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

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

SUBMITTER: Peng B 

PROVIDER: S-EPMC11768712 | biostudies-literature | 2025 Jan

REPOSITORIES: biostudies-literature