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SalivaDirect

Indications: - screening for COVID-19 * FDA has authorized test for emergency use [1] Prodedure: - PCR for SARS CoV2 RNA - does not require a separate nucleic acid extraction step [4] - results in < 3 hours, - 92 tests can be processed simultaneously Specieen: - saliva is self-collected in a sterile container under supervision of health care worker - no And agency remains independent on vaccine approval, promises Anand Shah, MDAnd agency remains independent on vaccine approval, promises Anand Shah, MDAnd agency remains independent on vaccine approval, promises Anand Shah, MDspecific swab or collection device needed Notes: - the National Basketball Association (NBA) has been a partner in funding development & is using the test to test asymptomatic people (players staff) for coronavirus [1,3] - created by the Yale School of Public Health [2] - Yale doen not intend to commercialize the test [3] - anticipated cost $10/sample

General

SARS CoV-2 RNA in specimen point of care test

References

  1. Mascarenhas L FDA grants emergency use authorization to quick, inexpensive saliva-based Covid-19 diagnostic test. CNN Health, Aug 16, 2020 https://www.cnn.com/world/live-news/coronavirus-pandemic-08-15-20-intl/h_1144c22081a8f66bbdea33bde13edd2b
  2. Yan H, Maxouris C New saliva-based Covid-19 test could be a fast and cheap 'game changer'. CNN Health. Aug 16, 2020 https://www.cnn.com/2020/08/16/health/us-coronavirus-sunday/index.html
  3. Stelloh T Yale's COVID-19 saliva test used in NBA gets FDA emergency approval . NBC News. Aug 16m 2020 https://www.msn.com/en-us/news/us/yales-covid-19-saliva-test-used-in-nba-gets-fda-emergency-approval/ar-BB181TE9
  4. FDA News Release. Aug 15, 2020 Coronavirus (COVID-19) Update: FDA Issues Emergency Use Authorization to Yale School of Public Health for SalivaDirect, Which Uses a New Method of Saliva Sample Processing. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-issues-emergency-use-authorization-yale-school-public-health
  5. Basen R, Enterprise & Investigative Writer Saliva COVID Tests Have Real Potential, FDA Leader Says - And agency remains independent on vaccine approval, promises Anand Shah, MD MedPage Today August 20, 2020 https://www.medpagetoday.com/infectiousdisease/covid19/88186