The Cost of Biotin Interference Solutions

In this Biotin Brief, we run some of the numbers on fixing the interference issues of afflicted instruments. Commercial products have come to market that can alleviate the dangers of biotin interference, and studies are now being published evaluating these products:

"Neutralization of biotin interference: preliminary evaluation of the VeraTest Biotin?, VeraPrep Biotin? and BioT-Filter?." Favresse J, Bayart JL, Stoefs A, Gheldof D, Douxfils J, Dogné JM, Gruson D. Clin Chem Lab Med. 2020 Feb 24. pii: /j/cclm.ahead-of-print/cclm-2019-1121/cclm-2019-1121.xml. doi: 10.1515/cclm-2019-1121.

The key finding: "Our study shows that the streptavidin beads treatment and the VeraPrep Biotin? appeared to be the best solution to efficiently deplete patients’ samples from biotin."

If you visit the website for VeraPrep, as the image shows, the list price for a vial of reagent that can treat 20 serum samples is $199.00 https://www.veravas.com/order

Now, by my crude math, using this method costs about $9.95 per serum sample. So let's do some bar-napkin calculations:

In the Mayo Clinic ER study, which is probably our best estimate of the US biotin prevalence, they looked at 1944 patients for whom there were 1442 tests ordered over a 17 day period, (or about 85 test orders a day), and they found that 7.4% of those patients had biotin supplementation.

If we just treated about 7 patients a day for a year, that's $69.65 a day, or $25,400 a year (I'm rounding) to keep biotin interference at bay. But that of course presumes you can identify which 7.4% of the ER patients are taking biotin - which is a magical feat of prediction in the ER, and if you can do that, you might be able to diagnose the patient without running any diagnostic tests at all.

Instead, if you treat every patient coming through the ER as a potential user of biotin supplementation, then the costs go up dramatically. Now you're spending $845.75 per day or over $308,000 per year. At some point, obviously this solution becomes cost-prohibitive. It's cheaper to buy another instrument, you know, one that isn't vulnerable to biotin interference.

Now I realize there are some gross simplifications here: I'm using list prices for a small test kit, and as your volume increases, your lab should get a better price break. I'm also assuming the laboratory is picking up this bill - whereas it's possible the manufacturer of your biotin interference instrument will be paying for this, in order to keep you happy and keep you being their customer. So your actual cost may be less that this crude calculation here.

But I'm also not including some of the other costs of running the test, including the other components you have to purchase, including the extra cost of labor, the extra cost of having to try and guess which patient is taking biotin, the extra time (at least 15 minutes) that gets added to TAT while you perform the steps to flush out biotin from the sample, nor the extra validation studies you'll have to perform to get this now-laboratory-developed test in compliance.

Here's the point: labs are bending over backwards to do nothing or essentially nothing about removing the risk of biotin interference, and it's going to cost them time, money, and opportunity. Not to mention what it could be costing the patient.

The solution is so simple: use biotin interference free methods. No extra kits, no extra expenses, no extra TAT, no extra costs, and no risk to patients.

Please note: I have no stake or commercial interest in the VeraTest, VeraPrep, or other biotin removing products and solutions on the market. We do, however, work with diagnostic manufacturers, some of whom have methods free from biotin interference: https://www.westgard.com/consulting.htm