Alere

Triage MeterPro Customer Training Guide

Customer Training Guide

13 Pages

File Type: PDF

File Size: 728 KB

File Name: Alere - Triage MeterPro Customer Training Guide.pdf

Preview

Page 1

Alere Triage® MeterPro

Customer Training Guide

Contents

Training overview

Precautions

Alere Triage MeterPro overview

Alere Triage CODE CHIP™ overview

Alere Triage test device overview

Tests the Alere Triage MeterPro performs

Sample type and volume

Materials required to perform a test

Alere Triage Test process

Cleaning, Care and Maintenance

Quality Control – Alere Triage MeterPro

Quality control – Alere Triage test device

Key Alere contacts

References

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.

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 display)

Navigation Keys

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

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 Sample enters here

Reaction Chamber A small fraction of the sample mixes with the dried reagents (Ab)

Internal Controls Independent high control zones and a zero control confirm that the test has been completed correctly

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

Time Gate A hydrophobic surface acts as a time barrier and ensures an appropriate reaction time (90 seconds)

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

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.

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.

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

Alere Triage Test process 1.

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

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.

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.

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

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).

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

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).

Results will be displayed in approximately 15-20 minutes.

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.

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.

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 [email protected] To order please contact: 1800 622 642 Free call in Australia +61 7 3363 7166 Phone +61 7 3363 7199 Fax [email protected]

References 1.

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

Alere: The leader in point of care testing

Previous Page Next Page