Korean J Pediatr Infect Dis.  2007 May;14(1):91-96. 10.14776/kjpid.2007.14.1.91.

Evaluation of a rapid diagnostic kit “BIOLINE RSV™” for the detection of respiratory syncytial virus

• Kim SH
• Sung JY
• Yang MA
• Eun BW
• Lee JA
• Choi EH
• Lee HJ

• KMID: 2439968
• DOI: http://doi.org/10.14776/kjpid.2007.14.1.91

Abstract

PURPOSE
This study was performed to evaluate a new rapid diagnostic kit (BIOLINE RSVâ„¢; Standard Diagnostics Inc., Yongin, Korea), a lateral-flow immunoassay, in the detection of respiratory syncytial virus (RSV) from the nasopharyngeal aspirates (NPA) of children with lower respiratory tract infections (LRTIs) in comparison with other diagnostic methods.
METHODS
Three hundred and nineteen NPAs were selected from a large pool of NPAs that had been obtained from children with LRTIs. All specimens had already been tested for RSV by culture and immunofluorescent (IF) test, and had been kept frozen. Tests with BIOLINE RSVâ„¢ were performed at least twice. All who conducted the experiments or interpreted the test results were blinded to the results of both culture and IF tests.
RESULTS
One hundred seven (97.3%) of 110 specimens that were positive for RSV by both culture and IF test, 29 (87.9%) of 33 that were positive by IF test only, 20 (76.9%) of 26 that were positive by culture only, and 140 (93.3%) of 150 that were negative by both methods were negative for RSV by BIOLINE RSVâ„¢. By combining the above results, the following 5 diagnostic values of BIOLINE RSVâ„¢ were determined in comparison with viral culture or IF test; sensitivity, 92.3% (156/169, 95% confidence interval [CI], 87.1-97.5%); specificity, 93.3% (140/150, 95% CI, 88.4-98.2%); positive predictive value, 94.0% (156/166, 95% CI, 89.5-98.5%); negative predictive value, 91.5% (140/143, 95% CI, 86.0-97.0%); and agreement, 95.9% (306/319, 95% CI, 92.1-99.7%), respectively.
CONCLUSION
This study revealed that BIOLINE RSVâ„¢ demonstrated good sensitivity and specificity for the detection of RSV antigen from NPAs of children with LRTIs. Because of simple methods and quick results, this test may be useful for the diagnosis of RSV infection during the epidemic periods.

Keyword

Respiratory syncytial virus; Diagnostic method; Lateral-flow immunoassay

MeSH Terms

Child
Diagnosis
Gyeonggi-do
Humans
Immunoassay
Respiratory Syncytial Viruses*
Respiratory Tract Infections
Sensitivity and Specificity