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Journal of Clinical Microbiology, August 2004, p. 3731-3733, Vol. 42, No. 8
0095-1137/04/$08.00+0     DOI: 10.1128/JCM.42.8.3731-3733.2004
Copyright © 2004, American Society for Microbiology. All Rights Reserved.

Evaluation of the QuickLab RSV Test, a New Rapid Lateral-Flow Immunoassay for Detection of Respiratory Syncytial Virus Antigen

Robert Slinger,^1* Rose Milk,² Isabelle Gaboury,³ and Francisco Diaz-Mitoma²

Children's Hospital of Eastern Ontario,¹ Eastern Ontario Regional Virology Laboratory,² Chalmers Research Group, Ottawa, Ontario K1H 8L1, Canada³

Received 6 January 2004/ Returned for modification 3 February 2004/ Accepted 22 April 2004

Rapid respiratory syncytial virus (RSV) diagnosis is vital to the prevention of nosocomial RSV infections. We evaluated a new rapid lateral-flow RSV immunoassay, the QuickLab RSV test, that requires use of only one reagent. We compared QuickLab to the Directigen RSV (DIR) assay, which requires six reagents, and direct fluorescent antibody (DFA) testing. DFA results were considered the "gold standard." For 133 nasopharyngeal aspirates tested, DFA results were 77 (57.8%) positive, 47 (35.3%) negative, and 9 (6.8%) indeterminate. The sensitivities, specificities, positive predictive values, and negative predictive values of QuickLab and DIR tests were 93.3% (70 of 75) and 80.8% (59 of 73), 95.6% (43 of 45) and 100.0% (46 of 46), 97.2% (70 of 72) and 100.0% (59 of 59), and 89.6% (43 of 48) and 76.7% (46 of 60), respectively. QuickLab was significantly (P = 0.02) more sensitive than DIR; the difference in specificities was not significant. DFA was more sensitive than DIR (P < 0.001) but not more sensitive than QuickLab (P = 0.45). The results of DIR testing were initially uninterpretable and required retesting with 15% of the specimens compared to 3% of QL results (P < 0.001). We conclude that the QuickLab RSV test has sensitivity similar to that of the DFA assay and better than that of the DIR assay. QuickLab testing is also simpler to perform and interpret than both DFA and DIR testing.

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* Corresponding author. Mailing address: Division of Infectious Disease, Children's Hospital of Eastern Ontario, 401 Smyth Rd., Ottawa, Ontario K1H 8L1, Canada. Phone: (613) 737-7600, ext. 2651. Fax: (613) 738-4832. E-mail: slinger{at}cheo.on.ca.

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Journal of Clinical Microbiology, August 2004, p. 3731-3733, Vol. 42, No. 8
0095-1137/04/$08.00+0     DOI: 10.1128/JCM.42.8.3731-3733.2004
Copyright © 2004, American Society for Microbiology. All Rights Reserved.

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