J Lab Med Qual Assur 2013; 35(2): 107-114
Published online December 31, 2013
Copyright © Korean Association of External Quality Assessment Service.
Hyun Soo Kim, Ji Sun Noh, Jeongwon Hyun, Han-Sung Kim, Jae-Seok Kim, Wonkeun Song, and Kyu Man Lee
Department of Laboratory Medicine, Hallym University Dongtan Sacred Heart Hospital, Hallym University College of Medicine, Hwaseong, Korea
Correspondence to:Hyun Soo Kim
Department of Laboratory Medicine, Hallym University Dongtan Sacred Heart Hospital, Hallym University College of Medicine, 7 Keunjaebonggil, Hwaseong 445-170, Korea Tel: +82-31-8086-2775 Fax: +82-31-8086-2789 E-mail: firstname.lastname@example.org
Background: Rotaviruses are the primary cause of severe acute gastroenteritis in infants and young children worldwide. We evaluated the performance of the new GENEDIA Rotavirus Ag Rapid test (Greencross Medical Science, Korea) immunochromatographic assay (ICA) for detecting human rotavirus in stool specimens, in comparison with ELISA and PCR assays.
Methods: One hundred rotavirus-positive stool samples and 150 rotavirus-negative stool samples, confirmed by ELISA and PCR tests, were analysed using the GENEDIA Rotavirus Ag rapid test. The positive agreement (sensitivity), negative agreement (specificity), and total agreement rates of the ICA compared to ELISA and PCR were determined. To assess the analytical performance of the ICA, we tested its detection limit, reproducibility, and cross-reactivity.
Results: The positive, negative, and total agreement rates of the ICA were 99%, 100%, and 99.6%, respectively, when compared with the results confirmed by ELISA and PCR. The total turnaround time of the ICA was less than 20 minutes. The lower limit of detection of the ICA for rotavirus was 1.33×103 TCID50/mL, which was similar to that of ELISA but higher than that of PCR. No cross-reactivity was detected for 11 viruses and 19 bacteria.
Conclusions: The GENEDIA Rotavirus Ag rapid test was easy to perform and provided rapid results, which showed high agreement with those obtained using ELISA and PCR. This test appears to be a useful tool for the diagnosis of rotavirus infection. (J Lab Med Qual Assur 2013;35:107-14)
Keywords: Rotavirus, Immunochromatography, Enzyme-linked immunosorbent assay, Polymerase chain reaction