Is Roche change in progesterone reagent responsible for new reference range?

[Osprey]

Roche Diagnostics is the company that makes the immunoassay analyzer used to measure serum progesterone as well as many other hormones that use the ECLIA methodology.

On the Labcorp website for the progesterone test in the first footnote they list the package insert for the reagent used for the test. If you do a search for that insert you will find that it comes up as the Progeterone II reagent. I found a copy in Portugese:
http://www.biodinamica-ltda.com.br/documentos/elecsys/fertilidade/Progesterone%20II%2012142236001%20V8_pt.pdf

You don't need to understand much Portugese to go to page 3 where they list the reference range for men to be 0.2 to 1.4 ng/ml which, if I remember right, is the old Labcorp range, or close to it. Note that the median level is 0.6ng/ml, but the sample size is only 33.

A month or 2 ago Roche came out with the new Progesterone III reagent. A copy of the package insert is here, in English this time:
https://pim-eservices.roche.com/eLD/(S(pjfwzwolefl50reliuwzkbzs))/cn/en/Documents/GetDocument?documentId=f3cd9bf4-2b61-e511-f1bd-00215a9b3428

If you go to page 3 you can see that the reference range has changed considerably. From <0.05, basically undetectable, to 0.149 ng/ml, with a median value of <0.05. The sample size this time was 147.

This is pure speculation on my part but I would guess that Labcorp switched to the new reagent but didn't update the footnotes on their webpage yet.

[timmy11]

So glad to see this.  Thxx.  This has been an issue for me.  Mine just came back at 0.1!! I freaked out a bit, then seen someone mentioned the changes!!

[PeakT]

Roche Diagnostics is the company that makes the immunoassay analyzer used to measure serum progesterone as well as many other hormones that use the ECLIA methodology.

On the Labcorp website for the progesterone test in the first footnote they list the package insert for the reagent used for the test. If you do a search for that insert you will find that it comes up as the Progeterone II reagent. I found a copy in Portugese:
http://www.biodinamica-ltda.com.br/documentos/elecsys/fertilidade/Progesterone%20II%2012142236001%20V8_pt.pdf

You don't need to understand much Portugese to go to page 3 where they list the reference range for men to be 0.2 to 1.4 ng/ml which, if I remember right, is the old Labcorp range, or close to it. Note that the median level is 0.6ng/ml, but the sample size is only 33.

A month or 2 ago Roche came out with the new Progesterone III reagent. A copy of the package insert is here, in English this time:
https://pim-eservices.roche.com/eLD/(S(pjfwzwolefl50reliuwzkbzs))/cn/en/Documents/GetDocument?documentId=f3cd9bf4-2b61-e511-f1bd-00215a9b3428

If you go to page 3 you can see that the reference range has changed considerably. From <0.05, basically undetectable, to 0.149 ng/ml, with a median value of <0.05. The sample size this time was 147.

This is pure speculation on my part but I would guess that Labcorp switched to the new reagent but didn't update the footnotes on their webpage yet.

Wow!  You should win some kind of an award for this one.. 

Hey, I see what you are talking about on p.3, but that simply makes no sense.  The old top of the range was seven times higher than that!  Furthermore, many men have used the old test and seen their progesterone go up after taking pregnenolone, so the old test seemed to work the way one would expect it to.

So something is really not right here if you ask me. 

[Osprey]

Roche Diagnostics is the company that makes the immunoassay analyzer used to measure serum progesterone as well as many other hormones that use the ECLIA methodology.

On the Labcorp website for the progesterone test in the first footnote they list the package insert for the reagent used for the test. If you do a search for that insert you will find that it comes up as the Progeterone II reagent. I found a copy in Portugese:
http://www.biodinamica-ltda.com.br/documentos/elecsys/fertilidade/Progesterone%20II%2012142236001%20V8_pt.pdf

You don't need to understand much Portugese to go to page 3 where they list the reference range for men to be 0.2 to 1.4 ng/ml which, if I remember right, is the old Labcorp range, or close to it. Note that the median level is 0.6ng/ml, but the sample size is only 33.

