USFDA authorises first C-19 diagnostic test using breath samples

The authorisation is yet another example of the rapid innovation occurring with diagnostic tests for C-19

171
USFDA
USFDA

Last Updated on October 15, 2024 by The Health Master

The U.S. Food and Drug Administration (USFDA) issued an emergency use authorisation (EUA) for the first C-19 diagnostic test that detects chemical compounds in breath samples associated with a SARS-CoV-2 infection.

The test can be performed in environments where the patient specimen is both collected and analysed, such as doctor’s offices, hospitals and mobile testing sites, using an instrument about the size of a piece of carry-on luggage.

The test is performed by a qualified, trained operator under the supervision of a health care provider licensed or authorised by state law to prescribe tests and can provide results in less than three minutes.

Jeff Shuren, M.D., J.D., director of the USFDA’s Center for Devices and Radiological Health said, “The authorisation is yet another example of the rapid innovation occurring with diagnostic tests for C-19.

The FDA continues to support the development of novel C-19 tests with the goal of advancing technologies that can help address the current pandemic and better position the U.S. for the next public health emergency.”

The performance of the InspectIR C-19 Breathalyzer was validated in a large study of 2,409 individuals, including those with and without symptoms. In the study, the test was shown to have 91.2 per cent sensitivity (the percent of positive samples the test correctly identified) and 99.3 per cent specificity (the percent of negative samples the test correctly identified).

The study also showed that, in a population with only 4.2 per cent of individuals who are positive for the virus, the test had a negative predictive value of 99.6 per cent, meaning that people who receive a negative test result are likely truly negative in areas of low disease prevalence.

The test performed with similar sensitivity in a follow-up clinical study focused on the omicron variant.

The InspectIR C-19 Breathalyzer uses a technique called 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.

When the InspectIR C-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.

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 C-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.

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 C-19 Breathalyzer is expected to increase by approximately 64,000 samples per month.

USFDA gives approval to Aleor for Lidocaine & Prilocaine cream

USFDA gives nod to Indoco Remedies for Lacosamide injection

USFDA gives tentative approval to Alembic for generic Pradaxa capsules

USFDA approves Cell Therapy for earlier lymphoma

USFDA approves Ozempic 2 mg to treat Type-II Diabetes

USFDA gives nod to Lupin for Sildenafil for oral suspension

Govt wants to ease compliance burden on Pharma Industry

FDA Maharashtra issues show cause notices to 95 Pharma units

NPPA fixes retail price of 23 formulations: April 2022

FDA warns websites illegally selling Amphetamine and Dextroamphetamine

16 Pharma units get ‘stop production orders’ for norm violations

Changes in Pharma Licensing: A tour

USFDA gives approval to Aleor for Lidocaine & Prilocaine cream

DCGI approves Glenmark’s phase-I clinical trial for its novel molecule GRC 54276

NPPA fixes ceiling price of these two vaccines

Latest Notifications regarding Pharmaceuticals

For informative videos on the news regarding Pharma / Medical Devices / Cosmetics / Homoeopathy etc., click on the below YouTube icon:

YouTube Icon

For informative videos by The Health Master, click on the below YouTube icon:

YouTube Icon

For informative videos on Medical Store / Pharmacy, click on the below YouTube icon:

YouTube Icon

For informative videos on the news regarding Pharma / Medical Devices / Cosmetics / Homoeopathy etc., click on the below YouTube icon:

YouTube Icon

For informative videos on consumer awareness, click on the below YouTube icon:

YouTube Icon
Telegram
WhatsApp
Facebook
LinkedIn
YouTube Icon
Google-news