Download standard operating procedure (sop) for use of

Southern Health and Social Care Trust
POCTTRIAGETOX
Pathology and Laboratory Service
Page 1 of 10
POCT
Date of issue 20/05/2011
STANDARD OPERATING PROCEDURE (SOP) FOR USE OF
BIOSITE TRIAGE METERPLUS
For Tox Drug Screen
This SOP has been compiled by the POCT committee to provide a document
compatible with Clinical Pathology Accreditation standards, containing information
users need to achieve consistently reliable and accurate results. This SOP should
be read in conjunction with the manufacturer’s manual and test device package
insert.
Clinical Relevance/Purpose
Drug abuse is an increasingly significant social and economic problem.
Opiates, cocaine, THC, amphetamines and phencyclidine are among the most
frequently abused illicit drugs. Benzodiazepines, tricyclic antidepressants,
barbiturates and opiate compounds are among a group of prescription drugs that
also are frequently abused. Acetaminophen/paracetamol overdose is a significant
concern due to the risk of hepatotoxicity. The opiate class of compounds that may
produce a positive result include illicit opiates as well as cough medications
containing codeine and antidiarrhoeal preparations. Methadone, although known for
its use in the maintenance treatment of heroin addicts, has abusive potential
because it produces morphine-like drug dependence.
Urine-specific screening tests for drugs of abuse range from simple immunoassay
tests to complex analytical procedures. The speed and sensitivity of immunoassays
have made them the most accepted method for screening urine for the presence of
drugs.
Principle of examination
The Triage® TOX Drug Screen is a competitive fluorescence immunoassay used for
the qualitative determination of parent compound and major metabolites of drugs of
abuse in urine specimens. After addition of a urine sample to the sample port of the
test device, the urine passes through a filter. The sample moves by capillary action
into a reaction chamber and is allowed to react with fluorescent antibody conjugates
or mix with fluorescent drug conjugates within the reaction chamber to form a
reaction mixture. After an incubation period, the reaction mixture flows through the
test device detection lane. The presence of drug or drug metabolite in the urine
specimen prevents binding of the fluorescent conjugates to the solid phase on the
detection zone. Excess urine washes the unbound fluorescent conjugates from the
SOP for use of Triage MeterPlus with Tox Drug Panel
Controlled Document at: 09/05/2017
Southern Health and Social Care Trust
POCTTRIAGETOX
Pathology and Laboratory Service
Page 2 of 10
POCT
Date of issue 20/05/2011
detection lane into a waste reservoir. The Triage Meter reads the fluorescence bound
to the detection zone and reports a positive or negative result.
Specimen Requirements
Freshly voided urine specimens should be collected in a clean, previously unused
glass or plastic container. If the specimen is not tested immediately it should be
refrigerated at 2 °C to 8 °C for a maximum of two days. If longer storage is required,
specimens may be stored frozen at –20 °C or colder.
Frozen and refrigerated specimens must be allowed to reach room temperature and
be mixed thoroughly prior to testing.
Specimens containing a large amount of particulate matter may be clarified by
centrifuging or allowed to settle prior to testing.
Sample rejection
See Specimen requirements.
Equipment
The Triage® MeterPlus is a portable fluorescence instrument used to measure the
results of tests manufactured by Biosite Incorporated®. The Triage® MeterPlus can
be used in a laboratory or in a point-of-care setting.
Northern Ireland Biosite representative
Liam Donnelly, Sales Manager
Alere Health Ltd
14 Pilot’s View, Heron Road,
Belfast BT3 9LE
Tel. 028 9046 9992
Mobile 07771642360
The Triage® MeterPlus uses a laser as a light source. Light from the laser hits a test
device that has been inserted in the meter. This causes the fluorescent dye in the
test device to give off energy. The more energy the fluorescent dye gives off, the
stronger the signal.
Triage® Test Devices - A test device holds the sample and also contains the
reagents and other materials needed for the test.
