Comparison of Rapid Antigen Test and Real-Time Reverse Transcriptase PCR for Diagnosing Novel Swine Influenza A (H1N1)

Aerin Kwon; Jae-Seok Kim; Han-Sung Kim; Wonkeun Song; Ji-Young Park; Hyoun Chan Cho; Kyu Man Lee

doi:10.5145/KJCM.2010.13.3.109

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Kwon, Kim, Kim, Song, Park, Cho, and Lee: Comparison of Rapid Antigen Test and Real-Time Reverse Transcriptase PCR for Diagnosing Novel Swine Influenza A (H1N1)

Original Article

Korean J Clin Microbiol 2010;13(3):109-113.

Published online: 21 September 2010

DOI: https://doi.org/10.5145/KJCM.2010.13.3.109

Comparison of Rapid Antigen Test and Real-Time Reverse Transcriptase PCR for Diagnosing Novel Swine Influenza A (H1N1)

Aerin Kwon, Jae-Seok Kim, Han-Sung Kim, Wonkeun Song, Ji-Young Park, Hyoun Chan Cho, Kyu Man Lee

Department of Laboratory Medicine, Hallym University College of Medicine, Seoul, Korea

Correspondence: Jae-Seok Kim, Department of Laboratory Medicine, Hallym University College of Medicine, Kangdong Sacred Heart Hospital, 445 Gil-dong, Gangdong-gu, Seoul 134-701, Korea. (Tel) 82-2-2224-2327, (Fax) 82-2-2224-2214, (E-mail) jaeseok@hallym.or.kr

Received 7 January 2010 Revised 6 July 2010 Accepted 20 July 2010

This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/3.0/) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.

Abstract

Background

Novel swine influenza (H1N1) was first identified in Mexico in April 2009. Because of its high infectivity and worldwide distribution, a rapid and efficient screening test is necessary. Here we evaluated the usefulness of a rapid antigen test currently in use, compared to realtime RT-PCR (rRT-PCR) as a screening test for detection of novel swine influenza (H1N1).

Methods

A total of 1,228 patients who visited Hallym University Kangdong Sacred Heart Hospital with influenza-like illness between 14 August 2009 and 30 September 2009, and were tested by both rapid antigen and rRT-PCR tests, were enrolled in this study.

Results

Sensitivity, specificity, predictive value of a positive test, and predictive value of a negative test for the rapid antigen test were 30.5%, 99.2%, 86.4% and 90.1%, respectively. Fifty-one (4.2%) patients were positive for both rapid antigen test and rRT-PCR, and 1,053 (85.7%) were negative for both rapid antigen test and rRT-PCR. A total of 124 (10.1%) patients showed a discrepancy between the two tests. Among them, 116 (9.4%) were only positive for rRT-PCR and 8 (0.7%) were only positive for the rapid antigen test. The latter 8 patients all showed negative H1/M2 results in rRT-PCR. There were significant differences in detection rates of the rapid antigen test between different H1 Ct (threshold cycle) interval groups and for different age groups (P ＜0.05).

Conclusion

Although the rapid antigen test is easy to perform and provides fast results, its limits as a screening test for detection of novel swine influenza (H1N1) due to its low sensitivity compared to rRT-PCR need to be considered in practical situations.

Keywords: Novel swine influenza, H1N1, Rapid antigen test, Real-time PCR, Sensitivity

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Fig. 1.

Comparison of rapid antigen test sensitivity between different H1 Ct∗ interval groups among novel swine influenza A (H1N1) patients confirmed by realtime RT-PCR. ∗Ct, threshold cycle.

Table 1.

Comparison of rapid antigen test and realtime RT-PCR for detection of novel swine influenza A (H1N1)

Real-time RT-PCR	Rapid antigen test^∗
Real-time RT-PCR	Positive	Negative	Total
Positive	51 (4.2%)	116 (9.4%)	167 (13.6%)
Negative	8 (0.7%)	1,053 (85.7%) 1	1,061 (86.4%)
Total	59 (4.8%)	1,169 (95.2%) 1	1,228 (100.0%)

^∗ No. (%) of patients.

Table 2.

Comparison of rapid antigen test results between different age groups among novel swine influenza A (H1N1) patients confirmed by realtime RT-PCR

Age (year)	Rapid antigen test^∗
Age (year)	Positive	Negative	Total
＜13	20 (44.4%)	25 (55.6%)	45
13∼29	29 (26.9%)	25 (55.6%)	108
≥30	2 (14.3%)	116 (69.5%)	14
Total	51 (30.5%)	116 (69.5%)	167

^∗ No. (%) of patients.

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