Nanjing Synthgene Medical Technology Co., Ltd

【Product name】 FluA/FluB Antigen Rapid Test Kit (Colloidal gold method)  

【Packaging specification】 1 test/bag, 1/5/10/25/50 Test(s) /kit 

【Intended use】 FluA/FluB Antigen Rapid Test Kit (Colloidal gold method) is used for in vitro qualitative  detection of influenza A/B virus antigens in human nasal swab and oropharyngeal swab  samples. Influenza viruses include three types: A (Flu A), B (Flu B), and C (Flu C). Type A is the  most likely to cause epidemics, followed by type B, and type C rarely causes epidemics.  Influenza A virus can be divided into 16 subtypes (H1-H16) and 9 subtypes ( N1-N9).  Among influenza A viruses, there have been reports of human infection with subtypes H1,  H2, H3, H5, H7 and H9. Influenza virus is mainly transmitted by air droplets, often  causing fever, fatigue, muscle aches and mild to moderate respiratory symptoms. In  severe cases, it can cause pneumonia, myocarditis and heart failure.This product can be  used for the auxiliary diagnosis of influenza. The antigen detection reagents for each  subtype of influenza A virus can also be used to distinguish seasonal influenza viruses  from new influenza A viruses, and to obtain epidemiological information on influenza  outbreaks. Clinically, it is mainly used for the differential diagnosis of influenza A/B. This  product is suitable not only for professional medical personnel to test in medical  institutions, but also for consumer self-test. The traditional laboratory diagnostic technique is the isolation, culture and identification  of viruses. For rapid diagnosis of patients, indirect or direct immunofluorescence and  ELISA methods are used to detect viral antigens. Methods such as PCR, nucleic acid  hybridization, or sequence analysis are also used to detect influenza virus nucleic acid or  for typing

【Testing principle】 The product adopts the principle of double antibody sandwich. During detection, if there  is influenza A/B virus antigen in the sample, the influenza A/B virus antigen in the sample  is bound to the colloidal gold-labeled antibody (colloidal gold-chicken IgY-influenza A  monoclonal antibody 1 and colloidal gold-chicken IgY-influenza B monoclonal antibody  1 ) on the binding pad, to form a labeled antibody-antigen complex.The complex is  chromatographed upwards by capillary action and is captured by the detection area (A, B)  coated antibodies (Influenza A monoclonal antibody 2 and Influenza B monoclonal  antibody 2) on the nitrocellulose membrane, and red band(s) appear.  The complex continues to move forward and is captured by goat anti-chicken IgY  antibody coated on the quality control area (C) of the nitrocellulose membrane, and a red  band appears. When the content of analyte in the sample is lower than the minimum  detection limit, the detection area (A, B) does not develop color. 

【Main components】 

1.Test pad, individually packaged in aluminum foil bag (1 piece/bag, 1/5/10/25/50  piece(s)/kit) 

2. Sample diluent (1 piece/bag, 1/5/10/25/50 piece(s)/kit) 

3. Medical waste bag (1 piece/bag, 1/5/10/25/50 piece(s)/kit)  

4. Extraction tube (1 piece/bag, 1/5/10/25/50 piece(s)/kit) 

5. Instruction manual (1 copy/bag, 1 copy/kit) 

Note: The components in different batch numbers of kits are not interchangeable.

【Sample requirements】

Sample collection 

Nasal swab: First, blow the nose with toilet paper, carefully unpack the nasal swab, and avoid touching  the swab head. Raise the head slightly, hold the swab tail in one hand, and slowly insert  the swab 1-1.5 cm into one nasal cavity (for subjects aged 2-14 years, 1 cm deep), then  rotate at least 4 times (with a duration of not less than 15 seconds). Next, repeat the same  operation for the other nasal cavity using the same swab.