The Clinical Usefulness of a Newly Rapid Diagnosis Kit, Detection of Respiratory Syncytial Virus

Abstract

ImmunoCard STAT!^TM RSV (Meridian Bioscience, Inc, USA) is a rapid immunoassay method newly developed for detection of respiratory syncytial virus (RSV) by immunochromatography. We carried out an evaluation of the ImmunoCard STAT!^TM RSV.
One hundred fifty-nine nasal wash samples and nasopharyngeal aspirates from patients were used to evaluate three different kits, which are ImmunoCard STAT!^TM RSV, RSV testpack (Abbott JAPAN) and Directigen^TM EZ RSV (Nippon Becton, Dickinson and Company). One hundred twentyeight samples showed equivalent results.
When nested reversed transcription-PCR (nested RT-PCR) results for 31 samples showing discrepancies among three kits, 10 samples were positive, and 21 samples were negative by nested RTPCR. Compared to Nested RT-PCR results, ImmunoCard STAT!^TM RSV showed a sensitivity of 90.5% (19/21) and a specificity of 80.0% (8/10), as well as RSV testpack showed a sensitivity of 10.0% (2/21) and a specificity of 100% (10/10), Directigen^TM EZ RSV showed 95.2% (20/21) and 0.0% (0/10), respectively.
Furthermore, the detection limits were also evaluated by using ACTT No. VR1540 for RSV A-2 strain, and ACTT No. VR1401 for Wash strain.
The detection limit of ImmunoCard STAT!^TM RSV was 5.15×10⁶ TCID₅₀/mL in subgroup A strain and was 7.58×10⁵ TCID₅₀/mL in subgroup B strain. This result was similar to RSV testpack, and was better than the detection limit of Directigen EZ RSV.
It is concluded that ImmunoCard STAT!^TM RSV is useful in detecting RSV in a clinical setting with equivalent performance to conventional other detecting kits.