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Covid-19 test results in three minutes? For the first time, the U.S. FDA approved the use of the Gas Inspection Act

A respiratory sample was used to test for covid-19 and the results were available within three minutes

Covid-19 test results in three minutes? For the first time, the U.S. FDA approved the use of the Gas Inspection Act

Figure/IC

Wen | Special Correspondent of Caijing Jin Yan from Washington

Edit | Su Qi

Recently, the number of new confirmed covid-19 cases and deaths around the world has continued to decline, and WHO Director-General Tedros Adhanom Ghebreyesus said at a press conference on April 13: "There is good news. Last week's (global increase) number of COVID-19 deaths hit a record low since the early stages of the COVID-19 pandemic." "At the moment, we are closely monitoring a number of Opmi-Kjung acenes, including BA.2, BA.4 and BA.5, as well as another recombinant consisting of BA.1 and BA.2," Tedros said. ”

On April 14, local time in the United States, the US Food and Drug Administration (FDA) issued the first Emergency Use Authorization (EUA) to use exhaled gas to detect whether sampled people are infected with the new crown virus, which mainly detects 5 volatile organic compounds (VOCs) related to new crown virus infection in the exhaled gas. The FDA says the InspectIR COVID-19 respiratory analyzer is about the size of a carry-on bag, so collection and analysis can be performed in the same environment, such as hospitals and other mobile testing sites. On top of that, it can give results in less than three minutes.

In the United States, about two-thirds of Americans have been fully vaccinated — they have two doses of the Pfizer or Modena vaccine or one dose of Johnson & Johnson vaccine. Only half of these people who were eligible for booster injections received their first booster injection. According to the latest estimates from the U.S. Centers for Disease Control and Prevention (C.D.C.), 86 percent of COVID-19 cases in the U.S. last week were caused by subtype BA.2. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, said he wasn't sure what effects the BA.2 subvariate strain would have.

On April 11, Philadelphia became the first major city in the United States to announce the reinstatement of the indoor mask order. Cases in the region have risen by 50% over the past ten days, pushing the city above the threshold for triggering mask injunctions. The Caijing reporter learned that the northeast of the United States has the fastest growth in cases, and it is the most transmitted area of the BA.2 sub-variant strain in the United States. However, only a few universities in the Washington area, including Johns Hopkins University, American University, George Washington University and Georgetown University, have reinstated the indoor mask order.

Covid-19 test results in three minutes? For the first time, the U.S. FDA approved the use of the Gas Inspection Act

Several universities in Washington, D.C., recently reinstated the indoor mask order. Photo/ Caijing reporter Jin Yan

While the vaccine did not stop the widespread spread of Omikeron, health officials say the vaccine helped those infected avoid severe illness or death. The U.S. government is also considering approving a fourth dose of the vaccine for all in the fall, fearing that the number of cases could spike again by then.

Dr. Jeff Shuren, director of the FDA's Center for Device and Radiological Diagnostic and Therapeutic Health, noted in a statement that the FDA continues to support the development of new coronavirus tests with the goal of improving technology to help address the current epidemic and better prepare for the next public health emergency in the United States. It is understood that the InspectIR COVID-19 respiratory analyzer uses a technique called gas chromatography-mass spectrometry (GC-MS) to separate and identify chemical mixtures and can quickly detect 5 volatile organic compounds (VOCs) in exhaled gases associated with SARS-CoV-2 infection.

When the AspectIR COVID-19 respiratory analyzer detects the presence of a VOC marker for SARS-CoV-2, it returns a presumptive (unconfirmed) positive test result and should be confirmed by molecular testing. Negative results should also take into account the patient's recent history and clinical ailments associated with COVID-19, as they did not exclude SARS-CoV-2 infection. This should not be used as the sole basis for decision-making in the treatment or management of patient management.

In a study of 2,409 people, the InspectIR COVID-19 respiratory analyzer correctly identified a positive sample with a 91.2 percent chance of being correct, and also performed well in a subsequent study evaluating its effectiveness against the Omiljung variant of the new coronavirus, according to a statement released by the FDA.

InspectIR expects it to eventually be able to produce about 100 Covid-19 breath analyzers per week, each tested about 160 times a day, the FDA said. At InfoIR's current production levels, the Covid-19 breath analyzer could increase testing capacity by about 64,000 samples per month in the U.S., the agency said.

Meanwhile, U.S. pharmaceutical company Pfizer and Its COVID-19 vaccine partner BioNTech in Germany announced on April 14 that the latest trials have shown that their vaccines against the new coronavirus Omilton variant have an effective protective effect on healthy children aged 5 to 11 years. In the press release, the companies noted that their phase III trial looked at data from 140 children aged 5 to 11 years who received a booster about six months after initially receiving two doses of the Pfizer-Biotech COVID-19 vaccine. While all trial participants showed significantly enhanced protective effects, 30 participants showed a 36-fold increase in antibodies that neutralized Omiljung than those who received only the first two doses of the vaccine.

More than 10,000 children under the age of 12 participated in clinical trials investigating the Pfizer-Biotechnology COVID-19 vaccine, during which no new safety feedback was found. However, the relevant research has not yet been published and has not yet undergone independent scientific review. Pfizer and Biotech plan to apply for emergency use authorization in the United States in the coming days for the vaccination of the 5- to 11-year-old age group, and will subsequently submit an application to global regulatory agencies such as the European Medicines Agency (EMA).

Earlier this year, the U.S. Food and Drug Administration (FDA) approved a third dose of the Pfizer-Biotechnology vaccine for minors ages 12 to 15, as well as minors aged 5 to 11 with impaired immune systems. The FDA also approved a fourth dose of the vaccine for people aged 50 and older.

Covid-19 test results in three minutes? For the first time, the U.S. FDA approved the use of the Gas Inspection Act

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