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Monday, March 27, 2023

Next corona influenza waves: First combination test in the USA

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Image: Marcus Brandt (dpa)
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The Covid-19 drug molnupiravir, on the other hand, will probably have little importance in the EU. The European Medicines Agency has spoken out against approval. Influenza currently plays hardly any role in Europe as far as flu or flu-like infections are concerned. But the next seasonal wave of influenza will definitely come at the end of the year, and Covid-19 will probably not go away. For both infections – with similar symptoms – there are drug treatment options that only work within a few days of the infection or symptoms. Therefore, rapid diagnosis and at the same time distinguishing cases of the two diseases would be important.

test at home

The US diagnostics company Lucira Health is likely to have achieved success here: At the end of February, its first combination home test was granted emergency use approval by the US drug agency FDA. “This approval of the first over-the-counter (OTC) test that can detect influenza A and B and SARS-CoV-2 represents a major milestone in giving consumers easier access to diagnostics at home ” Jeff Shuren, director of the FDA’s Center for Medical Devices and Radiology, was quoted as saying in a release from the agency.

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Approval was granted on February 24th. It is not an antigen test, but a molecular test that can detect genetic material from influenza A, influenza B and Covid-19 pathogens, including the omicron variants. The test kit, in which a nasal swab is examined, is based on the so-called RT-Lamp technology to detect and identify the RNA of the viruses. In a first phase, any RNA present is converted into a DNA form (cDNA) by a reverse transcriptase enzyme. Then the test kit heats up via an included battery and multiplies the DNA of viruses – just like in a PCR test – until it can then be detected and the result can be converted into a readable color signal.

According to the FDA, if the test fails, 99.3 percent of the time there is no influenza A and 99.9 percent no influenza B. A Covid-19 disease is completely ruled out if the result is negative. Conversely, the method detects 90 percent of existing influenza A infections (positive result) and 88.3 percent of existing SARS-CoV-2 infections (positive result). There were not enough positive results for influenza B by the time of the approval process because too few infections of this type had occurred in the clinical tests.

Test kit available without a prescription

The test method, which is available in pharmacies without a prescription, is intended to enable timely quarantine measures on the one hand and the early use of antiviral drugs such as oseltamivir (Tamiflu/Influenza) or Paxlovid (SARS-CoV-2) on the other. The symptoms of influenza or Covid-19 are often similar and only have an effect in the initial phase of the disease.

One of the previously approved Covid-19 drugs, molnupiravir, will probably play a much smaller role in the future. “The European Medicines Agency (EMA; n.) has recommended that Lagevrio (brand name for active ingredient molnupiravir; n.) be rejected as a drug for the treatment of Covid-19,” the EMA wrote in a statement on February 24. The US pharmaceutical company Merck, Sharp & Dohme (MSD) can request a new assessment within two weeks.

“Based on all the data, no conclusion could be drawn that Lagevrio reduces the risk of hospitalization or death or the duration of illness (in the case of Covid-19; NB) or recovery in adults at risk of serious illness accelerated,” wrote the drug agency. In Germany, according to the journal of the German Medical Association, the drug can no longer be prescribed at health insurance costs and can no longer be dispensed in pharmacies.

Molnupiravir should work against SARS-CoV-2 by inserting copying errors into the genetic material of the Covid-19 pathogen. In the first interim evaluation of the approval study, the effectiveness against severe disease progression and death was still around 50 percent. A further evaluation of the clinical examination then showed a protection rate of only 30 percent. Apparently, further data were not convincing.

The corona vaccination should remain important for this. It can protect against serious illnesses, but apparently also has a positive effect against other complications of Covid-19. Alan Kwan from Cedars Sinai Medical Center in Los Angeles (USA) and his co-authors analyzed data from a population of almost 24,000 Covid patients between March 2020 and June 2022. They found an almost 80 percent increased risk of developing diabetes within 90 days of infection compared to three months earlier if people had not been vaccinated. In the case of vaccinated people, this risk remained de facto the same even with Covid 19 disease, as they found in their study in the US Medical Association’s JAMA Network Open.

Source: Nachrichten

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