QIAGEN SARS-CoV-2 Quick Start Guide
QIAreach™ SARS-CoV-2 Antigen Test
Quick Reference Guide
Please study the QIAreach SARS-CoV-2
Anti g e n Test Inst r u c tions f o r U se
thoroughly before referring to this Quick
Reference Guide. This Quick Reference
Guide is not intended as an exhaustive
instructional document.
646533REF
www.qiagen.com
800-362-7737
Technical suppor t: techservice-na@qiagen.com
Test Kit Contents (REF 646533)
60 x QIAreach SARS-CoV-2 Antigen eSticks
60 x QIAreach SARS-CoV-2 Antigen
Processing Tubes
2 x 10ml QIAreach SARS-CoV-2
Antigen Diluent Buffer
Additional Components Required
QIAreach eHub
Adjustable Volume Pipettes + tips
Volume/s required: 100µl, 400µl
Swab and transport media (VTM or PBS)
Minimum collection volume 1ml
Pre-analytical Steps
Patient sample collected through
Nasopharyngeal swab.
QIAreach™ eHub Setup
Remove QIAreach
eHub and various
acc esso ries f rom
packaging.
NB: Refer to Q IAreach eHub User
Manual for a complete guide to device
ope rati on and t r oub l esh ooti ng.
Remove the dust
cover from the front
of the QIAreach™
eHub.
Patent sample stored in
viral transport media (VTM
or PBS) to manufacturers
instructions. Please refer to
IFU for further details.
Power USB
Connect the eHub to
power via USB (wall
plug or PC). Press the
power button to turn on
the QIAreach eHub.
Sample to Insight
Test Procedure
Note: Refer to the QIAreach SARS-CoV-2 Antigen Test Instructions for Use for Warnings
and Precautions, Directions for Use, Results Analysis and Test Interpretation, Technical
Information, and Troubleshooting.
Ensure that the QIAreach eHub is
1
turned on, then insert the
Processing Tube and eStick.
Allowance for 13 mm
collection tubes
Record patient
information
Cycle the pipette at least 4 times
5
to mix the sample in the
**eStick must be
used within 1hr
of unwrapping**
Processing Tube.
Transfer 100 µl of Diluent Buffer
2 3 4
solution into the Processing Tube.
Draw 400 µl of patient sample
from VTM or PBS. Refer to IFU
for further detail.
100 μl
Transfer 100 µl from the
6 7
Processing Tube to the QIAreach
SARS-CoV-2 Antigen eStick.
The test will run automatically
and display a result within 2–15
minutes.
CoV2 Ag
09:59
CoV2 Ag
or
Disclaimer:
- QIAreach SARS-CoV-2 Antigen results should not be
used to diagnose or exclude acute infection. Results
are not intended to be used as the sole basis for patient
management decisions. Test results should be
interpreted in conjunction with clinical observations,
patient histor y, epidemiological information, and
other laboratory ndings.
- The QIAreach SARS-CoV-2 Antigen Test has been
validated but FDA’s independent review of this
validation is pending.
Transfer the sample to
Processing Tube.
400 μl
At least
4 times
Sample to Insight
2–15
min
100 μl
Wait for result before
removing QIAreach
eStick
Trademarks: QIAGEN®, Sample to Insight®, QIAreach™, (QIAGEN Group). Registered names, trademarks, etc. used in this document, even when not
speci cally marked as such, are not to be considered unprotected by law.
1122816, © 2020 QIAGEN, all rights reserved.
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