Earlier this week, the US-FDA announced the issue of an Emergency use authorisation (EUA) for new technology: a breathing covid detector named InspectIR developed by IR Systems LLC.
The diagnostic system, looking for specific molecules in the breath, can detect the signature of Covid-19 ongoing infection. The detection of those molecules is performed by gas chromatography gas mass-spectrometry (GC-MS). This technique is widely used in many analytical labs to detect, identify and quantify volatile organic compounds (VOCs), especially for active ingredients testing.
In the present case, the InspectIR Breathanalyzer analyses the air blown by the user and detects the presence of molecules known as a signature of Covid-19 infection. A positive result still needs to be confirmed any a PCR Test.
During a study involving 2’409 participants, the system achieved a 91.2% sensitivity and 99.3% specificity (correct positive testes detection and correct negative tests detection respectively).
Besides the technical performance, the system appears clearly as a first industrial attempt, and reminds me of the first iPhone, unable to send MMS messages.
Every test requires 3 minutes and the FDA announced that every system can handle 160 samples per day (not as optimistic as 3 minutes per test). And that company is planning to manufacture 100 instruments per week. The diagnostic system is for the moment presented as a Pelicase (beloved technical cases by IT tech experts) with a screen. Clearly, the company should be working hard now to convince large scale customers, refine the “Look and Feel” and prepare the v2 of this device.
We like this device, we like the fact that a well known analytical method was applied to solve a problem: avoiding that a patient with an airborne disease contaminates others.