The Sofia RSV Fluorescent Immunoassay (FIA) uses advanced immunofluorescence-based lateral-flow technology to detect respiratory syncytial virus (RSV) nucleoprotein antigen directly from nasopharyngeal swab and nasopharyngeal aspirate/wash specimens from symptomatic patients. The high sensitivity of the Sofia RSV FIA offers confidence in rapid RSV testing.
The Sofia RSV FIA involves the disruption of RSV viral antigens. To perform the rapid respiratory test, the patient specimen is placed in the Reagent Tube, during which time the virus particles in the specimen are disrupted, exposing internal viral nucleoproteins. After disruption, the specimen is dispensed into the Cassette sample well. From the sample well, the specimen migrates through a test strip containing various unique chemical environments. If RSV viral antigens are present, they will be trapped in a specific location.
Sofia will scan the test strip and measure the immunofluorescent signal by processing the results using method-specific algorithms and display the test results (Positive, Negative, or Invalid) on its display screen. The test results can also be automatically printed on an integrated printer if this option is selected.
An internal control line helps ensure that the rapid test has been executed properly, that the kit reagents are performing appropriately, and that adequate flow has occurred through the test strip. Another fluorescent line should form at the Control position on the test strip each time a specimen or control is tested. If no control line is detected, the test will be reported as invalid by Sofia. The enhanced sensitivity of the Sofia RSV FIA gives you accuracy and confidence in rapid testing.
The Sofia RSV FIA – a trusted rapid RSV test kit – is one in a growing menu of the fluorescent antibody tests available for use on Sofia. This easy-to-use qualitative fluorescent test can be used as an aid in the rapid diagnosis of acute RSV infections in pediatric patients.
Features & Benefits
Feature
Benefit
Compatible with Influenza A+B Extraction Reagent
A single specimen can be used to run both Sofia RSV FIA and Sofia Influenza A+B FIA
Dual work modes
Flexible work flow options give users the control based on their work demand
Self-contained test cassette
Clean, easy to use and disposible
Fixed-volume pipette
Collects and dispenses correct amount of sample needed for testing
Objective result
Eliminates the subjectivity of a visual result interpretation
All components included in kit
Ready to use with Sofia, no need for additional equipment
Room temperature storage
No refrigerator space needed. No need to wait for reagents to warm up.
Product Specifications
Sample type
Nasopharyngeal swab, aspirate/wash
Time to results
15 minutes
Kit storage conditions
Room temperature (15 °C to 30 °C/59 °F to 86 °F)
Controls
Positive and negative
Nasopharyngeal swab sensitivity*
86 % [Ages 0 to less than 19 years]; (CLIA Waiver Studies: 87% [Ages 0 to less than 7 years])
Nasopharyngeal swab specificity*
97 % [Ages 0 to less than 19 years]; (CLIA Waiver Studies: 96% [Ages 0 to less than 7 years])
Aspirate/wash sensitivity*
89 % [Ages 0 to less than 19 years]; (CLIA Waiver Studies: 92% [Ages 0 to less than 7 years])
Aspirate/wash specificity*
98 % [Ages 0 to less than 19 years]; (CLIA Waiver Studies: 98% [Ages 0 to less than 7 years])
Nasopharyngeal swab sensitivity – VTM*
87 %
Nasopharyngeal swab specificity – VTM*
97 %
Aspirate/wash sensitivity – VTM*
88 %
Aspirate/wash specificity – VTM*
98 %
Shelf life
24 months from date of manufacture
CLIA complexity
Moderately Complex for pediatric patients 7 to less than 19 years of age; WAIVED for children less than 7 years of age
