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

Sauleda, Silvia; Palacios, Lourdes; Brès, Vanessa; Piñana, Maria; Alonso-Hernandez, Lorena; Bes, Marta; Piron, Maria; Entrena, Edurne; Minguez-Micolau, Antonio M.; Marimón, Jose Maria; Gurrola, Adrian; Soria, Gloria; Puig, Lluís; Antón, Andrés; Pumarola, Tomás; Linnen, Jeffrey M.

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. 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. 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. CONCLUSIONS: These studies showed that the Procleix SARS-CoV-2 assay was a sensitive and specific tool for detecting COVID-19.