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Final chapter in the Labcorp <0.006 vs <0.014 saga

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Posted 11/9/2020 6:01 PM (GMT 0)
After I heard back from ROCHE on their uPSA assay and reported in the thread Next chapter in the Labcorp <0.006 vs <0.014 saga, I wrote (once again) to Labcorp through their portal for confirmation of the info I had. Today, after many messages, I finally got a reply from one of Labcorp's medical directors:

"Good afternoon, sorry for the delayed response,
The ultrasensitive PSA assay has the same sensitivity as the assay we offered historically. However, because of new FDA regulations and because Roche is now offering it on new and improved analyzers, it is no longer allowed to report to limit of blank of the assay (as it was before: <0.006 ng/mL) but only to a limit of quantitation (<0.014 ng/mL). Roche is now only allowed to report to <0.014 ng/mL.

Please call me with questions. Happy to help further clarify."

This jives with the info TJ123 posted that the change originated with ROCHE: "I called the Labcorp regional lab for an explanation. I was told the manufacturer changed the lower limit for their test." It just puts more meat on the bone smile

As discussed in the previous thread, it does come down to reporting the limit of quantitation vs the limit of blank. (See the other thread and the paper linked there for definitions and an illustration of Limit of Blank, Limit of Detection, and Limit of Quantitation.) Since the revision is upwards, my hunch is that this change has more to do with FDA regulations than it does with more sensitive analyzers.

Djin
Posted 11/9/2020 6:42 PM (GMT 0)
I don't care ;-)

I'd be ecstatic with either <0.006 or <0.014
Posted 11/9/2020 8:25 PM (GMT 0)

garyi said...
I don't care ;-)

I'd be ecstatic with either <0.006 or <0.014

Happy, yes. I'll reserve ecstatic for the arrival of no-cal ice cream and a veggy red meat substitute that both taste as good as the evil ones. Let's get our priorities right!

Djin
Posted 11/10/2020 1:13 AM (GMT 0)
Thanks Djin for this tasty morsel in analytical (uPSA) chemistry.
I remember the days of the balance swinging back and forth in my analytical chemistry lab. And having to buy my own set of weights.
Posted 11/10/2020 1:21 AM (GMT 0)

Sr Sailor said...
Thanks Djin for this tasty morsel in analytical (uPSA) chemistry.
I remember the days of the balance swinging back and forth in my analytical chemistry lab. And having to buy my own set of weights.

Yup. I remember that we calibrated our balances the first lab day of analytical chem. There was one electronic, single-pan (and off-limits) balance in the lab that we drooled at. Those were the days of slide rules, trig and log tables, protractors, compasses and French curves (not those-- the plastic ones), and, come to think of it, pocket protectors for pens.

Djin
Posted 11/10/2020 2:32 AM (GMT 0)
Sailor and Djin,

I HAVE a 2 pan, wooden and glass case balance, with a calibrated set of S-weights up to 50 grams, including the foils and the hair weight for the top beam. My dad taught me how to use it. I think I still could.
Posted 11/10/2020 4:49 PM (GMT 0)
Yeah, but have any of you guys saved your slide rules, and remember how to use them??

No cal-ice cream that tastes as good as the real thing and doesn't upset our guts, is a much wished for discovery, Djin. I hardly miss red meats, however.
Posted 11/10/2020 5:11 PM (GMT 0)

garyi said...
I hardly miss red meats, however.

Merely seeing the words in print has me salivating.

Pavlov
Posted 11/10/2020 5:55 PM (GMT 0)
Hey Dijn, thanks for finding out the answer on this. My doc thought that that may be the case with the change and I let him know too!
Posted 11/10/2020 6:01 PM (GMT 0)

DjinTonic said...

garyi said...
I hardly miss red meats, however.

Merely seeing the words in print has me salivating.

Pavlov

Made me smile!
Posted 11/10/2020 7:02 PM (GMT 0)
garyi - Still have my Dad's K&E slide rule that I used for two years in college before calculators became helpful and somewhat affordable.

I rarely miss meat, usually first try with a fork gets it in my mouth....
Posted 11/19/2020 1:25 AM (GMT 0)
Wow I have not posted here in a long time, in fact I know my profile is not current but I absolutely have to thank you for posting this and following up so diligently! After completing SRT my husband has been at <0.006. We test every 6 months, the last test was in May (result was <0.006) which led us to our November test. Pushing the button to open those test results is something I have to gear up for weeks in advance and when it comes down to the actual moment I literally stop breathing. I am looking for the <0.006 and anything different is an immediate panic attack for me. So of course this time when I talked myself into opening the file and saw the <0.014 I was thrown for a loop, it was different from what I was expecting but what the heck is going on?? I immediately Google Labcorp <0.014 and sure enough like usual Djin saves the day! I knew what was going on and I knew I could trust the source! Just want to make sure you know how much you help people with all your dedication! I was Ready2Fight on the other site (guess its been a few years now since that went away?) and you also wrote about the Decipher test which caused me to get it for my hubby. It was high risk and that played a big role in our decision to pull the SRT trigger. Been back to <0.006 ever since... or well I guess I mean <0.014 now smile thank you Djin!!

Post Edited (Jack & Diane) : 11/18/2020 6:36:54 PM (GMT-7)

Posted 11/19/2020 1:32 AM (GMT 0)
Jack & Diane, you are very welcome, and I thank you.

Djin
Posted 11/19/2020 5:10 PM (GMT 0)

Jack & Diane said...
.....Just want to make sure you know how much you help people with all your dedication! I was Ready2Fight on the other site (guess its been a few years now since that went away?) and you also wrote about the Decipher test which caused me to get it for my hubby......thank you Djin!!

Most of us feel the same way, R2F, miss the old hang-out and Djin's life saving PCa link. Good to hear your husband is doing well. Keep the faith!

Gary
Posted 11/18/2023 8:04 PM (GMT 0)
Quick update to my update 3 years ago...wow that went fast!

Just has our 6 month test and still <0.006!

Djin, thinking of you again. I think of you every time we see that beloved < sign! It was the Decipher that you wrote about that led us to early SRT and he's been <0.006. Praying that it stays that way!

Thank you and everyone on this forum! Reading today I see so many names of people that got me through all of it when my husband was first diagnosed.
Posted 11/18/2023 11:44 PM (GMT 0)
J&D, thats great news, wonderful for you guys. And for all of us, we all feel good when we see success like that.
Posted 11/18/2023 11:54 PM (GMT 0)
Jack & Diane, That's great to hear!

All the best for continued smooth sailing!

Djin
Posted 11/19/2023 7:37 PM (GMT 0)
My latest PSA (labcorp) a few weeks ago was reported at <0.006.

It's all about lies, damn lies, and statistics. As long as I keep getting "<" I'm good. As a surgery patient, however, I'd be less than comfortable with the standard 0.1 assay.
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