Strep A 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 In-Line Strep A Test uses a unique in-line extraction to detect group A streptococcal antigen directly from patient throat swab specimens. Two-color results give clear readability and proven accuracy provides for dependable results. This is a true one-step test and is the first rapid strep A test waived under CLIA '88.
|
Sample type
|
Throat swab |
|
Time to
results
|
5 minutes |
|
Kit storage
conditions
|
Room temperature (15°C to 30°C/59°F to 86°F) |
|
Internal controls
|
Positive and negative |
|
External
controls
|
Positive and negative |
|
Overall
accuracy*
|
96% overall agreement to SBA culture |
|
Shelf life
|
24 months from date of manufacture |
|
CLIA
complexity
|
Waived |
