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					                                      POLICY/ PROCEDURE/PROTOCOL
 Title:   Triage Cardiac Panel/Profile                                                Policy # LB-POC.20
 Audience:    All Clinical Departments performing POCT

 Key Word: Cardiac Markers, Troponin, POCT, Triage Meter, Myoglobin, CK               Date              Page:
                                                                                      Issued:
                                                                                      3/3/08               1 of 8
 Distribution: All holders of Policy and Procedure Manual


 Prepared by:     Supervisor, BGH Core Laboratory                                     Effective
                                                                                      Date: 8/15/11

 Approved by:                                                                            Date:

 Medical Director, Point of Care Testing

 Laboratory Site Director
 Regulation/Standards:
 NYS DOH Clinical Laboratory Standards of Practice
     CAP Standards
 Federal: N/A
 Accreditation Standards: DNV
 Review Date 1/15/09 1/12/10 2/1/11
 Revision         3/21/08   8/15/10   6/7/11
 Date

Review/Revision by:                                                                                Date:

Clarified acceptable specimen and enhanced QC device section                                       3/21/08

Reviewed Susan F. Howard, M.S.                                                                     1/15/09

Reviewed Susan F. Howard, M.S.                                                                      1/12/10

Revised testing frequency of External Wet Control to monthly; Modified external Triage controls in use; Included
instructions for performing calibration verification and lot to lot testing                         8/15/10

Reviewed Hassan Nakhla, M.D.                                                                       2/1/11

Revised Carol G. Schwartz,CLS, MT(ASCP) for, new procedure format, new manufacturer Alere          6/7/11




                                                            Date removed from service:             ________

 I.       Introduction
Title: Triage Cardiac Panel/Profile                                    Date          Page           Policy #
                                                                       Issued:       2 of 8         LB-POC.20
                                                                       3/3/08

       The intention of this policy is to provide guidelines for ensuring accurate POC Cardiac Marker results
       using the “moderately complex” Triage Cardiac Panels. In order to maintain quality, it is important that all
       persons performing Cardiac Markers on the Triage MeterPro adhere to the following procedures.
       LIS INFORMATION:
       Triage Cardiac Panel (Cardiac POC) – includes CK-MB, Myoglobin and Troponin I

       Triage Cardio ProfilER Panel (Cardiac + BNP POC) – includes CK-MB, Myoglobin, Troponin I and
       BNPeptide (B-type natriuretic peptide)


II.    Communication and Responsibility
       The Department of Pathology and Laboratory Medicine: Laboratory Administration and POCT Laboratory
       Committee
       Nursing Administration through the Nursing/Laboratory Liaison Committee
       It shall be the responsibility of those designated in “prepared by” or “approved by” above or their
       designees, to initiate revisions to this policy as appropriate and necessary.
       The Medical Director of Point of Care (POC) Testing for the Kaleida Health Laboratories in conjunction
       with the Site Director and Supervisor of the Essential Service Laboratory at the Kaleida Health facility
       where Cardiac POC Testing has been approved is responsible for the administration of this policy. In
       addition, the Medical Director and Nurse Manager of the clinical unit where cardiac POC testing occurs
       are responsible for the compliance of staff performing POC tests to all regulatory requirements.


III.   Scope of Practice
       This policy applies to all personnel holding a current certification to perform the Alere Triage Cardiac
       Marker testing within Kaleida Health.


IV.    Policy
       The NYS Department of Health Laboratory Standards define that the Laboratory Director is responsible
       for the quality and oversight of all point of care tests used within the Kaleida Health Organization. All staff
       performing POC for Cardiac Marker must use the approved Alere Triage meter. Since cardiac marker
       testing on the Alere Triage is classified as moderately-complex by the FDA, only licensed professionals
       who have been initially trained and recredentialed at 6 months and annually thereafter are approved to
       perform POC cardiac markers. The quality control and testing procedures in this procedure must be
       followed. Failure to follow the procedural steps in this policy may cause an inaccurate test and result in
       disciplinary action and loss of testing privileges.


