DiagCORE Respiratory Panel 2 Instructions for Use 13
3.4
Sample collection and cartridge loading
The collection of samples and their subsequent loading into the DiagCORE
®
cartridge should be
performed by personnel trained in safe handling of biological samples.
The following steps are involved and must be executed by the user:
1.
A nasopharyngeal swab sample is collected.
2.
The nasopharyngeal swab is placed into transport medium only in the case of transport medium
liquid sample type.
3.
The sample information is manually written on or a sample label is affixed to the top of a
DiagCORE
®
cartridge.
4.
Sample is loaded manually into the DiagCORE
®
cartridge:
Dry swab sample type: The nasopharyngeal swab sample is inserted into the swab port of
the DiagCORE
®
cartridge.
Transport medium liquid sample type: 300 µL of the sample is transferred into the
DiagCORE
®
cartridge using a transfer pipette.
In the case of transport medium liquid sample loading, the user performs a visual check of
the sample inspection window (see image below) to confirm that the liquid sample has
been loaded.
5.
The sample barcode and DiagCORE
®
cartridge QR code are scanned in the DiagCORE
®
Analyzer.
6.
The DiagCORE
®
cartridge is introduced into the DiagCORE
®
Analyzer.
7.
The test is started on the DiagCORE
®
Analyzer.
3.5
Sample preparation, nucleic acid amplification, and detection
The extraction, amplification, and detection of nucleic acids in the sample are performed
automatically by the DiagCORE
®
Analyzer.
1.
The liquid sample is homogenized, and cells are lysed in the lysis chamber of the DiagCORE
®
cartridge, which includes a rotor that turns at high speed.
