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Author Topic: LabCorp Quietly Changes E2 Sensitive Test to LC/MS  (Read 9117 times)

helix26404

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LabCorp Quietly Changes E2 Sensitive Test to LC/MS
« on: April 04, 2015, 04:56:35 pm »
If you've read many of my posts here you know I'm a huge advocate for the LC/MS test for E2 over the RIA or ECLIA methodologies that are used rampantly by healthcare providers due to accessibility and cost.

Recently (I can't tell exactly when) LabCorp has quietly changed their "Estradiol, Sensitive" test #140244 from the RIA method to LC/MS. They've also added a ton of commentary with footnoted research that essentially says LC/MS is the only reliable choice for E2 testing for men.

Various individuals on this forum continue to claim that the use of the sensitive/ultrasensitive (LC/MS-based methodology) test is only "anecdotally supported" by various stories. There is nothing but overwhelming scientific evidence (as well anecdotal claims from those like me, who have been utterly screwed by the standard E2 assay well before these findings were available) invalidating the standard E2 assay for men.

Please heed this advice and demand the correct test from your doctor. There are life-long implications associated with low E2. Stop using it if at all possible, and if you are one of those who is claiming it doesn't matter...it does.

"New" Estradiol, Sensitive (LC/MS) #140244
https://www.labcorp.com/wps/portal/!ut/p/c1/04_SB8K8xLLM9MSSzPy8xBz9CP0os_hACzO_QCM_IwMLXyM3AyNjMycDU2dXQwN3M6B8JG55AwMCuv088nNT9SP1o8zjQ11Ngg09LY0N_N2DjQw8g439TfyM_MzMLAz0Q_QjnYCKIvEqKsiNKDfUDVQEAOrk-dE!/dl2/d1/L0lJWmltbUEhL3dQRUJGUUFoTlFBaERhQUVBWEtHL1lJNXlsdyEhLzdfVUU0UzFJOTMwT0dTMjBJUzNPNE4yTjY2ODAvdmlld1Rlc3Q!/?testId=408440#7_UE4S1I930OGS20IS3O4N2N6680

"The importance of E2 testing and the need for reliable and accurate estradiol measurements throughout the analytic range are emphasized in several recent publications...E2 levels in children, postmenopausal women and men and are much lower than in women of reproductive age. The increased sensitivity and specificity that are achieved by LC/MS-MS are the more appropriate choice for these clinical situations. LC/MS-MS offers superior analytical sensitivity, specificity and a larger dynamic range than immunoassays."

"In males, estradiol is present at low concentrations in blood, but it is extraordinarily high in semen...The use of a sensitive, LC/MS assay for serum E2 measurement in males is preferred over direct immunoassays because of its greater sensitivity and lesser interference by other steroids."

In addition, from the Endocrine Society:

Comparisons of Immunoassay and Mass Spectrometry Measurements of Serum Estradiol Levels and Their Influence on Clinical Association Studies in Men
http://press.endocrine.org/doi/full/10.1210/jc.2012-3861

"In conclusion, our findings suggest interference in the standard immunoassay-based E2 analyses, possibly by CRP or a CRP-associated factor. Although this interference does not seem to affect association studies between immunoassay E2 levels and skeletal parameters, we propose a reevaluation of previous association studies between immunoassay-based E2 levels and inflammation-related outcomes. In addition, MS-based assays are to be preferred for the quantification of E2 levels in men."
« Last Edit: April 04, 2015, 05:00:35 pm by helix26404 »

PeakT

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Re: LabCorp Quietly Changes E2 Sensitive Test to LC/MS
« Reply #1 on: April 04, 2015, 05:38:54 pm »
Don't know who you are referring, but, if you are talking about moi, what I said was this:

--The LCMS is the best technology.

--The LCMS range for estradiol changed dramatically from what I can tell.

--We now have little data, due to this range change, for what values of LCMS estradiol reads are low and high and, in particular, which ones will lead to osteopenia / osteoporosis.

Again, I am completely pro-LCMSMS, but I am just asking for you guys to look for guidelines out there for the above as I have not seen any. 

Basically, my point is this:  a test is useless if you have no research data to go with it.  From what I can tell, this new methodology is bumping down estradiol reads by 50-100%, which makes it very difficult to interpret.

In fact, I'll ask you the question:  if you have a read of 28 pg/ml with LCMS, what would you do?  Under the old way of thinking,  you'd be thinking "that is perfect."  Now, with the new test, you are actually near the top of the range.

