Performance comparison of two dengue NS1 rapid diagnostic tests against RT-PCR: Sensitivity and specificity across...

Dengue virus (DENV) is a mosquito-borne flavivirus that remains a global public health threat, particularly in tropical regions where it is endemic. Accurate and timely diagnosis is critical for optimal patient care and effective outbreak containment. While reverse transcription-polymerase chain reaction (RT-PCR) remains the gold standard for dengue diagnosis, nonstructural protein 1 (NS1) rapid diagnostic tests (RDTs) offer a more accessible alternative. However, their performance may vary with infection type, serotype, and the timing of sample collection.

We evaluated the diagnostic performance of two NS1 RDTs, Abbott NS1 and PBF NS1, against RT-PCR as the reference standard. A total of 183 dengue-positive and 40 dengue-negative samples were obtained during the 2023 dengue outbreak in Kaohsiung, Taiwan. Sensitivity, specificity, and predictive values were comprehensively assessed based on infection type, serotype, and post-symptom onset (PSO) intervals. Additionally, we analyzed the diagnostic benefits of combining NS1 detection with anti-DENV IgM serology.

Abbott NS1 exhibited notably higher sensitivity (87.4 % vs. 83.1 %) and specificity (100 % vs. 97.5 %) compared to PBF NS1, though the differences were not statistically significant. Sensitivity varied by PSO, with Abbott NS1 achieving significantly higher sensitivity beyond three days (97.4 % vs. 76.9 %, P = 0.034). In secondary infections, Abbott NS1 outperformed PBF NS1 (86.8 % vs. 79.2 %). When combined with anti-DENV IgM serology, both RDTs demonstrated improved diagnostic sensitivity, particularly in secondary infections.

Our findings underscore the importance of context-specific diagnostic tools. Combining NS1 antigen detection with IgM serology enhances diagnostic accuracy. While Abbott NS1 demonstrated slightly better performance, PBF NS1 remains a viable and non-inferior alternative.