Diagnostic testing for the new coronavirus strain COVID-19 can be carried out through molecular analysis or by ELISA. In the United States, the CDC employs molecular test methodologies to diagnose active infections and serology antibody testing for surveillance and investigational purposes. Since antibodies continue to circulate after an infection has cleared, serology tests can misdiagnose individuals who have previously been infected and have since recovered.
Although molecular diagnostics have served as the current standard for COVID-19 screening assays there have be challenges in obtaining accurate results, specifically in avoiding false-negative outcomes. False-negative results can arise from (1) low viral loads or unsuitable collection, (2) handling and/or storage of nasopharyngeal aspirate/swabs or throat swabs or (3) failure of the extraction, purification, reverse transcription or amplification of COVID-19. The latter can be monitored with a novel positive control, VLP-RNA Extraction Control. This control is added before the sample is processed, identifying true negative from false negative results that are caused by inhibition, nucleic acid degradation, sample processing error or thermocycler malfunction.
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