Kit Contains:
Test Devices
SOP for use of Triage MeterPlus with Tox Drug Panel
Controlled Document at: 09/05/2017
Southern Health and Social Care Trust
POCTTRIAGETOX
Pathology and Laboratory Service
Page 3 of 10
POCT
Date of issue 20/05/2011
Transfer Pipettes
Reagent CODE CHIP™ module
Printer Paper
Reagents, standards or calibrators, and IQC material
Reagents
Panels are obtained through Receipt and Distribution as a non stock item.
TOX Drug Screen (Catalogue no 94400)
The Test Device contains:
• Murine monoclonal antibodies against drug metabolites
• Fluorescent dye
• Solid phase
• Stabilizers
Store the Test Devices in a refrigerator at 2 °C to 8 °C.
Once removed from refrigeration, the pouched Tox Drug Screen Test Devices are
stable for up to 14 days, but not beyond the expiration date printed on the pouch.
Once equilibrated to room temperature do not return to refrigeration.
Do not remove the Test Device from the pouch until ready for use
Before using refrigerated Test Devices (2 °C to 8 °C), allow individual foil pouched
Test Devices to reach room temperature before use. This will take a minimum of 15
minutes. If a kit containing multiple Test Devices is being removed from refrigeration,
allow the kit and Test Devices to reach room temperature before use. This will take a
minimum of one hour.
If the Test Device is not used on the same day of removal from refrigeration, gently
write the date of removal from the refrigerator and the date to discard on the foil
pouch and/or the kit box. Use a soft, felt tip marker to avoid damage to test device.
Calibration
When a new lot of Test Devices is opened, the calibration and expiration data for that
lot of Test Devices must be transferred to the meter before patient testing. Use the
Reagent CODE CHIP module supplied with the new lot of Test Devices to transfer
the data to the meter.
Perform one time for each new lot of Test Devices
1. From the main screen, select <Install New Code Chip>. Press Enter.
2. Place the Reagent CODE CHIP module into the lower left front corner of the Meter
and follow the prompts on the screen.
3. Remove the Reagent CODE CHIP module from the Meter when data transfer is
complete.
Internal Quality Control
QC Device - Use the QC Device to verify instrument performance.
(For instructions see IQC section below)
SOP for use of Triage MeterPlus with Tox Drug Panel
Controlled Document at: 09/05/2017
Southern Health and Social Care Trust
POCTTRIAGETOX
Pathology and Laboratory Service
Page 4 of 10
POCT
Date of issue 20/05/2011
Instructions for performance of examination
Add patient specimen
1. Open the pouch and label the Test Device with the patient identification.
2. Place the device on a level, horizontal surface.
3. Using the transfer pipette, squeeze the larger (top) bulb completely and insert the
tip into the patient specimen.
4. Release the bulb slowly. The transfer pipette barrel should fill completely with
some fluid flowing into the smaller (lower) bulb.
5. Place the transfer pipette tip into the sample port of the Test Device and squeeze
the larger bulb completely. The entire contents of fluid in the transfer pipette barrel
must flow into the sample port. The sample in the smaller (lower) bulb will not be
expelled.
5. Remove the transfer pipette tip from the sample port and then release the larger
(top) bulb.
6. Discard the transfer pipette in a clinical waste bin.
Run Test
1. From the main screen, select <Run Test> and press Enter.
2. Select <Patient Sample> and press Enter.
3. Enter the patient identification (preferably Health and Care Number) and press
Enter.
4. Confirm that the number was entered correctly by selecting <Confirm Patient ID>
and pressing Enter. If the number was not entered correctly, select <Correct Patient
ID>, press Enter and repeat the previous step.
5. Holding the Test Device by the edges gently insert into the meter until you feel the
device catch on the pin. You will hear an audible click that tells you the test device
has been inserted properly. Press Enter. The results will be displayed when the
analysis is complete.
Note: The Test Device should be inserted into the Meter within 30 minutes from the
time the patient specimen was added. A delay longer than 30 minutes may cause the
results to be invalid and blocked out on the printout.
