COMPANY
CLIA WAIVED RAPID TESTS
CLIA LABORATORY
CONTACT US
6320 Canoga Ave. Ste. 1500, FL 15
Woodland Hills, CA 91367
QuickVue® RSV Test, CLIA Waived
Due to FDA regulations, this product needs to be shipped to a CLIA-Waived or Moderately Complex licensed location.
We kindly ask that you provide an licensed facility address during checkout to ensure prompt delivery.
Thank you for your understanding and cooperation.
description
The QuickVue RSV Test is a dipstick immunoassay that detects respiratory syncytial virus (RSV) antigen (viral fusion protein) directly from nasopharyngeal swab, nasopharyngeal aspirate, or nasal/nasopharyngeal wash specimens for symptomatic pediatric patients (eighteen years of age and younger).
|
Sample type
|
Nasopharyngeal swab, nasopharyngeal aspirate, nasal/nasopharyngeal wash |
|
Time to
results
|
15 minutes or less |
|
Kit storage
conditions
|
Room temperature (15°C to 30°C/59°F to 86°F) |
|
Internal
controls
|
Positive and negative included |
|
External
controls
|
Positive and negative included |
|
Sensitivity*
|
92% – Nasopharyngeal swab; 99% – Nasopharyngeal aspirate; 83% – Nasal/nasopharyngeal wash |
|
Specificity*
|
92% – Nasopharyngeal swab; 92% – Nasopharyngeal aspirate; 90% – Nasal/nasopharyngeal wash |
|
PPV*
|
56% – Nasopharyngeal swab; 84% – Nasopharyngeal aspirate; 86% – Nasal/nasopharyngeal wash |
|
NPV*
|
99% – Nasopharyngeal swab; 99% – Nasopharyngeal aspirate; 88% – Nasal/nasopharyngeal wash |
|
Overall accuracy
*
|
92% – Nasopharyngeal swab; 94% – Nasopharyngeal aspirate 87% – Nasal/nasopharyngeal wash |
|
Shelf life
|
24 months from date of manufacture |
|
CLIA
complexity
|
Waived |
CLIA WAIVED RAPID TESTS
CLIA LABORATORY
6320 Canoga Ave. Ste. 1500, FL 15
Woodland Hills, CA 91367
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