Lab Med Online.  2020 Apr;10(2):160-164. 10.3343/lmo.2020.10.2.160.

Evaluating the Diagnostic Performance of Two Rapid Influenza Diagnostic Tests

Affiliations
  • 1Department of Laboratory Medicine, Severance Hospital, Yonsei University College of Medicine, Seoul, Korea

Abstract

Rapid influenza diagnostic test (RIDT) is widely used for the diagnosis of influenza owing to its simplicity and convenience of use. This study aimed to evaluate the performance of a new RIDT, SD Standard F influenza A/B FIA (SD Biosensor, Inc., Korea) (Standard F) and compare its performance with BD Veritor Flu A+B (Veritor), using the results of real-time reverse transcription PCR (rRT-PCR) analysis as the standard for reference. On comparing the results obtained from both the RIDTs and rRT-PCR qualitatively, it was found that the Veritor and Standard F assays have the sensitivity of 65.6% (21/32) and 71.9% (23/32), respectively, for the detection of influenza A with a specificity of 100.0% (68/68). Additionally, both the assays demonstrated a sensitivity of 66.7% (12/18) and specificity of 100.0% (68/68) for the detection of influenza B. The cutoff index (COI) value of the fluorescence color intensity from the Standard F assay, displayed on the device along with the qualitative results, indicated a negative correlation with the Ct value from rRT-PCR for both influenza A and B (P<0.001). The sensitivity of the new RIDT for the detection of influenza was comparable with that of the Veritor assay and the new RIDT could be used as a substitute for existing RIDTs by providing additional information to predict the approximate viral burden of influenza.

Keyword

Influenza; Rapid diagnostic test; Evaluation; BD Veritor; SD Standard F

Figure

  • Fig. 1 Comparison of cycle threshold (Ct) values of the influenza-positive specimens. (A), influenza A: N=32 and (B), influenza B: N=18. Specimens with negative RIDT results are indicated by an empty box. The maximum Ct value with positive RIDT result was 20.31 and 13.26 for influenza A and B, respectively. Abbreviations: rRT-PCR, real-time reverse transcription polymerase chain reaction; RIDT, rapid influenza diagnostic test; Veritor, BD Veritor assay; Standard F, SD Standard F assay.

  • Fig. 2 Correlation of cutoff index (COI) values obtained from SD Standard F assay with cycle threshold (Ct) values of influenza-positive specimens. (A), influenza A and (B), influenza B. Abbreviation: rRT-PCR, real-time reverse transcription polymerase chain reaction.


