Clinical Performance of MAGLUMI Diagnostic Tests for the Automated Detection of Dengue Virus

Viruses. 2025 Jan 14;17(1):106. doi: 10.3390/v17010106.

Abstract

Aims: The screening and diagnosis of dengue virus infection play a crucial role in controlling the epidemic of dengue fever, highlighting the urgent need for a highly sensitive, simple, and rapid laboratory testing method. This study aims to assess the clinical performance of MAGLUMI Denv NS1 in detecting dengue virus NS1 antigen.

Methods: A retrospective study was conducted to assess the sensitivity and specificity of MAGLUMI Denv NS1 using residual samples. Dengue-confirmed and excluded samples, validated by qPCR, were subjected to testing with MAGLUMI Denv NS1 in accordance with the manufacturer's instructions. The linear range, endogenous interference, and cross-reactivity of MAGLUMI Denv NS1 were verified, and a consistency analysis with commercial comparator products was carried out.

Results: The diagnostic specificity of MAGLUMI Denv NS1 is 98.41% (62/63), and the sensitivity is 98.32% (117/119). It effectively detects various serotypes of dengue virus, with no observed endogenous interference or cross-reactivity. Additionally, the consistency of NS1, IgM, and IgG tests on the MAGLUMI platform compared to commercial comparator reagents reaches 85.71%, 99.25%, and 98.97%, respectively.

Conclusions: The MAGLUMI Denv NS1 represents a highly sensitive laboratory testing method capable of enhancing the diagnostic accuracy and efficiency of dengue virus infection detection.

Keywords: NS1; antigen; chemiluminescence immunoassay; dengue virus.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Antibodies, Viral / blood
  • Antigens, Viral
  • Cross Reactions
  • Dengue Virus* / genetics
  • Dengue Virus* / immunology
  • Dengue Virus* / isolation & purification
  • Dengue* / diagnosis
  • Dengue* / virology
  • Diagnostic Tests, Routine* / methods
  • Humans
  • Immunoglobulin G / blood
  • Immunoglobulin M / blood
  • Retrospective Studies
  • Sensitivity and Specificity
  • Viral Nonstructural Proteins* / immunology

Substances

  • Viral Nonstructural Proteins
  • Antibodies, Viral
  • Immunoglobulin G
  • Antigens, Viral
  • Immunoglobulin M