CLINICAL VALIDATION OF BIOTEK-MTM DENGUE AQUA KIT IN THE DIAGNOSIS OF DENGUE INFECTIONS IN THE PHILIPPINES
Regina P Berba1,2,3, Joy Ann P Santos4,5, Kristine Marie G Flores1,6, Angelo dela Tonga1,6, Ma Jowina Galarion1,6, Mark B Carascal3,5, Antonio Camacho7, Cynthia A Aguirre3,7, Julius A Lecciones8 and Ma Liza MGonzales1,2
Keywords:BIOTEK-MTM Dengue Aqua kit, dengue, early detection, RT-LAMP assay
Owing to the non-specific signs and symptoms of patients during the acute phase of dengue illness, accurate detection of dengue virus (DENV) infection by a reliable yet simple laboratory test during the early phase of illness is crucial for proper management and better clinical outcome of patients. In order to address this need, a miniature loop mediated amplification (LAMP) kit, BIOTEK-MTM Dengue Aqua kit, was developed and evaluated at four hospitals in the Philippines among 517 patients greater than six months of age who presented with prior fever of no longer than seven days. Diagnostic accuracy was determined by comparing with the gold standard of a combination of dengue heminested RT-PCR, IgM ELISA, and NS1 and paired acute-convalescent IgG ELISA, with 91.7% meeting the criteria for true DENV infection. Sensitivity, specificity, positive predictive value, and negative predictive value were 81.9% (95% confidence interval (CI): 89.3-94.1), 85.7% (95% CI: 46.7-99.3), 99.7% (95% CI: 98.3-100), and 7.5% (95% CI: 3.3-15.4), respectively. The positive likelihood ratio was 6.549 (95% CI: 1.046-40.981) and the negative likelihood ratio was 0.207 (95% CI: 0.165-0.260). These results validate the application of BIOTEK-MTM Dengue Aqua kit for detection of early DENV infection and should be a useful tool in dengue control and elimination programs in the Philippines and other dengue endemic countries.