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Evaluation of the analytical and clinical performance of two RT-PCR based point-of-care tests; Cepheid Xpert® Xpress CoV-2/Flu/RSV plus and SD BioSensor STANDARD™ M10 Flu/RSV/SARS-CoV-2.
Jensen, Christel Barker; Schneider, Uffe Vest; Madsen, Tina Vasehus; Nielsen, Xiaohui Chen; Ma, Chih Man German; Severinsen, Jette Krogh; Hoegh, Anne Mette; Botnen, Amanda Bolt; Trebbien, Ramona; Lisby, Jan Gorm.
Afiliación
  • Jensen CB; Statens Serum Institut, Department of Virus & Microbiological Special Diagnostics, Artillerivej 5, 2300 Copenhagen S, Denmark.
  • Schneider UV; Statens Serum Institut, Department of Virus & Microbiological Special Diagnostics, Artillerivej 5, 2300 Copenhagen S, Denmark.
  • Madsen TV; Zealand University Hospital Slagelse, Department of Clinical Microbiology, Ingemannsvej 46, 4200 Slagelse, Denmark.
  • Nielsen XC; Zealand University Hospital Slagelse, Department of Clinical Microbiology, Ingemannsvej 46, 4200 Slagelse, Denmark.
  • Ma CMG; Statens Serum Institut, Department of Virus & Microbiological Special Diagnostics, Artillerivej 5, 2300 Copenhagen S, Denmark.
  • Severinsen JK; Statens Serum Institut, Department of Virus & Microbiological Special Diagnostics, Artillerivej 5, 2300 Copenhagen S, Denmark.
  • Hoegh AM; Statens Serum Institut, Department of Virus & Microbiological Special Diagnostics, Artillerivej 5, 2300 Copenhagen S, Denmark.
  • Botnen AB; Statens Serum Institut, Department of Virus & Microbiological Special Diagnostics, Artillerivej 5, 2300 Copenhagen S, Denmark.
  • Trebbien R; Statens Serum Institut, Department of Virus & Microbiological Special Diagnostics, Artillerivej 5, 2300 Copenhagen S, Denmark.
  • Lisby JG; Copenhagen University Hospital Hvidovre, Department of Clinical Microbiology, Kettegaard Allé 30, 2650 Hvidovre, Denmark. Electronic address: jan.gorm.lisby@regionh.dk.
J Clin Virol ; 172: 105674, 2024 Jun.
Article en En | MEDLINE | ID: mdl-38643722
ABSTRACT

BACKGROUND:

Rapid and accurate detection of viral respiratory infections is important for infection control measures. This study compares the analytical and clinical performance of the Xpert® Xpress CoV-2/Flu/RSV plus test ("Xpert", Cepheid) and the STANDARD™ M10 Flu/RSV/SARS-CoV-2 test ("M10", SD Biosensor). Both tests are quadruplex RT-PCR assays for rapid diagnosis of SARS-CoV-2, influenza A/B and RSV. STUDY

DESIGN:

Analytical sensitivities were determined by limit of detection for SARS-CoV-2, influenza A, influenza B and RSV, respectively. Additionally, the clinical performance of the Xpert and the M10 tests was evaluated against standard-of-care RT-PCR by testing of 492 clinical specimens.

RESULTS:

The analytical sensitivities for Xpert versus M10 test was 10, 50, 50 and 300 versus 300, 200, 800 and 1500 copies/mL for SARS-CoV-2, influenza A, influenza B and RSV, respectively. Clinical sensitivity for the Xpert test was superior across all four pathogens compared to the M10 test. Xpert showed clinical sensitivity of 100 % in all Ct-ranges for all four pathogens whereas M10 showed clinical sensitivity of 100 % in the 25-30 Ct-range, 84-100 % in the 30-35 Ct-range and 47-67 % in the >35 Ct-range across the four pathogens. Translating into real-life clinical sensitivity, the Xpert would detect 100 % of all four pathogens, whereas M10 would detect 92.1, 92.4, 84.8 and 94.7 % for SARS-CoV-2, influenza A, influenza B and RSV.

CONCLUSION:

This study demonstrates improved analytical and clinical performance of Xpert Xpress CoV-2/Flu/RSV plus compared to STANDARD M10 Flu/RSV/SARS-CoV-2, which is important for ensuring accuracy of diagnosis at all stages of a respiratory infection.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Virus de la Influenza A / Virus de la Influenza B / Sensibilidad y Especificidad / Infecciones por Virus Sincitial Respiratorio / Gripe Humana / SARS-CoV-2 / COVID-19 Límite: Humans Idioma: En Revista: J Clin Virol Asunto de la revista: VIROLOGIA Año: 2024 Tipo del documento: Article País de afiliación: Dinamarca Pais de publicación: Países Bajos
Texto completo
Añadir a Mi BVS
Imprimir
XML
PubMed Links
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Virus de la Influenza A / Virus de la Influenza B / Sensibilidad y Especificidad / Infecciones por Virus Sincitial Respiratorio / Gripe Humana / SARS-CoV-2 / COVID-19 Límite: Humans Idioma: En Revista: J Clin Virol Asunto de la revista: VIROLOGIA Año: 2024 Tipo del documento: Article País de afiliación: Dinamarca Pais de publicación: Países Bajos