In 1983, when I first entered the clinical lab world (we were called Med Techs back then), the instruments were much different than they are today. Let us take a look back and see how far the industry has come.
Where It All Began
For those of us who have been around a long time, we remember the old Technicon SMA1 (sequential multiple analyzer) and SMAC2 (sequential multiple analyzer chemistry) that tested serum for routine chemistries. They were so large that they had their own rooms. The operation of the instruments’ calibration and reagent stabilities allowed them to only operate for part of the day. After the rush of the morning samples was completed, the analyzers usually shut down and maintenance was performed. The SMA was so popular at the time that even after other companies and instruments came to the market, the standard orders for chemistry panels were known for quite a long time as SMA-12s for a 12-panel test or a SMAC-24 for the larger panel. These were the forerunners of what we refer to today as comprehensive metabolic panels (CMPs) and basic metabolic panels (BMPs).
Technological Advances – Then and Now
Forty years ago, I recall how consequential and how much of a change in thinking it was to perform capillary glucoses at a patient’s bedside. It caused so much angst in the central testing lab to have these tests out of our control. Now, tests like these are much simpler to perform.
Many technological advances have taken place in the clinical laboratory over the years. It is amazing to see how far we have come, and how much attitudes have changed.
SMA 12 Analyzer. Credit: American Association for Clinical Chemistry (AACC)
The Early ‘90s
In the early ‘90s, Med Techs began hearing about what was called an i-STAT. This quickly performed multiple tests at the point of care using just a few drops of blood. The i-STAT changed the way many hospitals tested patients that needed critical lab values in the shortest amount of time. These proliferated in the emergency departments and in the cardiac surgical suites.
We then saw the much smaller “at the point of care” instruments utilized in more non-traditional areas such as imaging centers, where patients who were scheduled for contrast imaging could get an immediate creatinine test done in a matter of minutes without needing to reschedule their procedure.
As instrument testing technology became more advanced, instrumentation and test methods became smaller and easier to perform. This led to more tests moving from traditional core lab settings to near-patient testing.
The Mid-2000s
Lateral flow testing (LFT) technology, first described in the 1950s, was a tremendous breakthrough in the development of the rapid testing market. One of the first tests I remember being adapted to LFT technology was the test for Human Chorionic Gonadotropin (bHCG) or rapid pregnancy test. I was introduced to the pregnancy test as a tube test utilizing hemagglutination inhibition (HAI) using coated red blood cells. The test performer looked for a pattern or nonpattern of agglutination of the red blood cells. With the advent of LFTs, this process was simplified by adding urine to a testing device and looking for the presence or absence of that tell-tale line.
The proliferation of LFT technology and the application of its use for testing in other areas of diagnostics, such as infectious disease and respiratory testing, led to an increase in the number of companies developing LFT kits by the mid-2000s. Along with the passing and implementation of Clinical Laboratory Improvement Amendments-88 (CLIA) and the classification of testing in the waived, moderate, and high complexity categories, companies began submitting their LFT test kits to the Food and Drug Administration (FDA) to try to achieve waived status.
Once waived status was accomplished, the increase in easy- to-use test kits with reduced quality control and compliance requirements resulted in the ability of physicians to begin CLIA waived testing in their offices. This gave physicians the ability to perform tests that were usually reserved for the hospital laboratory or the reference laboratory. Rapid testing at the point of care, while the patient was in the office, was a clear advantage over the traditional wait times associated with “send out” tests.
The list of FDA CLIA waived tests and manufacturers can be found on the FDA website.3
The 2010s
In the mid-2010s, the next advancement came in the form of instrument-based readers for LFTs. This removed the variability of time, subjectivity in reading results, the ability of results storage, and in some cases, results transmission to lab information systems or electronic health records.
