PCR testing protocol
Tissue from any donor who tests positive for COVID-19 using PCR is ruled out for surgical use. Some of Eversight's eye donors are also organ and other tissue donors; a number of our partner hospitals and procurement organizations are performing PCR testing for COVID-19 on these donors using nasopharyngeal swabs. Starting in June, Eversight will begin performing this same PCR testing on eye-only donors and any otherwise untested donors who pass the symptomatic and behavioral screening.
PCR testing will be performed by a Clinical Laboratory Improvement Amendments (CLIA) certified laboratory utilizing BD BioGX SARS-CoV-2 reagents and the BD Max System, which received Emergency Use Authorization from the FDA in April 2020. The limit of detection for this PCR test is ≥ 40 Genomic Equivalents (GE) per mL.
The PCR test has not been studied to determine sensitivity on cadaveric donor samples. As such, Eversight will utilize the PCR test in conjunction with our rigorous screening criteria. In our commitment to providing the safest possible tissue to you and your patients, we will continually evaluate our approach as COVID-19 screening tools and technologies improve.
Standard infection prevention
Eversight continually assesses the latest scientific research and eye banking practices to ensure our techniques best mitigate any and all infection risk, not just risk of COVID-19 (SARS-CoV-2). We researched, developed and implemented an improved infection prevention protocol in October 2019, further mitigating the risk of tissue contamination at the time of procurement with a proven double 5.0% povidone-iodine (PVP-I) antiseptic soak.
PVP-I is a proven antiseptic that inactivates wide-spectrum microorganisms, including viruses, and its safety profile up to 10% concentration is well established.1 Studies demonstrate virucidal activity of PVP-I against other viruses that are similar to SARS-CoV-2, such as MERS-CoV and SARS-CoV.2-5 Eversight's stringent donor preparation protocol remains in effect for all tissue procurement and we are investigating its efficacy in inactivating the SARS-CoV-2 virus.
1 Kanagalingam, J., et al., Practical use of povidone-iodine antiseptic in the maintenance of oral health and in the prevention and treatment of common oropharyngeal infections. Int J Clin Pract, 2015. 69(11): p. 1247-56. doi: 10.1111/ijcp.12707
2 Eggers, M., et al., In Vitro Bactericidal and Virucidal Efficacy of Povidone-Iodine Gargle/Mouthwash Against Respiratory and Oral Tract Pathogens. Infect Dis Ther, 2018. 7(2): p. 249-259. doi: 10.1007/s40121-018-0200-7
3 Eggers, M., M. Eickmann, and J. Zorn, Rapid and Effective Virucidal Activity of Povidone-Iodine Products Against Middle East Respiratory Syndrome Coronavirus (MERS-CoV) and Modified Vaccinia Virus Ankara (MVA). Infect Dis Ther, 2015. 4(4): p. 491-501. doi: 10.1007/s40121-015-0091-9
4 Kampf, G., et al., Persistence of coronaviruses on inanimate surfaces and their inactivation with biocidal agents. J Hosp Infect, 2020. 104(3): p. 246-251. doi: 10.1016/j.jhin.2020.01.022
5 Kariwa, H., N. Fujii, and I. Takashima, Inactivation of SARS coronavirus by means of povidone-iodine, physical conditions and chemical reagents. Dermatology, 2006. 212 Suppl 1: p. 119-23. doi: 10.1159/000089211