Clinical Performance of MAGLUMI Diagnostic Tests for the Automated Detection of Dengue Virus
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 det...
Saved in:
| Main Authors: | , , , , , , , , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
MDPI AG
2025-01-01
|
| Series: | Viruses |
| Subjects: | |
| Online Access: | https://www.mdpi.com/1999-4915/17/1/106 |
| Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
| _version_ | 1832587268776263680 |
|---|---|
| author | Bo Peng Zhonggang Fang Cong Li Kun Liu Ting Wang Ke Huang Fan Yang Yalan Huang Chunli Wu Yue Li Dana Huang Qian Zhang Yijun Tang Xiaolian Liu Wei Rao Xiaolu Shi |
| author_facet | Bo Peng Zhonggang Fang Cong Li Kun Liu Ting Wang Ke Huang Fan Yang Yalan Huang Chunli Wu Yue Li Dana Huang Qian Zhang Yijun Tang Xiaolian Liu Wei Rao Xiaolu Shi |
| author_sort | Bo Peng |
| collection | DOAJ |
| description | 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. |
| format | Article |
| id | doaj-art-23d1ccfc02b949f886a87b243c90edfd |
| institution | Kabale University |
| issn | 1999-4915 |
| language | English |
| publishDate | 2025-01-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Viruses |
| spelling | doaj-art-23d1ccfc02b949f886a87b243c90edfd2025-01-24T13:52:36ZengMDPI AGViruses1999-49152025-01-0117110610.3390/v17010106Clinical Performance of MAGLUMI Diagnostic Tests for the Automated Detection of Dengue VirusBo Peng0Zhonggang Fang1Cong Li2Kun Liu3Ting Wang4Ke Huang5Fan Yang6Yalan Huang7Chunli Wu8Yue Li9Dana Huang10Qian Zhang11Yijun Tang12Xiaolian Liu13Wei Rao14Xiaolu Shi15Microbiology Laboratory, Shenzhen Center for Disease Control and Prevention, Shenzhen 518055, ChinaResearch & Development Department, Shenzhen New Industries Biomedical Engineering Co., Ltd., No. 23, Jinxiu East Road, Pingshan District, Shenzhen 518122, ChinaResearch & Development Department, Shenzhen New Industries Biomedical Engineering Co., Ltd., No. 23, Jinxiu East Road, Pingshan District, Shenzhen 518122, ChinaResearch & Development Department, Shenzhen New Industries Biomedical Engineering Co., Ltd., No. 23, Jinxiu East Road, Pingshan District, Shenzhen 518122, ChinaResearch & Development Department, Shenzhen New Industries Biomedical Engineering Co., Ltd., No. 23, Jinxiu East Road, Pingshan District, Shenzhen 518122, ChinaResearch & Development Department, Shenzhen New Industries Biomedical Engineering Co., Ltd., No. 23, Jinxiu East Road, Pingshan District, Shenzhen 518122, ChinaMicrobiology Laboratory, Shenzhen Center for Disease Control and Prevention, Shenzhen 518055, ChinaMicrobiology Laboratory, Shenzhen Center for Disease Control and Prevention, Shenzhen 518055, ChinaMicrobiology Laboratory, Shenzhen Center for Disease Control and Prevention, Shenzhen 518055, ChinaMicrobiology Laboratory, Shenzhen Center for Disease Control and Prevention, Shenzhen 518055, ChinaMicrobiology Laboratory, Shenzhen Center for Disease Control and Prevention, Shenzhen 518055, ChinaMicrobiology Laboratory, Shenzhen Center for Disease Control and Prevention, Shenzhen 518055, ChinaMicrobiology Laboratory, Shenzhen Center for Disease Control and Prevention, Shenzhen 518055, ChinaMicrobiology Laboratory, Shenzhen Center for Disease Control and Prevention, Shenzhen 518055, ChinaResearch & Development Department, Shenzhen New Industries Biomedical Engineering Co., Ltd., No. 23, Jinxiu East Road, Pingshan District, Shenzhen 518122, ChinaMicrobiology Laboratory, Shenzhen Center for Disease Control and Prevention, Shenzhen 518055, ChinaAims: 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.https://www.mdpi.com/1999-4915/17/1/106dengue virusNS1antigenchemiluminescence immunoassay |
| spellingShingle | Bo Peng Zhonggang Fang Cong Li Kun Liu Ting Wang Ke Huang Fan Yang Yalan Huang Chunli Wu Yue Li Dana Huang Qian Zhang Yijun Tang Xiaolian Liu Wei Rao Xiaolu Shi Clinical Performance of MAGLUMI Diagnostic Tests for the Automated Detection of Dengue Virus Viruses dengue virus NS1 antigen chemiluminescence immunoassay |
| title | Clinical Performance of MAGLUMI Diagnostic Tests for the Automated Detection of Dengue Virus |
| title_full | Clinical Performance of MAGLUMI Diagnostic Tests for the Automated Detection of Dengue Virus |
| title_fullStr | Clinical Performance of MAGLUMI Diagnostic Tests for the Automated Detection of Dengue Virus |
| title_full_unstemmed | Clinical Performance of MAGLUMI Diagnostic Tests for the Automated Detection of Dengue Virus |
| title_short | Clinical Performance of MAGLUMI Diagnostic Tests for the Automated Detection of Dengue Virus |
| title_sort | clinical performance of maglumi diagnostic tests for the automated detection of dengue virus |
| topic | dengue virus NS1 antigen chemiluminescence immunoassay |
| url | https://www.mdpi.com/1999-4915/17/1/106 |
| work_keys_str_mv | AT bopeng clinicalperformanceofmaglumidiagnostictestsfortheautomateddetectionofdenguevirus AT zhonggangfang clinicalperformanceofmaglumidiagnostictestsfortheautomateddetectionofdenguevirus AT congli clinicalperformanceofmaglumidiagnostictestsfortheautomateddetectionofdenguevirus AT kunliu clinicalperformanceofmaglumidiagnostictestsfortheautomateddetectionofdenguevirus AT tingwang clinicalperformanceofmaglumidiagnostictestsfortheautomateddetectionofdenguevirus AT kehuang clinicalperformanceofmaglumidiagnostictestsfortheautomateddetectionofdenguevirus AT fanyang clinicalperformanceofmaglumidiagnostictestsfortheautomateddetectionofdenguevirus AT yalanhuang clinicalperformanceofmaglumidiagnostictestsfortheautomateddetectionofdenguevirus AT chunliwu clinicalperformanceofmaglumidiagnostictestsfortheautomateddetectionofdenguevirus AT yueli clinicalperformanceofmaglumidiagnostictestsfortheautomateddetectionofdenguevirus AT danahuang clinicalperformanceofmaglumidiagnostictestsfortheautomateddetectionofdenguevirus AT qianzhang clinicalperformanceofmaglumidiagnostictestsfortheautomateddetectionofdenguevirus AT yijuntang clinicalperformanceofmaglumidiagnostictestsfortheautomateddetectionofdenguevirus AT xiaolianliu clinicalperformanceofmaglumidiagnostictestsfortheautomateddetectionofdenguevirus AT weirao clinicalperformanceofmaglumidiagnostictestsfortheautomateddetectionofdenguevirus AT xiaolushi clinicalperformanceofmaglumidiagnostictestsfortheautomateddetectionofdenguevirus |