The Triage® Meter measures the patient specimen automatically. The results
are displayed on the screen and printed automatically on thermal paper. Normal
ranges are displayed on the report.
Discard the Test Device into a clinical waste bin after release from the meter.
More detailed instructions can be found in the manufacturer’s Operating Manual.
Recording and calculation of results
A blocked out result indicates the result was invalid and the test should be repeated.
SOP for use of Triage MeterPlus with Tox Drug Panel
Controlled Document at: 09/05/2017
Southern Health and Social Care Trust
POCTTRIAGETOX
Pathology and Laboratory Service
Page 5 of 10
POCT
Date of issue 20/05/2011
Results must be recorded in the POCT results log sheet (can be obtained on POCT
site on Trust intranet) and in the patient notes.
The thermal printer paper fades with time so for a permanent record all patient
results must be written into the patient’s medical notes and the POCT results log
sheet.
Results must always correlate with the patient’s condition and patient history.
Unexpected or suspect negative results should be repeated immediately. If doubt still
remains, then a sample should be sent to the Regional Toxicology Laboratory,
Belfast Link Labs.
A positive result MUST be confirmed by sending a sample to the Regional Toxicology
Laboratory, Belfast Link Labs for confirmatory analysis.
The RCPath/IBMS recommend that near patient testing results be entered on the
patient’s record.
The log of specimens analysed should be retained for at least the lifetime of the
instrument, minimum of 10 years.
The following threshold concentrations are established for the drug assays:
These threshold concentrations are used to separate a negative result from a
presumptive positive result.
Acetaminophen/Paracetamol (APAP) 5 µg/mL
Amphetamines (AMP) 1000 ng/mL
Methamphetamines (mAMP) 1000 ng/mL
Barbiturates (BAR) 300 ng/mL
Benzodiazepines (BZO) 300 ng/mL
Cocaine (COC) 300 ng/mL
Methadone (MTD) 300 ng/mL
Opiates (OPI) 300 ng/mL
Phencyclidine (PCP) 25 ng/mL
THC (THC) 50 ng/mL (active ingredient in Cannibis)
Tricyclic Antidepressants (TCA) 1000 ng/mL
The Meter displays the results as either “POS” if the result is at or above the
threshold or “NEG” if the result is below the threshold.
A specimen may contain drug and/or drug metabolites at concentrations that do not
exceed the threshold concentrations that would otherwise classify the test result as
positive. In order to obtain a confirmed analytical result, a more specific alternate
chemical method is needed. Gas Chromatography/Mass Spectroscopy (GC/MS) is
the preferred confirmatory method.
A quantitative serum acetaminophen/paracetamol measurement is the common
confirmatory method for preliminary positive acetaminophen/paracetamol results.
SOP for use of Triage MeterPlus with Tox Drug Panel
Controlled Document at: 09/05/2017
Southern Health and Social Care Trust
POCTTRIAGETOX
Pathology and Laboratory Service
Page 6 of 10
POCT
Date of issue 20/05/2011
Limitations (interferences, cross reactions and reportable intervals)
Adulterants, such as bleach or other strong oxidizing agents, added to urine
specimens may produce erroneous results regardless of the method of analysis. If
adulteration is suspected, obtain an additional specimen and re-test using a new Test
Device.
A presumptive positive result does not indicate the level of intoxication, nor does it
indicate the route of administration.
There are no uniformly recognized threshold concentrations for urine-based
acetaminophen/ paracetamol assays. The test indicates that the analyte was or was
not present above the threshold concentration.
Test results must always be evaluated with other data available to the physician.
The performance of this product has been established for human urine only.
NB Be aware that a negative result may be obtained with a diluted
urine sample and that some legal or prescription drugs will cause a
positive result e.g. codeine
A positive result MUST be confirmed by sending a sample to the
Regional Toxicology Laboratory, Belfast Link Labs for confirmatory
analysis.
Refer to Test Device package insert (available on POCT website) for lists of drugs
found not to cross react and results of specificity testing and potential interfering
substances tests.
