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No nose poke 3 minutes out of the results! Respiratory samples were first approved for COVID-19 testing

The World Health Organization has issued a new warning: As some countries relax COVID-19 measures and reduce large-scale virus testing, many cases may not be counted.

No nose poke 3 minutes out of the results! Respiratory samples were first approved for COVID-19 testing

Screenshot of the Huffington Post website report

On April 12, Ashish Jha, white house COVID-19 response coordinator, said in an interview with NBC's Today Show: "We've been underreporting throughout the pandemic, right? This problem has always existed."

No nose poke 3 minutes out of the results! Respiratory samples were first approved for COVID-19 testing

Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, said he "believes there will be undercalculations." (Image source: screenshot of the report)

On the same day, Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases (NIAID), also said in an interview with CNN that "I believe there will be undercounting cases." He called on Congress to approve the importance of funding for additional testing, drugs and vaccinations.

One important reason why the US epidemic response policy is falling into a vicious circle of "tightening-liberalizing-worsening the epidemic-tightening-re-opening" is that scientific issues are politicized.

Recently, the number of confirmed cases of COVID-19 in the United States has once again shown an upward trend. U.S. epidemiologists said that due to the U.S. government's reduction of new crown virus testing efforts and related subsidies, incomplete statistics on the epidemic and other factors, it may make the number of confirmed cases in the United States and other indicators be seriously underestimated, so that the severity of the epidemic is "covered up".

"Funding for the U.S. fight against COVID-19 is in short supply." The New York Times notes that funding for COVID-19 vaccines, testing and treatment for those without health insurance is running out.

Bloomberg reported that as the U.S. government stopped subsidies for new coronavirus testing programs, large-scale virus testing efforts have been greatly weakened, and people rely more on rapid home testing methods, making it difficult for public health officials to accurately grasp the true scope of the epidemic. "The United States is in the middle of a new surge in the epidemic without knowing it."

For any highly contagious disease, the delay in time is fatal. It is crucial to obtain pathogen test results quickly so that infected people do not continue to infect others.

Unfortunately, the most accurate COVID-19 nucleic acid testing usually takes 6 hours or more to return results from the laboratory, and if nucleic acid testing is encountered by all staff, according to the "Guidelines for the Implementation of Regional Novel Coronavirus Nucleic Acid Testing Organizations (Third Edition)" issued by the Joint Prevention and Control Mechanism of the State Council on March 18, it is necessary to ensure that the results can be queried within 24 hours after nucleic acid sampling.

Household antigen testing can provide results within 15 minutes, but the accuracy and sensitivity are reduced.

Now, there is a new option.

On April 14, the official website of the US Food and Drug Administration (FDA) announced that the first device to test for COVID-19 through respiratory samples was authorized for emergency use (EUA) and could provide results within 3 minutes.

Since the outbreak of the new crown epidemic, whether it is nucleic acid detection or antigen testing, nasopharyngeal samples are required, and this is the first time that the US Food and Drug Administration has approved the new crown testing through breath samples.

This is another new case of the rapid innovation of COVID-19 testing. According to the introduction, this new crown detection device is called The InfoIR New Crown Breath Analyzer, which is about the same size as carry-on baggage.

In principle, the device uses a technique called gas chromatography (GC-MS) to separate and identify chemical mixtures and rapidly detect five volatile organic compounds (VOCs) associated with COVID-19 infection in exhaled gas, Bloomberg reported.

Is it accurate? Through a large study of 2409 participants, the effect was validated: the device had a sensitivity of 91.2% to identify positive samples and a specificity of 99.3% to identify negative samples.

The study also showed that in only 4.2 percent of people who were positive for the virus, the test had a negative predictive value of 99.6 percent.

This means that people who test negative may be truly negative in low-risk areas.

It is worth noting that in a follow-up clinical study of the Omilon variant, the sensitivity of the device was similar to the above.

However, the U.S. Food and Drug Administration also stressed that the device should not be used as the sole basis for treatment, patient management decisions, or infection control decisions.

It is worth noting that on March 11, the Comprehensive Group of the Joint Prevention and Control Mechanism of the State Council issued a notice, deciding to add antigen detection as a supplement to nucleic acid testing, and organized the formulation of the "New Coronavirus Antigen Detection Application Plan (Trial)", which also emphasized that antigen detection cannot be used as the basis for confirming the diagnosis of new coronavirus infection.

When the respiratory analyzer detects the presence of 5 volatile organic compounds associated with COVID-19 infection, it returns a presumed (unconfirmed) positive test result, which should subsequently be confirmed by molecular testing.

Even a negative result should be considered in the light of the patient's recent exposure history, medical history, and the presence of clinical signs and symptoms consistent with COVID-19.

In addition, according to the Financial Associated Press reported on March 14, the United States also has a newly developed new crown testing equipment, the accuracy is the same as PCR, 30 seconds out of the results!

Recently, researchers at the University of Florida in the United States helped develop a new crown detection device that can detect the new crown virus infection in just 30 seconds, and the sensitivity and accuracy are no less than PCR, that is, polymerase chain reaction detection, which is the current gold standard for new crown testing.

Notably, they are working with scientists at Yangming University in Taiwan.

According to a recently published peer-reviewed study by the UF team, the researchers said that as with PCR nucleic acid testing, the device had 90 percent accuracy and the same sensitivity.

The device has not yet been approved by the FDA. The researchers believe they must ensure that the test results are not undermined by cross-contamination of other pathogens that may be present in the mouth and saliva.

It is understood that this handheld instrument is powered by a 9-volt battery and uses only an inexpensive test strip, similar to the test strip used in the blood glucose meter, with new coronavirus antibodies attached to the gold-plated film at the top of it.

During the test, a strip of test strips is placed on the tongue to collect a small sample of saliva. After that, insert the test strip into a card reader connected to the board.

If someone is infected, the higher the coronavirus concentration, the conductivity of the sample will change. This, in turn, changes the voltage of the electrical pulse. The voltage signal is amplified a million times and converted into a numerical value, in a sense, an electrochemical fingerprint of the sample. This value will indicate a positive or negative result, and the lower the value, the higher the viral load.

As of April 15, Beijing time, the cumulative number of deaths from covid-19 in the United States 987997, close to 1 million.

Resources:

1. On April 15, the US Food and Drug Administration approved the new crown test with respiratory samples for the first time, and the results were released within three minutes" Surging News reporter Li Xiaoxiao

2. April 14, "30 Seconds out of the Results!" The Accuracy of the New Coronavirus Detection Equipment developed in the United States is the same as that of PCR, and the cost is cheap" Financial Associated Press

3. On April 14, the number of confirmed cases of new crown pneumonia in the United States rose, but government departments were promoting the relaxation of epidemic prevention and control. The US media said that "the US move will eventually damage people's lives and health" (in-depth observation) International online reporters Li Zhiwei, Liu Gang, Zhang Yuannan, Washington, Beijing, April 14

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Editor| Xiaoyang

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