V.     Procedure
                        ®
       The Alere Triage Cardiac Panel/ProfilER utilizes a fluorescence immunoassay for the simultaneous,
       quantitative determination of the cardiac proteins Creatine Kinase MB (CK-MB), Myoglobin, Troponin I
       (TN I) and BNP in whole blood and plasma specimens using EDTA as the anticoagulant.

       After the addition of the sample to the sample port of the Triage cartridge, the cells are separated from
       the plasma via a filter contained in the device. A predetermined quantity of sample is allowed to react
       with fluorescent antibody conjugates within the reaction chamber. After sufficient incubation has
       occurred, the reaction mixture flows down the device detection lane. Complexes of the analytes and
       fluorescent antibody conjugates are captured on discrete zones resulting in binding assays that are
       specific for each analyte. The concentration of the analyte in the specimen is directly proportional to the
       fluorescence detected.



       A.      Supplies:
               1.     Materials Provided
                                               ®
                      Alere Incorporated Triage Cardiac Panel – 25 tests per kit #97000 (Lawson # 132029)
Title: Triage Cardiac Panel/Profile                                 Date        Page          Policy #
                                                                    Issued:     3 of 8        LB-POC.20
                                                                    3/3/08

                       (Includes CK-MB, Myoglobin and Troponin I)

                       Alere Triage Cardio ProfilER Panel – 25 tests per kit #97100CP (Lawson # 132030)
                       (Includes CK-MB, Myoglobin, Troponin I and BNP)

               2.      Materials Required but Not Provided
                             ®
                       Triage MeterPro
                             ®
                       Triage Total Control 5 – Level 1 Lawson # 194765
                                               Level 2 Lawson # 194766

                       Triage Total Five Calibration Verification

               3.      Reagents
                              ®
                       Triage Cardiac Panel contains all the reagents necessary for the simultaneous
                       quantification of the cardiac proteins CK-MB, Myoglobin, and TN I in EDTA
                       anticoagulated whole blood and plasma.
                       The device contains stabilizers, murine monoclonal and polyclonal antibodies against
                       CK-MB, Myoglobin, TN I and BNP labeled with a fluorescent dye and immobilized on a
                       solid phase.

               4.      WARNINGS AND PRECAUTIONS
                       a.   Carefully follow the instructions and procedures.
                       b.   Patient specimens, used test devices and transfer pipettes may be potentially
                            infectious. Proper handling and disposal methods should be followed according
                            to the Kaleida Health Biohazard policies and procedures.
                       c.   The Triage Cardiac and Cardio ProfilER Panels, like all cardiac marker tests,
                            does not provide a definitive diagnosis and the results should not be used solely
                            as absolute evidence of a myocardial infarction or CHF. As with all in vitro
                            diagnostic tests, the test results should be interpreted by the physician in
                            conjunction with clinical findings, other laboratory and ECG test results.
                       d.   Blood concentrations of BNP may be elevated in patients who are experiencing a
                            heart attack, patients that are candidates for renal dialysis and patients that have
                            renal dialysis.
                       e.   The transfer pipette should be used only once. Discard after each use.
                       f.   Keep cartridge sealed in the pouch until ready to use. Discard after each use.

       B.      Storage and Stability of Reagents:
               1.     The Triage Cardiac and Cardio ProfilER devices are stable (in the sealed pouch) up to
                      the expiration date when stored refrigerated at 2 - 8C.
               2.     Once removed from the refrigeration, the pouched Triage Cardiac and the Cardio
                      ProfilER are stable up to 14 days, but not beyond the expiration date on the pouch.
               3.     If not used on the same day of removal from refrigeration, write the date of removal on
                      the box and the new expiration date for 14 days later on the box.
               4.     When first removed from refrigeration, allow a minimum of 15 minutes for the device to
                      reach room temperature while still in the sealed pouch.
               5.     Do not remove the device from the pouch until ready to use.



