Title : Detection of SARS-COV-2 Armored RNA in Global Interlaboratory Harmonization Study
Abstract:
BACKGROUND:
owards the beginning of 2020 a global effort began to effectively respond to the COVID-19 pandemic by developing molecular tests that could accurately and rapidly diagnose this emerging disease. A critical component lacking was a control to harmonize the results of the myriad of tests being developed. In order to address this urgent need, a Coronavirus Standards Working Group was formed in March of 2020 to provide recommended infrastructure for COVID-19 testing and ensure reliability of test results. This international consortium was convened by the Joint Initiative for Metrology in Biology at Stanford University and included a variety of represented disciplines. The group systematically considered different aspects of the measurement process, including standards and controls, and how they impacted various stages of the testing process.
METHODS:
Part of this effort was a study planned by the consortium and executed globally by independent laboratories to assess multiple sources and types of molecular controls. The study involved fourteen laboratories running digital and real-time RT-qPCR worldwide that were provided SARS-CoV-2 RNA control material from eight vendors, one of which was Asuragen. Additionally, World Health Organization International Standards (WHO-IS) were prepared for each laboratory to use as calibrators.
RESULTS:
Measurements of the Asuragen Armored RNA Quant SARS-CoV-2 (RUO) control were reported by each institution and plotted. In general, replicates within each institution were very tight as reported.
CONCLUSION:
Despite the differences in quantitation methods of starting material, dilution schema, assays used, detection chemistry involved, platform used, and laboratory location, all controls submitted to this interlaboratory global study demonstrated linearity, accuracy, and precision acceptable for clinical testing. The data summary highlights that bacteriophage-like RNA controls like Armored RNA Quant® perform as well as inactivated virus in the hands of laboratorians. These types of commutable, surrogate controls can be rapidly and widely deployed as an important part of future response planning. Another advantage of Armored RNA controls is that once agreement on a consensus sequence is achieved, sufficient flexibility remains to allow quick updates when new variants emerge. Regardless of which control format is utilized, agreement between control suppliers and assay developers should be made to ensure that the supply of controls and standards does not become a limiting factor when faced with an aggressive timeline for assay development and validation during emerging pandemics.
