Clinical evaluation of the Procleix SARS-CoV-2 assay, a sensitive, high-throughput test that runs on an automated system

Abstract

\n BACKGROUND: Testing is crucial in controlling COVID-19. The Procleix® SARS-CoV-2 assay, a transcription-mediated amplification nucleic acid test that runs on an automated system, was evaluated using inactivated virus and clinical samples.\n STUDY DESIGN AND METHODS: The sensitivity of the assay was assessed using heat-inactivated SARS-CoV-2 and compared to three other tests. Clinical validation utilized two sets of samples: 1) Nasal, nasopharyngeal and oropharyngeal samples (n=963) from asymptomatic individuals, and 2) nasopharyngeal samples from symptomatic patients: 100 positive and 100 negative by RT-PCR.\n RESULTS: The Procleix assay had greater sensitivity (3-fold to100-fold) than the comparators and had high specificity (100%) in asymptomatic subjects. In symptomatic patients, the Procleix assay detected 100% of PCR-positives and found 24 positives in the initial PCR-negatives. Eighteen of these were confirmed positive and six were inconclusive.\n CONCLUSIONS: These studies showed that the Procleix SARS-CoV-2 assay was a sensitive and specific tool for detecting COVID-19.\n