title: Comparison of the Anyplex(TM) II RV16 and Seeplex(®) RV12 ACE assays for the detection of respiratory viruses.
abstract: The Anyplex(TM) II RV16 detection kit (RV16; Seegene, Seoul, South Korea) is a multiplex real-time PCR assay based on tagging oligonucleotide cleavage extension. In this prospective study, we evaluated the RV16 assay by comparing with the Seeplex(®) RV12 ACE detection kit (RV12; Seegene), a multiplex end-point PCR kit. A total of 365 consecutive respiratory specimens were tested with both RV16 and RV12 assays in parallel and detected 140 (38.4%) and 89 (24.4%) positive cases, respectively. The positive percent agreement, negative percent agreement, and kappa values for the 2 assays were 95.6% (95% confidence interval [CI], 89.4-98.3%), 80.4% (95% CI, 75.3-84.6%), and 0.64 (95% CI, 0.56-0.72), respectively. The monoplex PCR and sequencing for the samples with discrepant results revealed that majority of the results were concordant with the results from RV16 assays. In conclusion, the RV16 assay produces results comparable to the RV12 assay.
authors.affiliation: Department of Laboratory Medicine and Genetics, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.
authors.forename: Hee Jae
authors.initials: HJ
authors.lastname: Huh
authors.affiliation: Department of Laboratory Medicine and Genetics, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.
authors.forename: Kyung Sun
authors.initials: KS
authors.lastname: Park
authors.affiliation: Center for Clinical Medicine, Samsung Biomedical Research Institute, Samsung Medical Center, Seoul, Republic of Korea.
authors.forename: Ji-Youn
authors.initials: JY
authors.lastname: Kim
authors.affiliation: Center for Clinical Medicine, Samsung Biomedical Research Institute, Samsung Medical Center, Seoul, Republic of Korea.
authors.forename: Hyeon Jeong
authors.initials: HJ
authors.lastname: Kwon
authors.affiliation: Department of Laboratory Medicine and Genetics, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.
authors.forename: Jong-Won
authors.initials: JW
authors.lastname: Kim
authors.affiliation: Department of Laboratory Medicine and Genetics, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea. Electronic address: changski@skku.edu.
authors.forename: Chang-Seok
authors.initials: CS
authors.lastname: Ki
authors.affiliation: Department of Laboratory Medicine and Genetics, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.
authors.forename: Nam Yong
authors.initials: NY
authors.lastname: Lee
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002648:Child; D002675:Child, Preschool; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D008875:Middle Aged; D060885:Multiplex Polymerase Chain Reaction / Q000379:methods; D011446:Prospective Studies; D060888:Real-Time Polymerase Chain Reaction / Q000379:methods; D015203:Reproducibility of Results; D012141:Respiratory Tract Infections / Q000175:diagnosis* / Q000821:virology*; D012680:Sensitivity and Specificity; D014780:Viruses / Q000235:genetics*; D055815:Young Adult
keywords: Korea; Multiplex real-time PCR; Respiratory virus; Validation