[The clinical usefulness of a newly rapid diagnosis kit, detection of respiratory syncytial virus].
ImmunoCard STAT! 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! RSV. One hundred fifty-nine nasal wash samples and nasopharyngeal aspirates from patients were used to evaluate three different kits, which are ImmunoCard STAT! RSV, RSV testpack (Abbott JAPAN) and Directigen EZ RSV (Nippon Becton, Dickinson and Company) . One hundred twenty-eight 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 RT-PCR. Compared to Nested RT-PCR results, ImmunoCard STAT! 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 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! RSV was 5.15 x 10(6) TCID50/mL in subgroup A strain and was 7.58 x 10(5) 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! RSV is useful in detecting RSV in a clinical setting with equivalent performance to conventional other detecting kits.
Department of Laboratory Medicine, Nihon University School of Medicine.
Kuniki
K
Hayashi
Takahisa
T
Uchiyama
Michiko
M
Iwat
Kazumitsu
K
Sano
Mitsuru
M
Yanai
Kazunari
K
Kumasaka
Yasuji
Y
Inamo
D005069:Evaluation Studies as Topic; D006801:Humans; D007118:Immunoassay; D009305:Nasopharynx / Q000821:virology; D011933:Reagent Kits, Diagnostic / Q000592:standards*; D015203:Reproducibility of Results; D018357:Respiratory Syncytial Virus Infections / Q000175:diagnosis*; D012136:Respiratory Syncytial Viruses / Q000302:isolation & purification*; D012680:Sensitivity and Specificity
D011933:Reagent Kits, Diagnostic