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PEVIVA® Keratin 18 biomarkers and COVID-19

The coronavirus-2 (SARS-CoV-2) is currently a public health crisis all over the world with a fatal rate between 2-6 %, and mostly affecting our elderly and people with underlying risk factors such as diabetes, heart disease and hypertension. New research shows that hepatic dysfunction has been seen in 14-53 % of the covid-19 patients, and acute liver injury is associated with higher mortality. The liver injury in covid-19 patients could be a result of the changes in the host cells caused by the viral invasion (cytopathic effect), sepsis or drug-induced liver injury1.

M30 Apoptosense® ELISA and M65 EpiDeath® ELISA are prognostic biomarkers at ICU admission and for drug-induced liver injury progression

For research use only in USA and Canada.

VLV KITS ELISA

M30 Apoptosense® ELISA is correlated with biomarkers of inflammation, renal- and liver failure in critically ill patients. A study performed by Koch et al., demonstrates that patients at the ICU that later died had higher levels of serum M30® at admission in comparison to patients that survived. Patients with M30® values >250,8 U/L displayed an excessive short-term mortality2.

The PEVIVA® Keratin 18 biomarkers have also been recommended for assessing and anticipating the risk of progression in severe drug-induced liver injury patients in clinical trials, and the biomarkers are strongly associated with liver related death or transplantation within six months of drug-induced liver injury onset3.

The PEVIVA® Keratin 18 biomarkers are the ideal tools for disease monitoring and prognosis in research- and clinical use in critically ill covid-19 patients.

Covid-19 IgM/IgG Rapid Tests

During the current covid-19 pandemic, a lot of focus and energy has been put into testing people for the new corona virus and thus tracking and managing the spread of infection in society. VLVbio has therefore chosen to include a rapid test for Covid-19 IgM and IgG antibodies in our product portfolio. The antibody test we offer is a POC test that within 10 minutes gives a reliable answer if the patient has IgM and / or IgG antibodies to the new coronavirus. The test has been studied extensively in previous research, including a study where the Danish Statens Serum Institut (SSI), examined and validated the test4. The rapid test has been shown to have a high sensitivity of up to 96% and a specificity of up to 100% from various studies performed on a total of 857 patients, making it one of the best performing tests available today. The test also does not show any cross-reactivity with other common viruses.

The test, 2019-nCoV IgM / IgG Rapid Test, is imported from the Swiss international distributor TECOmedical AG, where development and production takes place at Dynamiker Biotechnology Co. together with the Chinese Institute of Medical Biology.

The test is of course CE-IVD marked, and has been shown to have similar or even more sensitive test performance than the antibody tests used in the clinical labs for covid-19 today.

Please contact us for more references and quotation.

References

  1. Jothimani et al, 2020, COVID-19 and the liver. DOI: https://doi.org/10.1016/j.jhep.2020.06.006
  2. Koch et al, High circulating caspase-cleaved keratin 18 fragments (M30) indicate short-term mortality in critically ill patients. DOI: https://doi.org/10.1155/2018/8583121
  3. The Drug induced liver injury work package of Innovative Medicines Initiative SAFE-T Consortium and The Hepatotoxicity Working Group of Critical Path Institutes PSTC.
  4. Lassaunière et al, Evaluation of nine commercial SARS-CoV-2 immunoassays. DOI: https://doi.org/10.1101/2020.04.09.20056325