> [The InspectIR COVID-19 Breathalyzer test] can provide results in less than three minutes. [It] uses... gas chromatography gas mass-spectrometry (GC-MS) to separate and identify chemical mixtures and rapidly detect five Volatile Organic Compounds (VOCs) associated with SARS-CoV-2 infection in exhaled breath

> [It] was shown to have 91.2% sensitivity [correctly identified positives] and 99.3% specificity [correctly identified negatives]; ... similar sensitivity [was seen for] the omicron variant

> InspectIR expects to be able to produce approximately 100 instruments per week, which can each be used to evaluate approximately 160 samples per day. At this level of production, testing capacity using the InspectIR COVID-19 Breathalyzer is expected to increase by approximately 64,000 samples per month

The press release from InspectIR is at https://inspect-ir.com/inspectir-systems-begins-covid-19-det... . Said press release is relatively old, «May 28, 2020», and reported «ha[ving] begun clinical trials» (from the FDA page it seems at least a couple have concluded, one more recent relevant to the detection of the omicron variant).

> InspectIR ... has developed a patent-pending real-time, mobile testing device for the detection of hundreds of volatile organic compounds on the breath, such as illicit drugs.[...] We quickly realized our devices could identify COVID-19[: i]t provides detection of VOCs on the breath, including COVID-19, Influenza A and more, in as little as 90 seconds. .... One of the many challenges of facing the current COVID-19 testing is the frequency of false positives as well as false negatives, which have been reported potentially as high as 48.5%. COO John Redmond states, “Accuracy has been an issue with COVID-19 testing since the beginning of the crisis. Our device is specifically designed for trace detection in the high part-per-trillion. We believe it will provide the most accurate results on the market. There are few viable non-invasive detection tools available today.”

The homepage of InspectIR underlines:

> InspectIR is the only testing methodology that does not create cross reactivity, which leads to pre-analytical error, based on adding a solvent or another reagent to bind to a specimen for analysis. There is also no storage of any biologic material in the InspectIR test

A PDF at https://www.fda.gov/media/157723/download , "Instructions for use [for the] InspectIR COVID-19 Breathalyzer (for use on PNY-1000)", contains much of the most interesting data:

> The InspectIR COVID-19 Breathalyzer is a portable, rapid gas chromatography-mass spectrometry (GC- MS) test for the in vitro qualitative detection of five Volatile Organic Compounds (VOCs) in the ketone and aldehyde families [...] metabolites associated with SARS-CoV-2 infection.

> Patients should be instructed not to #eat#, #drink#, or #use any tobacco# products 15 minutes before providing a breath sample [the highlighted 'eat', 'drink', and 'use any tobacco' are all-caps in the original, with special evidence and insistence throughout the text. A number of «potential cross reactant or interfering substances» are listed, including chewing gum, nicotine and alcohol: none of them «cause a false positive», and «none of the interfering substances when tested in human breath and with the five target analytes spiked at a concentration of 3 x LoD [Limit of Detection cause a false negative result». I understand the "interfering substances" just impact the Limit of Detection, reducing the sensitivity.]

> [The Limit of Detection for] the five target analytes [... is] of 10 part per billion