Evaluation of a rapid diagnostic test for detection of dengue infection using a single-tag hybridization chromatographic-printed array strip format
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A dipstick DNA chromatography assay, a single-tag hybridization-printed array strip (STH-PAS), was evaluated for its efficacy to detect dengue virus (DENV). Reverse-transcribed DNA was amplified by PCR, and the amplified DNA was detected using the STH-PAS system. The method was evaluated using stored RNA samples previously identified to carry all 4 serotypes of dengue, chikungunya, and influenza viruses. Clinical performance was also assessed in a prospective study using plasma from 269 febrile cases from the Emergency Department of St. Luke’s Medical Center, Quezon City, Philippines, and 30 afebrile normal healthy volunteers. A Taqman real-time PCR (RT-PCR) assay and a rapid Dengue NS1 test, SD Bioline, were used for comparison. The STH-PAS system was more sensitive in detecting dengue infection compared to Taqman RT-PCR. For DENV serotypes 1, 2, and 3, the detection was 1 to 2 dilutions (10-fold) higher, and for DENV serotype 4, the detection was 2–4 dilutions higher. In clinical studies, the STH-PAS system showed 100% sensitivity with 88.9% and 86.6% specificities compared to Taqman RT-PCR and SD Dengue Duo NS1 test, respectively. The STH-PAS system was found to have a superior sensitivity than the Taqman system. Further evaluation of its performance in the field may provide important data to extend its usefulness for surveillance and epidemiological research in outbreak situations.
KeywordsDengue Rapid diagnostics Polymerase chain reaction STH-PAS
We acknowledge the valuable assistance of Sheena Marie Asur in patient recruitment.
Conceived and designed the experiments: YT, TH, MK, HCY, MLGD, MTAD.
Performed the experiments: VRL, LASP, RSR, MKB.
Analyzed the data: VRL, LASP, RSR, MLGD, MTAD, MPSD, YT, TH, MK, HCY.
Contributed reagents/materials/analysis tools: MK, YT, TH, PASL, AM, GB.
Wrote the paper: MLGD, VRL, LASP, HCY, TH.
Contributed to the logistics of kits: YT, TH.
This research was financially supported by Tohoku Bureau of Economy, Trade, and Industry and the Japan Society for the Promotion of Science (JSPS) Grants-in-Aid for Scientific Research (KAKENHI) grant number JP17H01690.
Compliance with ethical standards
The study was approved by the Institutional Ethics Review Committee, EC No. CT-17010, and conducted in St. Luke’s Medical Center, Quezon City, Philippines.
The authors declare that they have no conflict of interest.
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