IQC
Use the QC Device to verify instrument performance.
• Upon initial setup of the Meter.
• Each day of patient testing.
• When the Meter has been transported or moved.
• Whenever there is uncertainty about the performance of the Meter.
1. The first time a new QC Device is run in the Meter, install the QC Device CODE
CHIP™ module. The QC Device CODE CHIP module data is stored in the meter
memory. The QC Device CODE CHIP module does not need to be reinstalled after
the first time.
a. From the main screen, select <Install New Code Chip> and press Enter.
b. Place the QC Device CODE CHIP module into the lower left front corner of the
Meter. Follow the prompts on the screen.
c. Remove the QC Device CODE CHIP module from the Meter when data transfer is
complete.
2. From the main screen, select <Run Test> and press Enter.
3. If User ID is enabled enter your User ID number and press Enter.
SOP for use of Triage MeterPlus with Tox Drug Panel
Controlled Document at: 09/05/2017
Southern Health and Social Care Trust
POCTTRIAGETOX
Pathology and Laboratory Service
Page 7 of 10
POCT
Date of issue 20/05/2011
4. Select <QC Device> and press Enter.
5. Insert QC Device and press Enter.
6. A Pass or Fail result will be displayed when completed.
Each parameter should pass before patient testing is performed.
7. Remove the QC Device from the meter and place in the special black QC Device
Box. DO NOT THROW THE QC DEVICE AWAY.
8. The results of the QC Device check should be recorded on the POCT results log
sheet.
Every Triage® TOX DS Test Device is a qualitative test device that includes negative
and positive controls that are run automatically with every patient specimen, external
liquid control solution, or proficiency testing sample.
If the automatic check of these built-in controls shows that the control value results
are within the limits set during manufacturing, the meter will report a result for the
specimen being tested. If the automatic check of these built-in controls shows that
the control value results are not within the limits set during manufacturing, a test
result will not be reported. Instead, the meter will display a warning or error message
that is described in the Triage® Meter User Manual.
The Triage® tests have been designed to include assay controls in each test device
that monitor the assay procedure and the reagent integrity.
It is still valuable to apply the traditional approach to quality control by testing quality
control samples. These controls will check the total integrity of the system. The
interval for analysing these controls, however, can be extended due to the many
other Total Quality Assurance features inherent in the Triage® tests.
Based on the current CLIA guidelines and other regulating bodies, Biosite
Incorporated makes the following QC recommendations:
• Run two levels or POS and NEG external liquid control samples as appropriate with
each new lot of reagents and once every thirty days with continued use of the same
reagent lot number
• Run the QC Device daily
EQA
Enrolled in Ranox Urine Toxicology Programme (see POCTEQA document).
Maintenance
For troubleshooting refer to operators manual - available in the POCT section of the
Trust Intranet. QPulse document PI-POCTTRIAGEMETERPLUS
SOP for use of Triage MeterPlus with Tox Drug Panel
Controlled Document at: 09/05/2017
Southern Health and Social Care Trust
POCTTRIAGETOX
Pathology and Laboratory Service
Page 8 of 10
POCT
Date of issue 20/05/2011
In the event of instrument failure contact the Biomedical Engineering Department
(Medical Technical Officers) or POCT team for advice.
If any service or maintenance is required, the Triage® MeterPlus should be sent to
the manufacturer via the Biomedical Engineering Department.
No maintenance other than paper replacement and periodic external cleaning is
required of the operator.
Paper Replacement
Changing paper between functions
1. Tear off any excess paper sticking out of the Triage® MeterPlus.
2. Remove the paper compartment cover by pulling up on the cover as indicated by
the arrow on the back of the cover.
3. Remove unused paper or the empty paper spindle from paper compartment.
4. Tear or cut a clean, straight edge to feed into the printer. Do not cut paper at an
angle, as the printer must sense the edge of the paper along the feed path.
5. Insert the new roll of paper into the paper compartment.
6. Position the paper such that the paper will feed from under the roll (as opposed
to over the top of the roll).
