User Instructions

Page 1 of 7
For use under the Emergency Use Authorization (EUA) only
For in vitro diagnostic
A symbols glossary can be found at quidel.com/glossary.
Sofia Q is a small analyzer intended to be used with Sofia Cassette-based immunofluorescent in vitro
diagnostic assays manufactured by Quidel Corporation and software (Quidel App) residing on an Apple
iPhone manufactured by Apple. Procedural operation of the Sofia Q and test interpretation is performed
by the App.
Sofia Q is intended for professional and laboratory use.
Connection of Sofia Q to a micro-USB compliant power source powers on the Sofia Q, rendering it both
functional and discoverable via Bluetooth, the latter allowing pairing of the Sofia Q with the smartphone.
The device pairs to the smart phone after the MAC address is retrieved from the label barcode at the bottom
of the Sofia Q
Once the Sofia Q and the phone are paired via Bluetooth, the App can control the various functions
necessary to perform a test as described below. The App provides instructions for the collection and
manipulation of a biological sample with a swab, as well as the application to an immunofluorescent Assay
(IFA) cassette. In addition, the temperature is read by an internal sensor to ensure that it is in the
appropriate range (15
o
C to 30
o
C).
Upon proper insertion of a test cassette into the Sofia Q, a sensor triggers the assay countdown timer on
the phone.
Once the countdown timer on the app reaches zero, images of the test strip are transferred to the iPhone
where they are analyzed for QC metrics to determine whether the test is valid or invalid. If valid, the status
of the test is determined, and a Positive or Negative test result is displayed on the screen of the phone. If
invalid, an Invalid test result is displayed.
The image, the test raw data, and result can be uploaded in a dedicated server using the WIFI functionality
of the phone, or maintained in the phone, within the App.
A multi-color indicator light is used to produce a visual cue that signifies the status of the Sofia Q.
The color and pattern combination and their meaning are as shown in Table 1 below:
Table 1. Sofia Q status light colors and meanings
Status Light Sofia Q State