       C.      Specimen Requirements:
               1.    An EDTA whole blood specimen drawn in a lavender top tube is required. Other blood
                     specimen types have not been evaluated and cannot be used. Transport specimens at
                     room temperature or chilled. Avoid extreme temperatures.
               2.    The specimen should be at room temperature and homogenous before testing.
               3.    Mix specimen by gentle inversion of the tube at least 10 times before transferring
                     blood to the test device.
Title: Triage Cardiac Panel/Profile                                  Date          Page           Policy #
                                                                     Issued:       4 of 8         LB-POC.20
                                                                     3/3/08

               4.      Avoid severely hemolyzed specimens whenever possible. Obtain new specimen if
                       severely hemolyzed.

       D.      External Quality Control Procedure:
               1.     Quality Control and Acceptability of Results

                       a.      External Wet Controls - Used to verify the accurate performance of the reagents.
                               According to Kaleida Health policy, two (2) external controls (Triage Total Control
                               5) must be performed:
                               1)      Before a new shipment of devices is used, and
                               2)      Before a new lot # of devices is used, and
                               3)      At least, once per month

                       b.      The QC Device (QC Simulator) provided must be tested daily to verify
                               instrument performance. Each meter has its own specific QC device and only the
                               QC device that matches the SN of the instrument can be used. DO NOT
                               DISCARD QC DEVICE. The calibration, laser, and alignment tests must pass.
                               The Low and High Control must pass and be within +/- 15%. The QC device is
                               light sensitive and must be kept in its own black box when not in use. The user
                               will be prompted to run the QC device before any testing can be done if it has
                               been more than 24 hours from the time of the last check of the QC device.

                       c.      Internal Controls - Each Triage Cardiac/Cardio ProfilER Panel contains two
                               internal controls that satisfy daily quality control requirements. The controls are of
                               different concentrations that run automatically with every sample. These controls
                               indicate
                               1)       that sufficient sample was applied to the panel, and
                               2)       that unbound fluorescent label was washed sufficiently from the
                                        detection zone, and
                               3)       that the panel was inserted and read properly by the meter.

                               An unacceptable result from either control causes the display of a warning
                               message on the Triage Meter indicating that the test must be repeated.

                               If the automatic check of the built in controls are acceptable within the limits set
                               during the manufacturing, the meter will report a result for the specimen being
                               tested.

                       d.      Lot to Lot Testing - Lot to lot testing must be performed with each new shipment
                               and or lot of reagent. QC should be run in parallel on a test cartridge from the
                               previous lot and on the newly received lot. Additionally, a patient sample should
                               be tested on both the previous lot and on the new lot and results compared for
                               acceptability. Results should be recorded on Alere Cardiac Triage Meter Lot to
                               Lot Verification Log LB-POC-20.




               2.      QC Testing Procedure

                       a.      Lot Calibration Using the Reagent Code Chip
                               When a new lot of 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 with each new lot to transfer the data to the meter.
                               1)        From the main screen, select Install New Code Chip. Press Enter.
                               2)        Place the reagent code chip into the lower left front corner of the meter
                                         and follow the prompts on the screen.
Title: Triage Cardiac Panel/Profile                                 Date          Page           Policy #
                                                                    Issued:       5 of 8         LB-POC.20
                                                                    3/3/08

                               3)      Remove the reagent code chip from the meter when data transfer is
                                       complete.

