Chemiluminescence immunoassays is enough for E2?

[assguy22]

Hi!,

My labs use this method for E2, do you know how good is this method detecting E2 in men?

https://www.sciencedirect.com/scienc...03269717303597


Ty

[Youthful55guy]

Hi!,

My labs use this method for E2, do you know how good is this method detecting E2 in men?

https://www.sciencedirect.com/scienc...03269717303597


Ty

I have no idea. One more topic to be put into the 'read up on' column. Fortunately, LabCorp uses the LC/MS/MS method and that's what's considered the best for guys. Using the same lab and lab method allows one to compare results from one test to another.

[assguy22]

Ok, Thank you Youthful55guy!

[Ephemeral]

Hi!,

My labs use this method for E2, do you know how good is this method detecting E2 in men?

https://www.sciencedirect.com/scienc...03269717303597


Ty

This is the old ECLIA test that is pretty much useless for men. To quote Dr. John Crisler:

"You can absolutely count on the fact you can not count on any laboratory methodology for estrogen in adult males other than LC/MS (or Tandem Mass Spectroscopy "TMS").

I showed this more than 10 years ago. Every one of the Laboratory Directors agrees. In fact, at Quest, LabCorp, Mayo Clinic, ARUP, if a doctor orders the incorrect immunoassay test, the result will have a paragraph underneath it telling you it is not valid, and you should have ordered the "sensitive" assay instead.

There is simply no questioning this point.

You can draw NO conclusions whatsoever from the immunoassay test. It is worthless for adult males."

[Obs]

Your hair like Jimmy Neutron.
Sound awful smart too.

"BRAIN BLAST!"

[Ephemeral]

Interestingly though, Life Extension claims that ECLIA has been working out pretty well for them (unless u have very low E2), and they say that LCMS has its own problems in the real world:

"Our team of health advisors and doctors look at over 2000 labs a month and we do find very good correlation with E2 and the other hormones in males. If we did not, we would have had serious concerns years ago. From our vast real world experience and even in house studies in conjunction with LabCorp we can tell you with confidence that LC-MS is not perfect either. While it definitely has the POTENTIAL to be more accurate, the accuracy is highly dependent on the technicians running and calibrating it. LC-MS is much more sensitive to small errors while immunoassays are not. Further, it has a much greater turnaround time and significantly higher cost. We carefully evaluated this difference doing side by side comparisons with testosterone measurements and we found that immunoassays had good correlation with other hormones, were accurate for the vast majority of men, had faster turnaround times, and were significantly less costly. Thus, we currently have no intention of moving to LC-MS for testosterone or E2 at this point as we do not feel that the very slight gain in accuracy is worth the significantly higher cost and longer period of time to get results.

A perfect example of real world issues in commercial lab testing is what happened to Quest using MS (mass spectrometry) for Vitamin D testing years ago. The same argument was used stating that MS was the most “accurate” only to find out that accuracy is dependent on the people to a much higher degree than with immunoassays. Below is what the NY Times reported and we concur. Our point here is that yes, we absolutely agree, MS is the better more accurate test for hormones in an ideal world with perfect technicians and calibrated equipment. However, no such perfect world exists in commercial lab testing. Companies try their best but when shockingly bad failures happen, like with Quest, it highlights that what looks best on paper is not necessarily what is best in reality.

Quest’s problems with the vitamin D analysis arose after it shifted in 2006 and 2007 to a new test of its own design, replacing an older F.D.A.-approved test. The new test promised to be more accurate and offer more detailed information, Quest executives said. But the test relied on a sophisticated instrument called a mass spectrometer, which can be tricky to use, especially for high-volume testing. Dr. Wael A. Salameh, the medical director for endocrinology at Quest’s most sophisticated laboratory, which is in San Juan Capistrano, Calif., said some materials used to calibrate test results had been faulty. And four of the seven Quest testing laboratories around the country did not always follow proper procedures.

The Endocrine Society goes on to say much of the same regarding Mass Spec testing. Very few medical professionals appreciate the degree of difficulty required to get accurate mass spec results.
“It needs to be noted that mass spectrometry assays are highly complex and require both a high degree of manual adjustments and controlling of operational conditions. Therefore, a high level of skill and knowledge is required to properly set up and operate these methods. Inappropriately operated mass spectrometry methods can lead to profoundly incorrect and inconsistent results. To facilitate the implementation of mass spectrometry in the clinical laboratory, the Clinical and Laboratory Standards Institute (www.CLSI.org) is developing a series of guidance documents, with one specifically addressing methods for steroid hormones. Furthermore, organizations such as the American Association of Clinical Chemistry (www.AACC.org) are offering training opportunities on mass spectrometry for the clinical laboratory.”

Also, different methodologies need different optimal values. We try to establish optimal values on similar methodologies whenever possible. Though, it is a bit maddening trying to develop optimal values when research from around the world is using different methodologies for hormone testing. Regrettably, there is no standardization in hormone testing at this time. If a man uses LC-MS to determine his E2 he has to realize that he cannot just plug that number into the same optimal range as for an immunoassay. Look at the reference ranges for both tests and you will see they are different. Thus the 20-30 range we use for E2 is only applicable to the ECLIA and similar tests. For LC-MS the E2 optimal range might have to be lower because it is a different methodology with a lower reference range (ECLIA is 7.6−42.6 pg/mL for adult male while for LC-MS it is 8.0-35.0 pg/mL)"

[Youthful55guy]

Just my two cents worth (yet again). The LabCorp LC/MS/MS method has worked very well for me for well over 6 years. I trust it and it allows me to compare one lab to the next to understand what's going on. I have no reason to fix what's not broken.