So we just need some docs / researchers / LabCorp to help us understand how to use it imo.

Let me know what you think.
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Re: LabCorp Quietly Changes E2 Sensitive Test to LC/MS
« Reply #1 on: April 04, 2015, 05:38:54 pm »


Kierkegaard

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Re: LabCorp Quietly Changes E2 Sensitive Test to LC/MS
« Reply #2 on: April 04, 2015, 05:49:00 pm »
Great info.

Does this mean that the LCMS itself involves greater sensitivity, or that LCMS plus the sensitive assay does?  To my recollection you have six combinations:

RIA + regular assay
RIA + sensitive
ECLIA + regular
ECLIA + sensitive
LC/MS + regular
LC/MS + sensitive
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electrify

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Re: LabCorp Quietly Changes E2 Sensitive Test to LC/MS
« Reply #3 on: April 04, 2015, 06:43:54 pm »
I had the regular estradiol and the lcms test done recently so ill let you know what the differences are
Age:24

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Re: LabCorp Quietly Changes E2 Sensitive Test to LC/MS
« Reply #3 on: April 04, 2015, 06:43:54 pm »


Sighalot

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Re: LabCorp Quietly Changes E2 Sensitive Test to LC/MS
« Reply #4 on: April 04, 2015, 07:17:13 pm »
RIA + regular assay
RIA + sensitive
ECLIA + regular
ECLIA + sensitive
LC/MS + regular
LC/MS + sensitive
Also got CMIA, can measure down to 50 pmol/L

Osprey

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Re: LabCorp Quietly Changes E2 Sensitive Test to LC/MS
« Reply #5 on: April 04, 2015, 08:34:28 pm »
Don't know who you are referring, but, if you are talking about moi, what I said was this:

--The LCMS is the best technology.

--The LCMS range for estradiol changed dramatically from what I can tell.

--We now have little data, due to this range change, for what values of LCMS estradiol reads are low and high and, in particular, which ones will lead to osteopenia / osteoporosis.

Again, I am completely pro-LCMSMS, but I am just asking for you guys to look for guidelines out there for the above as I have not seen any. 

Basically, my point is this:  a test is useless if you have no research data to go with it.  From what I can tell, this new methodology is bumping down estradiol reads by 50-100%, which makes it very difficult to interpret.

In fact, I'll ask you the question:  if you have a read of 28 pg/ml with LCMS, what would you do?  Under the old way of thinking,  you'd be thinking "that is perfect."  Now, with the new test, you are actually near the top of the range.

So we just need some docs / researchers / LabCorp to help us understand how to use it imo.

Let me know what you think.

Agreed, the research is a mixed bag right now. I've seen several studies that have used the LC/MS methodology going back to at least the early 2000's. I used to naively think that all good researchers use LC/MS. Then I was rudely awakened to the fact the the big study that gets thrown around forums like this, and which is used as the basis for LEF's position paper in E2, used ECLIA.

As usual, caution is advised and more research needs to be done.

helix26404

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Re: LabCorp Quietly Changes E2 Sensitive Test to LC/MS
« Reply #6 on: April 04, 2015, 11:17:27 pm »
Don't know who you are referring, but, if you are talking about moi, what I said was this:

--The LCMS is the best technology.

--The LCMS range for estradiol changed dramatically from what I can tell.

--We now have little data, due to this range change, for what values of LCMS estradiol reads are low and high and, in particular, which ones will lead to osteopenia / osteoporosis.

Again, I am completely pro-LCMSMS, but I am just asking for you guys to look for guidelines out there for the above as I have not seen any. 

Basically, my point is this:  a test is useless if you have no research data to go with it.  From what I can tell, this new methodology is bumping down estradiol reads by 50-100%, which makes it very difficult to interpret.

In fact, I'll ask you the question:  if you have a read of 28 pg/ml with LCMS, what would you do?  Under the old way of thinking,  you'd be thinking "that is perfect."  Now, with the new test, you are actually near the top of the range.

So we just need some docs / researchers / LabCorp to help us understand how to use it imo.

Let me know what you think.

No, it's not you at all. You have been one of the advocates for driving the awareness here and that's fantastic. The one thing I would qualify from your post above is that based on what I've read, while the reference ranges have indeed changed, this doesn't change what numbers are optimal vs. not. The LC/GC/MS method is just more accurate at detecting E2 in the lower range. We still need to be shooting for the same numbers, just using the better test.

