LabCorp Testosterone Reference Range Changing (Decreasing) Effective July 17, 2017

As FYI and discussion topic for the community, effective July 17, 2017 the LabCorp reference range for total testosterone measurement in adult males will be changing (DECREASING) to 264 - 916 ng/dL (previously 348 - 1197 ng/dL). Please note the METHODOLOGY for the assay is not changing in any way, only the reference range is changing.

https://www.labcorp.com/assets/11476

Reasons for this change, as cited by LabCorp, include pressure from the CDC for standardization across labs of testosterone reference range and, ultimately, a different study/patient population used for the two ranges. The low end cut-off for both ranges is the bottom 2.5 percentile of the patient population.

As I already KNOW what OPTIMAL testosterone levels are for most males (based upon treating over 10,000 of them), this simple change in reference range is not going to negatively impact my patients...however, I fear this change is going to lead to even MORE guys walking in to their PCP or other provider with classic hypogonadal symptoms but T levels "in range" (now all the way down to 264!) and being told they're "normal" and given an SSRI + viagra and sent out the door to continue to suffer.

A great question in a separate discussion on this topic with my response:

Question: "Why is the medical community so scared of testosterone? Is it really just about politics? Or fear of giving out a controlled substance? Treating the symptoms of low testosterone (with antidepressants, viagra and in my case opioids), rather than treating the actual condition, is terrible medical care."

My response:

Well let's think this through.

Everything comes with possible risk, but in many men medically appropriate TRT (and other hormonal optimization) can reverse or improve obesity (which in and of itself can improve or even cure hypertension, high cholesterol, diabetes/insulin resistance), can reverse or improve depression, anxiety, and a host of other mental health symptoms, can improve bone density (less risk of osteopenia and osteoporosis), can improve libido/erections (how much profit do the PDE-5i such as viagra net the pharm companies?), the list goes on...

Let's not even talk about all of the guys I see come in with full-blown metabolic syndrome (from a combination of the above - obesity, hypertension, high cholesterol, insulin resistance), which ultimately culminates in heart disease and heart attack - where the first step down that path towards metabolic syndrome was often a hormonal deficiency (Testosterone, thyroid) that began YEARS beforehand and went either undetected or, even worse, ignored by their doctor as "normal".

Now look into the financials of how much big pharma profits from the treatment of these "sick patient" conditions - hypertension, high cholesterol, diabetes, obesity, erectile dysfunction, depression, anxiety, heart disease...then realize the immense influence that big pharma has not only on practicing physicians (their reps are in the doc offices every week for "lunch") AND big pharma's influence on medical education and research in general...the dots are then left to you to connect.

You know how many pharmaceutical reps we host at my office???

None, zero, never!

For those curious or unaware, "Dollars for Docs" is a searchable database that details payments from the industry to physicians (I believe most recent data is from 2013-2015). I don't believe this encompasses the most common spending on physicians, however, which are paid "lunches" which are more accurately labeled "sales pitches" for their pharmaceuticals. Academic-oriented physicians tend to be the biggest targets for pharma (search some names).

https://projects.propublica.org/docdollars/

Dr. Saya, thank you for posting this. Do you know if there will be any changes to the free testosterone reference range as well?

Thanks!!

Vettester Chris said:

Dr. Saya, thank you for posting this. Do you know if there will be any changes to the free testosterone reference range as well?

Thanks!!

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Interestingly, I *believe* the free Testosterone range will remain the same. If so, this would demonstrate how misguided (and misunderstood) this adjustment is.

Thank you for shedding some light on the pharmaceutical industry's sway over doctors, Dr Saya. I had always heard this but never directly from a practicing physician. Every day I learn more and more that money makes the world go around.

Just spoke to a guy who had a level of 268ng/dl. He asked what he should do, I said "Don't worry, next month you'll be in range so you won't have a problem!!".

It's sad, that suddenly and very arbitrarily this guy will be considered "in range" when now most doctors would consider this guy to be very below range and worthy of treatment!

I got my latest blood work from LabCorp. On it was a note:

Effective July 17, 2017 the reference interval for Testosterone, Serum Males > 18 years old will be changing to: Adult Males: 264 -916. Adult male reference interval is based on a population of lean males up to 40 years old.

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What they don't say is that the blood test for testosterone is not a standard test and men don't get it unless they fear they are low.

Does this mean in any way that we're all out of guys who produce 1000+ naturally? I wonder what percentage of the male population falls into that category, and if they'll somehow be classified as hypergonal now lol.

AbsoluteZ3R0 said:

Does this mean in any way that we're all out of guys who produce 1000+ naturally? I wonder what percentage of the male population falls into that category, and if they'll somehow be classified as hypergonal now lol.

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The upper end cutoff is, quite simply, the top 2.5% in the SPECIFIC STUDIES that they are utilizing for the reference range determination. The reference range is *meant* to be extrapolated to the overall population, however that extrapolation is tenuous.

Another important point to realize is that these reference ranges are established WITHOUT meaningful clinical consideration of symptoms, longevity, quality of life, professional achievement (which is an often overlooked benefit of optimal T levels - more ambition, motivation, drive = more professional/career achievement).

Dr Justin Saya said:

The upper end cutoff is, quite simply, the top 2.5% in the SPECIFIC STUDIES that they are utilizing for the reference range determination. The reference range is *meant* to be extrapolated to the overall population, however that extrapolation is tenuous.

