Respiratory Syncytial Virus Antigen Rapid Test

INTENDED USE

The Respiratory Syncytial Virus Antigen Rapid Test is a rapid chromatographic immunoassay for the qualitative detection of Respiratory Syncytial Virus (RSV) antigen in human nasopharyngeal swab, or oropharyngeal swab specimen.

SUMMARY

Respiratory Syncytial Virus (RSV), which causes infection of the lungs and breathing passages, is a major cause of respiratory illness in young children. In adults, it may only produce symptoms of a common cold, such as a stuffy or runny nose, sore throat, mild headache, cough, fever, and a general feeling of being ill. But in premature babies and kids with diseases that affect the lungs, heart, or immune system, RSV infections can lead to other more serious illnesses. RSV is highly contagious and can be spread through droplets containing the virus when someone coughs or sneezes. It also can live on surfaces (such as countertops or doorknobs) and on hands and clothing, so it can be easily spread when a person touches something contaminated. RSV can spread rapidly through schools and childcare centers. Babies often get it when older kids carry the virus home from school and pass it to them. Almost all kids are infected with RSV at least once by the time they're 2-3 years old. RSV infections often occur in epidemics that last from late fall through early spring. Respiratory illness caused by RSV — such as bronchiolitis or pneumonia — usually lasts about a week, but some cases may last several weeks.

The Respiratory Syncytial Virus Antigen Rapid Test is designed as a simple tool in detection of RSV for regular clinical diagnosis.

MATERIALS

Materials Provided

1) Foil pouches, each contains one test cassette, and one desiccant bag

2) Assay buffer tubes (0.5ml each) with tips

3) Sterile swabs (each bag contains one nasopharyngeal swab and one oropharyngeal swab)

4) Paper tube holder

5) Instruction for use

Materials Required But Not Provided

1)Timer

TEST PROCEDURE

Allow the rapid test, specimen, buffer, and/or controls to equilibrate to room temperature (15-30°C) prior to testing.

1. 1. Bring the pouch to room temperature before opening. Remove the rapid test cassette from the sealed pouch and use it as soon as possible.
2. 2. Place the test device on a clean and horizontal surface. Reverse the specimen collection tube, extrude 3 drops of the prepared specimen into the specimen well (S) of the test cassette and start the timer.
3. 3. Wait for the colored line(s) to appear. Read results at 8-10 minutes. Do not interpret the result after 15 minutes.

PRINCIPLE

The Respiratory Syncytial Virus Antigen Rapid Test is consist with one test strips which could be observed in the window of the rapid test cassette. The strip is based on sandwich method immunochromatographic assay. The generic RSV antigens are targeted individually.

In the test strip, anti-RSV monoclonal antibodies are coated in the test lines and conjugated with the colloidal gold. During testing, the specimen reacts with the anti-RSV antibodies conjugate in the test strip. The mixture then migrates upward on the membrane chromatographically by capillary action and reacts with the pre-coated RSV monoclonal antibodies in the test regions.

To serve as a procedural control, a colored line will always appear at the control line regions(C) indicating that proper volume of specimen has been added and membrane wicking has occurred.

INTERPRETATION OF RESULTS

POSITIVE: Two or three colored bands appear on the membrane. One band appears in the control region (C) and another band appears in the test region (T).

NEGATIVE: Only one colored band appears in the control region (C). No apparent colored band appears in the test region (T).

INVALID: Control band fails to appear. Results from any test which has not produced a control band at the specified read time must be discarded. Please review the procedure and repeat with a new test. If the problem persists, discontinue using the kit immediately and contact your local distributor.

NOTE:

1. The intensity of color in the test region (T) may vary depending on the concentration of analytes present in the specimen. Therefore, any shade of color in the test region should be considered positive. Note that this is a qualitative test only, and cannot determine the concentration of analytes in the specimen.
2. Insufficient specimen volume, incorrect operating procedure or expired tests are the most likely reasons for control band failure.
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