The pandemic certainly didn’t invent in-vitro diagnostics, but thought leaders in this medical technology space now recognize how COVID revealed both the potential and challenges inherent in scaling molecular diagnostics.
No matter which disease process clinical interventions based on in vitro diagnostics are aimed at – infectious agents, diabetes, cancer, biomarkers for brain, heart or other organ pathologies, etc. – there is a marked advantage of patient-friendly test methods that use easily collected samples such as saliva, exhalations, or pin prick blood samples. Often though, the quantity of genetic material culled by these sampling techniques is minute. This is the same challenge that researchers faced when studying COVID and immunity.
PCR (Polymerase Chain Reaction) testing – a method developed in the late 20th Century for copying and in effect amplifying very small segments of genetic material – is at the heart of the COVID testing that is now ubiquitous. PCR testing’s ability to do the equivalent of multiplying a minute sample many times over is projected to be the cornerstone of nearly all molecular diagnostic methods in the coming years. In fact, it already is at the heart of most immunodiagnostic and molecular assay tests in clinical laboratories worldwide today. From an engineering standpoint, the integrity of PCR testing requires microscale leak testing to the most stringent standards (e.g. detecting leaks as small as 0.008 sccm, 8 microliters per minute, equivalent to a 0.5 micron hole). Consider also the challenge of then scaling successful molecular diagnostics just as COVID testing has required. If one has not grappled with the challenges of scaling such solutions – and doing so rapidly – this task can appear daunting.
Helping the medical technology innovators that scaled rapid COVID testing is exactly how InterTech has assisted in the taming of the pandemic-creating leak test solutions used in rapid testing systems. These PCR testing solutions were made possible and scalable with InterTech MicroScale Testing Technology to achieve the 8 microliters per minute standard with high repeatability and reliability.
These turnkey microleak testing solutions – for both in-line testing and audit testing – have at their core InterTech’s unsurpassed proprietary test technologies – superior mass flow test sensors, pressure decay test sensor designs, and unique test fixtures.
InterTech continues to partner with global leaders in in vitro diagnostics and molecular assays requiring leak-proof testing components and assured closed container integrity.
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