Reference

1. Nicholson KG, Wood JM, Zambon M. 2003; Influenza. Lancet. 362:1733–45. DOI: 10.1016/S0140-6736(03)14854-4. PMID: 14643124. PMCID: PMC7112395.
Article
2. Merckx J, Wali R, Schiller I, Caya C, Gore GC, Chartrand C, et al. 2017; Diagnostic accuracy of novel and traditional rapid tests for influenza infec-tion compared with reverse transcriptase polymerase chain reaction: A systematic review and metaanalysis. Ann Intern Med. 167:394–409. DOI: 10.7326/M17-0848. PMID: 28869986.
3. Centers for disease control and prevention (CDC). Information for clinicians on influenza virus testing. https://www.cdc.gov/flu/profes-sionals/diagnosis/index.htm. Updated on Feb. 2018.
4. Tsushima Y, Uno N, Sasaki D, Morinaga Y, Hasegawa H, Yanagihara K. 2015; Quantitative RT-PCR evaluation of a rapid influenza antigen test for efficient diagnosis of influenza virus infection. J Virol Methods. 212:76–9. DOI: 10.1016/j.jviromet.2014.10.019. PMID: 25449113.
Article
5. Chartrand C, Leeflang MM, Minion J, Brewer T, Pai M. 2012; Accuracy of rapid influenza diagnostic tests: a meta-analysis. Ann Intern Med. 156:500–11. DOI: 10.7326/0003-4819-156-7-201204030-00403. PMID: 22371850.
6. World Health Organization. WHO recommendations on the use of rapid testing for influenza diagnosis. https://www.who.int/influenza/resources/documents/rapid_testing/en/. Updated on Jul. 2005.
7. Park S, Lee M, Chung HS. 2015; Evaluation of the performance of a new chro-matographic assay BD Veritor™ System for rapid detection of influenza A & B. Ann Clin Microbiol. 18:27–32. DOI: 10.5145/ACM.2015.18.1.27.
8. Yeo SJ, Bao DT, Seo GE, Bui CT, Kim DTH, Anh NTV, et al. 2017; Improvement of a rapid diagnostic application of monoclonal antibodies against avian influenza H7 subtype virus using Europium nanoparticles. Sci Rep. 7:7933. DOI: 10.1038/s41598-017-08328-9. PMID: 28801679. PMCID: PMC5554140.
Article
9. Peaper DR and Landry ML. 2014; Rapid diagnosis of influenza: state of the art. Clin Lab Med. 34:365–85. DOI: 10.1016/j.cll.2014.02.009. PMID: 24856533. PMCID: PMC7172071.
10. Webster RG, Bean WJ, Gorman OT, Chambers TM, Kawaoka Y. 1992; Evo-lution and ecology of influenza A viruses. Microbiol Mol Biol Rev. 56:152–79. DOI: 10.1128/MMBR.56.1.152-179.1992. PMID: 1579108. PMCID: PMC372859.
Article
11. Kim JS, Lee SK, Ko DH, Hyun J, Kim HS. 2019; Performance evaluation of the automated fluorescent immunoassay system rotavirus assay in clinical samples. Ann Lab Med. 39:50–7. DOI: 10.3343/alm.2019.39.1.50. PMID: 30215230. PMCID: PMC6143470.
Article
12. Ryu JH, Kwon M, Moon JD, Hwang MW, Lee JM, Park KH, et al. 2018; Development of a rapid automated fluorescent lateral flow immunoassay to detect hepatitis B surface antigen (HBsAg), antibody to HBsAg, and antibody to hepatitis C. Ann Lab Med. 38:578–84. DOI: 10.3343/alm.2018.38.6.578. PMID: 30027702. PMCID: PMC6056386.
Article
13. Yoo Y, Sohn JW, Park DW, Kim JY, Shin HK, Lee Y, et al. 2007; 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. 14:1050–2. DOI: 10.1128/CVI.00465-06. PMID: 17567765. PMCID: PMC2044486.
Article
14. Ryu SW, Suh IB, Ryu SM, Shin KS, Kim HS, Kim J, et al. 2018; Comparison of three rapid influenza diagnostic tests with digital readout systems and one conventional rapid influenza diagnostic test. J Clin Lab Anal. 32:e22234. DOI: 10.1002/jcla.22234. PMID: 28407318. PMCID: PMC6817280.
Article
15. Self WH, McNaughton CD, Grijalva CG, Zhu Y, Chappell JD, Williams JV, et al. 2012; Diagnostic performance of the BinaxNow Influenza A&B rapid antigen test in ED patients. Am J Emerg Med. 30:1955–61. DOI: 10.1016/j.ajem.2012.04.018. PMID: 22795995.
16. Mese S, Akan H, Badur S, Uyanik A. Istanbul Rapid Test Study Group. 2016; Analytical performance of the BD Veritor™ System for rapid detection of influenza virus A and B in a primary healthcare setting. BMC Infect Dis. 16:481. DOI: 10.1186/s12879-016-1811-9. PMID: 27612949. PMCID: PMC5016879.
Article
17. Hassan F, Nguyen A, Formanek A, Bell JJ, Selvarangan R. 2014; Comparison of the BD Veritor™ System for Flu A+B with the Alere BinaxNOW® In-fluenza A&B card for detection of influenza A and B viruses in respiratory specimens from pediatric patients. J Clin Microbiol. 52:906–10. DOI: 10.1128/JCM.02484-13. PMID: 24391198. PMCID: PMC3957768.
18. Ryu SW, Lee JH, Kim J, Jang MA, Nam JH, Byoun MS, et al. 2016; Comparison of two new generation influenza rapid diagnostic tests with instrument-based digital readout systems for influenza virus detection. Br J Biomed Sci. 73:115–20. DOI: 10.1080/09674845.2016.1189026. PMID: 27327199.
Article
19. Dunn J, Obuekwe J, Baun T, Rogers J, Patel T, Snow L. 2014; Prompt detec-tion of influenza A and B viruses using the BD Veritor™ System Flu A+B, Quidel® Sofia® Influenza A+B FIA, and Alere BinaxNOW® Influ-enza A&B compared to real-time reverse transcription-polymerase chain reaction (RT-PCR). Diagn Microbiol Infect Dis. 79:10–3. DOI: 10.1016/j.diagmicrobio.2014.01.018. PMID: 24582581.
20. Selove W and Rao LV. 2016; Performance of rapid SOFIA Influenza A+B test compared to Luminex x-TAG respiratory viral panel assay in the diagnosis of influenza A, B, and subtype H3. J Investig Med. 64:905–7. DOI: 10.1136/jim-2016-000055. PMID: 26911275. PMCID: PMC4819670.
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