Item

Name of manufacturer

Name and model of breathalyser

1

Alcolizer Pty Ltd

Alcolizer LE5

1(a)

For the conduct of Step 1 of an initial drug test using the DrugWipe 5S approved drug testing device

Step 1 — Taking body samples with the DrugWipe 5S approved testing device (the device):

Having checked that the device has not passed its expiry date, the approved tester is to open the packaging and slide the cap in the direction of the arrow until the approved tester can read all of the word PRESS. The approved tester is to separate the sample collector (with sampling pads) of the device from the test cassette. The approved tester should not touch the sampling pads.

The approved tester is then to ask the donor to moisten the inside of their cheeks by rolling the tongue around the inside of their mouth.

The approved tester is then to ask the donor to hold the sample collector and apply moderate pressure in using the sample collector to collect saliva by wiping their tongue in a downward movement, or the interior of their cheek, ensuring the sampling pads are in contact with the tongue or cheek.

The approved tester is to check sampling pads to confirm sufficient saliva has been successfully collected.

Preparing body samples:

Once a saliva sample has been obtained, the approved tester is to:

• Reattach the saliva collector to the test cassette. A double click will be heard on successful reattachment.

• Bring the device into a vertical position with the ampoule at the bottom, press with a thumb on the word PRESS marked on the ampoule section to open the ampoule. A snap will be heard on the successful opening of the ampoule. After this snap is heard, continue to hold the device vertically for a further 10 seconds.

• Place the device horizontally on a surface for a period of not less than 5 minutes after breaking the ampoule but not more than 15 minutes.

Within this time period, the display window on the device will show the control lines. If control lines do not appear on all control strips, the test result is not valid, and the device must be discarded.

Within the time period mentioned above, if an indicator line, or part of an indicator line, does not appear in any of the segments containing an abbreviation code for a testable drug group, the test has resulted in a Step 1 screening negative.

• Ignore any indicator line or part of an indicator line that FIRST appears after 15 minutes have elapsed from breaking the ampoule.

The approved tester must not ignore any indicator line or part of an indicator line that first appears BEFORE 5 minutes have elapsed EVEN IF it goes on developing until 15 minutes have elapsed.

If the test has resulted in a Step 1 screening negative, testing is complete at that point and Step 2 is not required.

However, if, during the time period mentioned above, another indicator line or part of an indicator line DOES appear in any of the segments containing an abbreviation code for a testable drug group, the test has resulted in a Step 1 screening positive.

Step 2 of the initial drug test is then to commence.

Definitions

For the purpose of preparing body samples for Step 1:

part of an indicator line includes any indicator line that is faint, interrupted or irregular.

Note   This is the kind of line that having appeared in some form BEFORE 5 minutes have elapsed, may go on developing until 15 minutes have elapsed.

testable drug group means the pharmacological grouping into which particular testable drugs fall, namely, the amphetamine group, the cannabis group, the cocaine group, and the opiates group.

1(b)

For the conduct of Step 2 of an initial drug test using the Abbott SoToxaTM approved drug testing device

Step 2 – Taking body samples with the Abbott SoToxaTM testing device (the device):

• turn the device on
• allow the device to perform start-up checks during the start-up process to make sure the device is in good operating condition. During this testing, the screen will display the Abbott logo

Note   The device will not be able to run start-up checks if a test cartridge is already inserted. Remove cartridge before turning on.

• when the device is ready to begin a test, the screen will display “Insert cartridge to start new test” with a picture of a cartridge being inserted into a SoToxa device
• show the donor that a new and unopened SoToxa test cartridge is being used and is opened in view of the donor
• 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
• 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 the 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 SoToxa Oral Fluid Collection swab packaging and ask the donor to remove the 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 SoToxa Oral Fluid Collection swab around their gums, tongue and inside their cheeks, 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)
• the approved tester is to insert the SoToxa Oral Fluid Collection swab into the test cartridge currently located in the device. Insert 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 will be heard. The approved tester must 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 SoToxa Oral Fluid Collection swab has been inserted into the test cartridge in the device, the screen will display “test in progress” and a countdown timer will appear
• when the device has finished processing the test, a results screen will be displayed showing either positive or negative for each drug group
• the approved tester is to record the result
• the approved tester is to select “OK” using the right select key to move to the next screen
• to print results, the approved tester should select YES using the left select key. After printing is complete, the print option screen will be displayed again for additional copies of results. Select YES again for another copy
• the approved tester is to produce 2 hardcopy printouts
• if the result of the analysis is negative for all testable drug groups, the test has resulted in a Step 2 screening negative and, therefore, a negative initial drug test result. Testing is complete at that point

      however, if the result of the analysis is positive for any testable drug group, the test has resulted in a Step 2 screening positive for that testable drug group

      the result of the initial drug test is, therefore, a positive test result:

–      for each testable drug group which returned a positive result under Step 1; and

–      each testable drug group which returned a positive result under Step 2

The approved tester is to proceed to the procedures in item 2 as the case may be.

