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

Background: The rapid detection of influenza viruses from clinical samples is important for providing information to assist public health and clinical decision-making, including infection prevention and control measures. The SD Bioline rapid influenza test is a point-of-care (POC) diagnostic test that is 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 in influenza-like illness (ILI) surveillance activity. Methods: A total of 4,262 nasal and throat swab specimens were collected from ILI patients at sentinel hospitals and public health centers across 10 provinces in Indonesia. Specimens were tested with the SD Bioline rapid influenza test in the sentinels, and rRT-PCR test was conducted in referral laboratory in Jakarta. Data analysis was performed by comparing the results of the rapid test and the rRT-PCR test. Results: The performance evaluation on the SD Bioline rapid influenza demonstrated the specificity of test 97% for both influenza A and B. However, the overall sensitivity of this rapid influenza test for these samples was low at 28% for influenza A and 21% for influenza B. Conclusions: Overall, the results indicated that the SD Bioline rapid influenza test has a high specificity but has only low sensitivity for the detection of influenza from the throat and nasal swabs. Therefore, the integration of rapid test in the influenza surveillance needs further assessment to obtain optimal benefits for both clinical and public health sectors.