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Comparison of Diagnostic Tests for Detection of Nonstructural-1(Ns1) Antigen Dengue Virus Using Immunochromatography and Fluorescence Immunoassay Methods


Affiliations
1 Clinical Pathology Specialization Program, Faculty of Medicine, Universitas Airlangga, Surabaya, Indonesia
2 Clinical Pathology Sub-Specialization Program, Faculty of Medicine, Universitas Airlangga, Surabaya, Indonesia
3 Master Program of Tropical Medicine, Faculty of Medicine, Universitas Airlangga, Surabaya, Indonesia
4 Department of Clinical Pathology, Faculty of Medicine, Universitas Airlangga, Surabaya, Indonesia
5 Institute of Tropical Disease, Universitas Airlangga, Surabaya, Indonesia
6 6Department of Pediatric, Faculty of Medicine – Universitas Airlangga, Surabaya., Indonesia
7 Department of Chemistry, Faculty of Science and Technology – Universitas Airlangga, Surabaya., Indonesia
8 Directorate of Vector Borne and Zoonotic Disease, Ministry of Health Republic of Indonesia, Jakarta,, Indonesia
     

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Background : NS1 is currently widely used for diagnosis of dengue virus (DENV) infection. Various methods are used to diagnose DENV infection (DVI), either ELISA, immunochromatography (ICT) or most recently the fluorescence immunoassay (FIA) method which are commercially available. Objective: This study aimed to compare the detection capabilities of dengue NS1 antigens using (1) Dengue NS1 ICT Ag (Standard Q - SD Biosensor, Inc.), (2) Dengue NS1 ICT Ag (SD Bioline - Standard Diagnostic, Inc), and (3) Dengue NS1 Ag FIA (Standard F - SD Biosensor, Inc.) Methods: This study consisted of serum samples (n=80) with the number of DVI patients (n=50), non-DVI (n=30). All samples were examined using all three commercial kits for NS1 antigen testing. All DVI samples showed results of reverse-transcriptase polymerase chain reaction (RT-PCR - SIMPLEXAᵀᴹ Dengue - Focus Diagnostics) and/or positive dengue NS1 (Panbio® Dengue Early ELISA) antigen. Results: Standard F showed the highest sensitivity (82%) compared to Standard Q (74%) and SD Bio line (74%). These three commercial kits had the same specificity 100%. The positive predictive value all of these kits was 100% each. The negative prediction value of Standard F, Standard Q, and SD Bio line were 76.9%, 63.8%, 63.8%, respectively. These three NS1 antigen tests had a good agreement (κ 0.681-0.774). Conclusions: FIA test performance (Standard F SD - Biosensor, Inc.) were a quick and easy examination, showing a higher sensitivity and specificity than ICT for detecting DENV infection. Further research is needed to confirm the diagnosis of primary or secondary infection.

Keywords

Dengue Viral Infection, NS1 Dengue antigen, ICT, FIA.
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  • Comparison of Diagnostic Tests for Detection of Nonstructural-1(Ns1) Antigen Dengue Virus Using Immunochromatography and Fluorescence Immunoassay Methods

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Authors

Nelly Zuroidah
Clinical Pathology Specialization Program, Faculty of Medicine, Universitas Airlangga, Surabaya, Indonesia
May Fanny Tanzilia
Clinical Pathology Sub-Specialization Program, Faculty of Medicine, Universitas Airlangga, Surabaya, Indonesia
I Gusti Agung Ayu Eka Putri Sunari
Clinical Pathology Specialization Program, Faculty of Medicine, Universitas Airlangga, Surabaya, Indonesia
Billy Jordan Wrahatnala
Master Program of Tropical Medicine, Faculty of Medicine, Universitas Airlangga, Surabaya, Indonesia
Faradila Khoirun Nisa Haki
Master Program of Tropical Medicine, Faculty of Medicine, Universitas Airlangga, Surabaya, Indonesia
Aryati
Department of Clinical Pathology, Faculty of Medicine, Universitas Airlangga, Surabaya, Indonesia
Puspa Wardhani
Institute of Tropical Disease, Universitas Airlangga, Surabaya, Indonesia
Dominicus Husada
6Department of Pediatric, Faculty of Medicine – Universitas Airlangga, Surabaya., Indonesia
Ali Rohman
Department of Chemistry, Faculty of Science and Technology – Universitas Airlangga, Surabaya., Indonesia
Siti Nadia Tarmizi
Directorate of Vector Borne and Zoonotic Disease, Ministry of Health Republic of Indonesia, Jakarta,, Indonesia

Abstract


Background : NS1 is currently widely used for diagnosis of dengue virus (DENV) infection. Various methods are used to diagnose DENV infection (DVI), either ELISA, immunochromatography (ICT) or most recently the fluorescence immunoassay (FIA) method which are commercially available. Objective: This study aimed to compare the detection capabilities of dengue NS1 antigens using (1) Dengue NS1 ICT Ag (Standard Q - SD Biosensor, Inc.), (2) Dengue NS1 ICT Ag (SD Bioline - Standard Diagnostic, Inc), and (3) Dengue NS1 Ag FIA (Standard F - SD Biosensor, Inc.) Methods: This study consisted of serum samples (n=80) with the number of DVI patients (n=50), non-DVI (n=30). All samples were examined using all three commercial kits for NS1 antigen testing. All DVI samples showed results of reverse-transcriptase polymerase chain reaction (RT-PCR - SIMPLEXAᵀᴹ Dengue - Focus Diagnostics) and/or positive dengue NS1 (Panbio® Dengue Early ELISA) antigen. Results: Standard F showed the highest sensitivity (82%) compared to Standard Q (74%) and SD Bio line (74%). These three commercial kits had the same specificity 100%. The positive predictive value all of these kits was 100% each. The negative prediction value of Standard F, Standard Q, and SD Bio line were 76.9%, 63.8%, 63.8%, respectively. These three NS1 antigen tests had a good agreement (κ 0.681-0.774). Conclusions: FIA test performance (Standard F SD - Biosensor, Inc.) were a quick and easy examination, showing a higher sensitivity and specificity than ICT for detecting DENV infection. Further research is needed to confirm the diagnosis of primary or secondary infection.

Keywords


Dengue Viral Infection, NS1 Dengue antigen, ICT, FIA.

References