Virology
Performance of the Influ a + B K-SeT® assay as compared to two RT-PCR assays for detection of influenza virus,☆☆,☆☆☆

https://doi.org/10.1016/j.diagmicrobio.2020.115097Get rights and content

Highlights

  • We evaluated performance of a rapid influenza antigen detection kit, Influ A + B K-SeT®.

  • Influ A + B K-SeT® kit's results were compared with two RT-PCR based assays.

  • The sensitivity and specificity of the Influ A + B K-SeT® kit were 91.2–94.5% and 98.2%, respectively

  • Influ A + B K-SeT® kit's implementation as a point-of-care will aid in decision-making.

  • Using the kit will minimize time-to-result and reduce healthcare costs.

Abstract

Objectives

To evaluate the performance of Influ A + B K-SeT®, a rapid influenza antigen detection kit, in order to determine whether its implementation as a point-of-care test in the emergency room (ER) is justified.

Methods

Nasopharyngeal swabs (n = 170) were collected in triplicates from patients with suspected influenza infection. One sample was tested by the Influ A + B K-SeT® kit and the other two samples were analyzed with Simplexa™ Flu A/B & RSV Direct Kit and Xpert® Flu, two RT-PCR-based assays routinely used in the ER.

Results

The sensitivity and specificity of the Influ A + B K-SeT® kit were 91.2%–94.5% and 98.2%, respectively, compared to the Xpert® Flu assay and the Simplexa™ Flu A/B & RSV Direct Kit, respectively.

Conclusions

Considering the satisfactory diagnostic performance of the Influ A + B K-SeT® test, its implementation as a point-of-care is expected to aid in decision-making, minimize time-to-result and reduce healthcare costs.

Section snippets

Background

Influenza is an infectious disease of the respiratory tract that is caused by viruses from the Orthomyxoviridae family of RNA viruses (Monto et al., 2000; Kreijtz et al., 2011). The infection involves symptoms of the upper or the lower respiratory tract, as well as fever, headache, myalgia and weakness.

Three types of influenza viruses exist: A, B and C. Most of the pandemics of the 20th-21st century were caused by influenza A, which infects humans, pigs, horses, birds and other species (Song et

Sample collection

Nasopharyngeal swabs (n = 170) were collected in triplicates with flocked swabs, into universal transport medium (UTM) tube- UTM™ (Copan Diagnostics, Inc., CA, USA), from patients, aged 18-97, with suspected influenza infection, admitted to the emergency room at the Poriya Baruch Padeh Medical Center, between September 2017 and March 2020. Patients included 97 men and 73 women.

For each patient, one sample was tested with the Influ A+B K-SeT® (Coris Bioconcept, Gembloux, Belgium) test in the

Results

A total of 170 nasopharyngeal swabs were collected in triplicates; 57 (33.5%) samples were found positive and 113 (66.5%) samples were found negative for influenza A/B by the Xpert® Flu assay (Table 1). When analyzed by the Simplexa™ Flu A/B & RSV Direct Kit assay, two (1.2%) samples had an invalid result, 55 (32.3%) samples were positive and 113 (66.5%) samples were negative.

Five (2.9%) samples had a false negative result and 2 (1.2%) samples were false positive when analyzed by the Influ A+B

Discussion

RIADTs offer a rapid diagnosis that allows for earlier antiviral intervention and minimization of antibiotic abuse. Furthermore, the use of RIADTs reduces the need for additional laboratory tests, and healthcare costs (Woo et al., 1997; Chan et al., 2009; Pollock et al., 2009; Taylor et al., 2009; Reynders et al., 2012). The current study compared the performance of the Influ A+B K-SeT® RIADT assay to those of two RT-PCR-based assays routinely used for influenza diagnosis in our laboratory. The

Conclusions

Taken together, the current study demonstrated a good performance of the Influ A+B K-SeT® assay, and justifies its implementation as a point-of-care test in the emergency room. This is expected to improve patient care, decrease turnaround time, reduce the use of other laboratory tests and minimize the associated healthcare costs. Future research will be required to test the effect of sensitivity-impacting factors on the performance of the Influ A+B K-SeT® assay.

References (18)

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Declaration of interests: none.

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Author contributions: AP: Conceptualization; Data curation; Formal analysis; Funding acquisition; Project administration; Supervision; Validation; Visualization; Roles/Writing - original draft; Writing - review & editing. BSZ: Conceptualization; Data curation; Formal analysis; Investigation; Methodology; Writing - review & editing; MA: Conceptualization; Data curation; Formal analysis; Supervision; Validation; Visualization; Roles/Writing - original draft; Writing - review & editing.

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Funding: This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors.

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