Definition

For the purpose of preparing body samples for confirmatory drug testing testable drug group means the pharmacological grouping into which particular testable drugs fall, namely, the amphetamine group, the cannabis group, the cocaine group, and the opiates group.

2

For the conduct of a confirmatory test on a further body sample taken under subregulation 99.170 (1), where the result of an initial drug test using the Abbott SoToxaTM approved drug testing device on an earlier body sample is a positive result

Taking body samples:

The approved tester must:

• ensure each Quantisal® Oral Fluid Collection kit contains 1 oral fluid collection swab and 1 sealed collection tube containing the buffer solution
• ensure each kit is enclosed in a sealed clip seal transit pouch
• ensure each kit is within its expiry date by checking the labels on the Quantisal collection tubes and oral fluid collection swabs

Note   If the Quantisal® Oral Fluid Collection kits are within date but the collection tubes have different batch numbers, the approved tester is to make a note of this on the Transmission to Lab form.

• in the presence of the donor, with gloves on, open the required number of sealed Quantisal® Oral Fluid Collection kits and open required number of Quantisal® Oral Fluid Collection Device with Volume Adequacy Indicator (swabs) within the packaging.

The approved tester is to ask the donor to:

• remove collectors of the Quantisal® Oral Fluid Collection Device with Volume Adequacy Indicator from their packaging, by holding the plastic stems that are fixed to the cellulose pad (swab) of each collector
• move the donor’s tongue within their mouth to accumulate saliva
• actively move the swabs around their gums, tongue and inside their cheeks, then leave the swabs in their mouth under their tongue

• ensure both collectors remain under the donor’s tongue until the indicator on each collector turns blue to indicate a sufficient sample of oral fluid has been obtained or at least 10 minutes has elapsed
• remove both collectors from the donor’s mouth by holding the plastic stem.

If an indicator on a collector has not turned blue within 10 minutes, the approved tester may require the donor to place new collectors in the donor’s mouth until the indicator of each collector turns blue.

Preparing body samples:

Once a sufficient sample has been obtained, the approved tester must:

• remove the cap from both specimen tubes (transport tubes) containing buffer liquid and insert 1 collector into each tube, swab end first
• place the cap over the top of the stem of the collector in each transport tube and forcefully push the cap downward until cap snaps flush with top of tube
• mix the saturated swab of the collector with the buffer liquid in each transport tube by gently shaking the tube
• write the donor’s date of birth and the approved tester’s initials on a tamper‑evident seal marked “A” and on a tamper-evident seal marked “B” provided in the CASA Transmission of sample to approved laboratory form
• request that the donor initial the tamper‑evident seals
• fix the tamper-evident seal “A” across the top of the cap and down the sides of 1 of the transport tubes, ensuring that the centre oval with the letter “A” in the middle is placed over the top of the cap on the tube
• fix the tamper-evident seal “B” across the top of the cap and down the sides of the other transport tube, ensuring that the centre oval with the letter “B” in the middle is placed over the top of the cap on the tube

Note   If tamper-evident seal A or B are damaged while fixing to transport tubes then tamper-evident seal C is to be used.

• place both sealed transport tubes back into a clip-seal transit pouch, for dispatch to the approved laboratory for confirmatory testing of the fluid collected
• The unused clip-seal transit pouch can be discarded.

1

For the conduct of an initial alcohol test on a person using the Alcolizer LE5 (in this item, the device)

Taking body samples:

The approved tester must first ask the donor if the donor has consumed anything in the preceding 15 minutes.

If the donor advises that they have consumed anything in the preceding 15 minutes, the approved tester must request the donor not consume anything further (except water) until the testing, including confirmatory testing if necessary, is completed. The approved tester must inform the donor that if the donor consumes anything further (except water) until the testing, including confirmatory testing if necessary, is completed, it may be considered that the donor has refused, or failed to give, a body sample.

If the donor has advised the approved tester that they have consumed something containing alcohol in the preceding 15 minutes, the approved tester must wait until at least 15 minutes have elapsed since the approved tester first asked the donor if they had consumed anything containing alcohol.

Having turned on the device by pressing the Test Key or Up/Down buttons, the CASA logo with “Alcolizer LE5 alcohol tester” will appear for a period of 5 seconds prior to the test screen displaying. A soft clicking sound should be heard. This is normal and is the internal pumps self-test at start-up.

The display will show “press to test” on the screen along with the date, time and battery status indicator.

Note   The approved tester may decide to start with a passive (no mouthpiece) initial test where the donor is required to talk into the end of the device. This is not advised in circumstances where the environment is windy or other environmental factors, such as other chemicals in the area, may affect the result. If the device detects any alcohol present, the device will automatically continue to the standard test (with mouthpiece) to complete the initial test.