Another important point to realize is that these reference ranges are established WITHOUT meaningful clinical consideration of symptoms, longevity, quality of life, professional achievement (which is an often overlooked benefit of optimal T levels - more ambition, motivation, drive = more professional/career achievement).

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Interesting, is that cutoff point the same for all blood tests? In other words, do all reference ranges always refer to the lowest and highest 2.5% of the sampled group(s)? Also, if you don't mind me asking, what is the highest naturally attained total testosterone value you have ever seen in your career?

AbsoluteZ3R0 said:

Interesting, is that cutoff point the same for all blood tests? In other words, do all reference ranges always refer to the lowest and highest 2.5% of the sampled group(s)? Also, if you don't mind me asking, what is the highest naturally attained total testosterone value you have ever seen in your career?

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No, not all reference ranges (hormone or otherwise) are established based on the middle 95th percentile (chopping off top/bottom 2.5%), though this could be considered a common "default" reference range.

I've seen 1400's (a couple) naturally. Just last week had a 58yo man with natural 980...wonder what his level was when he was 21yo?!?! On a related interesting topic, I've seen over a dozen of my clomid guys achieve T 1400 range. Although these aren't "natural" levels per se, they have achieved physiologic LH levels (upper range) meaning that those same levels were at least POSSIBLE for them naturally (if the "stars were to align" as it were).

Dr Justin Saya said:

No, not all reference ranges (hormone or otherwise) are established based on the middle 95th percentile (chopping off top/bottom 2.5%), though this could be considered a common "default" reference range.

I've seen 1400's (a couple) naturally. Just last week had a 58yo man with natural 980...wonder what his level was when he was 21yo?!?! On a related interesting topic, I've seen over a dozen of my clomid guys achieve T 1400 range. Although these aren't "natural" levels per se, they have achieved physiologic LH levels (upper range) meaning that those same levels were at least POSSIBLE for them naturally (if the "stars were to align" as it were).

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Thank you again for spreading your knowledge and wisdom, and answering our questions. That is very interesting about clomid. I would not be surprised if such a level were attainable pushing the LH well past the 10 mIU/mL range in some men, but for you to say that these patients achieved 1400 with physiologic LH levels is really quite impressive.

In furtherance of the above discussion, let's not forget that the same 2.5% threshold holds true for the LOWER limit. In other words, someone below the lower threshold of the reference range - 264, would fall into the lowest 2.5% of the study patient population.

Imagine if we ONLY treated the worst 2.5% of the patient population for diabetes, hypertension, vision loss, obesity, etc and told all of the rest "sorry you're normal"...

projects.propublica.org/docdollars/ Find out how much big pharma is paying your doctor

My father is 65. His last TT showed over 900. Not lean. Does not exercise or eat right. Go figure.

How in the world can they get "averages" of the US population using lean men? Those are few and far in between these days.

I don't really trust doctors due to the experiences I've had. What I experienced and read about regarding hormone treatment just cements those feelings.

Dr Justin Saya said:

Another important point to realize is that these reference ranges are established WITHOUT meaningful clinical consideration of symptoms, longevity, quality of life, professional achievement (which is an often overlooked benefit of optimal T levels - more ambition, motivation, drive = more professional/career achievement).

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Absolutely ridiculous. I noticed that in one of the studies, they want a statistical average, not a healthy range. What is the purpose of that?

If you make a test for memory but don't exclude people with alzheimer's, you cannot use that to assess healthy people. The range is meaningless if you do not exclude those with symptoms.

If what I read on the Internet is correct (always a gamble) the reason for the drop in LabCorp ranges is that the population of men included in the survey was changed from men with BMI < 25 to men with BMI < 30. This lowers the range because overweight men have lower testosterone on average. This means I will have to decrease my testosterone to match the levels of an overweight, out of shape man, which makes no sense to me.

AbsoluteZ3R0 said:

Does this mean in any way that we're all out of guys who produce 1000+ naturally? I wonder what percentage of the male population falls into that category, and if they'll somehow be classified as hypergonal now lol.

Click to expand...

Decreasing the lower end range to 264 is completely ridiculous but decreasing the top end from 1197-916 is not as big a deal as some may make it out to be. If one does not experience symptom relief from a 900 trough considering e2 and other hormones are in check then something is not right as the majority of young healthy males hit TT 600-800 ng/dL. Sure there are outliers in the 1000+ range but if one thinks there tt needs to be 1000+ to see benefits from trt then they need to look into other underlying health issues.

madman said:

Decreasing the lower end range to 264 is completely ridiculous but decreasing the top end from 1197-916 is not as big a deal as some may make it out to be. If one does not experience symptom relief from a 900 trough considering e2 and other hormones are in check than something is not right as the majority of young healthy males produce 800-900 tt naturally. Sure there are others in the 1000+ range but if one thinks there tt needs to be 1000+ to see benefits from trt than they need to look into other underlying health issues.

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Most of the studies I've seen show the majority of young men producing between 600-700 ng/dL. More recent studies seem to place young guys between 500-600. I just thought it was interesting because if your run-of-the-mill doctor uses the reference range as a gold standard for diagnosis, a 1000+ male could technically be considered hypergonadal. I am beginning to wonder if there's something to the hypothesis that testosterone levels have declined considerably over the past century.