Respiratory Syncytial Virus Rapid Test

Intended Use

Respiratory Syncytial Virus Rapid Test is an in vitro immunoassay for the direct and qualitative detection of respiratory syncytial virus (RSV) antigens from human nasal/nasopharyngeal swabs or nasal washes/aspirates. Respiratory Syncytial Virus Rapid Test is intended to aid in the rapid diagnosis of RSV infection. Negative results do not preclude RSV infection and should be confirmed via bacterial culture or molecular assay. The RSV Antigen Rapid Test Device is for professional use only.

Introduction

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.

Materials

● Individually packed test devices

● Extraction tube

● Swab

● Package insert

● RSV assay buffer

● Nozzle with filter

● Tube stand

Test Procedure

Bring devices, reagents and specimens and/or controls to room temperature (15~30℃) before use.

1. For each specimen swab, open the foil pouch just before testing and remove the test device, and put it on a clean, level surface. Label the tube with the patient identification. For best results, the assay should be performed within one hour.

2. Gently mix assay buffer. Add 10 drops into the extraction tube.

For Nasal/ Nasopharyngeal Swabs

a. Insert the swab into the extraction tube. Mix well and squeeze the swab several times by compressing the walls of the tube against the swab.

b. Roll the swab head against the inside of the tube as you remove it. Try to release as much liquid as possible. Dispose of the used swab in accordance with your biohazard waste disposal protocol.

For Nasal Wash/Aspirate

a. Vortex or thoroughly mix specimen. Do not centrifuge, as the removal of cellular material may adversely affect test sensitivity.

b. Transfer 300 uL of specimen into the extraction tube using transfer pipette.

3. Insert filtered nozzle into sample extraction tube. Invert the tube and add 2 drops (approximately 100 uL) of test sample into the sample well by gently squeezing the tube.

4. Read results at 15 minutes and disregard after 20 minutes.

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