                       b.      Performing Triage System Quality Control – QC Device
                               Perform daily to insure proper function of the Triage MeterPro.
                               1)     The first time a new QC Device is run in the meter, install the QC Device
                                      Enhanced Code Chip. Once installed, the chip data is retained in the
                                      meter and does not need to be reinstalled. To order lost devices, call
                                      Inverness technical service and ask for an Enhanced QC Device and
                                      Chip.
                                      a)        From the main screen, select Install New Code Chip and press
                                                Enter.
                                      b)        Place the QC Device Code Chip into the lower left front corner of
                                                the Meter. Follow prompts on screen.
                                      c)        Remove the QC Device Code Chip from the meter when data
                                                transfer is complete.
                               2)     Daily QC Device (QC Simulator):
                                      a)        From the main screen, select Run Test and press Enter.
                                      b)        Select QC Device and press Enter.
                                      c)        Insert QC Device and press Enter.
                                      d)        A Pass or Fail result will be displayed/printed when the testing is
                                                completed. Each parameter must pass QC before patient
                                                testing is performed.
                                      e)        Remove QC Device from meter and place in special black box.
                                      f)        Do not Throw QC Device away.

                       c.      Calibration Verification
                               Calibration Verification will be performed on a bi-annual basis utilizing Triage
                               Total Five Calibration Verification material.

       E.      Patient Test Procedure:
               1.      On the Triage meter, select RUN TEST using ▲or ▼keys.
               2.      Press the ← enter key
               3.      Scan your badge user ID # using the barcode on the back of your ID badge.
               4.      Press the ← enter key
               5.      Select PATIENT SAMPLE using ▲or ▼keys.
               6.      Press the ← enter key
               7.      Scan the patient‟s financial # from the bar-coded PLUE label on the blood tube
               8.      Press the ← enter key
               9.      Review the patient‟s financial ID# that has been scanned in. If correct, press the ← enter
                       key to confirm the patient financial ID#

               10.     ADD SAMPLE – Open the pouch, label the test device with patient‟s “last name, first
                       name”, and add EDTA whole blood into the sample chamber using the transfer pipette
                       provided:
               11.     To use the Transfer Pipette:
                       a.      Mix the specimen by gentle inversion at least 4 times. (Do not shake).
                       b.      Depress the larger (top) bulb completely and insert the tip into the specimen.
                       c.      Release the bulb slowly. The tube should fill completely. Some fluid must remain
                               in the smaller lower bulb.
                       d.      Place the tip of the pipette into the sample port of the device and depress the
                               larger bulb completely. The entire amount of sample in the pipette tube must be
                               dispensed. The sample in the smaller bulb will not be expelled.
                       e.      Remove the tip from the sample port and then release the bulb.
                       f.      Discard the transfer pipette into the biohazard waste.
Title: Triage Cardiac Panel/Profile                                 Date          Page           Policy #
                                                                    Issued:       6 of 8         LB-POC.20
                                                                    3/3/08

                                                                              ®
               12.     INSERT – Gently insert the test device into the Triage MeterPro after adding the
                       specimen 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 the ← enter key. The meter
                       pulls in the test device and scans it. The measurement will take ~ 15 minutes. The device
                       may alternatively be incubated on the countertop. Do not let the device incubate more
                       than 30 minutes after addition of the specimen. When the test is complete, the meter will
                       beep, eject the device and display the results on the meter‟s screen and automatically
                       print the results.

               13.     READ RESULTS – Read the assay results from the meter display screen or the printed
                       paper. The results will automatically be put into the patient‟s record thru the POCT
                       interface to Power Chart. Discard the used test device using appropriate procedures.

       F.      Limitations
               1.      The results of the Triage Cardiac Panel and Cardio ProfilER panel should be evaluated
                       in the context of all the clinical and laboratory data available. In those instances where
                       the laboratory results do not agree with the clinical evaluation, additional tests should
                       be performed accordingly.

               2.      This test has been evaluated with whole blood and plasma using EDTA as the
                       anticoagulant. Serum and blood or plasma specimens obtained using other
                       anticoagulants have not been evaluated and should not be used.

               3.      There is the possibility that factors such as technical or procedural errors, as well as
                       additional substances in the blood specimens that are not listed, may interfere with the
                       test and cause erroneous results.

