Thank you for your inquiry.
We have dealt with this issue on a number of occasions on our website, and the information contained in the responses to these inquiries will be extremely helpful to you, and in part will answer the questions that you posed. They are a little too numerous and lengthy to copy here. You can find these by performing two separate searches using three separate key word phrases. The first key word is “metals,” the second is “lymphocyte transformation to metals,” and the third is “patch testing to metals.”
As noted, you will get detailed responses to your inquiry with these previous entries, and having said that, I will address, as best I can, your specific question.
The allergEAZE patch test chambers are a reasonable way to test for delayed hypersensitivity. The question is not related to the validity of the test, but rather to the interpretation of a positive result. The literature regarding this issue is mixed, and you will find reviews of it in the entries above. The difficulty, therefore, is interpreting the results in relation to their sensitivity and specificity in regards to the potential for a clinically significant delayed hypersensitivity reaction to an implant.
The same is true regarding the use of lymphocyte transformation tests to detect clinically significant delayed hypersensitivity to metal implants. The lymphocyte transformation test is a a valid test to detect for delayed immunity, but I am not aware of any definitive data that determines the specificity and sensitivity of this test. Several of the entries noted above deal with this issue, and you will find summaries of the literature in this regard as well.
So, in essence, we are not actually talking about the validity of the testing system, but rather of our lack of definitive data to allow us to accurately interpret the meaning of a positive test, and for that matter, the incidence of false-negative reactions.
Thank you again for your inquiry and we hope this response is helpful to you.
Phil Lieberman, M.D.