INTENDED USE

The Influenza A/B+RSV Antigen Rapid Test Kit (Nasal Swab Test)is a lateral flow chromatographic immunoassay for the qualitative detection of Influenza A/B and Respiratory Syncytial Virus in human oropharyngeal swab, nasopharyngeal swabs and Anterior nasal swab specimens. It is suitable for the auxiliary diagnosis of Influenza A/B and Respiratory Syncytial Virus infection.

INTRODUCTION

Influenza is a highly contagious, acute, viral infection of the respiratory tract. The causative agents of the disease are immunologically diverse, single-strand RNA viruses known as influenza viruses. There are three types of influenza viruses: A, B, and C. Type A viruses are the most prevalent and are associated with most serious epidemics. Type B viruses produce a disease that is generally milder than that caused by type A. Type C viruses have never been associated with a large epidemic of human disease. Both type A and B viruses can circulate simultaneously, but usually one type is dominant during a given season. Influenza antigens may be detected in clinical specimens by immunoassay. The Influenza A+B Test is a lateral-flow immunoassay using highly sensitive monoclonal antibodies that are specific for influenza antigens. The test is specific to influenza types A and B antigens with no known cross-reactivity to normal flora or other known respiratory pathogens.
Respiratory Syncytial Virus(RSV) is the most common cause of bronchiolitis and pneumonia among infants and children under 1 year of age.IIIness begins most frequently with fever,runny nose,cough and sometimes wheezing. Severe lower respiratory tract disease may occur at any age,especially among the elderly or among those with compromised cardiac, pulmonary or immune systems.RSV is spread from respiratory secretions through close contact with infected persons or contact with contaminated surfaced or objects.

PRINCIPLE

The Influenza A/B+RSV Antigen Rapid Test Kit is based on the principle of a qualitative immunochromatographic assay for the determination of Influenza A/B+RSV antigens in the Nasal Sawb specimen.
StripA consists of: Anti-influenza A and B antibodies are immobilized on the test region A and B of the membrane respectively. During testing, the extracted specimen reacts with anti- influenza A and B antibodies conjugated to colored particles and precoated onto the sample pad of the test. The mixture then migrates through the membrane by capillary action and interacts with reagents on the membrane. If there is sufficient influenza A and B viral antigens in the specimen, colored band(s) will form at the according test region of the membrane.
Strip B consists of : 1) a burgundy colored conjugate pad containing recombinant antigen conjugated with colloid gold (monoclonal mouse anti Respiratory Syncytial Virus(RSV) antibody conjugates) and rabbit IgG-gold conjugates, 2) a nitrocellulose membrane strip containing test band (T bands) and a control band (C band). The T band is pre-coated with monoclonal mouse anti- Respiratory Syncytial Virus(RSV) antibody for the detection of Respiratory Syncytial Virus(RSV) glycoprotein F antigen, and the C band is pre-coated with goat anti rabbit IgG.

Strip A:The mixture then migrates through the membrane by capillary action and interacts with reagents on the membrane. If there is sufficient influenza A and B viral antigens in the specimen, colored band(s) will form at the according test region of the membrane. The presence of a colored band in the A and/or B region indicates a positive result for the particular viral antigens, while its absence indicates a negative result. The appearance of a colored band at the control region serves as a procedural control, indicating that the proper volume of specimen hasbeen added and membrane wicking has occurred.

Strip B:When an adequate volume of test specimen is dispensed into the sample well of the test cassette, the specimen migrates by capillary action across the cassette. Respiratory Syncytial Virus(RSV) if present in the specimen will bind to the monoclonal mouse anti-Respiratory Syncytial Virus(RSV) antibody conjugates. The immunocomplex is then captured on the membrane by the pre-coated mouse anti-Respiratory Syncytial Virus(RSV) antibody, forming a burgundy colored T band, indicating a Respiratory Syncytial Virus(RSV) antigen positive test result. Absence of test band (T) suggests a negative result. The test contains an internal control (C band) which should exhibit a burgundy colored band of the immunocomplex of goat anti rabbit IgG/rabbit IgG-gold conjugate regardless of the color development on any of the test bands. Otherwise, the test result is invalid, and the specimen must be retested with another device.