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CC BY-NC-ND 4.0 · J Lab Physicians 2019; 11(01): 063-067
DOI: 10.4103/JLP.JLP_140_18
Original Article

Can rapid dengue diagnostic kits be trusted? A comparative study of commercially available rapid kits for serodiagnosis of dengue fever

Atul Garg
Department of Microbiology, Sanjay Gandhi Post Graduate Institute of Medical Sciences, Lucknow, Uttar Pradesh, India
,
Jaya Garg
Department of Microbiology, RML Institute of Medical Sciences, Lucknow, Uttar Pradesh, India
,
Dharam Singh
Department of Microbiology, Sanjay Gandhi Post Graduate Institute of Medical Sciences, Lucknow, Uttar Pradesh, India
,
TN Dhole
Department of Microbiology, Sanjay Gandhi Post Graduate Institute of Medical Sciences, Lucknow, Uttar Pradesh, India
› Author Affiliations Financial support and sponsorship: We gratefully acknowledge the funding received from Indian Council of Medical Research, New Delhi (VIR/24/2011/ECD-1).
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Abstract

BACKGROUND: Dengue virus infection is an important emerging disease of the tropical and subtropical regions and is mainly diagnosed by serological detection of NS1 antigen and IgM antidengue antibodies. Since enzyme-linked immunosorbent assay (ELISA) facilities are not easily available at most diagnostic centers, so most of them use various commercially available rapid diagnostic tests (RDTs) kits.

AIMS AND OBJECTIVES: This study was designed to access the diagnostic accuracy of four commercially available and widely used RDTs for serodiagnosis of dengue virus infection in Indian laboratories.

SUBJECTS AND METHODS: The study was conducted at Department of Microbiology, G.S.V.M Medical College, Kanpur, India, to estimate the sensitivity and specificity of following RDTs: (1) Dengue Cassette (Panbio, Australia), (2) Bioline Dengue Duo (SD Diagnostics, Korea), (3) Dengue Day 1 test (J Mitra and Co., India), and (4) Dengucheck Duo (Tulip Diagnostics, India) on 72 confirmed dengue serum samples that were positive by dengue reverse transcription-polymerase chain reaction, dengue NS1, and IgM ELISA along with 80 serum samples from nondengue febrile illness patients.

RESULTS: The majority of the RDTs demonstrated low sensitivity but good specificity for detecting NS1 antigen. Detection of antidengue IgM antibodies by RDTs demonstrated low sensitivity ranging from 27.8% to 77.7%. However, specificity was generally higher (50%–86.2%) and more consistent across the assays.

CONCLUSION: The study results differed markedly from the RDTs manufacturers’ claimed performance characteristics. Therefore, the RDT results should be interpreted cautiously and ELISA should be performed as far as possible for serodiagnosis of dengue virus infection.

Key words

Dengue - enzyme-linked immunosorbent assay - IgM antibodies - NS1 antigen - rapid diagnostic test kits


Publication History

Received: 26 December 2018

Accepted: 06 January 2019

Article published online:
06 April 2020

© 2019.

Thieme Medical and Scientific Publishers Private Ltd.
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