QuickVue RSV test kit (Quidel 20193) is a rapid in vitro diagnostic test that aids in the detection of respiratory syncytial virus (RSV) infection in pediatric patients 18 years of age and younger. The dipstick immunoassay uses nasopharyngeal swab, nasopharyngeal aspirate, or nasal/nasopharyngeal wash specimens and provides results in about 15 minutes.
Each kit contains 20 tests and includes all reagents, controls, and collection swabs needed to perform the assay. The test is CLIA waived and is designed for use in professional healthcare settings where timely RSV results support evaluation and management during respiratory illness season.
Who uses this product
The QuickVue RSV test is used by trained healthcare professionals who collect nasal or nasopharyngeal specimens from pediatric patients 18 years of age and younger. The test is not validated for adult or immunocompromised patients.
Why consider this RSV rapid test
- Provides rapid RSV results in approximately 15 minutes
- Uses familiar nasal and nasopharyngeal collection methods
- Dipstick format with easy-to-read two-color result lines
- Single reagent bottle with a three-step test procedure
- Kit includes positive and negative control swabs
- Stored at room temperature for up to 24 months from manufacturer date
- One swab sample can be used with other QuickVue tests when appropriate
Important information
- Intended use: Rapid detection of RSV in pediatric patients (≤ 18 years)
- Test format: Dipstick lateral flow immunoassay
- Sample types: Nasopharyngeal swab, nasopharyngeal aspirate, nasal/nasopharyngeal wash
- Time to results: Approximately 15 minutes
- Number of tests per box: 20
- Storage temperature: Room temperature, 59 to 86 °F (15 to 30 °C)
- Shelf life: 24 months from manufacturer date
- Country of origin: United States
- CLIA complexity: Waived
- Latex: Not made with natural rubber latex
- Shipping weight (approximate): 1 pound
- Shipping dimensions (approximate): 14 in (L) x 11 in (W) x 6 in (H)
Reagents and materials supplied
- 20 individually packaged test strips
- 1 extraction reagent bottle with detergents and 0.2% sodium azide
- 20 extraction tubes
- 20 disposable droppers
- 20 nasopharyngeal swabs
- 1 positive RSV control swab coated with noninfectious RSV antigen
- 1 negative control swab coated with formalin-inactivated, noninfectious Streptococcus C antigen
- 1 package insert with detailed instructions
- 1 quick reference instructions card
Features and benefits
- Easy-to-read two-color result lines
- Simple dipstick design with minimal handling steps
- Single extraction reagent for all three specimen types
- Controls included to verify test strip performance
- Room temperature storage to simplify inventory management
- Designed for one office visit to test and act on results
Suggested related products
- Covidien sterile specimen container for collection and transport when needed
- Nacosa nitrile exam gloves to protect hands during specimen collection and testing
Additional Quidel test products
- QuickVue at-home COVID-19 test for SARS-CoV-2 detection
- Quidel Sofia RSV FIA test using fluorescent immunoassay technology
- QuickVue influenza A+B test for influenza A and B detection
Frequently asked questions (FAQs)
Can different swabs be used to collect the sample?
No. To help ensure test performance, only the swabs included in the kit should be used.
How long can specimens be stored before testing?
Specimens should be tested as soon as possible after collection. If necessary, a sample may be kept at room temperature in a clean, closed container for up to 8 hours before testing.
Can RSV be contracted from contact with the controls?
No. The kit controls use noninfectious antigens.
How often should external controls be run?
Quidel recommends running positive and negative controls for each kit lot number, for each untrained operator, and according to facility quality control procedures.
Product specifications
- Manufacturer: Quidel
- Product number: 20193
- Application: Rapid RSV test kit (infectious disease immunoassay)
- User age: Pediatric patients 18 years of age and younger
- Sample types: Nasopharyngeal swab, nasopharyngeal aspirate, nasal/nasopharyngeal wash
- Test format: Dipstick
- Test method: Lateral flow
- Time to results: Approximately 15 minutes
- CLIA complexity: Waived
- Storage temperature: 59 to 86 °F (15 to 30 °C)
- Shelf life: 24 months from manufacturer date
- UNSPSC code: 41116144
- Latex indicator: Not made with natural rubber latex
Sample type performance
- Nasopharyngeal aspirate
Sensitivity: 99%
Specificity: 92%
Accuracy: 94% - Nasal / nasopharyngeal wash
Sensitivity: 83%
Specificity: 90%
Accuracy: 87% - Nasopharyngeal swab
Sensitivity: 92%
Specificity: 92%
Accuracy: 94%
Warnings and precautions
- For in vitro diagnostic use only
- Follow institutional protocols for obtaining nasal and nasopharyngeal specimens
- Intended for pediatric patients 18 years of age and younger; performance is not established for adults or immunocompromised patients
- Do not use components beyond their expiration date
- Wear appropriate protective clothing, exam gloves, and eye/face protection when handling specimens and reagents
- Keep test strips sealed in their protective foil until use
- Use only the swabs provided in the kit
- Once the test strip is placed in the extraction reagent, do not remove it until the 15-minute development time is complete
- Do not freeze kit components
- Protect components from direct sunlight
Manuals and documents
- Sales sheet with procedure steps for all three specimen collection methods
- Safety data sheet with first-aid, handling, storage, and disposal information
- Quick reference instructions with at-a-glance steps and result interpretation
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