7. Insert the paper edge under the paper roller (platen) until it firmly seats or
resistance is felt.
8. Press the paper feed key.
9. Replace the cover of the printer and continue operation.
Service and Maintenance Procedures
Changing Paper While Printing
If the meter runs out of paper while in the middle of a printing task and is displaying
the message PRINTER FAILURE, CHECK PRINTER OR REPLACE PAPER, the
paper may be changed and the print job continued without loss of data or reprinting
from the beginning. Perform the following steps prior to pressing any new keys:
1. Remove the paper compartment cover by pulling up on the cover as indicated by
the arrow on the back of the cover.
2. Gently pull remaining paper slowly up through the printer.
3. Remove paper spindle from the paper compartment.
4. Tear or cut a clean, straight edge to feed into the printer. Do not cut paper at an
angle, as the printer must sense the edge of the paper along the feed path.
5. Insert the new roll of paper into the paper compartment.
6. Position the paper such that the paper will feed from under the roll (as opposed
to over the top of the roll).
7. Insert the paper edge under the paper roller (platen) until it firmly seats or a
resistance is felt.
8. Press the paper feed key.
9. When the printer begins to pull the paper in, release the paper. The printer will
feed a few lines and re-commence the print job. To ensure no data is lost, the
printer will reprint up to the previous 5 lines.
10. After the paper has appeared above the printer, replace the printer cover, taking
care to ensure the paper does not get caught inside the meter.
SOP for use of Triage MeterPlus with Tox Drug Panel
Controlled Document at: 09/05/2017
Southern Health and Social Care Trust
POCTTRIAGETOX
Pathology and Laboratory Service
Page 9 of 10
POCT
Date of issue 20/05/2011
Cleaning
Occasional cleaning of the exterior with mild soap and water solution is required.
After using a damp, not wet, sponge or cloth to apply a mild soap and water solution
on the outside of the meter, wipe the meter dry using a soft cloth or absorbent tissue.
Do not allow water to seep into the printer. Do not immerse the meter in water or
other liquids.
If outer surfaces are contaminated with blood 50:50 bleach mixture or other suitable
disinfectant may be used.
If blood or other fluids are not allowed enough time to fully absorb into 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.
Reporting reference limits
Qualitative test - not applicable.
Alert critical values
Local protocol in relation to the reporting of critical results should be adhered to.
Qualitative test - see advice given under “Recording and Calculation of Results” and
“Limitations”
Responsibilities of personnel in authorising, reporting and
monitoring reports
Only those formally trained to use the Biosite Triage meter should do so.
Support will be provided as follows:
Manufacturer
 Initial training
 Service or Maintenance (via Medical Engineering Department, (Medical
Technical Officers) - CAH ext. 2928)
The laboratory POCT team (CAH ext 2660/3709)
 Audit
 Advice on POCT QMS
SOP for use of Triage MeterPlus with Tox Drug Panel
Controlled Document at: 09/05/2017
Southern Health and Social Care Trust
POCTTRIAGETOX
Pathology and Laboratory Service
Page 10 of 10
POCT
Date of issue 20/05/2011
The Biomedical Engineering Department (Medical Technical Officers) (CAH ext.
2928)
 Advice on troubleshooting or instrument failure
Hazards and Safety Precautions
Universal precautions must be followed when handling the body fluids used for
testing.
Dispose of waste in the appropriate clinical waste bins.
See COSHH Risk assessment form – available in the POCT section of the Trust
Intranet. QPulse COSHH document POCTBIOSITETRIAGE
Performance Criteria
See product insert – available in kits and in the POCT section of the Trust Intranet.
Q Pulse Document PI-POCTTOXDRUG.
References
Biosite Triage MeterPlus Operators Manual
Biosite Triage Tox Drug Screen Package Insert
RCPath/IBMS The retention and storage of pathological records and specimens (4th
edition 2009)
SOP for use of Triage MeterPlus with Tox Drug Panel
Controlled Document at: 09/05/2017