AU2020100588A4

AU2020100588A4 - A mind-altering substance testing unit with orientation sensor and early call lateral flow test

Info

Publication number: AU2020100588A4
Application number: AU2020100588A
Authority: AU
Inventors: James John BROWN
Original assignee: ALCOLIZER Pty Ltd
Current assignee: ALCOLIZER Pty Ltd
Priority date: 2020-04-17
Filing date: 2020-04-17
Publication date: 2020-06-04
Anticipated expiration: 2028-04-17

Abstract

The present invention relates a mind-altering substance testing unit. The unit includes a substance sensor for sensing the mind-altering substance from a sample. An orientation sensor is provided for sensing an orientation of the testing unit. An indicator is provided for indicating correct or incorrect operation of the testing unit using the sensed orientation when sensing the mind-altering substance. Advantageously, the indicator may be used to correctly orient the testing unit for correct operation when sensing the mind-altering substance for improved substance sensing. to 6 to° 200 -202 5 , -

Description

A MIND-ALTERING SUBSTANCE TESTING UNIT WITH ORIENTATION SENSOR

AND EARLY CALL LATERAL FLOW TEST

TECHNICAL FIELD

The present invention generally relates to a mind-altering substance testing system used in testing for the presence of mind-altering substances, such as alcohol or drugs.

BACKGROUND [0001] The reference to any prior art in this specification is not, and should not be taken as an acknowledgement or any form of suggestion that the prior art forms part of the common general knowledge.

[0002] Mind-altering substances such as alcohol or drugs may impair human performance.

[0003] In Australia, drivers may be stopped along any road by a police officer for a “random breath test”, commonly referred to as an RBT. For an operation involving a large number of police (typically 10-20) at a fixed location, the colloquial term booze bus is often used. The RBT is conducted using a hand-held RBT unit in which the driver is required to blow (or breath). The RBT unit senses the driver’s blood alcohol content (BAC) from the sampled breath, and a maximum BAC of 0.05% is typically enforced. Drivers who are found to have a preliminary BAC reading of greater than 0.05% are required to wait for a predetermined period, after which time they are retested.

[0004] In recent times, random drug testing has been performed by police. However, random drug testing is not as straightforward as conducting an alcohol RBT. Random drug testing involves swabbing the driver before analyzing the sample using an analyzer, usually located in the police vehicle.

[0005] Testing units with drug sensing modules having lateral flow sensors are known. The testing unit is initially trained (i.e. configured) to sense a drug.

2020100588 17 Apr 2020 [0006] In practice, the Applicant has discovered that orientations of the testing units during testing can adversely influence the fluidics and performance of the unit.

[0007] The preferred embodiment provides an improved mind-altering substance testing unit.

[0008] Traditionally, a visual lateral flow strips operates when a test line site indicates the presence or non-presence of drugs. Dynamically, the test site starts off with no line and will develop into a line over time if the level of drug is below the target threshold.

[0009] A result is determined as follows:

IF a minimum prescribed time has elapsed

AND the elapsed time has not exceeded a prescribed maximum

AND there is a valid control line

THEN, IF the test line is detected

THEN a negative result is determined

ELSE a non-negative result is determined

ELSE

... result is not valid [00010] A control line site is used to ensure that the test site is valid. Dynamically, the control site will start with no line and develop into a line if there has been successful fluidics and chemistry. The prevailing logic is that the test site cannot be considered valid unless there is a valid control site.

[00011] The preferred embodiment provides an improved mind-altering substance testing method.

SUMMARY OF THE INVENTION [00012] According to one aspect of the present invention, there is provided a mindaltering substance testing unit including:

a substance sensor for sensing the mind-altering substance from a sample;

an orientation sensor for sensing an orientation of the testing unit; and

2020100588 17 Apr 2020 an indicator for indicating correct or incorrect operation of the testing unit using the sensed orientation when sensing the mind-altering substance.

[00013] Advantageously, the indicator may be used to correctly orient the testing unit for correct operation when sensing the mind-altering substance for improved substance sensing. The orientation of the testing unit for correct operation may correspond with the orientation in which it was previously configured.

[00014] The unit may further include a swab including the sample, and incorrect operation of the testing unit may result in non-upright positioning of the swab. The sample may be saliva.

