Biosafety in the Time of Severe Acute Respiratory Syndrome Coronavirus 2 Pandemic: The Philippine Experience.

Abstract

The coronavirus disease 2019 (COVID-19) that begun in December 2019 has spread worldwide and is caused by a novel coronavirus named severe acute respiratory syndrome coronavirus 2 (SARS-CoV2). In the Philippines, the first case of COVID-19 was reported on January 20, 2020. Early in the SARS-CoV2 outbreak, clinical samples from suspected COVID-19 patients had to be sent to a reference laboratory in Australia for confirmation. However, as of November 11, 2020, there are now 164 Department of Health (DOH) licensed COVID-19 testing laboratories in the country. The Department of Health-Research Institute for Tropical Medicine (DOH-RITM) is the National Reference Laboratory for emerging and re-emerging infectious diseases. The RITM follows the guidelines set forth by the World Health Organization (WHO) when responding to outbreaks. One of its functions is to conduct risk assessment and proficiency testing to ensure and maintain the safety and high-quality performance of independent laboratories. The majority of the COVID-19 testing centers use a real-time reverse transcription-polymerase chain reaction platform. As of November 14, 2020, there are >404,000 confirmed cases of COVID-19 in the Philippines of which 83% are mild cases. It is worthwhile to mention that before full-scale implementation and issuance of a license to operate a COVID-19 testing regimen, both hospital and nonhospital-based diagnostic laboratories undergo a multistage process for COVID-19 laboratory assessment. The requirements prescribed in the DOH assessment tool for licensing a COVID-19 testing laboratory include but are not limited to the availability of safety equipment and trained laboratory personnel, the facility must be a BSL-2 laboratory, and must have an updated protocol including a biosafety manual. In this article, the biosafety concerns associated with establishing a COVID-19 testing laboratory and running COVID-19 clinical samples will be highlighted. In addition, mitigation control measures that can be put into place for aerosol-generating procedures and key performance indicators will also be identified.