Alere Triage® MeterPro

Customer Training Guide

alere.com.au
© 2013 Alere. All rights reserved. The Alere Logo, Alere and Triage are trademarks of the Alere group of companies. A1782. 1
Contents

Training overview 3

Precautions 3

Alere Triage MeterPro overview 4

Alere Triage CODE CHIP™ overview 4

Alere Triage test device overview 5

Tests the Alere Triage MeterPro performs 6

Sample type and volume 7

Materials required to perform a test 7

Alere Triage Test process 8

Cleaning, Care and Maintenance 9

Quality Control – Alere Triage MeterPro 9

Quality control – Alere Triage test device 10

Key Alere contacts 11

References 11

© 2013 Alere. All rights reserved. The Alere Logo, Alere and Triage are trademarks of the Alere group of companies. A1782. 2
Training overview

The training session will cover the contents of this guide and focus on how to perform a test using the
Alere Triage MeterPro. During the session you will be given the opportunity to run a test, read and
interpret results, and ask any questions you may have. At the end of the training session you will
need to complete a short knowledge assessment to demonstrate competency in performing the test.

Precautions

Occupational risk of transmission of blood borne viruses (BBVs), HIV, Hepatitis B (HBV) and
Hepatitis C (HCV) arises from the possibility of exposure to blood and bodily fluids from infected
patients.

The following control measures are important in order to address the potential source of infection and
reduce the risk of occupational exposure to BBVs:

• Staff should wear gloves and use single safety lancet devices.
• Staff to wash hands before and after contact with each patient and before putting on and
removing disposable gloves.
• Staff to change gloves between patients.
• Staff and patients to cover existing wounds, skin lesions and all breaks in exposed skin with
waterproof dressings. Staff to wear gloves if hands are extensively affected.
• Staff to wear gloves where contact with blood and bodily fluids can be anticipated.
• All contaminated material must be disposed of as clinical waste.
• Avoid sharps usage where possible and where sharps is essential, exercise particular care in
handling and disposal.
• Staff to avoid wearing open footwear in situations where blood may be spilt or where needles or
sharps are handled.
• Staff to clear up spillage of blood/contaminated material promptly and keep surfaces disinfected.

Guidelines for good Point of Care (PoC) testing practice should be developed by the facility and
ensure compliance with current workplace health and safety legislation.

For further guidance on infection control, safety, hygiene and decontamination, refer to the
appropriate State or National guidelines. Guidelines which may be relevant include, but are not
limited to, the following:

• Point of Care Testing, Implementation Guide (2008) Australasian Association of Clinical

Biochemists.
• Australia Guidelines for the Prevention and Control of Infection in Healthcare (2010) Australian
Government.

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Alere Triage MeterPro overview

• The Alere Triage MeterPro is a portable immunoflurometer which uses reverse sandwich
immunoenzymatic assay technology when used in conjunction with test devices
• It provides quantitative results in around 15-20 minutes (Tox screen: qualitative results)
• It has built-in quality control functions
• It can run on AC or batteries
• It has a built-in printer
• It can hold 750 patient results and 200 quality control results
• It has connectivity capability with LIS/HIS

Thermal Printer

LCD (liquid crystal Navigation Keys

display)

di Power Button
Test device
insertion port

Alere Triage CODE CHIP™ overview

The Alere Triage CODE CHIPS™ transfer information into the meter’s memory. The Alere Triage
MeterPro will prompt the user to install a CODE CHIP™ when required.

Types of CODE CHIPS™:

• Reagent CODE CHIP™ module – in each new lot of test devices

• Control CODE CHIP™ module – in each box of controls
• Quality Control (QC) Device CODE CHIP™ module– for the external QC device
• Supervisor CODE CHIP™ module – allows access to setting parameters on the meter
• Program CODE CHIP™ module– downloads new software to the meter

© 2013 Alere. All rights reserved. The Alere Logo, Alere and Triage are trademarks of the Alere group of companies. A1782. 4
Alere Triage test device overview

The test device holds the sample and also contains the reagents and other materials needed to run a
test.

 Test devices are to be stored between 2-8°C.

