Question
Asked 30th Jan, 2018
  • Cell-Logic Pty Ltd

Can anyone comment on the likely validity of the Oligoscan device being used by Australian clinicians to test heavy metals via the skin?

Oligoscan www.oligoscan.net.au is being widely used by Australian and NZ complementary Medicine clinicians as a way to detect heavy metal levels in their patients. The device claims to have been internally validated. It’s customers seem to accept that this is enough. Can someone with experience in spectrophotomeyour comment on the likelihood that holding this device on the hand is capable of detecting heavy metal levels for clinical purposes?

Most recent answer

17th Jul, 2022
Jon Gamble
Macquarie University
Are you still interested in doing a validation study, Tim?

Popular Answers (1)

7th Feb, 2018
Mike Fitzpatrick
Mike Fitzpatrick Consulting Ltd
We are all on the same page. I am in the last throes of developing a hand-held device to measure Vitamin C in blood (finger prick) and there are very clearly defined processes (such as CE marking) that ensure such devices work as they say they do and, subsequently, protect the consumer. In my opinion any device worth it's salt should be CE-marked, or similar, otherwise I would run a mile from it.
External validation in just one of several key components of CE-marking and, sadly, the Oligoscan appears to fall short. I say sadly because I think it would be pretty cool to have such a device that worked. On the issue of sensitivity, I think even very low concentrations could be detected spectrometrically, but it couldn't be based solely on emission; it would require fluorescence techniques etc. And specificity isn't much of an issue at all because (a) there are multiple bands for each element and (b) even though some bands may appear close to each other modern detectors can distinguish them. Accuracy in most all hand-held analytical devices is +/- 10-15% minimum, which is indeed lower than the variability seen in individuals. It's not at all uncommon to see people with orders of magnitude differences in post-provocation urine metal concentrations.
6 Recommendations

All Answers (12)

6th Feb, 2018
Mike Fitzpatrick
Mike Fitzpatrick Consulting Ltd
Chemical elements have characteristic emission spectra, i.e., they emit unique wavelengths of electromagnetic radiation, such as visible light. This is the basis of emission spectroscopy, whereby it is possible to determine the chemical composition of a material by examining its emission spectra. One such use of this technique is how scientists can figure out the chemical composition of stars.
This Oligoscan device appears to 'work' by making measurements of light emitted from the skin. The problem I have here is one that's common in analytical chemistry; an analytical result is only as good as the sample tested. In this case I don't know how sample (in the Oligoscan video it's a person's hand) integrity is assured because chemical elements on the skin's surface can be from numerous sources, not just from bodily excretion. And it's not like you can wash your hands first, because that would wash away any elements that were excreted also.
I would like to see some validation data for this device, which I consider the manufacturers are obligated to provide. Something like blood data compared with the Oligoscan results would be helpful.
2 Recommendations
6th Feb, 2018
C.A. (Kees) Kan
None
For some toxic elements that are stored in certain tissues like Cd in kidney or Pb in bone, it is unlikely to me that blood levels will tell the whole story.
So extensive validation is on the one hand essential and on the other hand probably very hard to perform.
2 Recommendations
6th Feb, 2018
Furkan Alaraji
University Of Kufa
I agree with Dr. Kan
1 Recommendation
6th Feb, 2018
Mike Fitzpatrick
Mike Fitzpatrick Consulting Ltd
Sure Kees, although I don't think the manufacturer of the device was claiming it gives an indication of metals in stores or the total body burden, rather that which is in circulation and potentially readily removed. In this regard blood data is clearly helpful, not that I consider the results would bear much resemblance to those obtained by the device.
2 Recommendations
6th Feb, 2018
Christine Houghton
Cell-Logic Pty Ltd
Thank you to all those who have responded to my query. What concerns me is that the manufacturer of this device has no external validation but claims that the device is validated internally. I would be more convinced if a proper trial were to be conducted and published through the peer-review process.
2 Recommendations
7th Feb, 2018
C.A. (Kees) Kan
None
The validation of any analytical method comprises at least the following elements: sensitivity, specificity and accuracy
The sensitivity of measuring on or trough the skin might be sufficient for macro-elements, but I very much doubt that micro-elements can be detected.
I am always worried about specificity of any (simple) spectrofotometric method as spectra might/will be overlapping, especially when no special marker/enhancer is used.
Accuracy might be the least of our worries as the natural variation between individuals is probably quite large and thus larger than the inherent variability of the analytical method.
So, all in all, I am not really optimistic about the value of this device.
4 Recommendations
7th Feb, 2018
Mike Fitzpatrick
Mike Fitzpatrick Consulting Ltd
We are all on the same page. I am in the last throes of developing a hand-held device to measure Vitamin C in blood (finger prick) and there are very clearly defined processes (such as CE marking) that ensure such devices work as they say they do and, subsequently, protect the consumer. In my opinion any device worth it's salt should be CE-marked, or similar, otherwise I would run a mile from it.
External validation in just one of several key components of CE-marking and, sadly, the Oligoscan appears to fall short. I say sadly because I think it would be pretty cool to have such a device that worked. On the issue of sensitivity, I think even very low concentrations could be detected spectrometrically, but it couldn't be based solely on emission; it would require fluorescence techniques etc. And specificity isn't much of an issue at all because (a) there are multiple bands for each element and (b) even though some bands may appear close to each other modern detectors can distinguish them. Accuracy in most all hand-held analytical devices is +/- 10-15% minimum, which is indeed lower than the variability seen in individuals. It's not at all uncommon to see people with orders of magnitude differences in post-provocation urine metal concentrations.
6 Recommendations
3rd Sep, 2018
Alejandro García
Universidad Santo Tomás
Are there scientific publications of the product?
5th Sep, 2018
Lawrence Retief
I'm being told that this device now has a CE mark (Class IIA medical device). Would this change any of your previous view points?
5th Sep, 2018
C.A. (Kees) Kan
None
I still would like to be able to read the validation report myself. Otherwise I would remain very cautious about the system.
2 Recommendations
13th Feb, 2019
Tim M. Sharpe
University of Western States
External validation of this method would be simple to perform as it appears to, in the case of heavy metals, be a non-invasive proxy for whole blood testing (most commonly arsenic, lead, and mercury). I could probably design, conduct, and submit for publication such a validation study in under six months at extremely low cost. The fact that no such validation exists after this long is a large waving red flag. Currently there is no reason to expect meaningful results from this test. I would implore anyone considering such a device to demand validation first.
2 Recommendations

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