2019-09-11 14:04
(edited by Monic on 2019-09-11 14:16)

Posting: # 20584
Views: 1,468

 Evaluation of Heparin as a potentially interfering substance [Bioanalytics]

Hi everyone,

Is it required to evaluate the interaction of "heparin" with your analyte of interest during concomitant medication effect as a part of bio-analytical method validation parameter?
since heparin is infused during blood collection to prevent formation of blood clots in clinical phase.

Note: The anticoagulant used for the blood collection in vacutainer is K2EDTA.


Edit: Category changed; see also this post #1[Helmut]

2019-09-11 18:06

@ Monic
Posting: # 20585
Views: 1,241

 Evaluation of Heparin as a potentially interfering substance

Hi Monic,

this is actually a pretty good question, in my opinion. I don't have a good answer, unfortunately. I can only offer to ramble a bit.

You give a tiny amount of Hep in the catheter with the intent to keep it exactly there. No Hep is intended to be injected/infused into the blood stream. Yet, there will of course be some diffusion.
Although the level of circulatory Hep will be low, who knows if they could interfere?

I have seen on several occasions how catheters may get clogged. In those cases the phlebotomist may do multiple push/pulls with Hep solution to clear the passage (and the subject will flinch in pain, but that is another story).
In those cases, surely you will get much more Hep into the blood stream. Will you get enough to interfere? My gut feeling says "no", but who am I to actually qualify that? May even be depending on the type of Hep, who knows?!?
There is other stuff in the Hep solution, most often Glucose but sometimes there is a gelling agent, because this solution has to be much like a marmelade to serve its purpose. So what about that gelling agent?

Technicality: Hep is not infused during sampling. It is only instilled in the catheter. This, I assume, is also what you meant.

I could be wrong, but...

Best regards,

"Pass or fail" (D. Potvin et al., 2008)

2019-09-11 19:32

@ ElMaestro
Posting: # 20586
Views: 1,220

 Evaluation of Heparin as a potentially interfering substance

Heparin is a polyanion, so: Calculate the amount instilled, the volume of fresh blood used to "flush" this amount to the blood collecting device, the resulting concentration in the blood/plasma sample. Use common sense to asses these numbers.

If in doubt (due to physico-chemical properties of analyte), do some in vitro studies with fresh blood/heparin.

Kindest regards, nobody

2019-09-11 21:25

@ nobody
Posting: # 20588
Views: 1,222

 Evaluation of Heparin as a potentially interfering substance

Hi all,

» If in doubt (....)

If in doubt use Heparin in the validation and in the study vacutainers. Problem solved.

I could be wrong, but...

Best regards,

"Pass or fail" (D. Potvin et al., 2008)
 Admin contact
20,810 posts in 4,355 threads, 1,447 registered users;
online 11 (0 registered, 11 guests [including 7 identified bots]).
Forum time: 06:15 CEST (Europe/Vienna)

One of the symptoms of an approaching nervous breakdown
is the belief that one’s work is terribly important.    Bertrand Russell

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz