Evaluation of Commercially Available Assays for Diagnosis of Acute Dengue in Schoolchildren During an Epidemic Period in Medellin, Colombia

Abstract

Abstract. During an active surveillance study in school children in Medellin, we assessed the performance of two diagnostic strategies for dengue virus. A total of 41 patients with suspected dengue acute infection were evaluated. Diagnostic strategies consisted of one combining Panbio ® Dengue virus IgM and IgG Capture ELISAs (enzyme-linked immunosorbent assays) with reverse transcriptase polymerase chain reaction (RT-PCR) and another using a commercial rapid SD Bioline Dengue Duo (IgG/IgM + NS1 Ag) test. These two strategies were compared with the enzymelinked immunospot microneutralization test (ELISPOT-MNT). The sensitivity and specificity were 53.9% and 80.0% for the combination of Panbio ® ELISAs and RT-PCR tests, and 30.8% and 73.3% for the SD Bioline Duo test, respectively. ELISPOT-MNT detected 16.4% additional cases and revealed the presence of neutralizing antibodies in all the acute samples, evidencing that they were all secondary infections. In contrast, Panbio ® and SD Dengue Duo rapid tests only classified 23.0% and 26.9% of the cases as secondary dengue infections, respectively. Cohen's kappa coefficient and McNemar's association tests demonstrated a significant disagreement between the two diagnostic strategies and ELISPOT-MNT. Overall, these results evidence the relatively poor performances of commercial assays for the diagnosis of acute and secondary dengue infections, compared with ELISPOT-MNT, and raise concern about the accuracy of these assays for the diagnostic of dengue in endemic areas.

Rapid diagnostic tests for determining dengue serostatus: a systematic review and key informant interviews

“…The ten studies included prospective and retrospective cohort studies [25] , [26] , [27] , [28] , [29] , [30] , [31] , [32] , [33] , [34] . Four dengue RDT brands were represented: SD BIOLINE Dengue Duo (Alere/Abbott), Panbio Dengue Duo (Alere/Abbott), OneStep Dengue Fever IgG/IgM RapiCard InstaTest (Cortez), and the GenBody Dengue IgG/IgM test.…”

Accuracy of the SD BIOLINE Dengue Duo for rapid point-of-care diagnosis of dengue

“…Yet, a previous evaluation of this RDT in Cambodia, enrolling children hospitalized due to a febrile illness of no clear source, showed an overall low sensitivity (57.8%) [21]. An even lower sensitivity (30.8%) was observed during a prospective cohort study that followed school-aged children to detect febrile episodes in Colombia [21,25].…”

Risk Factors Associated with Dengue Transmission and Spatial Distribution of High Seroprevalence in Schoolchildren from the Urban Area of Medellin, Colombia

“…Enzyme-linked immunospot and microneutralization tests (ELISPOT-MNT) [21] were performed in 278 serum samples following a standardized previously published protocol [22]. The ELISPOT-MNT 50 titer was determined as the serum dilution that reduces the number of foci or plaques by at least 50% when compared with wells with virus control.…”