My understanding from the studies I've read, including the Endocrine Society study that's been the most revealing, is that the LC/MS methodology is by its very nature the most sensitive and accurate, due to its immunity from interference by other steroids, mainly CRP.

Here are a couple of more interesting excerpts. The first study is perhaps the most interesting because it studies AIs (even though it uses gas chromatography vs. liquid, but MS is used in tandem.

Superiority of gas chromatography/tandem mass spectrometry assay (GC/MS/MS) for estradiol for monitoring of aromatase inhibitor therapy
http://www.ncbi.nlm.nih.gov/pubmed/17588628

"Levels of estradiol were lower when assayed by GC/MS/MS compared to RIA under all conditions...the degree of suppression with the aromatase inhibitors as detected by RIA was 58% versus >89% by GC/MS...these results suggest that most RIA methods detect cross-reacting estrogen metabolites and yield higher measured levels than GC/MS/MS. Several pharmacological and clinical considerations suggest that GC/MS/MS should become the preferred method for monitoring aromatase inhibitor therapy."

Clinical applications of LC-MS sex steroid assays: evolution of methodologies in the 21st century
Department of Laboratory Medicine and Pathology, Mayo Clinic
Department of Pathology, Heartlands Hospital, Heart of England NHS Foundation Trust, Birmingham, UK

"...As testing demand increased, they were displaced by automated immunoassays. These offered better throughput and precision, but suffered worse specificity problems. Moreover, agreement between different immunoassays has often been poor and they are all compromised by a limited dynamic measurement range. To overcome these problems, LC-MS/MS methods have been developed and validated for quantitation of sex steroids. These (LC/MS) methods reduce interferences, provide better specificity, improve dynamic range, and reduce between-method bias."



« Last Edit: April 04, 2015, 11:21:59 pm by helix26404 »

helix26404

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Re: LabCorp Quietly Changes E2 Sensitive Test to LC/MS
« Reply #7 on: April 04, 2015, 11:27:37 pm »
Don't know who you are referring, but, if you are talking about moi, what I said was this:

--The LCMS is the best technology.

--The LCMS range for estradiol changed dramatically from what I can tell.

--We now have little data, due to this range change, for what values of LCMS estradiol reads are low and high and, in particular, which ones will lead to osteopenia / osteoporosis.

Again, I am completely pro-LCMSMS, but I am just asking for you guys to look for guidelines out there for the above as I have not seen any. 

Basically, my point is this:  a test is useless if you have no research data to go with it.  From what I can tell, this new methodology is bumping down estradiol reads by 50-100%, which makes it very difficult to interpret.

In fact, I'll ask you the question:  if you have a read of 28 pg/ml with LCMS, what would you do?  Under the old way of thinking,  you'd be thinking "that is perfect."  Now, with the new test, you are actually near the top of the range.

So we just need some docs / researchers / LabCorp to help us understand how to use it imo.

Let me know what you think.

Agreed, the research is a mixed bag right now. I've seen several studies that have used the LC/MS methodology going back to at least the early 2000's. I used to naively think that all good researchers use LC/MS. Then I was rudely awakened to the fact the the big study that gets thrown around forums like this, and which is used as the basis for LEF's position paper in E2, used ECLIA.

As usual, caution is advised and more research needs to be done.

This is the kind of stuff I am referring to and that I don't understand. Here's what I see:

You: "Caution is advised and more research needs to be done."

Research: "Endocrine Society and Urology Society guidelines have highlighted the limitations of the immunoassays for sex steroids and have provided convincing evidence that mass spectrometric methods are preferable for measurement of sex steroid hormones. In this review, we describe LC-MS/MS methods for measurement of testosterone and estradiol."

The better test doesn't change the fact we should stay in the same 20-30 range; it just reads it more accurately.

Tell me where you are reading in a scientific study that the standard E2, RIA/ECLIA test is preferred for men, and I'll yield.
« Last Edit: April 04, 2015, 11:35:37 pm by helix26404 »

PeakT

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Re: LabCorp Quietly Changes E2 Sensitive Test to LC/MS
« Reply #8 on: April 04, 2015, 11:41:56 pm »
Great info.

Does this mean that the LCMS itself involves greater sensitivity, or that LCMS plus the sensitive assay does?  To my recollection you have six combinations:

RIA + regular assay
RIA + sensitive
ECLIA + regular
ECLIA + sensitive
LC/MS + regular
LC/MS + sensitive

Hopefully, EH or Sam will jump in here.  Man, I'd love a tour of LabCorp some day!
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Osprey

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Re: LabCorp Quietly Changes E2 Sensitive Test to LC/MS
« Reply #9 on: April 05, 2015, 01:35:07 am »

The better test doesn't change the fact we should stay in the same 20-30 range; it just reads it more accurately.

