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Abstract
Background
Respiratory syncytial virus (RSV) is one of the most important causes of lower respiratory tract infection. The rapid antigen test is a simple, cheap, and quick method for RSV detection, however, it has an acknowledged low sensitivity. The aim of this study is to evaluate the diagnostic performance of the rapid antigen test by comparing it with a multiplex reverse transcription-PCR (RT-PCR).
Methods
A total of 557 nasopharyngeal aspirates or swabs that were submitted for both a rapid antigen test, Binax NOW RSV (Binax; Alere Scarborough, Inc., USA) and multiplex RT-PCR, Seeplex RV7 (Seegene Inc., Korea) were included in this study. We performed both tests according to the manufacturer's recommendations and analyzed the diagnostic performances of a rapid antigen tests based on the results of multiplex RT-PCR.
Results
Among the 557 specimens, the positive rates determined from the rapid antigen test and multiplex RT-PCR were 12.2% (N=68) and 25.1% (N=140), respectively. The relative sensitivity and specificity of the rapid antigen test were 46.4% and 99.3% based on the multiplex RT-PCR, respectively. Positive and negative predictive values were 95.6% and 84.7%, respectively. The diagnostic sensitivity was lower (28.6%) in children >36 months compared with children ≤36 months of age. Test sensitivity declined when RSV infection was accompanied by infection with other respiratory viruses.
Figures and Tables
Table 1
Diagnostic performance of the rapid antigen test compared to multiplex RT-PCR
| RT-PCR | Binax NOW RSV | Total | |
|---|---|---|---|
| Positive | Negative | ||
| Positive | 65 | 75 | 140 |
| Negative | 3 | 414 | 417 |
| Total | 68 | 489 | 557 |
Table 2
Sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of the rapid antigen test according to age, seasonality, and presence of other viruses
Table 3
Comparison of the antigen immunoassay with other diagnostic methods with respect to sensitivity, specificity, PPV and NPV
| Test method and Standard method | Sensitivity (95% CI) | Specificity (95% CI) | PPV (95% CI) | NPV (95% CI) | Reference |
|---|---|---|---|---|---|
| Binax NOW RSV vs. Multiplex RT-PCR (N = 557) | 46.4% (38.0-55.1%) | 99.3% (97.9-99.9%) | 95.6% (87.6-99.1%) | 84.7% (81.2-87.7%) | This study |
| Binax NOW RSV vs. RT-qPCR (N = 311) | 72.2% (60.9-81.7%) | 97.0% (94.5-99.1%) | 90.0% (80.4-96.4%) | 91.0% (86.9-94.4%) | [2] |
| Binax NOW RSV vs. RSV culture (N = 270) | 81.7% (73.2-88.1%) | 98.7% (94.9-99.8%) | 97.9% (92.0-99.6%) | 87.9% (81.9-92.2%) | [19] |
| Binax NOW RSV vs. RSV culture (N = 118) | 89.0% (73.3-96.8%) | 100.0% (95.7-100.0%) | 100.0% (88.8-100.0%) | 95.0% (88.6-98.7%) | [15] |
| Binax NOW RSV vs. RSV culture (N = 14,756) | 81.0% (78.0-83.6%) | 93.2% (92.8-93.6%) | 40.4% (38.0-42.9%) | 98.9% (98.7-99.0%) | [18] |
| Binax NOW RSV vs. RSV shell vial culture (N = 89) | 94.6% (81.8-99.3%) | 88.5% (76.6-95.7%) | 85.4% (70.8-94.4%) | 95.8% (85.8-99.5%) | [16] |
| Binax NOW RSV vs. DFA+RSV shell vial culture (N = 162) | 74.0% (58.9-85.1%) | 100.0% (96.8-100.0%) | 100.0% (90.3-100.0%) | 90.0% (83.0-94.4%) | [17] |
| BD Directigen EZ vs. RSV culture (N = 88) | 59.0% (36.4-79.3%) | 98.0% (91.8-100.0%) | 93.0% (66.1-99.8%) | 88.0% (78.2-94.3%) | [15] |
| BD Directigen EZ vs. RSV shell vial culture (N = 89) | 86.5% (71.2-95.5%) | 92.3% (81.5-97.9%) | 88.9% (73.9-96.9%) | 90.6% (79.3-96.9%) | [16] |
| BD Directigen RSV vs. RSV shell vial culture (N = 89) | 86.5% (71.2-95.5%) | 88.5% (76.6-95.7%) | 84.2% (68.8-94.0%) | 90.2% (78.6-96.7%) | [16] |
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