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RSV Antigen Rapid Test

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RSV Antigen Rapid Test

A rapid test for the qualitative detection of respiratory syncytial virus antigens in nasal swab and nasal aspirate specimenss.

For professional In Vitro Diagnostic Use Only.


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INTENDED USE

The RSV Rapid Test Device is an in vitro diagnostic test for the qualitative detection of Respiratory Syncytial Virus antigens in Nasal Swab and nasal aspirate samples, using the rapid immunochromatographic method.The identification is based on the monoclonal antibodies specific for the F protein of the Respiratory Syncytial Virus. It will provide information for clinical doctors to prescribe correct medications. Negative results should be confirmed by other methods, such as cell culture.

SUMMARY

RSV is a negative single-stranded RNA virus of the Paramyxoviridae family1. It is the causative agent of a highly contagious,acute,viral infection of the respiratory tract.Worldwide,RSV contributes to the deaths of up to 1,000,000 infants and children under the age of five each year2. It is also the major viral cause of nosocomial illness in children already hospitalized for other reasons3. Among children hospitalized with RSV infection, the mortality rate is estimated to be as low as 0.3% to 1.0%4 and in the range of 2.5% to 4.0% for children with underlying cardiac or pulmonary disease5. RSV infection confers only limited protective immunity.Thus,persons can be repeatedly infected and develop serious disease throughout their lifetime6.

RSV has only one serotype, and is divided into two antigenic subgroups, A and B7.Both groups circulate simultaneously in the community. Subtype B is characterized as the asymptomatic strains of the virus that the majority of the population experiences. The more severe clinical illnesses involve subtype A strains, which tend to predominate in most outbreaks. RSV may be suspected based on the time of year of the infection; prevalence usually coincides with the winter flu season.

RSV can be tested in lab using respiratory secretions.Sensitivity of virus isolation from respiratory secretions in cell culture varies among laboratories.High sensitive RT-PCR assays should be considered when testing adults,because they may have low viral loads in their respiratory specimens. Although useful for research,serologic tests are less frequently used for diagnosis. Seroconversion does not occur for at least 2 weeks and may require 4~6 weeks. Most clinical laboratories currently utilize antigen detection tests. Antigen detection tests and culture are generally reliable in young children but less useful in older children and adults.

The RSV Antigen Rapid Test Device is a simple lateral flow immunoassay for the direct detection of RSV antigens. It will provide a presumptive diagnosis of RSV infection.

DIRECTIONS FOR USE

Allow the test device, test sample and buffer to equilibrate to room temperature (15-30°C) prior to testing. Please refer to procedure card in this kit.

1) Remove test device from the sealed pouch just prior to the testing and lay flat on work bench.

2) Insert a nozzle with filter into the sample extraction tube tightly.

3) Reverse the sample extraction tube,and add 3 drops (about 100μl) of test sample by squeezing the extracted solution tube into the sample window.

4) Read result at 15 minutes..

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