[00015] The indicator may be a visual indicator. The indicator may be a binary indicator. The visual indicator may be displayed on a display. The indicator may be an audible indicator. The audible indicator may include a buzzer.

[00016] The orientation sensor may be a 3-axis orientation sensor.

[00017] The testing unit may abort the test responsive to an incorrect operation being sensed for a pre-determined period of time.

[00018] The mind-altering substance may be a drug, and the sensor module may include a lateral flow sensor.

[00019] According to another aspect of the present invention, there is provided a sensor module for a mind-altering substance testing unit, the sensor module including:

a substance sensor for sensing the mind-altering substance from a sample;

an orientation sensor for sensing an orientation of the sensor module; and an indicator for indicating correct or incorrect operation of the sensor module using the sensed orientation when sensing the mind-altering substance.

[00020] According to another aspect of the present invention, there is provided a lateral flow substance testing method involving:

determining a negative result using a sensed site parameter, irrespective of a control.

2020100588 17 Apr 2020 [00021] Advantageously, the negative test result is obtained irrespective of the status of a control site which results in a faster negative result being determined when compared with waiting for the status of a control. Typically, the negative result is delivered in about one third of the time (i.e. less than about 1 minute).

[00022] The negative result may be determined when the sensed site parameter is an intensity exceeding a prescribed threshold (e.g. test line is present).

[00023] The determined negative result may further require a test time exceeding a prescribed minimum. The determined negative result may further require the passing of one or more other tests (e.g. wetting).

[00024] Any of the features described herein can be combined in any combination with any one or more of the other features described herein within the scope of the invention.

BRIEF DESCRIPTION OF THE DRAWINGS [00025] Preferred features, embodiments and variations of the invention may be discerned from the following Detailed Description which provides sufficient information for those skilled in the art to perform the invention. The Detailed Description is not to be regarded as limiting the scope of the preceding Summary of the Invention in anyway. The Detailed Description will make reference to a number of drawings as follows:

[00026] Figure 1 is a perspective view of a hand-held random breath test (RBT) unit in accordance with an embodiment of the present invention;

[00027] Figures 2a - 2c show a sequence of steps associated with a method of assembling the hand-held RBT unit of Figure 1;

[00028] Figure 3 is a block diagram of the hand-held RBT unit of Figure 1; and [00029] Figure 4 is a flowchart of a method of assembling the hand-held RBT unit of Figure 1; and [00030] Figure 5 is a front view of the unit of Figure 1 with a drug sample cartridge.

2020100588 17 Apr 2020

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS [00031] According to an embodiment of the present invention, there is provided a hand-held random breath test (RBT) unit 2 as shown in Figure 1. As can best be seen in Figure 2, the modular RBT unit 2 includes a display module 4 for displaying an indication of blood alcohol content (BAC) and a sensor module 6 for releasably fastening to the display module 4. The sensor module 6 includes a BAC sensor for sensing the BAC and can be released from the display module 4 for calibration. The exposed sensor module 6 houses the BAC sensor so that damage to the sensor or the compromising of its calibration is impeded. Accordingly, the integrity of the RBT unit 2 is improved when compared with other RBT units having exposed releasable BAC sensors.

[00032] The BAC sensor is completely contained or encapsulated within the sensor module 6 and cannot be accessed with a finger. The BAC sensor is also fluidically sealed in an air-tight and water-tight manner within the sensor module 6 to impede exposure of the sensor to the elements when the RBT unit 2 is used in the rain or dropped in a puddle, for example. The sensor module 6 can be either reusable, or disposable whereby it includes relatively inexpensive parts when compared with the display module 4. A detailed description of the RBT unit 2 is provided below.

[00033] Turning to Figure 2, the display module 4 includes a display module housing 8, and the sensor module 6 includes a sensor module housing 10 for housing the sensor. The sensor module housing 10 has a removable mouthpiece attachment 12 with inlet through which a breath sample can be provided. The modules 4, 6 include exposed electrical interfaces 14 which connect when the housings 4,6 are fastened together. With reference to Figure 2b, the sensor module housing 10 is translated relative to the display module housing 8 when fastening the housings 8, 10 together to connect the electrical interfaces 14. Upon fastening the housings 8, 10 together, the electrical interfaces 14 are no longer exposed and the RBT unit 2 defines a continuous body as shown in Figure 2c.

