Are your customers using them?
By Jim Poggi, Principal, Tested Insights
The capital equipment introduction process for new non-waived customers has followed a predictable pattern for many years. We have often started with hematology since the “one-button wonder” is easy to use and train, provides the same test result time after time and has high clinical utility for several disease states. We usually followed that with automated chemistry instruments since the assays are familiar to the practicing physician and the number of tests sent out is usually high. Think CMP, BMP and A1C.
Immunoassay (IA) systems usually were a somewhat distant third place. We usually sold it to our larger multi-specialty practices once they were satisfied with the core lab equipment we had already sold them. And then, we typically sold IA as a specialty testing system for tumor markers, cardiac assays or reproductive assays.
I was thinking about this process and product positioning recently and have concluded that we may have been missing the boat by not introducing it sooner and by not positioning it as a large menu system, just as we typically do for chemistry systems. Let’s think about this together for a moment and let me explain my reasoning.
Why was immunoassay our third product offering “back in the day”? For those of us who have been in the lab business for a number of years, there are several reasons and some painful lessons learned along the way. Early systems were very slow with throughput – less than 25 tests per hour. They were typically batch systems so there was no way to get a result during the patient visit.
This situation resulted in multiple dedicated specialty test menu systems (cardiac, hemoglobin A1c/diabetes and thyroid) entering the market. These smaller systems were typically better suited to the physician market with smaller reagent pack sizes and simpler to use and train systems. Some of the earlier IA systems had fairly high levels of waste since they were originally designed for hospital use and their reagent containers were sized for the typically higher volume of the hospital market.
Since they were usually spin offs of hospital systems, they were not often easy to train. Manufacturers often were reluctant to train to the level of the physician office market, except in high volume specialty practices, such as endocrinology, cardiac or reproductive.
At the same time, many of the early IA systems also had a limited number of tests in their menu, which limited their applicability for our typical practice. Then there was the awkward surprise that some methods (I am thinking of PSA in particular) had more than one reference standard and we had a difficult time explaining “why the system you sold me does not match the results I am getting from the hospital lab”.
What would you think if I told you that these concerns are a thing of the past and it’s time to re-think our approach to selling IA? Well, that’s exactly the message of this column.
Today’s market
Fast forward to 2024 and the typical full menu but compact IA system has conquered all these market difficulties. No longer are we dealing with systems intended for a higher volume market from manufacturers who would just as soon not set foot in a physician office practice. Many of these systems have been optimized for footprint, test menu, ease of training and performance, which makes them a suitable solution for a medium- to large-sized physician practice looking for a general menu IA system.
Waste is a thing of the past for the properly qualified customer, EMR connectivity is a given and menus of 50 tests or more and throughputs of 100 tests or more per hour hit the sweet spot of so many of our multiple specialty practices. As far as clinical utility goes, some of these sophisticated-but-easy-to-use systems offer up to 10 assays from the top 25 listed of the most commonly performed Clinical Lab Fee Schedule tests. And, as these tests have evolved, companion assays have become available for many disease states which takes them from routine screening to broader clinical applications.
For instance, PSA testing now has companion free PSA tests as well as some calculated “prostate health” tests based on these assays and others. Anemia also offers multiple assays for Vitamin B12 and folate. Thyroids are the last specific example I will point to, but newer IA systems offer no fewer than seven different but complementary thyroid assays. General screening, risk-based screening and follow up for many thyroid patients can be performed on a single system with the appropriate tests and confidence in results.
As a result, in my opinion, the market for newer generation immunoassay systems has grown along with their advancements in menu and ease of use. I would have no hesitation presenting this solution to a larger internal medicine of multi-specialty practice as a go to single system for multiple disease states.
Would I personally present it before automated chemistry? For the right customer, definitely. It would depend on which diseases they see most often, how sophisticated their understanding of the appropriate tests is, and their current send out or test in house solution. There is a lot to say here and a lot of value to sell.
IA test list
The list of test menus and disease states has been mentioned before, but here is a more comprehensive listing for your reference.
- Tumor markers
- Diabetes/A1C
- Bone metabolism
- Anemia
- Thyroid
- Reproductive
- Infectious diseases
A list of some of the more common IA tests, their CPT code information and clinical applicability is below. See the September Physician Office Lab column for more information specific to tumor marker assays.
Have you seen enough to consider making a change in how you view immunoassay testing and which customers are good candidates? I hope so. If you have, make a commitment to learn more. Contact your local trusted lab manufacturer and ask them to provide you with more information for your learning and to prepare you for your next customer conversations. Set up work and engage with your prospects to show them that immunoassay testing has come a LONG way since the last time they considered it. And, by the way, be sure to look for upgrade opportunities from your current IA customer base. You will be glad you did.
The well-informed account manager continually challenges their thoughts and information about how best to serve customers. Looking at IA testing from a new perspective just may be your next opportunity to learn more, sell more and deliver new, happy customers.
| Test Name | CPT Code | 2024 Clinical Lab Fee Schedule Reimbursement | Disease State | Comment |
| Vitamin D | 82306 | $29.60 | Bone metabolism | Often used with PTH, Ostase, US hGH |
| Parathyroid hormone (PTH) | 83970 | $41.28 | Bone metabolism | |
| Ferritin | 82728 | $13.63 | Anemia | Often used with folate and RBC folate |
| Folate | 82746 | $14.70 | Anemia | At least 8 common anemia assays are available |
| Thyroxine | 84436 | $6.87 | Thyroid disease | A broad range of thyroid tests are available |
| TSH | 84443 | $16.80 | Thyroid disease | There are at least 7 common thyroid tests |