Document ID: chunk:federal_register_of_legislation:F2024C01214:reg:1:p3
Version: federal_register_of_legislation:F2024C01214
Segment Type: reg
Provision Reference: reg 1 (pt 3/4)
Character Range: 14314–19653

or SoToxa test cartridge is being used and is opened in view of the donor

                                                                                                                                                                                                                                                                * the approved tester is to remove a new test cartridge from the foil wrapper and check the silica gel pack colour

                                                                                                                                                                                                                                                                * the test cartridge can be used if the silica gel pack is yellow or orange in colour, slight discolouration of the silica beads is normal. When the majority of the beads within the pack are green, the test cartridge should not be used as the performance of the product may have been compromised. If the silica gel pack has burst, do not use the test cartridge

                                                                                                                                                                                                                                                                * the approved tester is to insert the test cartridge into the cartridge slot on the front of the device

                                                                                                                                                                                                                                                                * if a QC test has not been conducted within the defined time interval, the QC lockout symbol and "Insert PQC Cartridge to start test" will be displayed on the screen when a test cartridge is inserted. Remove test cartridge and conduct QC test before continuing with test

                                                                                                                                                                                                                                                                * check on the screen that the device has identified the cartridge and verify it is within its expiry date. This is shown by the text "Cartridge valid" with the cartridge number and a green tick on the screen. Do not use cartridge if it has expired.
                                                                                                                                                                                                                                                             Preparing body samples:

                                                                                                                                                                                                                                                                     the approved tester is to open a DDS-2 or SoToxa Oral Fluid Collection swab packaging and ask the donor to remove the DDS-2 or SoToxa Oral Fluid Collection swab from the packaging, ensuring they hold the plastic stem of the collection device, and then place it in their mouth
                                                                                                                                                                                                                                                                     the donor must actively swab the bud-end of the DDS-2 or SoToxa Oral Fluid Collection swab around the gums, tongue and inside the cheeks of the donor, then leave the swab under the tongue until the sample presence indicator starts to turn blue to indicate that a sufficient sample has been obtained (any blue colouring is regarded as a sufficient sample)
                                                                                                                                                                                                                                                                     insert the DDS-2 or SoToxa Oral Fluid Collection swab into the test cartridge currently located in the device. Gently push the collection device all the way into the test cartridge to the stop position
                                                                                                                                                                                                                                                                     once the sample collection swab has been inserted, the device should be kept in a horizontal plane remaining as still as possible throughout testing. If the device is tilted beyond the acceptable range, a warning symbol will appear on the screen and a beeping sound. Correct the orientation of the device immediately to prevent disruption to the test. If the device is not corrected in the required time this may result in a testing error
                                                                                                                                                                                                                                                                     when the DDS-2 or