In summary –
Their test methodology is to make use of silicone chip technology to allow miniaturisation of many individual antigens into a multiplexed test (multiplexed = tests many antigens at once) so that it can be performed as an automated test for many infections in a single run and return results within a day with cost benefits.
I have previously been wary of this test company due to lack of rigorous validation studies or detailed descript
ion of exactly how its performance was evaluated.
But in this paper, they describe and provide more details of how the test is made and how it was validated
To my mind the paper is actually of better quality and thoroughness than the igenex paper we saw recently on their recombinant immunoblots - reasons being:
1. The number of positive control samples tested against was higher
2. This paper evaluated run to run consistency, lowest detection limits and other consistency and repeatability performance - which Igenex did not provide
3. The journal it is published in is regarded as the most prestigious of journals Nature - which is quite an achievement where lyme disease testing is concerned – and implies ( but does not guarantee) rigor in the peer review process and higher quality papers
4. The authors list exactly where the positive and negative reference samples came from and crucially – how they were deemed positive
this last issue is a key point as all sensitivity and specificity calculations depend on the reference or “golden samples” used as reference, and if, for instance , with a serologic test, all reference samples were also serologic positives – then some circular logic exists that has the potential to overestimate the new tests performance – an issue that does appears to exist with the igenex test )
There are similarities on how these two tests work - these are both still serological test – based on selected antigens for each pathogen. This test also uses recombinant proteins as antigens and also separates them physically - but here this is done on silicone chip arrays – rather than on paper as the Igenex approach uses. The vibrant test tests for many pathogens in one test - whereas Igenex prefer to do separate tests for each pathogen.
There are still things which are not detailed or that we cannot know - and there are still some limitations of all serologic testing in all chronic infections ( which may be partly compensated for by the use of multiple antigens ) but from what I have seen this approach looks as good as the Igenex test in terms of performance for lyme disease - and the validation data is more compelling with higher statistical value and less gaps than the igenex one - and this test has the advantage that with a single test it can detect many tick born infections with good sensitivity and specificity
Just thought I would post it up as I have been a little dismissive of them in the past as a “2nd tier lab” due to lack of available information – but based on this later publication I would have much better confidence
It has broad coverage for many borrelia species and strains, several key bartonella species, anaplasma and ehrlichia, many rickettsia species as well as many of the tick born viruses. It may be a little light on babesia species - focussing mainly on b. microti and duncani - but no mention of b. odecoilei or divergens - its not clear if the antigens used would react with these other species.
Especially for patients that haven’t done any testing and want to test for a broad array of pathogens in one go, cost effectively this would seem to be a decent option.
I hope the review is of some help
link to paper here
https://www.nature.com/articles/s41598-024-84467-0#