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Country of Origin: United States
Disclaimer: Please know that for all our CLIA WAIVED products, you need to fill out our CLIA Number section in order for us to process your order. If this section is empty and you proceed to check out, your order will be canceled.
The QuickVue RSV Test is a rapid diagnostic tool that can detect respiratory syncytial virus (RSV) from nasopharyngeal swab, nasopharyngeal aspirate, or nasal/nasopharyngeal wash specimens from symptomatic pediatric patients.
FDA Cleared and CLIA Waived. (FDA 510K#: K061008)
(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
(1) Quick Reference Instructions
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.
Quick Reference Instructions for larger images of test results in COLOR. POSITIVE Result*: At 15 minutes, the appearance of ANY shade of a pink-to-red Test Line AND a blue procedural Control Line indicates a positive result for the presence of RSV viral antigen. Results will remain stable for 5 minutes after the recommended read time. *A positive result does not rule out co-infections with other pathogens.
C = Control Line
T = Test Line
*Look closely! If you see a very faint, pink Test Line and a blue Control Line, you must report the result as POSITIVE.
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