Clinical Lab Handbook

This test is suitable for the pediatric population (less than 7 years of age) only.

Note: RSV Collection Kit is available from laboratory (directions included).

Specimen: Nasopharyngeal Aspirate/Wash Sample

Specimen Viability: Saline nasal wash 24 hours @ 2-8°C or 4 hours room temperature.

Minimum Volume:1 mL

Immunochromatographic Membrane Assay

The Sofia RSV FIA employs immunofluorescence for detection of respiratory syncytial virus (RSV) nucleoprotein antigen in nasopharyngeal swab and nasopharyngeal aspirate/wash specimens taken directly from symptomatic patients 7 years old or less. This qualitative test is intended for use as an aid in the rapid diagnosis of acute RSV infections in pediatric patients. Negative results do not preclude RSV infection and should not be used as the sole basis for treatment or for other management decisions. A negative result is presumptive, and it is recommended these results be confirmed by viral culture or an FDA-cleared RSV molecular assay.

RSV is a causative agent of highly contagious, acute, viral infection of the respiratory tract in pediatric and elderly populations. Respiratory syncytial virus is a single-stranded RNA virus.1 Nearly half of all children become infected with RSV in their first year of life. It is also the major viral cause of nosocomial illness in children already hospitalized for other reasons.2 In the United States, RSV is estimated to be responsible for 73,400 to 126,300 hospitalizations annually for bronchiolitis and pneumonia alone among children younger than 1 year.3 In an analysis of U.S. viral surveillance and mortality data, respiratory syncytial virus (RSV) was reported as the most common viral cause of death in children younger than 5 years when compared to influenza A H1N1, influenza A H3N2, and influenza B.4 Among children hospitalized with RSV infection, the mortality rate is estimated to be as low as 0.3% to 1.0%3, 5 and in the range of 2.5% to 4.0% for children with underlying cardiac or pulmonary disease.

Negative

A negative result does not exclude RSV viral infection. It is recommended that negative results be confirmed by viral culture or an FDA-cleared RSV molecular assay. A negative test result may occur if the level of antigen in a sample is below the detection limit of the test or if the sample was collected or transported improperly.

Monday through Sunday

Available STAT

87807

Follow your institution's Lippincott protocol for obtaining nasopharyngeal aspirate/wash samples. Use the minimal amount of saline that your procedure allows.

To collect a nasopharyngeal aspirate sample:

1. Instill a few drops of sterile saline into the nostril to be suctioned.
2. Insert the flexible plastic tubing along the nostril floor, parallel to the palate.
3. After entering the nasopharynx, aspirate the secretions while removing the tubing. The procedure should be repeated for the other nostril if inadequate secretions were obtained from the first nostril.

To collect a nasopharyngeal wash sample:

1. A child could sit in the parent’s lap facing forward, with the child’s head against the parent’s chest.
2. Fill the syringe or aspiration bulb with the minimal volume of saline required per the subject’s size and age.
3. Instill the saline into one nostril while the head is tilted back.
4. Aspirate the wash sample back into the syringe or bulb. The aspirated wash sample will likely be approximately 1 cc in volume. Alternatively, following instillation of the saline, tilt the head forward and let the saline drain out into a clean collection cup.