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Utility of plasma nucleocapsid protein in predicting severity and prognosis in severe COVID-19 patients with comorbidities.
Wang, Di; Shen, Yutao; Wu, Jianbo; Li, Yaju; Ma, Ke; Jiang, Guangjie; Li, Xiangyu; Qin, Huanhuan; Chen, Kun; Wu, Zhiyuan; Guan, Ming.
Afiliación
  • Wang D; Department of Laboratory Medicine, Huashan Hospital, Fudan University, Shanghai 200040, China.
  • Shen Y; Department of Laboratory Medicine, Huashan Hospital, Fudan University, Shanghai 200040, China.
  • Wu J; Department of Laboratory Medicine, Huashan Hospital, Fudan University, Shanghai 200040, China.
  • Li Y; Department of Laboratory Medicine, Huashan Hospital, Fudan University, Shanghai 200040, China.
  • Ma K; Department of Critical Care Medicine, Huashan Hospital, Fudan University, Shanghai 201907, China.
  • Jiang G; Department of Laboratory Medicine, Huashan Hospital, Fudan University, Shanghai 200040, China.
  • Li X; Department of Laboratory Medicine, Huashan Hospital, Fudan University, Shanghai 200040, China.
  • Qin H; Department of Laboratory Medicine, Huashan Hospital, Fudan University, Shanghai 200040, China.
  • Chen K; Department of Laboratory Medicine, Huashan Hospital, Fudan University, Shanghai 200040, China.
  • Wu Z; Department of Laboratory Medicine, Huashan Hospital, Fudan University, Shanghai 200040, China.
  • Guan M; Department of Laboratory Medicine, Huashan Hospital, Fudan University, Shanghai 200040, China. Electronic address: guanming88@yahoo.com.
Clin Chim Acta ; : 119951, 2024 Aug 29.
Article en En | MEDLINE | ID: mdl-39216815
ABSTRACT

OBJECTIVES:

The COVID-19 pandemic poses ongoing challenges to global public health systems, emphasizing the critical necessity for efficient diagnostic and prognostic markers. This study evaluates the MAGLUMI® SARS-CoV-2 Ag N protein chemiluminescent immunoassay (MAG-CLIA) for its analytical performance and its role in predicting disease severity and prognosis among severe COVID-19 patients with comorbidities.

METHODS:

Analytical validation of plasma MAG-CLIA SARS-CoV-2 Ag N protein encompassed precision, interference, LoQ and linearity. Plasma N protein concentrations and other biomarkers were measured within 48 h of admission, tracked until discharge or death. The Mann-Whitney U test explored the association between plasma N protein and COVID-19 severity or prognosis. Longitudinal monitoring of plasma N protein dynamics was conducted in representative patients.

RESULTS:

MAG-CLIA demonstrated precise quantification of plasma N protein with a CV below 10 % and minimal interference. The LoQ was 0.88 ng/L, with a broad linear range. Plasma N protein showed high diagnostic accuracy for COVID-19, achieving 95.42 % specificity and 78.32 % sensitivity at 2.388 ng/L. Plasma N protein emerged as a valuable prognostic indicator, correlating with mechanical ventilation need and patient survival. Plasma N protein concentrations ≥ 424.3 ng/L (AUC 0.8102, sensitivity 78.38 %, specificity 85.48 %) were associated with poor prognosis in severe COVID-19 patients with comorbidities.

CONCLUSIONS:

MAG-CLIA's SARS-CoV-2 N protein detection in plasma demonstrates both analytical reliability and clinical relevance in our inaugural evaluation. As a promising prognostic biomarker for severe COVID-19 patients, it offers crucial insights into disease severity and progression, emphasizing the significance of early monitoring and intervention, especially for patients with comorbidities.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Idioma: En Revista: Clin Chim Acta Año: 2024 Tipo del documento: Article País de afiliación: China Pais de publicación: Países Bajos
Texto completo
Añadir a Mi BVS
Imprimir
XML
PubMed Links
Buscar en Google

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Idioma: En Revista: Clin Chim Acta Año: 2024 Tipo del documento: Article País de afiliación: China Pais de publicación: Países Bajos