title: Evaluation of the SD Bioline Norovirus rapid immunochromatography test using fecal specimens from Korean gastroenteritis patients.
abstract: The analytical and clinical performance of a new rapid immunochromatography test, the SD Bioline Norovirus test, was evaluated for the detection of human norovirus in fecal specimens. The analytical performance studies were performed for detection limit, reproducibility, cross-reactivity, and interference. For comparison, 92 norovirus-positive stool samples and 126 norovirus-negative samples for which the results were confirmed by 2 different real-time PCR kits were used. The rapid immunochromatography test detected the equivalent of 4.48×10(6) copies/mL of the norovirus genome in stool samples. On performing the repeatability/reproducibility test, samples above this concentration all provided positive results (100%) and 97.8% of the samples slightly below this concentration (2.45×10(6) copies/mL) provided negative results. No cross-reactivity or interference was detected. Positive percent agreement (sensitivity), negative percent agreement (specificity), and overall percent agreement of the rapid immunochromatography test compared with testing by real-time PCR were 90.2%, 100%, and 95.9%, respectively. In addition, the rapid immunochromatography test was completed within 20 min. The SD Bioline Norovirus test was, therefore, easier and more rapid to perform and showed excellent reproducibility, no cross-reactivity, no interference, and high agreement compared with real-time PCR. Thus, this test is useful for rapid screening to identity norovirus infection.
authors.affiliation: Department of Laboratory Medicine, Hallym University College of Medicine, Seoul, Republic of Korea. hskim0901@empal.com
authors.forename: Hyun Soo
authors.initials: HS
authors.lastname: Kim
authors.forename: Jeongwon
authors.initials: J
authors.lastname: Hyun
authors.forename: Jae-Seok
authors.initials: JS
authors.lastname: Kim
authors.forename: Wonkeun
authors.initials: W
authors.lastname: Song
authors.forename: Hee Jung
authors.initials: HJ
authors.lastname: Kang
authors.forename: Kyu Man
authors.initials: KM
authors.lastname: Lee
mesh_terms: D017250:Caliciviridae Infections / Q000175:diagnosis*; D002675:Child, Preschool; D002846:Chromatography, Affinity / Q000379:methods*; D003429:Cross Reactions; D005243:Feces / Q000821:virology*; D005260:Female; D005759:Gastroenteritis / Q000821:virology*; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D008297:Male; D029322:Norovirus / Q000302:isolation & purification*; D015203:Reproducibility of Results; D056910:Republic of Korea; D012680:Sensitivity and Specificity; D013997:Time Factors