To conduct an initial drug test without a mouthpiece, “Test Type” is set to “Passive Standard”.

The display will show “press passive test”. The approved tester is to hold the device no further than 5 cm in front of the donor’s mouth so that the subject is breathing or talking directly into the device’s sample inlet port throughout the passive test process.

The approved tester is to ask the donor to talk (counting) or blow until the approved tester tells them to stop.

The approved tester is to press the Test button while the donor is talking or if the device has not automatically taken a breath sample while the donor is blowing. The device will have 3 short beeps and clicks followed by a longer beep indicating the breath collection is complete. The approved tester is to ask the donor to stop talking or blowing.

The device will display “Analysing Sample” until the result is shown. This can take a few seconds.

If a “Pass No Alcohol” with a green background result is displayed, this indicates that no alcohol was detected and the initial alcohol test is a Negative result. The device will return to the “press passive test” display ready for the next test.

If a “Warning Alcohol Present” with a red background, result is displayed, this indicates that alcohol was detected. Once the recovery period has ended the device automatically is enabled to take a Standard test using a mouthpiece.

Standard Test

The approved tester must then attach a mouthpiece to the device by following the instructions set out by the manufacturer:

• grasp the mouthpiece at the non‑ribbed end and tear the plastic wrapping from the non-ribbed end, downwards to expose the sample inlet hole
• locate the mouthpiece sample inlet port over the mouthpiece locator in line with the recesses that surround the spigot
• press the mouthpiece sample inlet port onto the locator until it is attached securely, the orientation of the mouthpiece does not affect the sampling.

The donor may remove the remaining portion of the plastic wrap just prior to testing to ensure hygienic use.

Note   A new mouthpiece must be used for every mouthpiece test.

Press the Test key and the device will perform a background self-test and display “Please Wait…” on the screen. When ready, the device will display “Blow” with the airflow and time graph on the screen.

The donor must be asked to take a deep breath, hold it, and then place the lipped end of the mouthpiece in their mouth, sealing their lips around it. The donor must then be asked to blow steadily and continuously until requested to stop blowing by the approved tester.

As the donor commences to provide a sample, “Blow” will be displayed with an airflow graph and a sample progress bar and a continuous audible beeping tone will be emitted.

A sufficient sample is necessary for the sample to be analysed. On the provision of a sufficient sample, an audible click is heard and a long tone from the device. At this time, the donor is to be requested to stop blowing.

The device will then show a half blue and half white screen with “Analysing Sample” displayed along with a circular indicator.

On the completion of the analysis of the sample, indicated by “please wait” ceasing to appear on the display screen, a reading will appear of either “PASS” and a green screen background indicating a NEGATIVE result or “Warning Alcohol Present” with a red screen background indicating a POSITIVE result.

1

Alcolizer LE5

Storing:

The device is to be stored in clean and dry conditions and not exposed to extreme weather conditions.

Testing:

The device is to be tested in a manner not inconsistent with the manufacturer’s instructions (as they exist from time to time) provided that compliance with any action recommended by the manufacturer in the instructions is mandatory.

Maintaining:

The device is to be maintained in a manner not inconsistent with the manufacturer’s instructions for use of the device (as they exist from time to time) provided that compliance with any action recommended in those instructions is to be regarded as mandatory.

The device is to be cleaned only with a slightly damp cloth and not exposed to cleaning products that contain solvents.

Operating:

The device is to be operated in a manner not inconsistent with the manufacturer’s instructions for use of the device (as they exist from time to time) provided that:

• calibration and configuration of the device’s Sample Module is to be undertaken only by the manufacturer or an agent approved by it
• the device is to be configured so that:

–     Test Type is set to Standard (mouthpiece) testing or Passive Standard testing

–     Digital Display Mode is set to Reveal

–     Display Format is set to PASS or Warning Alcohol Present

–     Measurement ratio is set to 2100:1

–     Display Mask is set to declare a result at or below 0.009 as PASS

–     Breath Sampling Parameters are set to be:

• for discard volume parameter — between 1 and 5 litres
• for drop or flow rate parameter — between 20 and 50 litres/minute

–     Display Reset Time is set to 10 seconds

–     Calibration Lock is to render the device inactive if the Sample Module recalibration has not been undertaken within the last 12 months

–     The Sampling Module may be swapped by the User/Tester and as per Alcolizer Pty Ltd replacement procedures

• time and date settings may be set by User/Tester (for interstate and time zone corrections)
• the User/Tester may enter a unique ID number for test identification
• the device is to be used in Standard or Passive Standard Type test modes
• the reusable sampling cup is not to be used when conducting a Passive Standard Type test
• a clean unused mouthpiece is to be used for every Standard Test Type test
• only mouthpieces manufactured or supplied by Alcolizer Pty Ltd are to be used
• printing of test results is not required.