[00034] With reference to Figure 2a, the display module housing 8 defines a docking bay 16 in which the sensor module housing 10 can be slid. The sensor module housing

2020100588 17 Apr 2020 defines a pair of opposed protruding rails 18 for being received within a pair of elongate recesses 20 defined by the display module housing 8. The sensor module housing 10 also defines a threaded fastening hole 22 which can be placed in register with a fastening hole 24 of the display module housing 8. As shown in Figure 2c, the holes 22, 24 can receive a threaded screw 26 (i.e. fastener) to fasten the housings 8, 10 together.

[00035] Turning to Figure 3, the electrical interfaces 14 of the display module 4 and sensor module 6 are power and communications interfaces. In addition, the display module 4 further includes another electrical interface 28 through which power is supplied to a battery and charging system 30 and for communications with a personal computer (PC).

[00036] The display module 4 includes display module controller circuitry 32 within the display module housing 8 and that is used to control the display module 4. A liquid crystal display (LCD) 34 is coupled to the display module controller circuitry 32 and displays the indication of BAC in the form of a numeric reading. Turning briefly to Figure 1, a user interface 36 is also coupled to the display module controller circuitry 32 and enables a user to operate the RBT unit 2.

[00037] Returning to Figure 3, the display module controller circuitry 32 includes a processor arrangement 36 for executing software in the form of computer readable instructions to operate the display module 4. The display module controller circuitry 32 also includes the exposed display module electrical interface 14 coupled to the processor arrangement 36 and for facilitating powering of and communication with the sensor module 6. The internal battery and charging system 30 is suitable for powering the processor arrangement 36 and charging an internal battery using power supplied through the interface 28. A blue tooth communication transceiver module 38 can be used to download a calibration record stored by the processor arrangement 36 from the RBT unit 2 and can interface with external devices. The display module controller circuitry 32 also includes a global positioning system module 40 for sensing the position of the RBT unit 2 to be stored by the processor arrangement 36 during testing.

[00038] The sensor module 6 includes a processor arrangement 42 for executing software in the form of computer readable instructions to operate the sensor module 6.

2020100588 17 Apr 2020

The processor arrangement 42 includes non-volatile memory for storing a unique identifier in the form of a serial number corresponding to the sensor module 6. Further, the sensor module 6 includes the exposed sensor module electrical interface 14 coupled to the processor arrangement 42 and for facilitating receipt of power from and communication with the display module 4. The internal BAC sensor 44 is an electrochemical fuel cell sensor for sensing BAC and is coupled to the processor arrangement 42. The sensor module 6 further includes a backup battery 46 for providing auxiliary power to the processor arrangement 42.

[00039] The sensor module 6 further includes known components to facilitate the breath test. In particular, the sensor module 6 includes a pressure sensor 48 for measuring the breath volume delivered to the sensor module 6 during the test and during calibration of the 44. The sensor module 6 further includes a pump and solenoid 50 coupled to the mouthpiece attachment point and inlet 12 through which the breath sample is provided during testing.

[00040] A method 60 of assembling the hand-held random breath test (RBT) unit 2 will now be described with reference to Figure 4.

[00041] Initially, the display module 4 and the sensor module 6 are separated as shown in Figure 2a.

[00042] At step 62, the sensor module 6 is releasably fastened relative to the display module 4. Elaborating further, the sensor module 6 is translated or slid relative to the display module 4 as shown in Figure 2b. The sensor module 6 is translated so that exposed electrical interfaces 14 of the modules 4, 6 connect and are, in turn, no longer exposed as shown in Figure 2c. The screw 26 is then received by the modules 4, 6 to impede their separation.

[00043] At step 64, the user interface 36 of the display module 4 is actuated by pressing any actuator.

[00044] At step 66 and responsive to actuating the user interface 36 at step 64, calibration settings of the sensor module 6 are verified with the display module 4. This step of verifying involves comparing stored calibration settings in the processor

2020100588 17 Apr 2020 arrangement 42 of the sensor module 6 with predetermined acceptable limits stored in the processor arrangement 36 of the display module 4. This step of verifying also involves: the display module 4 determining whether the unique identifier stored in the processor arrangement 42 of sensor module 6 is valid; the display module 4 determining whether a model number stored in the processor arrangement 42 of sensor module 6 is valid; and the display module 4 determining whether the firmware of the sensor module 6 is valid.

