Lab Med Online.  2020 Apr;10(2):160-164. 10.3343/lmo.2020.10.2.160.

Evaluating the Diagnostic Performance of Two Rapid Influenza Diagnostic Tests

• Kim JJ
• Cho Y
• Lee SG

• KMID: 2512247
• DOI: http://doi.org/10.3343/lmo.2020.10.2.160

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.

Keyword

Influenza; Rapid diagnostic test; Evaluation; BD Veritor; SD Standard F

Figure

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  Fig. 1 Comparison of cycle threshold (Ct) values of the influenza-positive specimens. (A), influenza A: N=32 and (B), influenza B: N=18. Specimens with negative RIDT results are indicated by an empty box. The maximum Ct value with positive RIDT result was 20.31 and 13.26 for influenza A and B, respectively. Abbreviations: rRT-PCR, real-time reverse transcription polymerase chain reaction; RIDT, rapid influenza diagnostic test; Veritor, BD Veritor assay; Standard F, SD Standard F assay.

• 

  Fig. 2 Correlation of cutoff index (COI) values obtained from SD Standard F assay with cycle threshold (Ct) values of influenza-positive specimens. (A), influenza A and (B), influenza B. Abbreviation: rRT-PCR, real-time reverse transcription polymerase chain reaction.

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