New Technologies Leading to a New Era for In Vitro Diagnostic Systems?

MedTech Outlook | Thursday, September 23, 2021

The advent of same-day testing and diagnosis is increasing in vitro diagnostics in healthcare.

FREMONT, CA: Frontline healthcare providers are developing measures to ensure the timely availability of in-vitro diagnostic results. Because same-day testing and diagnosis can quickly limit a patient's diagnosis and choose drugs based on precise information about their disease, patients and their families benefit from increased quality of life (QoL) and cost savings. In vitro diagnostic treatments include clinical chemistry and immunochemistry assays. Meanwhile, the patient waits, taking roughly 15 minutes for pre-treatment and 10 to 30 minutes for the test itself. If the analyzer is down for maintenance or consumable replacement, the patient will have to wait longer.

The following section speculates on the technologies that may be used in future in vitro diagnostic systems:

Maintenance and Servicing Based on Actual Use: Advances in big data analytics and data communications have enabled a shift away from simplistic metrics such as operational time or several tests processed toward actual use. Analyzer systems capture a variety of data, such as measurements, operating logs, and maintenance records. By gathering this data remotely on an upstream information system, applying machine learning or other kinds of artificial intelligence (AI), and integrating it with data stored by the system vendor, it is feasible to forecast what maintenance work should be performed and when it should be performed. One idea is for the upstream system to monitor parameters associated with component fatigue and recommend replacement when they reach a specified level. The parameter selection does not have to be restricted to operating duration or number of tests processed; it can vary according to how the customer uses the analyzer and the type of tests they do. This means that the upstream system can plan maintenance following actual usage based on these adjustments. Data analysis can also improve existing methods or design the next generation of systems by utilizing the knowledge gained about analyzer usage.

Utilization of IT to Achieve Test Result Portability: The exchange of test data via IT as a way of coordinating care between different healthcare institutions, the cross-border sharing of clinical trial data, and the use of anonymized big data in medical research are all making progress. Standardizing test results is necessary for remote data sharing since it ensures consistency in sample measurement regardless of which facility did the testing. In clinical chemistry and immunochemistry analysis, reference values and test results typically vary by country, area, and facility due to changes in reagent compositions or the combination of equipment and the measuring environment. Globally, progress is being made toward standardization of testing through consistent reagent compositions and ISO 15189 accreditation of clinical laboratories. Standardization enables access to a patient's timeline of data in scenarios such as when they are transferred from their primary care physician to a specialized clinic or from an emergency room to a rehabilitation center. Thus, the prerequisite for analyzers is a high degree of reliability in terms of low fluctuation in results and independence from their specific environment.