Yonsei Med J.  2011 Jul;52(4):683-685. 10.3349/ymj.2011.52.4.683.

The Clinical Usefulness of the SD Bioline Influenza Antigen Test(R) for Detecting the 2009 Influenza A (H1N1) Virus

• Choi WS
• Noh JY
• Huh JY
• Kee SY
• Jeong HW
• Lee J
• Song JY
• Cheong HJ
• Kim WJ

• KMID: 1728004
• DOI: http://doi.org/10.3349/ymj.2011.52.4.683

Abstract

Though the 2009 worldwide influenza A (H1N1) pandemic has been declared to have ended, the influenza virus is expected to continue to circulate from some years as a seasonal influenza. A rapid antigen test (RAT) can aid in rapid diagnosis and allow for early antiviral treatment. We evaluated the clinical usefulness of RAT using SD Bioline Influenza Antigen Test(R) kit to detect the influenza virus, considering various factors. From August 1, 2009 to October 10, 2009, a total of 938 patients who visited the outpatient clinic at Korea University Guro Hospital with influenza-like illnesses were enrolled in the study. Throat or nasopharyngeal swab specimens were obtained from each of the patients. Using these specimens, we evaluated the influenza detection rate by rapid antigen test based on the real-time reverse-transcriptase polymerase chain reaction (rRT-PCR) method. In comparison with rRT-PCR, the sensitivity and specificity of the RAT were 44.0% and 99.9%, respectively. The cyclic threshold values of RAT negative specimens were higher than RAT positive specimens (30.1+/-3.1 vs. 28.3+/-3.9, p=0.031). The sensitivity of the RAT kit was higher in patients who visited clinics within two days of symptom onset (60.4% vs. 11.1%, p=0.026). The results of this study show that the RAT cannot be recommended for general use in all patients with influenza-like illness because of its low sensitivity. The RAT may be used, only in the settings with limited diagnostic resources, for patients who visit a clinic within two days of symptom onset.

Keyword

Influenza; diagnosis; sensitivity; specificity

MeSH Terms

Antigens, Viral/genetics
Humans
Influenza A Virus, H1N1 Subtype/genetics/immunology/*isolation & purification
Influenza, Human/*diagnosis/virology
Reagent Kits, Diagnostic
Reverse Transcriptase Polymerase Chain Reaction
Sensitivity and Specificity
Time Factors

Reference

1. Biggs C, Walsh P, Overmyer CL, Gonzalez D, Feola M, Mordechai E, et al. Performance of influenza rapid antigen testing in influenza in emergency department patients. Emerg Med J. 2010. 27:5–7.

2. Choi YJ, Kim HJ, Park JS, Oh MH, Nam HS, Kim YB, et al. Evaluation of new rapid antigen test for detection of pandemic influenza A/H1N1 2009 virus. J Clin Microbiol. 2010. 48:2260–2262.

3. Louie JK, Guevara H, Boston E, Dahlke M, Nevarez M, Kong T, et al. Rapid influenza antigen test for diagnosis of pandemic (H1N1) 2009. Emerg Infect Dis. 2010. 16:824–826.

4. Vasoo S, Stevens J, Singh K. Rapid antigen tests for diagnosis of pandemic (Swine) influenza A/H1N1. Clin Infect Dis. 2009. 49:1090–1093.

5. Blyth CC, Iredell JR, Dwyer DE. Rapid-test sensitivity for novel swine-origin influenza A (H1N1) virus in humans. N Engl J Med. 2009. 361:2493.

6. WHO information for laboratory diagnosis of pandemic (H1N1) 2009 virus in humans-revised. World Health Organization. Updated 23 November 2009. http://www.who.int/csr/resources/publications/swineflu/WHO_Diagnostic_RecommendationsH1N1_20090521.pdf.

7. Hwang Y, Kim K, Lee M. Evaluation of the efficacies of rapid antigen test, multiplex PCR, and real-time PCR for the detection of a novel influenza A (H1N1) virus. Korean J Lab Med. 2010. 30:147–152.

8. 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. 14:1050–1052.

9. de la Tabla VO, Masiá M, Antequera P, Martin C, Gazquez G, Buñuel F, et al. Comparison of combined nose-throat swabs with nasopharyngeal aspirates for detection of pandemic influenza A/H1N1 2009 virus by real-time reverse transcriptase PCR. J Clin Microbiol. 2010. 48:3492–3495.