Soon after, the first molecular-based testing for Respiratory Infectious Diseases (RIDTs) for Influenza A/B and RSV became available. For those who remember how molecular testing was done previously, with the unidirectional workflow, clean rooms, and areas to reduce contamination during amplification, this was a groundbreaking advancement in the technology for molecular testing. No longer was it necessary for specialized areas within the core laboratory with highly trained personnel to perform molecular testing. Testing could now be performed by non-laboratory personnel who had been trained to perform these tests. Tests that were just a few years before considered complex were now available to any health care entity that possessed a CLIA waived license. From there, the availability of lab testing at the point of care continued to grow.
2020 and Beyond
The 2020 pandemic due to the novel coronavirus caused a public health emergency across the globe. There was a call for diagnostic companies all over the world to develop tests detecting the virus as quickly as possible. Lateral flow antibody tests were early to the market, but these were not ideal as they look at previous infections, or are dependent on the immune response to produce antibodies that the test could pick up. The molecular testing technology was already in place, so some companies were able to get tests to the market more quickly. These were still primarily office-based tests, and the supply chain simply could not keep up with the demand.
During that unprecedented time, health care professionals needed rapid diagnostic tools to help protect their safety and the safety of the population. In conjunction with our suppliers, Henry Schein served as the exclusive distributor in the United States of a second point-of-care rapid test kit that could detect antibodies associated with COVID-19 in as few as 15 minutes. The company was also a participant in the White House’s COVID-19 Supply Chain Task Force, and worked with the Strategic National Stockpile to deliver personal protective equipment to COVID-19 testing sites.
The next breakthrough in the technology advancement came in the form of molecular testing that could be performed in any location where patients were gathered. We remember the tents that were set up in parking lots and the drive-through testing sites. These molecular tests could be performed using readers that were no larger than a smartphone and, in many cases, provided results in 30 minutes or less. Some even utilized disposable readers that were included in each test kit.
There are currently more than 20 COVID-19 testing methods classified CLIA waived on the FDA website, designated as Emergency Use Authorized (EUA), and over 200 EUA COVID-19 tests overall.
The World Health Organization has recently declared the pandemic as no longer an emergency. But although the pandemic may no longer be considered an emergency, we must continue to be prepared. Luckily, there is testing in place to diagnose those affected.
Looking to the Future
In my years in the clinical laboratory, I have seen many changes. I have gone from being a Med Tech (MT), to a Clinical Laboratory Scientist (CLS), and now to a Medical Laboratory Scientist (MLS). I have seen the advancement in testing technology go from manual, complex methods, to automated, much simpler methods. I have watched the availability of the different tests go from a dream 40 years ago to the routine today. I do not know if we will ever get to the point of Star Trek and Dr. McCoy waving something handheld over a patient that tells us exactly what is wrong, but I never thought I would see the day where we could perform a molecular test at home for a virus that did not exist just a few short years ago.
It certainly has been an interesting ride, and I look forward to what is next!
References
1. American Association for Clinical Chemistry (AACC). SMA-12/60. https://www.aacc.org/science-and-research/analyzer-listing/1967/sma1260.
2. American Association for Clinical Chemistry (AACC). SMAC. https://www.aacc.org/science-and-research/analyzer-listing/1972/smac.
About the Author: Charles Starr is a member of Labcompare's Editorial Advisory Board. Starr graduated from Northeast Louisiana University in with a degree in Clinical Laboratory Science. For nearly 20 years, he held various roles ranging from an evening/night bench technologist to a hospital lab evening and night supervisor. In conjunction with his lab supervisory duties, Starr assumed a teaching role as a part-time instructor at Northeast Louisiana University where he taught clinical chemistry and toxicology. Later, he became program director of the Laboratory Internship Program at St. Francis Medical Center in Louisiana. Currently, Starr serves as the Senior Director of Sales for the Clinical Laboratory Services–West Area Sales Team at Henry Schein. In this role, he is responsible for driving company strategy for the sales of laboratory instrumentation, supplies, and consumable products in all laboratories, waived and non-waived, that provides testing at the point of care of the patient.