[김길원의 헬스노트] Doctor “Let’s use a rapid and accurate diagnostic kit in 20 minutes … urgent approval is required”



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The number of confirmed cases of infection by the new coronavirus (Corona 19) is increasing rapidly in the metropolitan area. Quarantine authorities define the current situation as the “initial stage of the pandemic” and are concentrating their quarantine capabilities on epidemiological investigations.

There is also the possibility that step 3 of social distancing will come up sooner or later.

Experts emphasize that at this point, to prevent the rapid increase in critically ill patients and paralysis of the medical system, rapid examination and subsequent rapid isolation should be prioritized.

Currently, screening institutions typically take 1 to 2 days to collect samples from suspected coronavirus patients19 and notify them if they have been confirmed using a standard genetic amplification test (RT-PCR).

This is because the Corona 19 test is still based on the RT-PCR method focused on large medical institutions and commissioned testing institutions. In RT-PCR, after extracting ribonucleic acid (RNA) from a sample, the RNA is amplified and two or more characteristic Corona 19 genes are determined to be positive.

Consequently, the “saliva (saliva) test method” and the “rapid antigen test method” are promoted as alternatives in Korea.

Citizens visiting the screening clinic at night

picture explanationCitizens visiting the screening clinic at night

The saliva test method uses saliva saliva in a separate sample collection container rather than the difficulty of collecting a sample by inserting a test kit deep into the nose or back of the neck. Compared with the nasopharyngeal sample, the sensitivity for diagnosing positive as positive is 92% and the specificity for diagnosing negative as negative is 100%. However, since the post-sample collection process is the RT-PCR method, the time required is similar to that of the nasopharyngeal sample.

On the other hand, the rapid antigen test method developed in Korea is a method that checks whether a sample has a specific antigen (protein) related to Corona 19 virus, and the test result comes out in about 30 minutes.

However, this test method has a high false negative rate compared to the standard RT-PCR test method, which is considered a disadvantage. This means that protons can be judged negative. Furthermore, since it does not undergo an amplification process, it is considered a limitation that more accurate results can be obtained only if it is used at the beginning of infection with a large amount of virus in the body.

For this reason, quarantine authorities did not use rapid antigen testing for diagnostic tests, but recently recommended the use of “subsidiary means”, as the number of confirmed cases has increased rapidly. If the test is positive, a safety device has also been prepared to perform additional RT-PCR tests.

Unlike quarantine authorities, medical experts pay more attention to the Corona 19 RT-PCR field test kit (cobas Liat) provided by Roche Diagnostics, a multinational company, rather than a saliva test or rapid test of antigens.

This equipment can detect a confirmed person in 20 minutes using a sample collected from the nasopharynx and a simultaneous diagnostic kit (reagent) for influenza (flu) and Corona 19. The biggest advantage is that the results are fast and there is little difference in sensitivity and specificity compared to the existing RT-PCR method. In the United States, it has been used for rapid diagnosis of Corona 19 since it obtained emergency use approval from the Food and Drug Administration (FDA) in September. In Europe, it was officially approved in October.

The problem is that this diagnostic kit still cannot be used in Korea. This is because Korea doesn’t always operate the emergency approval process like the United States or Europe, so it has to go through the blanket approval process.

Park Yang-dong, President of the Korea Children’s Hospital Association, said: “Based on published clinical data in the United States and Europe, the Corona 19 diagnostic kit released by Roche Diagnosis significantly shortens the testing time for diagnosis and is very accurate. ” He noted that the 2nd emergency approval has ended and it has to go through the formal approval process as before, so it won’t be available until next winter if it is.

President Park said: “Now OECD countries are competing for vaccines to secure Corona 19 equipment. If equipment is essential for COVID-19 quarantine, efforts to secure it first, leaving domestic and foreign companies are necessary “.

'Corona 19, take the free test'

picture explanation‘Corona 19, take the free test’

Consequently, the Korea Children’s Hospital Association and the Korean Society of Diagnostic Laboratory Medicine plan to apply for an emergency approval from the Ministry of Health and Welfare for the immediate use of this diagnostic kit in the medical field sooner or later.

Both institutions evaluated, “With this diagnostic kit, it is expected that asymptomatic patients can be evaluated early, minimizing infections in the family, as well as a rapid examination of hospitalized patients, thus speeding up emergency surgery.” Roche Diagnosis is also in the position that it will make every effort to supply diagnostic kits first if emergency approval is obtained in Korea.

Kwon Gye-cheol, president of the Korean Society of Diagnostic Laboratory Medicine, said: “The rapid antigen test recommended by the quarantine authorities has been reported to have been a case of precision errors, such as the diagnosis from positive to negative in the United States, and even the CDC has drawn attention. ” We will announce the results showing the comparison ”.

President Kwon continued: “Currently, major hospitals are conducting emergency RT-PCR testing to detect Corona 19 before urgent surgery, but (Corona 19) is a global situation, so the reagent supply is insufficient.” . The kits have a relatively large supply and can be used even without professional inspection personnel, so we look forward to the rapid government approval process in the event of a pandemic. “

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