Is this true? The study that seems to be the one that people get this number from is this one:http://jama.jamanetwork.com/article?articleid=183891
which used ECLIA. In my mind the question is, if 20-30 is the optimal range when measured using ECLIA, what is the optimum when using LC/MS? Is it lower? This is why I said more research is needed, unless of course there already exists a study that says 20-30 is good with LC/MS.

Tell me where you are reading in a scientific study that the standard E2, RIA/ECLIA test is preferred for men, and I'll yield.

LC/MS is the gold standard. I agree it is what should be used in men.

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Re: LabCorp Quietly Changes E2 Sensitive Test to LC/MS
« Reply #10 on: April 05, 2015, 04:57:19 am »
Don't know who you are referring, but, if you are talking about moi, what I said was this:

--The LCMS is the best technology.

--The LCMS range for estradiol changed dramatically from what I can tell.

--We now have little data, due to this range change, for what values of LCMS estradiol reads are low and high and, in particular, which ones will lead to osteopenia / osteoporosis.

Again, I am completely pro-LCMSMS, but I am just asking for you guys to look for guidelines out there for the above as I have not seen any. 

Basically, my point is this:  a test is useless if you have no research data to go with it.  From what I can tell, this new methodology is bumping down estradiol reads by 50-100%, which makes it very difficult to interpret.

In fact, I'll ask you the question:  if you have a read of 28 pg/ml with LCMS, what would you do?  Under the old way of thinking,  you'd be thinking "that is perfect."  Now, with the new test, you are actually near the top of the range.

So we just need some docs / researchers / LabCorp to help us understand how to use it imo.

Let me know what you think.

No, it's not you at all. You have been one of the advocates for driving the awareness here and that's fantastic. The one thing I would qualify from your post above is that based on what I've read, while the reference ranges have indeed changed, this doesn't change what numbers are optimal vs. not. The LC/GC/MS method is just more accurate at detecting E2 in the lower range. We still need to be shooting for the same numbers, just using the better test.

My understanding from the studies I've read, including the Endocrine Society study that's been the most revealing, is that the LC/MS methodology is by its very nature the most sensitive and accurate, due to its immunity from interference by other steroids, mainly CRP.

Here are a couple of more interesting excerpts. The first study is perhaps the most interesting because it studies AIs (even though it uses gas chromatography vs. liquid, but MS is used in tandem.

Superiority of gas chromatography/tandem mass spectrometry assay (GC/MS/MS) for estradiol for monitoring of aromatase inhibitor therapy
http://www.ncbi.nlm.nih.gov/pubmed/17588628

"Levels of estradiol were lower when assayed by GC/MS/MS compared to RIA under all conditions...the degree of suppression with the aromatase inhibitors as detected by RIA was 58% versus >89% by GC/MS...these results suggest that most RIA methods detect cross-reacting estrogen metabolites and yield higher measured levels than GC/MS/MS. Several pharmacological and clinical considerations suggest that GC/MS/MS should become the preferred method for monitoring aromatase inhibitor therapy."

Clinical applications of LC-MS sex steroid assays: evolution of methodologies in the 21st century
Department of Laboratory Medicine and Pathology, Mayo Clinic
Department of Pathology, Heartlands Hospital, Heart of England NHS Foundation Trust, Birmingham, UK

"...As testing demand increased, they were displaced by automated immunoassays. These offered better throughput and precision, but suffered worse specificity problems. Moreover, agreement between different immunoassays has often been poor and they are all compromised by a limited dynamic measurement range. To overcome these problems, LC-MS/MS methods have been developed and validated for quantitation of sex steroids. These (LC/MS) methods reduce interferences, provide better specificity, improve dynamic range, and reduce between-method bias."

Okay, but let's take the exam that is picking up some of the estrogen metabolites.  Doesn't this mean that the number it will produce is higher than the LCMS?  I think so.  And one of the tests picks up CRP I guess, so same thing.  So, unless I am missing something, tests with a lot of cross reactivity will tend to read higher, which is what we are talking about here I think.

Let me know if I'm missing something.
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Re: LabCorp Quietly Changes E2 Sensitive Test to LC/MS
« Reply #10 on: April 05, 2015, 04:57:19 am »