I aso nei, na tuʻuina atu e le US Food and Drug Administration le faʻatagaina o faʻalavelave faʻafuaseʻi (EUA) mo le suʻega muamua ole COVID-19 e iloa ai vailaʻau vailaʻau i manava faʻataʻitaʻiga e fesoʻotaʻi ma le SARS-CoV-2 faʻamaʻi. E mafai ona faia le su'ega i si'osi'omaga e aoina ma su'esu'e ai le fa'ata'ita'iga o tagata ma'i, e pei o ofisa o foma'i, falema'i ma nofoaga e su'e ai fe'avea'i, e fa'aaoga ai se meafaifa'aili e tusa ma le lapo'a o se ato ato. O le su'ega e faia e se tagata faigaluega ua a'oa'oina i lalo o le va'aiga a se tausi soifua maloloina ua laiseneina pe fa'atagaina e le tulafono a le setete e fa'atonu ai su'ega ma e mafai ona maua i'uga i lalo ifo o le tolu minute.

"O le faʻatagaina o aso nei o se isi faʻataʻitaʻiga o le vave faʻafouina o loʻo tupu faʻatasi ma suʻega faʻataʻitaʻiga mo le COVID-19," o le tala lea a Jeff Shuren, MD, JD, faʻatonu o le FDA's Center for Devices and Radiological Health. "O loʻo faʻaauau pea ona lagolagoina e le FDA le atinaʻeina o suʻega COVID-19 faʻatasi ma le sini o le faʻalauteleina o tekinolosi e mafai ona fesoasoani e foia ai le faʻamaʻi o loʻo iai nei ma sili atu le tulaga o le US mo le isi faʻalavelave faʻafuaseʻi o le soifua maloloina lautele."

O le faʻatinoga o le InspectIR COVID-19 Breathalyzer na faʻamaonia i se suʻesuʻega tele o tagata 2,409, e aofia ai i latou e iai ma leai ni faʻailoga. I le suʻesuʻega, o le suʻega na faʻaalia e 91.2% le maaleale (o le pasene o faʻataʻitaʻiga lelei na faʻamaonia saʻo) ma le 99.3% faʻapitoa (o le pasene o faʻataʻitaʻiga le lelei na faʻamaonia saʻo le suʻega). O le suʻesuʻega foʻi na faʻaalia ai, i totonu o le faitau aofaʻi e naʻo le 4.2% o tagata na maua i le siama, o le suʻega na i ai se tau le lelei o le 99.6%, o lona uiga o tagata e maua se faʻaiʻuga le lelei e foliga mai e leaga moni i vaega o faʻamaʻi maualalo. . O le suʻega na faia faʻatasi ma le faʻalogo tutusa i se suʻesuʻega faʻataʻitaʻi suʻesuʻe na taulaʻi ile suiga ole Omicron.

O le InspectIR COVID-19 Breathalyzer o loʻo faʻaogaina le auala e taʻua o le gas chromatography gas mass-spectrometry (GC-MS) e tuʻueseese ma faʻailoa vailaʻau faʻafefiloi ma vave iloa ai Volatile Organic Compounds (VOCs) e lima e fesoʻotaʻi ma le SARS-CoV-2 faʻamaʻi ile manava manava. A iloa e le InspectIR COVID-19 Breathalyzer o lo'o iai fa'ailoga VOC o le SARS-CoV-2, e toe fa'afo'i mai se fa'ai'uga lelei (e le'i fa'amaonia) ma e tatau ona fa'amaonia ile su'ega mole. O fa'ai'uga le lelei e tatau ona iloiloina i le tulaga o fa'amatalaga lata mai a le tagata ma'i, tala'aga ma le i ai o fa'ailoga ma fa'ailoga e tutusa ma le COVID-19, aua latou te le fa'asalaina le fa'ama'i SARS-CoV-2 ma e le tatau ona fa'aaogaina na'o le fa'avae. mo togafitiga po'o fa'ai'uga e fa'afoeina ma'i, e aofia ai fa'ai'uga fa'ama'i pipisi.

O lo'o fa'amoemoe le InspectIR e mafai ona gaosia pe tusa ma le 100 meafaifa'aili i le vaiaso, lea e mafai ona fa'aoga ta'itasi e iloilo ai pe tusa ma le 160 fa'ata'ita'iga i le aso. I le tulaga lea o le gaosiga, o le fa'ata'ita'iina o le gafatia e fa'aaoga ai le InspectIR COVID-19 Breathalyzer e fa'amoemoe e fa'atupula'ia e tusa ma le 64,000 fa'ata'ita'i ile masina.

OA MEA E AVEA MAI LENEI TUSI:

Negative results should be considered in the context of a patient’s recent exposures, history and the presence of clinical signs and symptoms consistent with COVID-19, as they do not rule out SARS-CoV-2 infection and should not be used as the sole basis for treatment or patient management decisions, including infection control decisions.
The test can be performed in environments where the patient specimen is both collected and analyzed, such as doctor’s offices, hospitals and mobile testing sites, using an instrument about the size of a piece of carry-on luggage.
When the InspectIR COVID-19 Breathalyzer detects the presence of VOC markers of SARS-CoV-2, a presumptive (unconfirmed) positive test result is returned and should be confirmed with a molecular test.