Prospective evaluation of the SD BIOLINE Dengue Duo rapid test during a dengue virus epidemic

Abstract

Dengue virus is endemic in French Guiana with occurrence of cyclical outbreaks. There is a need for rapid tests allowing dengue laboratory diagnosis in healthcare centers scattered throughout this wide Amazonian territory. Our objective was to evaluate the real-life performance of the SD BIOLINE Dengue Duo (IgG/IgM + NS1 Ag) rapid test (RDT) during the 2012-2013 dengue epidemics. The RDT was evaluated in parallel with routine laboratory tests, PlateliaTM Dengue NS1 Ag and Focus Diagnostics Dengue Fever Virus IgM Capture DxSelect. A total of 3,347 patients with suspected dengue acute infection were evaluated. The diagnostic performances of the SD BIOLINE NS1 Ag were equivalent to Platelia NS1, 471 patients (14.1%) were NS1 Ag positive with the RDT and 14.2% with Platelia. The Cohen's Kappa coefficient was 0.86 [95%CI: 0.83-0.88], indicating an almost perfect agreement. Moreover, the sensitivity of SD BIOLINE NS1 Ag relative to the RT-PCR method was 87% [95%CI: 80-93%] and the specificity was 92% [95% CI: 87-97%]. However, the SD BIOLINE IgM test was found positive in 6.3% of the samples in comparison to 10.7% with Dx Select IgM. The Cohen's Kappa coefficient was 0.53 [95%CI: 0.47-0.58] indicating a moderate agreement. This raised concern about the SD BIOLINE IgM for the diagnostic of dengue in endemic areas. When considering only NS1 Ag results and not IgM, the RDT could be a viable solution to manage dengue outbreaks in healthcare centers where no laboratory services are available, in the early phase of the disease.

Assessment of diagnostic and analytic performance of the SD Bioline Dengue Duo test for dengue virus (DENV) infections in an endemic area (Savannakhet province, Lao People's Democratic Republic)

“…The SD Bioline Dengue Duo rapid test results for NS1 antigen and IgM/IgG antibodies were compared to corresponding commercially available ELISA tests. As was reported previously for a sample panel originating from French Guiana [37], the SD Bioline Dengue Duo NS1 test results were in good concordance with the PLATELIA™ Dengue NS1 Ag ELISA. In contrast, significantly fewer samples were classified as positive in the SD Bioline Dengue Duo IgM test than in the Panbio1 Dengue IgM Capture ELISA, resulting in low Cohen's kappa value of 0.3.…”

“…In contrast, significantly fewer samples were classified as positive in the SD Bioline Dengue Duo IgM test than in the Panbio1 Dengue IgM Capture ELISA, resulting in low Cohen's kappa value of 0.3. Similarly, an only moderate agreement (Cohen's kappa = 0.53) was found between the SD Bioline Dengue Duo IgM test and another commercial DENV IgM ELISA (Dengue Fever IgM Capture DxSelect™, Focus Diagnostics) by Simonnet et al [37]. The analytical sensitivity of the SD Bioline Dengue Duo IgM test was found to be particularly low in comparison to the Panbio DENV IgM capture ELISA when serum samples from patients with high anti-DENV IgG titers were analyzed.…”

Evaluation of novel rapid detection kits for dengue virus NS1 antigen in Dhaka, Bangladesh, in 2017

“…8). Simonnet et al reported that the results of the SD Bioline kit were difficult to judge because of the occurrence of faint bands [24]. The color intensities provided by the TKK-1st kit and -2nd kit were apparently higher than those of the SD Bioline kit, meaning that the TKK-1st kit and -2nd kit should be easier to read and are expected to detect NS1 proteins at later time points post-infection than possible with the SD Bioline kit, given that the TKK kits can detect lower NS1 concentrations in patient sera.

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Clinical evaluation of a developed paper-based Dengue NS1 rapid diagnostic test for febrile illness patients

“…However, the PAD provided a positive predictive value (PPV) of 84.62% and an accuracy of 87.67%. The sensitivity and specificity of many commercial RDTs (Chong et al, 2020;Gaikwad et al, 2017;Jang et al, 2019;Lee et al, 2019;Piedrahita et al, 2016;Santoso et al, 2020;Shukla et al, 2017;Simonnet et al, 2017;Suzuki et al, 2019;Thai et al, 2010;Vivek et al, 2017) show variability (Table S3), which might be due to difference in study design, population, reference standard, and other characteristics (Kohn et al, 2013;Leeflang, 2014;Whiting et al, 2011). It is challenging to compare the diagnostic performance between different studies without proper assessment since there were differences in study characteristics.…”