Guidance on Quality Assurance for COVID-19 Molecular Laboratory Testing

October 1, 2020

As part of the global response to the COVID-19 pandemic, laboratory diagnosis has remained as the cornerstone to this intervention. Molecular assays performed on nasopharyngeal swabs or other upper respiratory tract specimens are the most commonly used and reliable tests for the diagnosis of COVID-19. A variety of RNA gene targets are used by different molecular assays, commonly targeting one or more of the envelope (env), nucleocapsid (N), spike (S), RNA-dependent RNA polymerase (RdRp), and the first open reading frame (ORF1) genes. Most molecular assays have achieved 100% specificity, since the primers are designed specifically for the target gene sequences of SARS-CoV-2. However, if inadequate quality measures are implemented throughout the entire testing phases (pre-examination, examination and post examination, including the support processes), sensitivity can be affected by specimen quality, sampling time to symptom onset, testing errors, or other technical deficiencies. This resource, Guidance on Quality Assurance for COVID-19 Molecular Laboratory Testing was compiled to enhance the quality of test results for detections of SARS-CoV-2, the causative agent of COVID-19. It was published by a wide range of stakeholders who included ASLM, Africa CDC and the African Union. The core this guidance document is to help Member States and partners as they set up comprehensive quality assurance measures for COVID-19 testing laboratory networks. The guidance emphasizes the use of standardised registration formats as a quality tool, quality control (QC), enrollment of laboratories in external quality assessment (EQA) schemes and use of EQA performance data for continuous quality improvement of COVID-19 testing laboratories. It is an essential resource for laboratory scientists, laboratory personnel involved in day-to-day testing of COVID-19, public health experts, members of COVID-19 taskforces, and program personnel involved in the COVID-19 response, among others.