May 2020 2019 International For use outside the USA - these statements have not been evaluated by the FDA Biomerica COVID-19 May 2020 rev 1.pptx
Who We Are We are an experienced manufacturer of FDA World Class Scientific Advisory Board – cleared products Members of the ROME Foundation We contract manufacture for 2 multinational Device manufacturing experience with over pharma companies, Bio-Rad and other 20 products leading organizations Two FDA registered manufacturing facilities Major customers 2 For use outside the USA - these statements have not been evaluated by the FDA
› Immunoassay test kit for the qualitative detection of IgG and IgM antibodies specific to SARS-CoV-2 in human capillary whole blood, serum, or plasma specimens. 3 For use outside the USA - these statements have not been evaluated by the FDA
Patient management Fast decision-making Does not require lab processing No equipment required Quick, simple to use Convenient. Read by eye. 10 minutes to result Reliable and accurate CE Mark. Combined Sensitivity: 100%, Specificity: 95% 4 For use outside the USA - these statements have not been evaluated by the FDA
› SARS-CoV-2 is a large positive-sense single- stranded ribonucleic acid (RNA) virus that comprises of four structural proteins; nucleocapsid protein (NP) that holds the viral RNA, spike protein (SP), envelope protein (EP), and membrane protein (MP), that create the viral envelope [1] . SARS-CoV-2 schematic [1] References: [1] Vashist, S.K. In Vitro Diagnostic Assays for COVID-19: Recent Advances and Emerging Trends. Diagnostics 2020, 10 , 202 [3] Ria Lassaunière1, Anders Frische1, Zitta B. Harboe2,3, Alex C.Y. Nielsen4, Anders Fomsgaard1, Karen A. Krogfelt1,5, Charlotte S. Jørgensen1* 5 For use outside the USA - these statements have not been evaluated by the FDA
› The World Health › Most common symptoms: Organization (WHO) termed › Fever. the disease, coronavirus › Dry cough. disease 2019 (COVID-19), › Tiredness and the causative virus, severe acute respiratory › Less common symptoms: syndrome coronavirus 2 (SARS-CoV-2). › Aches and pains › Diarrhea › Loss of taste and smell References: World Health Organisation. Questions and Answers on coronaviruses (COVID-19), M 2020, viewed 04 May 2020, <https://www.who.int/news-room/q-a-detail/q-a-coronaviruses> 6 For use outside the USA - these statements have not been evaluated by the FDA
To determine who is infected in conjunction with PCR [1] • Who should be isolated • Contact tracing • Clinical management To determine who has been infected • Who can return to work – healthcare workers, emergency services, public health stakeholders • Surveillance • Epidemiology (seroprevalence) Public Health • Social distancing strategy • ‘Immunity’ passports References: [1] Wei Zhang, Rong-Hui Du, Bei Li, Xiao-Shuang Zheng, Xing-Lou Yang, Ben Hu, Yan-Yi Wang, Geng-Fu Xiao, Bing Yan, Zheng-Li Shi & Peng Zhou (2020) Molecular and serological investigation of 2019-nCoV infected patients: implication of multiple shedding routes, Emerging Microbes & Infections, 9:1, 386-389, DOI: 10.1080/22221751.2020.1729071 7 For use outside the USA - these statements have not been evaluated by the FDA
› Testing for COVID-19 is broadly split into Tests for Viral RNA and Serology. References: Table Reproduced From: Patel R, Babady E, Theel ES, Storch GA, Pinsky BA, St. George K, Smith TC, Bertuzzi S. 2020. Report from the American Society for Microbiology COVID-19 International Summit, 23 March 2020: Value of diagnostic testing for SARS – CoV-2/COVID-19. mBio 11:e00722-20. https://doi.org/10.1128/mBio.00722-20. 8 For use outside the USA - these statements have not been evaluated by the FDA
9 For use outside the USA - these statements have not been evaluated by the FDA
› Serology looks at the development of an antibody response to infection which can be host dependent and take time. In the case of SARS – CoV-2, early studies suggest that the majority of patients seroconvert between 7 and 11 days postexposure to the virus, although some patients may develop antibodies sooner [1] . For illustrative purposes only. Data from Liu et al. (2020) and Li et al. (2020) [2,3] › References: [1] Patel R, Babady E, Theel ES, Storch GA, Pinsky BA, St. George K, Smith TC, Bertuzzi S. 2020. Report from the American Society for Microbiology COVID-19 International Summit, 23 March 2020: Value of diagnostic testing for SARS – CoV-2/COVID- 19. mBio 11:e00722-20. https://doi.org/10.1128/mBio.00722-20. [2] Li, Z, Yi, Y, Luo, X, et al. Development and clinical application of a rapid IgM‐IgG combined antibody test for SARS‐CoV‐2 infection diagnosis. J Med Virol . 2020; 1 – 7. https://doi.org/10.1002/jmv.25727. [3] Liu L, Liu W, Zheng Y, et al. A preliminary study on serological assay for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in 238 admitted hospital patients [published online ahead of print, 2020 May 18]. Microbes Infect . 2020;10.1016/j.micinf.2020.05.008. doi:10.1016/j.micinf.2020.05.008 10 For use outside the USA - these statements have not been evaluated by the FDA
› It is proposed that there is a place for viral RNA testing and antibody detection when accessible. › In some countries and settings this may not be possible and antibody detection may offer the best cost-effective option for identifying COVID-19 patients. References: Prestidge, Marelize; Amoore, Zara. 2020. Purpose and Options for Testing for SARS-Cov2 (the COVID-19 Virus) : Considerations for World Bank Task Teams Managing COVID-19 Fast Track Facility Operations (English) . Washington, D.C. : World Bank Group. http://documents.worldbank.org/curated/en/145161586536712080/Purpose-and-Options-for-Testing-for-SARS-Cov2-the-COVID-19-Virus-Considerations-for-World-Bank-Task-Teams-Managing-COVID-19-Fast-Track-Facility-Operations 11 For use outside the USA - these statements have not been evaluated by the FDA
› Remove test strip from cannister or test device from foil pouch. › Place test strip on test card or test device on a level surface. › Set timer for 10 minutes. › Add 20 µl whole blood or 10 µl serum/plasma. › Read result and control line after 10 minutes. 12 For use outside the USA - these statements have not been evaluated by the FDA
› Positive Results › Negative Results › Invalid Results 13 For use outside the USA - these statements have not been evaluated by the FDA
› The sensitivity and specificity of the BIOMERICA COVID-19 IgG/IgM Rapid Test was calculated in comparison with a commercial PCR (China-FDA, EUA) (Novel Coronavirus 2019-nCov PCR Kit). › Sensitivity of the BIOMERICA COVID-19 IgG/IgM is the percentage of patients correctly identified as having a positive IgG/IgM response when compared to a positive PCR result. › Specificity of the BIOMERICA COVID-19 IgG/IgM is the percentage of patients correctly identified as having a negative IgG/IgM response when compared to a negative PCR result. 14 For use outside the USA - these statements have not been evaluated by the FDA
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