Evaluation of an Immunochromatographic Assay for the Rapid and Simultaneous Detection of Rotavirus and Adenovirus in Stool Samples.
10.3343/alm.2014.34.3.216
- Author:
Jayoung KIM
1
;
Hyun Soo KIM
;
Han Sung KIM
;
Jae Seok KIM
;
Wonkeun SONG
;
Kyu Man LEE
;
Sunhwa LEE
;
Kyoung Un PARK
;
Woochang LEE
;
Young Jun HONG
Author Information
1. Department of Laboratory Medicine, College of Medicine, The Catholic University of Korea, Seoul, Korea.
- Publication Type:Original Article ; Evaluation Studies ; Research Support, Non-U.S. Gov't
- Keywords:
Rotavirus;
Immunochromatographic assay;
ELISA;
PCR
- MeSH:
Acute Disease;
Adenoviridae/genetics/*immunology/isolation & purification;
Cross Reactions;
DNA, Viral/analysis;
Enzyme-Linked Immunosorbent Assay;
Feces/*virology;
Gastroenteritis/diagnosis/virology;
Humans;
*Immunochromatography;
Multiplex Polymerase Chain Reaction;
RNA, Viral/analysis;
Reagent Kits, Diagnostic;
Reproducibility of Results;
Reverse Transcriptase Polymerase Chain Reaction;
Rotavirus/genetics/*immunology/isolation & purification
- From:Annals of Laboratory Medicine
2014;34(3):216-222
- CountryRepublic of Korea
- Language:English
-
Abstract:
BACKGROUND: We evaluated the analytical and clinical performances of the SD BIOLINE Rota/Adeno Rapid kit (SD Rota/Adeno Rapid; Standard Diagnostics, Inc., Korea), an immunochromatographic assay (ICA), for the simultaneous detection of rotaviruses and adenoviruses in human stool samples. METHODS: We tested 400 clinical stool samples from patients with acute gastroenteritis and compared the ICA results with the results obtained by using ELISA, enzyme-linked fluorescent assays (ELFA), PCR, and multiplex reverse transcription-PCR (mRT-PCR). To assess the analytical performance of the SD BIOLINE Rota/Adeno Rapid kit, we determined its detection limit, reproducibility, cross-reactivity, and analytical reactivity for adenovirus subtypes, and performed interference studies. RESULTS: The overall agreement rates among the tested methods were 91.5% for rotavirus and 85.5% for adenovirus. On the basis of mRT-PCR, the overall agreement, positive agreement, and negative agreement rates of the ICA were 95.6%, 100%, and 94.9% for rotavirus, and 94.0%, 71.4%, and 94.8% for adenovirus, respectively. Using the ICA, we detected all the subtypes of adenovirus tested, but the analytical reactivities for adenovirus subtypes were different between the 4 adenovirus detection methods. The high reproducibility was confirmed, and no cross-reactivity or interference was detected. CONCLUSIONS: The SD BIOLINE Rota/Adeno Rapid kit showed acceptable analytical and clinical performances. However, interpretation of adenovirus positive/negative result should be cautious because of different detectability for adenovirus subtypes among adenovirus detection methods.
