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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

References

  1. References
  2. Russell CA, Jones TC, Barr IG, Cox NJ, Garten RJ, Gregory V, Gust ID, Hampson AW, Hay AJ, Hurt AC, et al: The global circulation of seasonal influenza A (H3N2) viruses. In Science. Volume 320. New York, NY;2008:(5874):340-346.
  3. Pan American Health Organization (PAHO) (2004) Final report of the XIV Meeting on Vaccine Preventable Diseases of the Pan American Health Organization. Washington (District of Columbia): PAHO. Available at: http://www.paho.org/English/AD/FCH/IM/TAG16_FinalReport_2004.pdf. Accessed 19 November 2013.
  4. Vibound C, Alonso WJ, Simonsen L. Influenza in tropical region. PloS Med. 2006;3(4):e89.
  5. Moura FE, Perdigão AC, Siqueira MM. Seasonality of influenza in the tropics: a distinct pattern in northeastern Brazil. The American journal of tropical medicine and hygiene. 2009; 81(1):180-183.
  6. Saha S, Chadha M, Al Mamun A, Rahman M, Sturm-Ramirez K, Chittaganpitch M, et.al. Influenza seasonality and vaccination timing in tropical and subtropical areas of southern and south-eastern Asia. Bulletin of the World Health Organization. 2014; 92(5):318-330.
  7. Cate TR: Clinical manifestations and consequences of influenza. The American journal of medicine 1987, 82(6A):15-19.
  8. Lescano AG, Larasati RP, Sedyaningsih ER, Bounlu K, Araujo-Castillo RV, Munayco-Escate CV, et.al. Statistical analyses in disease survellance systems. BMC proceedings 2008;2(Suppl 3):57.
  9. World Health Organization Global Influenza Programme. WHO manual on animal influenza diagnosis and surveillance. (2002) [cited 30 September 2012]. Available from: http://www.who.int/csr/resources/publications/influenza/WHO_CDS_CSR_NCS_2002_5/en/print.html.
  10. Sakai-Tagawa Y, Ozawa M, Tamura D, et al. Sensitivity of influenza rapid diagnostic tests to H5N1 and 2009 pandemic H1N1 viruses. J Clin Microbiol.2010;48:2872–7.
  11. Kasper MR, Putnam SD, Sovann L, et al. Short Report: Rapid-Test Based Identification of Influenza as an Etiology of Acute Febrile Illness in Cambodia. Am. J. Trop. Med. Hyg. 2011;85(6):1144–1145.
  12. Yoo Y, Sohn JW, Park DW, Kim JY, Shin HK, Lee Y, et.al. Clinical Evaluation of the SD Bioline Influenza Virus Antigen Test for Rapid Detection of Influenza Viruses A and B in Children and Adults during the Influenza Season. Clin Vaccine Immunol. 2007;14(8):1050–1052.
  13. Tanei M, Yokokawa H, Murai K, et al. Factors influencing the diagnostic accuracy of the rapid influenza antigen detection test (RIADT): a cross-sectional study. BMJ Open 2014;4: e003885. doi:10.1136/bmjopen-2013-003885.
  14. Uyeki TM, Prasad R, Vukotich C, Stebbins S, Rinaldo CR, Ferng YH, et al. Low sensitivity of rapid diagnostic test for influenza. Clin Infect Dis 2009;48:e89— 92.
  15. Al Johani SM, Al Balawi M, Al Alwan B, et al. Validity of two rapid point of Care Influenza tests and Direct Fluorecence assay in comparison of Real Time PCR for swine of origin Influenza virus. J Infect Public Health. 2011; 4(1):7-11. doi: 10.1016/j.jiph.2010.10.004.
  16. Treanor JJ. Influenza virus. In: Mandell GL, Bennett JE, Dolin R.eds. Principles and practice of infectious diseases, 7th edn. Philadelphia: Churchill Livingstone. 2005:2271–2.

How to Cite

Setiawaty, V., Roselinda, R., Subangkit, S., & Pangesti, K. N. A. (2017). Assesing sensitivity and specificity of rapid diagnostic test : the importance and challenges of Influenza surveillance in Indonesia. Bali Medical Journal, 6(3), 500–504. https://doi.org/10.15562/bmj.v6i3.570

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Vivi Setiawaty
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Roselinda Roselinda
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Subangkit Subangkit
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Krisna Nur Andriana Pangesti
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