Last night a friend sent this to me...........This has just been announced - http://www.ceresnano.com/lyme.htm
The Ceres Solution
The Ceres' Nanotrap® High Sensitivity Lyme Antigen Test uses the Nanotrap® technology to directly measure Lyme antigens in urine using a Western Blot format. The Nanotrap® test is designed to provide high sensitivity and accuracy, delivering confident results at the earliest stages of infection. The Nanotrap® Lyme test is currently undergoing clinical trials. Anticipated clincial availabilty in late 2013 and early 2014.
It will be fascinating to see the results of their clinical trials! It would appear that with the nano-technology they are using, they may have worked out some of the issues with urine antigen testing, however I suspect there may be a few things that could still make this a less than sensitive test than might be advertised.
This is an article from 2005 outlining many of the problems faced when developing urine antigen testing and which at the time resulted in only one of twelve acute stage erythema migrans confirmed patients testing positive.
Critical Evaluation of Urine-Based PCR Assay for Diagnosis of Lyme Borreliosis
Carolin Rauter,1 Markus Mueller,1 Isabel Diterich,1 Sabine Zeller,1 Dieter Hassler,2
Thomas Meergans,1 and Thomas Hartung1,*
The kidney plays a role in the clearance of plasma DNA, and the human kidney barrier is permeable to DNA molecules
In an experiment with laboratory mice, only 0.06% of subcutaneously injected DNA was excreted into the urine within 3 days in a polymeric form. Thus, it appears unlikely that sufficient Borrelia DNA for a positive PCR result would be contained in 10 ml of urine.
Addition of EDTA to the samples immediately after collection inhibits nuclease activity in human urine, but DNA destruction due to nuclease activity in the bladder could not be ruled out. The predominant fraction of DNA fragments found in human urine was 150 bp to 250 bp. This is in line with our results, where the nuclease activity on plasmid DNA did not lead to complete degradation. Since the amplicon of our standard PCR is about 350 bp in length, most of the DNA fragments would be too short for amplification. But it could be that Borrelia DNA is bound to proteins and may thus be protected from nucleases better than the naked DNA used in our experiments. If urine of LB patients did contain Borrelia DNA, improved detection by inhibition of nuclease activity already in the bladder might be attained by systematic adjustment of the pH in the urine to at least pH 8 by bicarbonate-mediated alkalization of urine in vivo.
Taken together, we have developed an optimized, well-controlled, and highly sensitive PCR protocol for the species-specific detection of Borrelia DNA. Extrapolations indicate that even with this protocol, it is unlikely that Borrelia DNA will be detected in patient urine. In line, we were only able to detect Borrelia DNA in the urine of 1 of 12 EM patients. Although only 12 patient samples were tested, the combined results of spiked and patient urine samples enforce doubts that urine is a suitable material for the diagnosis of LB.
I wonder if they will find that the issues posed by urine having to first pass through a person's kidneys and bladder will be a problem with the trial.
Here is another article written back in the dark ages of such testing development, but again they seem to make a valid point.
http://www.ncbi.nlm.nih.gov/pmc/article ... 37/?page=1
Infect Immun. 1991 January; 59(1): 269–278.
Molecular detection of persistent Borrelia burgdorferi in the urine of patients with active Lyme disease.
J L Goodman, P Jurkovich, J M Kramber, and R C Johnson
In the Discussion section, the results of testing done by others which they mentioned seemed to point to sensitivity issues for urine antigen testing based on strain variation and also because of alterations in OspA.
This also makes me wonder whether the ticks that were tested in the article posted by Lorima and which were reported as either positive or negative were also tested with another form of more conventional PCR and whether all the negatives were true negatives, or only negative by their testing and were possibly different strains from what they used, or had somewhat varied OspA. Clearly that could pose sensitivity problems and would have to be addressed for use with a wider patient audience. Also, I imagine they would have to test against patients who had been vaccinated, not just one dog, to see if it doesn't react positively to the newer vaccine being tested in Europe.
I guess we will find out in due time.