Quidel QuickVue RSV Test Kit

SKU
QDL-20193
$260.00

(20 Tests)

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Respiratory Syncytial Virus (RSV) Test Kits, the QuickVue RSV test is a dipstick immunoassay which allows for the rapid, qualitative detection of respiratory syncytial virus (RSV) antigen (viral fusion protein) directly from nasopharyngeal swab or nasopharyngeal aspirate specimens for symptomatic pediatric patients (eighteen years of age and younger). The test is intended for use as an aid in the diagnosis of acute respiratory syncytial viral infections. It is recommended that negative test results be confirmed by cell culture. Negative results do not preclude RSV infection and it is recommended that they not be used as the sole basis for treatment or other management decisions. FDA Cleared and CLIA Waived. (FDA 510K#: K061008)

Who is at risk for RSV?

-Nearly half of all infants become infected during their first year of life, and virtually all children have been infected by the age of two.6 However, those at greatest risk of severe RSV infections include7:

  • Infants born prematurely
  • Term infants younger than 6 weeks old
  • Children with medical conditions such as:
    • Chronic lung disease
    • Serious heart conditions
    • Problems with their immune system

Product specifications

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

 12-18 Months

CLIA complexity 

 Waived

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