A month or 2 ago Roche came out with the new Progesterone III reagent. A copy of the package insert is here, in English this time:
https://pim-eservices.roche.com/eLD/(S(pjfwzwolefl50reliuwzkbzs))/cn/en/Documents/GetDocument?documentId=f3cd9bf4-2b61-e511-f1bd-00215a9b3428

If you go to page 3 you can see that the reference range has changed considerably. From <0.05, basically undetectable, to 0.149 ng/ml, with a median value of <0.05. The sample size this time was 147.

This is pure speculation on my part but I would guess that Labcorp switched to the new reagent but didn't update the footnotes on their webpage yet.

Wow!  You should win some kind of an award for this one.. 

Hey, I see what you are talking about on p.3, but that simply makes no sense.  The old top of the range was seven times higher than that!  Furthermore, many men have used the old test and seen their progesterone go up after taking pregnenolone, so the old test seemed to work the way one would expect it to.

So something is really not right here if you ask me.

Yeah, I don't think the new test is clinically useful for dosing pregnenolone.

Although if you look at the reference range for the Quest LC/MS/MS progesterone test, which should be more accurate, they also say that progesterone is pretty much undetectable in men. So who knows.

[PeakT]

Yeah, I don't think the new test is clinically useful for dosing pregnenolone.

Although if you look at the reference range for the Quest LC/MS/MS progesterone test, which should be more accurate, they also say that progesterone is pretty much undetectable in men. So who knows.

Okay, that's not what I wanted to hear.

[electrify]

Its really annoying cause how am I supposed to know if I am taking too much pregnenolone and its converting to progesterone now.

[Osprey]

Its really annoying cause how am I supposed to know if I am taking too much pregnenolone and its converting to progesterone now.

It's more expensive, but you can test serum pregnenolone directly.

[PeakT]

Its really annoying cause how am I supposed to know if I am taking too much pregnenolone and its converting to progesterone now.

It's more expensive, but you can test serum pregnenolone directly.

I've heard it's not the most accurate test.  What doc do you know that uses it?

[Osprey]

Its really annoying cause how am I supposed to know if I am taking too much pregnenolone and its converting to progesterone now.

It's more expensive, but you can test serum pregnenolone directly.

I've heard it's not the most accurate test.  What doc do you know that uses it?

I don't know anyone who uses it. I just saw that it is one of the tests offered by Nelson on Discountedlabs.com. So I assume he must think that there is some value to it.

[Dr Justin Saya, MD]

Its really annoying cause how am I supposed to know if I am taking too much pregnenolone and its converting to progesterone now.

It's more expensive, but you can test serum pregnenolone directly.

I've heard it's not the most accurate test.  What doc do you know that uses it?

I don't know anyone who uses it. I just saw that it is one of the tests offered by Nelson on Discountedlabs.com. So I assume he must think that there is some value to it.

The pregnenolone test is expensive and experience shows it to be difficult to interpret (likely due to significant temporal variation in shunting to downstream hormones). The more important parameters to know are the downstream byproducts (progesterone, DHEA, cortisol).

FYI, DiscountedLabs is an offshoot from our bulk LabCorp account. Consequently, labs offered are basically dictated by our bulk LabCorp account availability and not necessarily selected solely for utility.

[PeakT]

Its really annoying cause how am I supposed to know if I am taking too much pregnenolone and its converting to progesterone now.

It's more expensive, but you can test serum pregnenolone directly.

I've heard it's not the most accurate test.  What doc do you know that uses it?

I don't know anyone who uses it. I just saw that it is one of the tests offered by Nelson on Discountedlabs.com. So I assume he must think that there is some value to it.

Hey, sorry, didn't mean to sound short, but I was writing fast and furious.  Just trying to give a littel background.  The research, Osprey, as always, is much appreciated.