On 25 March 2020, ASLM and LabCoP convened an ECHO session on troubleshooting common challenges associated with establishing diagnostic testing for SARS-CoV-2 (the causative agent of COVID-19). This initiative was also supported by the Korea World Bank, the Africa Centres for Disease Control (Africa CDC), National Institute for Communicable Diseases (NICD) and IQVIA. Dr Jinal Bhiman, the Director of the National Influenza Centre at the NICD, presented practical solutions to address the most common challenges encountered by laboratory staff recently trained to detect SARS-CoV-2 virus. The session was attended by more than 130 participants, mostly from laboratories currently engaged in testing, as well as manufacturers of COVID-19 diagnostic tests, key implementing partners, and donors. Subject matter experts, from World Health Organization (WHO), the Office of the U.S. Global AIDS Coordinator and Health Diplomacy, the United States Centers for Disease Control and Prevention (CDC), Africa CDC, and research organizations were also represented.
Some of the key messages shared include:
- Countries and laboratories are advised to consider using tests listed on the FIND webpage of molecular diagnostic evaluations. In addition, the WHO provides an overview of available SARS-CoV-2 diagnostic protocols.
- For teams with sufficient technical capacity, developing in-house assays based on locally procured primers can overcome challenges related to international procurement, given the current travel restrictions. Some quality control material can be provided by NICD (contact Dr Jinal Bhiman for details). Standards and controls are also available from Bio-Rad laboratories.
- The Quality Control for Molecular Diagnostics (QCMD) 2020 Coronavirus Outbreak Preparedness External Quality Control (EQA) Pilot Study (CVOP20) is now offering the opportunity to assess the performance of in-house assays against international peer groups.
- While performance evaluation data for alternative rapid diagnostic tests (molecular and serological) is still limited and being gathered, Africa CDC is taking the lead in providing interim guidance to countries. Keep visiting the Africa CDC website for updates.
- On 20 March 2020, Cepheid received Emergency Use Authorization (EUA) approval from the United States Food and Drug Administration (FDA) for its Xpert® Xpress SARS-CoV-2, an automated in vitro diagnostic test that yield results in 45 minutes. The lead time for the availability of test kits to meet the expected demand is still to be determined.
- Public health leaders and laboratory managers should avoid the disruption of testing for other priority diseases.
Some of the key resources shared during the session include:
- FIND Diagnostic Pipeline
- Diagnostics under evaluation
- Standards and controls available from Bio-Rad laboratories
- Bio-Rad COVID-19 resources
- Genetic analysis research solutions for SARS-CoV-2
- For full details regarding this and other QCMD EQA programmes, please register, then login to your participant profile area via the QCMD EQA Management System (ITEMS) on http://www.qcmd.org, or contact your regional QCMD distributor.
- The package insert for the test kit that is being distributed by the Ethiopia PM Abiy-Jack Ma Foundation initiative
You can access the latest coronavirus outbreak updates from the World Health Organization, Africa CDC and the United States CDC on ASLM’s Outbreak Coverage web page.