 Test devices have to be brought to room temperature before use.
 Once the test device has been removed from the refrigerator its self-life varies from three days to
14 days depending on the test device (please check the test device product insert for further
information).

Sample Port
Blood Filter

Sample enters here

Cells are separated from
plasma, eliminating the
need for centrifugation
(this does not occur in
the PLGF test device)
Reaction Chamber

A small fraction of the

Time Gate
sample mixes with the
dried reagents (Ab)
A hydrophobic surface
acts as a time barrier and
ensures an appropriate
reaction time (90
Internal Controls
seconds)

Independent high control

zones and a zero control
confirm that the test has
been completed correctly
Assay Zones

The assay analytes and

the fluorescent-tagged
antibodies are captured
on separate zones of the
device
Waste Reservoir

The majority of the

sample acts as a wash
and collects in the
perimeter of the Device

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Tests the Alere Triage MeterPro performs

The Alere Triage MeterPro has single-test and multiple-test devices. The tests available are:

BNP (B-type natriuretic peptide) – aids in in the diagnosis and assessment of severity of heart failure.
The test also is used for the risk stratification of patients with acute coronary syndromes and for the
risk stratification of patients with heart failure.

Troponin l, Myoglobin and CK-MB– are cardiac markers used to aid in the diagnosis of an acute
myocardial infarction.

D-Dimer – aids in the in the assessment and evaluation of patients suspected of having
disseminated intravascular coagulation or thromboembolic events including pulmonary embolism.

NGAL (Human neutrophil gelatinase-associated lipocalin) – aids in the diagnosis of Acute Kidney
Injury (AKI).

NT-proBNP (N-terminal pro-Brain Natriuretic Peptide) – aids in the diagnosis of acute heart failure.

PlGF (Placental growth factor) –– aids in the diagnosis of pre-eclampsia in conjunction with other
diagnostic and clinical information.

Tox Drug Screen – is used to screen eleven drug classes. The results are displayed as positive or
negative in a qualitative measurement. The drugs screened are Amphetamines,
Acetaminophen/Paracetamol, Methamphetamines, Barbiturates, Benzodiazepines, Methadone,
Cocaine, Opiates, Phencyclidine, THC and Tricyclic Antidepressants.

© 2013 Alere. All rights reserved. The Alere Logo, Alere and Triage are trademarks of the Alere group of companies. A1782. 6
Sample type and volume

For all test devices 250 µl of fresh whole blood collected in an EDTA tube is required.

Except for:

1. The Tox Drug Screen: 250 µl of urine is required.

2. The PlGF test: 250 µl of EDTA plasma is required.

Materials required to perform a test

• The Alere Triage MeterPro

• An Alere Triage test device
• One transfer pipette
• An EDTA tube containing fresh whole blood or plasma or a urine specimen
• Centrifuge for PlGF test only
• PPE (Personal Protective Equipment) e.g. disposable gloves
• Sharps bin and clinical waste bin

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Alere Triage Test process

1. Remove the appropriate test device from the refrigerator and allow it to come to room
temperature (minimum 15 minutes).

2. Collect fresh, whole blood into an EDTA tube for all tests except the Tox Drug Screen and PIGF
tests. For the Tox Drug screen test collect a urine specimen. For the PlGF test only EDTA
plasma can be used.

3. Immediately prior to performing a test, remove test device from the foil pouch. The user can label
it with the date, time and patient ID.

4. Draw up 250 µl from the sample using the Transfer Pipette. Draw until Transfer Pipette is filled.

5. Add the full sample to the appropriate Alere Triage test device, leaving the test device on a flat
surface. (Residual sample in the Transfer Pipette’s smaller bulb does not need to be added).

6. Select ‘run test’ then ‘patient sample’ on the Alere Triage MeterPro, enter patient ID and then
confirm the patient ID.

7. When sample fluid has absorbed, insert test device into the Alere Triage MeterPro. (The test
device must be inserted into the Alere Triage MeterPro within 30 minutes of adding the sample).