[00045] At step 68, a calibration record is stored that forms a traceable record which can be used in the event of a legal challenge to the integrity of RBT unit 2. The calibration record is stored in the processor arrangement 36 of the display module 4 and includes: unique serial numbers of both the display module 4 and sensor module 6; firmware version numbers of both the display module 4 and sensor module 6; the date and time of actuating the user interface 36 in step 64, and verification confirmation of calibration settings of the sensor module 6 by the display module 4 performed at step 66.

[00046] At query step 70, the display module 4 polls the user interface 14 to determine when the sensor module 6 is unfastened from the display module 4. If the sensor module 6 is not unfastened from the display module 4, the method 60 remains at step 70 and the RBT unit 2 can operate normally to perform RBTs.

[00047] If the sensor module 6 is unfastened from the display module 4, the method 60 returns to step 62 where the sensor module 6 can be replaced with another sensor module during offsite calibration of the sensor module 6. During this procedure, the threaded fastener 26 is removed and the sensor module 6 is slid from the display module 8 to unfasten the sensor module 6 from the display module 4.

[00048] In conjunction with the method 60 described above, the RBT unit 2 also performs the background steps of:

monitoring the time elapsed relative to a last calibration date stored in the sensor module; and issuing warning notifications to the user on the LCD 34 both immediately prior to and upon the time elapsed exceeding a predetermined non-calibration period.

2020100588 17 Apr 2020 [00049] In conjunction with the method 60 described above, the RBT unit 2 also performs the background steps of:

tracking the date and time independently in each module 4, 6; and responsive to detecting a difference in the tracked dates or times, setting the date and time of the display module 4 to that of the sensor module 6.

The assembly and disassembly of the RBT unit 2 described above in relation to method 60 is straightforward and can be readily conducted by police officers without the need for any formal training. In addition, the method 60 can be conducted in poor weather conditions without fear of damaging or affecting calibration of the internal BAC sensor 44.

[00050] Turning to Figure 5, the hand-held RBT unit 2 is a mind-altering substance testing unit 2 for testing for a drug as well as alcohol. In particular, the mouthpiece 12 of the sensor module 6 can be removed and a drug sample cartridge 100 docked to the sensor module 6 in its place. Advantageously, the same testing unit 2 can be used to sense alcohol and the drug avoiding the need for separate testing units.

[00051] The sample cartridge 100 receives a saliva sample and is releasably fastened to the sensor module 6 so that the sensor module 6 can sense the mindaltering drug. The unit 2 further includes a swab 102 including the saliva sample. The swab 102 is fastened to the cartridge 100 by inserting a sample end 104 in a cartridge sample dock 106.

[00052] The sensor module 6 includes a lateral flow sensor for sensing the drug and wholly enclosed within the sensor module 6. The single-use cartridge 100 is disposable, yet includes an onboard electronic memory for storing information. The stored information relates to the age of the cartridge 100 or batch parameters of the cartridge 100. The sensor module 6 compensates sensing in accordance with the stored information for improved accuracy.

[00053] The display module 4 and sensor module 6 drug functionality is the same as that of the alcohol functionality previously described. The testing unit 2 includes an orientation sensor 200 for sensing the orientation of the testing unit 2. The orientation sensor 200 is a 3-axis orientation sensor and is located within the sensor module 6. The LCD 34 serves as a visual indicator for indicating correct or incorrect operation of the ίο

2020100588 17 Apr 2020 testing unit 2, using the sensed orientation from the orientation sensor 200 when sensing the mind-altering substance using the lateral flow sensor (i.e. substance sensor).

[00054] Advantageously, the visual indicator can be used to orient the testing unit 2 for correct operation when sensing the mind-altering substance to provide for improved substance sensing and an optimal test result. The orientation of the testing unit 2 for correct operation corresponds with the orientation in which it was trained (i.e. initially configured).

[00055] An incorrect operation of the testing unit 2 in a non-upright position, in turn, results in non-upright positioning of the elongate swab 102. The testing unit 2 aborts the test responsive to an incorrect operation being sensed for a pre-determined period of time.

