Biosafety Guidelines for COVID 19 Testing Laboratories Using GeneXperts

Severe Acute Respiratory Syndrome-Coronavirus-2 (SARS-COV-2) is a virus responsible for the 2019 Coronavirus disease (COVID-19). It is a disease-causing human pathogen. It is important that laboratories performing SARS-COV-2 diagnostic tests and related laboratory procedures adhere to the standard biosafety practices and procedures in compliance to the national guidelines as part of laboratory biorisk management.

A combination of engineering, administrative, practices and PPE mitigate the risk of exposure, infection, release and unintentional spread of contamination. Below are the mitigation measures recommended for laboratories handling and testing specimen for laboratory diagnosis of COVID-19 using GeneXperts.

At a minimum, laboratory must strictly enforce compliance with core requirements stated in the latest WHO Laboratory Biosafety Guidance related to Coronavirus Disease (COVID-19): Interim Guidance 13 May 2020 and the RITM Biorisk Management Office Interim Biosafety Guidelines for Laboratories Handling and Testing SARS-COV-2 (COVID 19) Specimen Version 2 March 15, 2020. Enhancements to the core biosafety requirements of WHO are incorporated in this guideline are based on risk assessment.

Laboratory manipulation of clinical specimen for GeneXperts from Person Under Investigation (PUI) and laboratory confirmed COVID-19 positive patients must be done in a laboratory meeting the core requirements of a basic containment laboratory (BSL2 as described in WHO Laboratory biosafety manual, 3rd edition in the interim before the 4th edition is released). Laboratory manipulation of sample prior loading to cartridges must be done in a certified and maintained Biological Safety Cabinet Class 2. A dedicated area for donning and doffing PPE must be identified. Standard Operating Procedures must incorporate specific biorisk mitigation control measures including emergency response and incident reporting. Laboratory workflow and practices following the clean to dirty principle must be maintained at all time. Laboratory personnel must use gloves, laboratory gown and respirator at minimum. A fit tested NIOSH-approved filtering face piece respirator that provides a level of filtration of 95% or greater, e.g. N-95 or its equivalent must be used.

Additional enhancement to the core requirement is dependent on individual local scenario. It must be based on local risk assessment and must be consulted with a biosafety professional. Enhancements include a directional airflow and the requirement for a negative pressure, anteroom, specific training, special practices, (e.g. working in buddy system and regular monitoring of body temperature) and the use of additional PPE like faceshield, dedicated laboratory shoes, shoe cover, and hair cover.