Assesing sensitivity and specificity of rapid diagnostic test : the importance and challenges of Influenza surveillance in Indonesia

Abstract

Background: The rapid detection of influenza viruses from clinical samples is important for establishing public health and clinical decisions, including infection prevention and control measures. The SD Bioline rapid influenza test (Standard Diagnostics, Inc., Suwon, Korea) is a point-of-care (POC) diagnostic test which based on influenza-specific monoclonal antibodies. The purpose of this study is to assess the performance of this assay against the reference diagnostic standards of RT-PCR for Influenza diagnosis in Surveillance activity.Methods: 4,262 nasal and throat swab specimens were collected from influenza-like illness (ILI) patients from sentinel hospital and health-care sites across 10 provinces in Indonesia. Specimens were tested with the SD Bioline rapid influenza test in sentinels and rRT-PCR test was conducted in referral laboratory in Jakarta. Data analysis was performed by comparing the results of rapid test conducted in the POC settting and the results of rRT-PCR test.Results: Testing of throat and nasal swabs from children and adults indicated the specificity of The SD Bioline rapid influenza test to be 97% for influenza A and B, respectively, in 4262 specimens. However, the overall sensitivity of the SD Bioline rapid influenza test for these samples was low at 25%.Conclusions: Overall, the results indicated that the SD Bioline rapid influenza test has a high specificity but low sensitivity for detection influenza from throat and nasal swabs therefore it will be a challenge of laboratory testing on site.Keywords: Influenza, rapid diagnostic test, surveillance