Pleural pH ?? How?
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I only see a few previous posts about this topic. Would someone please share how they are performing this test?
It sounds like the labs that are doing this are either using complicated pH meters OR creating an LDT on their blood gas platforms. Am I missing other options?
It sounds like the labs that are doing this are either using complicated pH meters OR creating an LDT on their blood gas platforms. Am I missing other options?
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Fluid pHs are performed in our main lab in the chemistry department. It's a manual test using a very easy-to-use pH meter. If there isn't enough volume, (which is rare) they are using pH paper.
Some POC instruments can perform pleural fluid pH, like the Siemens RP500e. And that was validated via FDA, so moderately complex method.
@Gloria, what meter are you using? I can't seem to find any meters listed in the FDA CLIA database, although I see many on the Fisher Scientific Website. What complexity is your meter?
Our main laboratory performs body fluid pH on a pH meter (ours is fairly easy to operate). The only pH testing done as POC for our facility is amniotic fluid and ocular pH which are both done using pH paper.
I obtained clearance under 510(k) with Moderate Complexity for pH in pleural and spinal fluid in 1996 for a blood gas analyzer. At that time, CLIA extended moderate complexity to all pH blood gas analyzers on the market at that time. Most current systems should include this clearance as well.
Ken, the meter we use is the ExTech ExStik PH100. I'm not sure of the complexity, but unlikely that it's waived. It's at least mod-complex. The procedure doesn't say, and the supervisor wasn't sure, either. They have a website: www.extech.com, if you'd like to investigate more.
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