8. Results will be displayed in approximately 15-20 minutes.

© 2013 Alere. All rights reserved. The Alere Logo, Alere and Triage are trademarks of the Alere group of companies. A1782. 8
Cleaning, care and maintenance

The Alere Triage MeterPro requires minimal maintenance. Cleaning should always follow the
facilities standard practice for cleaning electrical equipment and instruments.

Occasional cleaning of the exterior with mild soap and water solution is sufficient. After using a damp,
not wet, sponge or cloth to apply mild soap and water solution on the outside of the meter, wipe the
meter dry using a soft cloth or absorbent tissue.

If blood or other fluids are not allowed enough time to fully absorb into the test devices, the device
track door may occasionally require cleaning. Using a cotton swab dampened with isopropyl alcohol
and a pair of tweezers carefully lift the door and clean both front and back of the door.

Note:

• Do not allow water to seep into the printer.

• Do not immerse the meter in water or other liquids.
• Never insert any tools, swabs or cleaning material into the device track.

Quality control (QC) – Alere Triage MeterPro

1. Alere Triage MeterPro Self-Test

The Self-Test Mode is initiated each time the meter is turned ON. The test calibrates the meter. No
user procedures are required.

2. Quality control device

This device checks the meters laser and system alignment.

• The QC device is to be run each day before patient testing.

• The QC device is re-suable.
• The QC device is light sensitive. It should be stored at room temperature in the opaque case
provided.

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Quality control – Alere Triage test device

1. Built-in test device quality controls

Each test device includes built in quality controls which are run automatically. If any of these quality
controls fail an error message will be displayed on the meter.

2. External liquid quality controls

It is recommended that 2 levels of external liquid quality control material is run upon delivery of each
new lot number test device and one level quality control material run every 30 days thereafter or as
stipulated by your facility.

Storage:

• Controls are shipped frozen. Do not use controls that are thawed upon receipt.
• Controls to be stored frozen at -20°C or colder in a non-defrosting freezer. Do not store them
near freezer door.
• Controls should not be re-frozen.
• All controls contain materials of human origin. Handle these controls as if they are potentially
infectious.

Procedure:

• Remove only the control/s to be used from the control box.

• Thaw the control/s at room temperature (19-25°C) for at least 30 minutes. Use the control/s
within one hour of removal from frozen storage.
• Test the control/s using the appropriate Triage test device after inserting the Control CODE
CHIP™ module.
• Mix the control/s thoroughly by vortexing or inversion before use.
• Hold the tube with the tip facing upwards. Ensure that all the fluid is at the bottom of the tube and
then snap off the tab.
• Turn the tube over and dispense entire contents into the sample port of the test device.
• Testing is performed in a similar manner as for patient specimens except ‘QC Sample’ is
selected instead of ‘Patient Sample’. Once “QC Sample’ is selected enter the control lot number
(numbers only) and then proceed as for a patient test.

Results:

The Alere Triage MeterPro will report concentrations specific to the test device and selected
analytes. Results should fall within the expected ranges provided on the Expected Values card
provided with the control kit. The Alere Triage MeterPro will flag results that are out of range.

If values obtained fall outside the published ranges, please contact Alere Technical Support.

© 2013 Alere. All rights reserved. The Alere Logo, Alere and Triage are trademarks of the Alere group of companies. A1782. 10
Key Alere contacts

For technical assistance please contact the Alere Technical Support Team:
1800 622 642 Free call in Australia
+61 7 3363 7711 Phone
+61 7 3363 7199 Fax
au.techsupport@alere.com

To order please contact:

1800 622 642 Free call in Australia
+61 7 3363 7166 Phone
+61 7 3363 7199 Fax
au.orders@alere.com

References

1. Alere. 2013. “Triage MeterPro System Manual.” System Manual. Technical Support.

© 2013 Alere. All rights reserved. The Alere Logo, Alere and Triage are trademarks of the Alere group of companies. A1782. 11
© 2013 Alere. All rights reserved. The Alere Logo, Alere and Triage are trademarks of the Alere group of companies. A1782. 12
Alere: The leader in point of care testing

© 2013 Alere. All rights reserved. The Alere Logo, Alere and Triage are trademarks of the Alere group of companies. A1782. 13