Asuragen Molecular Diagnostics Publications

Detection of SARS-CoV-2 Armored RNA Quant® in Global Interlaboratory Harmonization Study


Towards 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 focus of this study was on
molecular controls. Molecular tests were chosen initially over antibody tests for
their ability to detect the virus directly at symptom onset and before antibody
load was sufficiently high to detect. Additionally, molecular tests provided
higher sensitivity and specificity to allow a definitive diagnosis using more easily
attained synthetic sequences as controls (Figure 1). Many of the first iterations
of molecular tests were problematic in terms of specificity and/or sensitivity1,2, a
result of accelerated development to meet the exponentially growing demand
for testing as cases soared. The Steering Committee systematically considered
different aspects of the measurement process, including standards and controls,
and how they impacted various stages of the testing process. Here we describe
a study planned by the consortium and executed globally by independent
laboratories to assess multiple sources and types of molecular controls.

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