Kajeno, Tsamaiso ea Lijo le Lithethefatsi ea US e fane ka tumello ea ts'ebeliso ea tšohanyetso (EUA) bakeng sa tlhahlobo ea pele ea tlhahlobo ea COVID-19 e fumanang metsoako ea lik'hemik'hale lisampong tsa phefumoloho tse amanang le ts'oaetso ea SARS-CoV-2. Teko e ka etsoa libakeng tseo ho tsona mohlala oa mokuli o bokelloang le ho hlahlojoa, joalo ka liofisi tsa lingaka, lipetlele le libaka tsa tlhahlobo ea mehala, ho sebelisoa sesebelisoa se ka lekanang le sekotoana sa thoto. Teko e etsoa ke motho ea tšoanelehang, ea koetlisitsoeng tlas'a tlhokomelo ea mofani oa tlhokomelo ea bophelo ea nang le laesense kapa ea lumelletsoeng ke molao oa naha hore a fane ka liteko 'me a ka fana ka sephetho ka nako e ka tlase ho metsotso e meraro.
"Tumello ea kajeno ke mohlala o mong oa boqapi bo potlakileng bo etsahalang ka liteko tsa tlhahlobo ea COVID-19," ho boletse Jeff Shuren, MD, JD, motsamaisi oa Setsi sa FDA sa Lisebelisoa le Radiological Health. "FDA e ntse e tsoela pele ho ts'ehetsa nts'etsopele ea liteko tse ncha tsa COVID-19 ka sepheo sa ho nts'etsapele mahlale a ka thusang ho sebetsana le seoa sena le ho beha US maemong a tšohanyetso a bophelo bo botle ba sechaba."
Ts'ebetso ea InspectIR COVID-19 Breathalyzer e netefalitsoe thutong e kholo ea batho ba 2,409, ho kenyeletsoa ba nang le matšoao le ba se nang matšoao. Phuputsong, tlhahlobo e bonts'itsoe hore e na le kutlo ea 91.2% (liperesente tsa lisampole tse nepahetseng li khethiloe ka nepo) le 99.3% e ikhethang (liperesente tsa lisampole tse mpe tseo tlhahlobo e hloailoeng ka nepo). Boithuto bo boetse bo bonts'itse hore, ho baahi ba nang le 4.2% feela ea batho ba nang le tšoaetso ea kokoana-hloko, tlhahlobo e bile le boleng bo fosahetseng ba 99.6%, ho bolelang hore batho ba fumanang sephetho se fosahetseng ba kanna ba ba mpe haholo libakeng tse nang le ts'oaetso e tlase ea mafu. . Teko e entsoeng ka kutloisiso e tšoanang thutong e latelang ea kliniki e tsepamisitse maikutlo ho mofuta oa Omicron.
InspectIR COVID-19 Breathalyzer e sebelisa mokhoa o bitsoang gas chromatography gas mass-spectrometry (GC-MS) ho arola le ho khetholla metsoako ea lik'hemik'hale le ho lemoha ka potlako Li-Volatile Organic Compounds (VOCs) tse hlano tse amanang le ts'oaetso ea SARS-CoV-2 moeeng o tsoang. Ha InspectIR COVID-19 Breathalyzer e lemoha boteng ba matšoao a VOC a SARS-CoV-2, ho khutlisetsoa sephetho sa tlhahlobo e nepahetseng (e sa netefatsoang) mme e lokela ho netefatsoa ka tlhahlobo ea limolek'hule. Liphetho tse mpe li lokela ho nahanoa molemong oa ho pepeseha ha mokuli haufinyane, nalane le boteng ba matšoao le matšoao a kliniki a tsamaellanang le COVID-19, kaha ha li qhelele ka thoko tšoaetso ea SARS-CoV-2 mme ha ea lokela ho sebelisoa e le eona feela motheo. bakeng sa liqeto tsa phekolo kapa tsamaiso ea mokuli, ho kenyeletsoa liqeto tsa taolo ea tšoaetso.
InspectIR e lebelletse hore e tla khona ho hlahisa lisebelisoa tse ka bang 100 ka beke, tse ka sebelisoang ho lekola lisampole tse ka bang 160 ka letsatsi. Boemong bona ba tlhahiso, matla a tlhahlobo a sebelisa InspectIR COVID-19 Breathalyzer e lebelletsoe ho eketseha ka lisampole tse ka bang 64,000 ka khoeli.
SEO U LOKELANG HO SE NKA HO SEHLOOHO ENA:
- 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.
