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A test kit that assists in determining the risk of aggravation in patients with new coronavirus infection has recently been covered by insurance and has become widely used clinically. It examines proteins whose concentration increases in the blood several days before the onset of severe symptoms, and it is expected that identifying the aggravation in advance will lead to early treatment.

60歳以上の新型コロナウイルス感染症患者の8.5%は、重症化により酸素吸入能力が低下し人工呼吸器や体外式膜型人工肺（ECMO）が必要になるといわれます。感染拡大の要因の1つとみられているのが変異ウイルスですが、大阪府の60歳以上の変異ウイルス感染者の重症化率は18.6%と一段と高くなっています。

In some cases, the new coronavirus infection becomes severe as the condition suddenly deteriorates from the symptoms that are considered to be mild in the early stage of onset. In the current situation where the number of corona patients is increasing due to the rapid expansion of highly infectious mutant strains and the medical field is tight, early identification of patients at risk of aggravation may lead to recovery by early treatment. there is.

The HISCL IFN-λ3 reagent, a test kit developed by Sysmex that assists in determining the risk of aggravation in patients with new coronavirus infections, was covered by insurance in February this year. By measuring IFN-λ3 in serum using the kit and a fully automated immunoassay, the risk of aggravation in corona patients is determined. The measurement is performed by chemiluminescent enzyme immunoassay using a two-step sandwich method. In patients with new coronavirus infection, it is said that the concentration of IFN-λ3 in the blood increases before the oxygen inhalation capacity, which indicates aggravation, decreases, and a positive value above the standard value is judged. The diagnostic accuracy of clinical trials is 88.9% for sensitivity and 84.6% for specificity. The minimum time required for the test is about 17 minutes, and if there is equipment in the hospital, the result will be obtained in 1 to 2 hours.

New Coronavirus Infectious Diseases (COVID-19) Medical Care Guide, Version 4.2 (issued February 19, 2021)

The target patients are "excluding patients with moderate or higher illness who require respiratory failure management" among the definitive diagnosed patients with new coronavirus infection. Moderate disease requiring respiratory failure management corresponds to moderate disease II (Sp0₂ ≤ 93%) in the severity classification described in the guideline for the treatment of new coronavirus infection (COVID-19).

In other words, the new coronavirus becomes positive, and IFN-λ3 in serum is measured regularly for (1) asymptomatic, (2) mild (SpO2 ≧ 96%), and (3) moderate disease I (93% <Sp02 <96%). It will be possible. Calculation of 340 points per inspection. It is expected that the same patient will be tested multiple times, and if the test is performed more than once, it is necessary to confirm that the previous test result is less than the standard value.

At the clinical site, the subjects who are in the hospital or during accommodation medical treatment are regularly inspected, the value of IFN-λ3 is checked, and if it is above the standard value, hospitalization is recommended or a respirator is attached. It will be.

It has been confirmed that if the condition becomes severe, early treatment will speed up recovery. It is important not to delay the treatment of potentially severe patients, and the role of the severity prediction test kit, which enables early intervention, may be significant.