[00056] Additionally, or alternatively, the testing unit 2 may include an audible buzzer 202 which serves as an audible indicator for indicating incorrect operation of the testing unit 2. The indicators are binary indicators indicating correct and incorrect orientations.

[00057] The drug the testing unit 2 has the ability to objectively determine a line intensity, and compare against a trained threshold for determining a site result.

[00058] The lateral flow substance testing method employed with the sensor module is as follows:

IF the site line intensity exceeds the prescribed threshold (e.g. test line is about to visually appear or is present)

AND the time exceeds a prescribed minimum

AND other tests such as wetting have passed

THEN

A negative result is returned (i.e. acceptable drug level in sample)

ELSE IF the site line intensity does not exceed the prescribed threshold

AND the time exceeds a prescribed maximum

AND other tests such as wetting have passed

AND the control site is valid

THEN

A non-negative result is returned (i.e. unacceptable drug level in sample)

2020100588 17 Apr 2020

ELSE

... test is invalid [00059] Importantly, the foregoing method does NOT wait for a valid control to draw a negative conclusion thereby resulting in a reliable early call on the test. The test unit 2 need only wait for the line intensity of the site to exceed the prescribed threshold.

[00060] The testing has an improved performance and accuracy, in particular SENSITIVITY is insignificant. A positive or non-negative result which requires a control can wait in the order of 3 minutes to be delivered. A negative result can be delivered in some cases in a third of that time a very substantial reduction in wait time. As the field negative rate runs at around 99% this is a significant improvement to the usability of the test unit 2.

[00061] Advantageously, the negative test result is obtained irrespective of the status of a control site which results in a faster negative result being determined when compared with waiting for the status of a control. Typically, the negative result is delivered in about one third of the time (i.e. less than about 1 minute).

[00062] A person skilled in the art will appreciate that many embodiments and variations can be made without departing from the ambit of the present invention.

[00063] In compliance with the statute, the invention has been described in language more or less specific to structural or methodical features. It is to be understood that the invention is not limited to specific features shown or described since the means herein described comprises preferred forms of putting the invention into effect.

[00064] Reference throughout this specification to One embodiment’ or ‘an embodiment’ means that a particular feature, structure, or characteristic described in connection with the embodiment is included in at least one embodiment of the present invention. Thus, the appearance of the phrases ‘in one embodiment’ or ‘in an embodiment’ in various places throughout this specification are not necessarily all referring to the same embodiment. Furthermore, the particular features, structures, or characteristics may be combined in any suitable manner in one or more combinations.

Claims

1. A mind-altering substance testing unit including:

a substance sensor for sensing the mind-altering substance from a sample;

an orientation sensor for sensing an orientation of the testing unit; and an indicator for indicating correct or incorrect operation of the testing unit using the sensed orientation when sensing the mind-altering substance.

2. A testing unit as claimed in claim 1, wherein the indicator can be used to correctly orient the testing unit for correct operation when sensing the mind-altering substance for improved substance sensing; and/or orientation of the testing unit for correct operation corresponds with the orientation in which it was previously configured.

3. A testing unit as claimed in claim 1, further including a swab including the sample, and incorrect operation of the testing unit results in non-upright positioning of the swab.

4. A testing unit as claimed in claim 1, wherein the indicator is a binary indicator, and is a visual and/or audible indicator.

5. A testing unit as claimed in claim 1, configured to abort the test responsive to an incorrect operation being sensed for a pre-determined period of time.

6. A lateral flow substance testing method involving:

7. A testing method as claimed in claim 6, wherein the negative test result is obtained irrespective of the status of a control which results in a faster negative result being determined when compared with waiting for the status of a control, the delivered result delivered in less than about two minutes, and preferably less than about 90 seconds.

8. A testing method as claimed in claim 6, wherein the negative result is determined when the sensed site parameter is an intensity exceeding a prescribed threshold, the intensity preferably being a line intensity.

2020100588 17 Apr 2020

9. A testing method as claimed in claim 6, wherein the determined negative result further requires a test time exceeding a prescribed minimum.

10. A testing method as claimed in claim 6, wherein the determined negative result further requires the passing of one or more other tests.