Evaluating the Diagnostic Performance of Two Rapid Influenza Diagnostic Tests
10.3343/lmo.2020.10.2.160
- Author:
Jin Ju KIM
1
;
Yonggeun CHO
;
Sang-Guk LEE
Author Information
1. Department of Laboratory Medicine, Severance Hospital, Yonsei University College of Medicine, Seoul, Korea
- Publication Type:Brief Report
- From:Laboratory Medicine Online
2020;10(2):160-164
- CountryRepublic of Korea
- Language:English
-
Abstract:
Rapid influenza diagnostic test (RIDT) is widely used for the diagnosis of influenza owing to its simplicity and convenience of use. This study aimed to evaluate the performance of a new RIDT, SD Standard F influenza A/B FIA (SD Biosensor, Inc., Korea) (Standard F) and compare its performance with BD Veritor Flu A+B (Veritor), using the results of real-time reverse transcription PCR (rRT-PCR) analysis as the standard for reference. On comparing the results obtained from both the RIDTs and rRT-PCR qualitatively, it was found that the Veritor and Standard F assays have the sensitivity of 65.6% (21/32) and 71.9% (23/32), respectively, for the detection of influenza A with a specificity of 100.0% (68/68). Additionally, both the assays demonstrated a sensitivity of 66.7% (12/18) and specificity of 100.0% (68/68) for the detection of influenza B. The cutoff index (COI) value of the fluorescence color intensity from the Standard F assay, displayed on the device along with the qualitative results, indicated a negative correlation with the Ct value from rRT-PCR for both influenza A and B (P<0.001). The sensitivity of the new RIDT for the detection of influenza was comparable with that of the Veritor assay and the new RIDT could be used as a substitute for existing RIDTs by providing additional information to predict the approximate viral burden of influenza.
