parasites were identified. Cryptosporidium parvum and Entamoeba histolytica/E. dispar ranked second and third in prevalence, respectively. Prevalence of infection was lowest (22 – 27%) in winter, gradually increased during the spring, reached peaks of 36 – 43% between July and October, and gradually decreased to 32% in December. A new superior method of parasite detection using the Proto-fixTM-CONSEDTM system for fixing, transport, and processing of fecal specimens is described. In single infections, pathogenic protozoa caused asymptomatic subclinical infections in 0 – 31% of the cases and non-pathogenic protozoa unexpectedly caused symptoms in 73 – 100% of the cases. The relationship between Charcot-Leyden crystals and infection with four species of intestinal parasites is examined and the list of provoking parasitic causes is expanded.
Parasitologic investigations of large patient populations are rarely conducted in the United States, where the illusion of freedom from parasitic infections still predominates. Such investigations are considerably more common in third-world countries where endemic parasitoses are more readily documented.1 In an attempt to address this problem we reported the results of routine examination of fecal specimen for parasites from 644 patients in the United States during the summer of 1996.1 Prevalence, patient age and sex, and intestinal and extra-intestinal symptoms, as well as variables related to foreign travel, infected household contacts, and previous parasitic infections were reported. An expanded version of the summer 1996 report is herein presented, in which complete seasonal data of 12 species of parasites from a considerably larger population is analyzed with emphasis on prevalence, symptomology, and Charcot-Leyden crystals. Few studies of large patient populations in the United States2,3 or more geographically limited populations, e.g., California4 or Ontario, Canada,5 have been reported.
For the rest…
http://members.cox.net/llyee/parasites_2000/parasites_us.html