Clinical evaluation of the Procleix SARS-CoV-2 assay, a sensitive, high-throughput test that runs on an automated system
| Autor: | Jose Maria Marimón, Tomás Pumarola, Jeffrey M. Linnen, Maria Piron, Andrés Antón, Vanessa Brès, Lourdes Palacios, Marta Bes, Lluís Puig, Silvia Sauleda, Maria Piñana, Antonio M. Minguez-Micolau, Edurne Entrena, Gloria Soria, Adrian Gurrola, Lorena Alonso-Hernandez |
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| Přispěvatelé: | Institut Català de la Salut, [Sauleda S, Bes M] Transfusion Safety Laboratory, Banc de Sang i Teixits, Servei Català de la Salut, Barcelona, Spain. [Palacios L, Alonso-Hernandez L] Progenika Biopharma, A Grifols company, Derio, Spain. [Brès V] Grifols Diagnostic Solutions Inc., San Diego, CA, USA. [Piñana M, Antón A, Pumarola T] Servei de Microbiologia, Vall d'Hebron Hospital Universitari, Barcelona, Spain, Vall d'Hebron Barcelona Hospital Campus |
| Jazyk: | angličtina |
| Rok vydání: | 2022 |
| Předmět: |
Microbiology (medical)
2019-20 coronavirus outbreak medicine.medical_specialty Transcription-Mediated Amplification (TMA) Investigative Techniques::Genetic Techniques::Nucleic Acid Amplification Techniques [ANALYTICAL DIAGNOSTIC AND THERAPEUTIC TECHNIQUES AND EQUIPMENT] Coronavirus disease 2019 (COVID-19) Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) Otros calificadores::/diagnóstico [Otros calificadores] técnicas de investigación::métodos epidemiológicos::diseño de la investigación epidemiológica::sensibilidad y especificidad [TÉCNICAS Y EQUIPOS ANALÍTICOS DIAGNÓSTICOS Y TERAPÉUTICOS] Asymptomatic Gastroenterology Sensitivity and Specificity Article Automation COVID-19 Testing Internal medicine Nucleic acid test (NAT) medicine Other subheadings::/diagnosis [Other subheadings] virosis::infecciones por virus ARN::infecciones por Nidovirales::infecciones por Coronaviridae::infecciones por Coronavirus [ENFERMEDADES] Humans Retrospective Studies medicine.diagnostic_test business.industry SARS-CoV-2 Nucleic acid test COVID-19 Virus Diseases::RNA Virus Infections::Nidovirales Infections::Coronaviridae Infections::Coronavirus Infections [DISEASES] General Medicine High-Throughput Screening Assays Àcids nucleics - Anàlisi Infectious Diseases Molecular Diagnostic Techniques Investigative Techniques::Epidemiologic Methods::Epidemiologic Research Design::Sensitivity and Specificity [ANALYTICAL DIAGNOSTIC AND THERAPEUTIC TECHNIQUES AND EQUIPMENT] COVID-19 (Malaltia) - Diagnòstic técnicas de investigación::técnicas genéticas::técnicas de amplificación de ácidos nucleicos [TÉCNICAS Y EQUIPOS ANALÍTICOS DIAGNÓSTICOS Y TERAPÉUTICOS] medicine.symptom Diagnòstic molecular business Clinical evaluation Nucleic Acid Amplification Techniques |
| Zdroj: | Scientia Diagnostic Microbiology and Infectious Disease |
| Popis: | COVID-19; Prueba de ácido nucleico; Amplificación mediada por transcripción COVID-19; Prova d'àcid nucleic; Amplificació mediada per la transcripció COVID-19; Nucleic acid test; Transcription-mediated amplification 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. The sensitivity of the assay was assessed using heat-inactivated SARS-CoV-2 and compared to 3 other tests. Clinical validation utilized 2 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. The Procleix assay had greater sensitivity (3-fold to 100-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 6 were inconclusive. These studies showed that the Procleix SARS-CoV-2 assay was a sensitive and specific tool for detecting COVID-19. This work was sponsored by Grifols Diagnostic Solutions, Inc. |
| Databáze: | OpenAIRE |
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