Evaluation of rapid diagnostic tests to detect dengue virus infections in Taiwan

Abstract

Early diagnosis is important for the clinical management of diseases caused by dengue virus (DENV) infections. We investigated the performance of three commercially available DENV nonstructural protein 1 (NS1) rapid diagnostic tests (RDTs) using 173 acute-phase sera collected from dengue fever-suspected patients during the 2012-2013 DENV outbreak in Taiwan. The results of the NS1 RDTs were compared with those of qRT-PCR to calculate the sensitivity and specificity of the NS1 RDTs. The anti-DENV IgM and IgG RDT results were included to increase the probability of detecting acute DENV infection. The anti-DENV IgM/IgG RDT results were also compared with those of IgM/IgG captured ELISA. The sera from DENV qRT-PCR-positive patients were subjected to NS1 RDTs, as well as IgM/IgG captured ELISA. These results suggested that there was no significant difference in the sensitivities of the three commercially available DNEV NS1 RDTs; the SD NS1 RDT results showed the highest agreement with the qRT-PCR reference results, followed in order by the Bio-Rad and CTK NS1 RDT results when the specificity was considered. Inclusion of the IgM or IgG RDT results increased the likelihood of diagnosing either a primary or secondary DENV infection. NS1 RDTs were more sensitive for the detection of primary infections than secondary infections, related to DENV viremia levels determined by qRT-PCR. These results suggested that anti-DENV antibodies reduced the sensitivity of NS1 rapid tests. We also analyzed the sensitivity for the detection of different DENV serotypes, and the results suggested that the NS1 RDTs used in this study were valuable for rapid screening of acute DENV infection with DENV-1, DENV-2 and DENV-3. Our results suggest that the NS1 RDT is a good alternative to qRT-PCR analysis for timely dengue disease management and prevention in dengue-endemic regions where medical resources are lacking or during large dengue outbreaks. However, the relatively low sensitivity for DENV-4 might miss the detection of DENV-4-infected cases.

Prospective Evaluation of a Commercial Dengue NS1 Antigen Rapid Diagnostic Test in New Caledonia

“…Data from significant recent evaluation studies [15][16][17][18][19][20][21][22][23], using RT-PCR as reference, are summarized in Table 3. These data confirm the variable performance observed in earlier studies.…”

Evaluation of a new NS1 rapid diagnostic test using a single acute‐phase serum panel collected during the largest dengue outbreak in Taiwan history in 2015

“…A Ct value ≤30 or a Tm ≥79°C was considered to indicate sample positivity 17,18 . The sequences of primers used in the detection and serotyping of DENV were described elsewhere 16,18 …”

“…16,17 The standards employed for the positive control were a threshold cycle value (Ct) ≤30 and Tm ≥79 C, and those for the negative control were Ct value ≥40 and Tm <79 C. A Ct value ≤30 or a Tm ≥79 C was considered to indicate sample positivity. 17,18 The sequences of primers used in the detection and serotyping of DENV were described elsewhere. 16,18…”

An Optical Sensor for Dengue Envelope Proteins Using Polyamidoamine Dendrimer Biopolymer-Based Nanocomposite Thin Film: Enhanced Sensitivity, Selectivity, and Recovery Studies

“…The antibodies are released in response to DENV up to 7 days post-infection, while NS1 products are produced within 5 days of infection after cleavage from E-proteins. Additionally, detection of antibodies (IgM and IgG) is not always highly specific to DENV as it can be cross-reactive against other flavivirus, while detection of NS1 tends to be less sensitive in secondary dengue (DENV-2) infection than in primary dengue (DENV-1) infection [ 64 , 65 , 66 , 67 ]. To overcome these issues, the envelope (E) proteins of the DENV-2 has become our determinant.…”