1. Intended Use
The Flu A+B Rapid Test Device is an in vitro diagnostic test for
the qualitative detection of influenza A and B nucleoprotein
antigens in nasopharyngeal (NP) swab, throat swab and nasal
aspirate samples, using the rapid immunochromatographic method. The
detection is based on the monoclonal antibodies specific for the
nucleoprotein of either Influenza virus A or B. It is intended to
aid in the rapid diagnosis of influenza A and B viral infection.
Negative results should be confirmed by other methods, such as cell
(1) The Flu A+B Rapid Test Device is an acute-phase screening test
for qualitative detection. Sample collected may contain antigen
titles below the reagent’s sensitivity threshold, so a negative
test result does not exclude infection with influenza.
(2) The Flu A+B Rapid Test Device detects both viable and
non-viable influenza antigens. Test performance depends on antigen
loaded in the sample and may not correlate with cell culture
performed on the same sample. A positive test does not rule out the
possibility that other pathogens may be present. Therefore,the
results must be compared with all other available clinical and
laboratory information to make an accurate diagnosis.
(3) Performance of the test has not been established for monitoring
antiviral treatment of influenza.
Hangzhou Laihe Biotech Co., Ltd
Address: Room 521 Floor 5 & Floor 1,Building No. 2B,Tianhe
High-Tech Park,No. 688,Bin'an Road,Changhe Sub-district,Binjiang
District,Hangzhou City,Zhejiang Province,China
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