               4.      Interfering Substances
                       a.       Hemoglobin (up to 1000 mg/dL), lipids (cholesterol up to 1000 mg/dL and
                                triglycerides up to 1000 mg/dL) or bilirubin (up to 20 mg/dL) added to EDTA-
                                anticoagulated plasma containing the four analytes did not interfere with the
                                recovery of any of the analytes. Severely hemolyzed samples should be rejected
                                and a new specimen obtained.

                       b.      The hematocrit was varied between 30% and 60% with no significant effect on
                               the recovery of troponin I, CK-MB, myoglobin or BNP.

                       c.      Drug interferences – A significant number of drugs were tested for potential
                               cross-reactivity and interferences at concentrations that represent the blood
                               concentrations that would result from a maximal therapeutic dose. There were no
                               interferences noted. See package insert for a list of drugs that were tested.

                       d.      Protein – See package insert for details on the evaluation of related protein
                               cross-reactivity.
                       e.      Reactivity with various forms of Cardiac Troponin I – no interference detected
                               with various complexes of cardiac troponin I. The cardiac Troponin I method
                               should detect the analyte in each of its forms on an equimolar basis (free and
                               complex).

       G.      Expected Results:

              Cardiac Marker          ED POCT Alere Triage
              Troponin I              0.00 – 0.04                           Reference Range
              Troponin I              0.05 – 0.40                           Consistent w/myocardial damage
              Troponin I              >0.40                                 Consistent w/AMI
Title: Triage Cardiac Panel/Profile                                   Date          Page           Policy #
                                                                      Issued:       7 of 8         LB-POC.20
                                                                      3/3/08

               CKMB                    0.0 – 4.3                             Reference Range
               Myoglobin*              0 - 140                               Reference Range
               BNPeptide               0 - 99                                Reference Range (same as lab method)

                The addition of Myoglobin, an early rising, although non-specific marker, in conjunction with
                Troponin and CKMB in a 0 and 90 minute rapid serial protocol can help to exclude AMI
                depending on the time from symptom onset to presentation. The shortening of cardiac marker
                turn-around time will decrease the time for patient triage and appropriate treatment which can be
                important in chest patients with non-ST elevation MI. The rapid protocol should be used along
                with clinical presentation, ECG results and time of symptom onset.

                * Myoglobin – appears in the blood 1-2 hours after symptom onset but may be cleared in as little
                as 6 hours. Myoglobin has a low specificity for cardiac necrosis in patients with renal failure or
                skeletal muscle injury and must be interpreted in conjunction with the other cardiac markers. A
                negative Myoglobin (< 140) measured at baseline and 90 minutes in patients presenting less than
                8 hours after symptoms onset may assist in ruling out a diagnosis of AMI.

                A significant rise in Myoglobin (doubling) over 90 minutes with at least 1 of the serially drawn
                Myoglobins greater than 140 ng/mL may support, but is not conclusive for AMI.

                Temporal elevations of CK-MB, myoglobin and Troponin I are observed in patients with
                myocardial infarctions. However, CK-MB and myoglobin, but not cardiac Troponin I, may be
                elevated in renal disease and skeletal muscle injury. Cardiac Troponin I appears to be elevated
                only in those diseases that directly involve the heart. Collectively, the diagnosis of myocardial
                infarction should include measurement of these cardiac markers and other clinical information
                including patient history and electrocardiographic data. Other conditions that may result in
                elevated cardiac proteins are: cardiac contusions, myocarditis, invasive examination of the heart,
                coronary artery bypass surgery, congestive heart failure and unstable angina.

                Analytical Meter Range:
                Troponin I:    0.05 - 30 ng/mL – Reported as <0.05 and >30 ng/mL.
                CK-MB:         1.0 – 80 ng/mL – Reported as <1.0 and >80 ng/mL
                Myoglobin:     5 – 500 ng/mL – Reported as <5 and >500 ng/mL
                BNP:           5-5000 pg/mL – Reported as <5 and >5000 pg/mL.


VI.     Protocol - Operator Certification:
        A.     Must be trained by an approved and designated trainer.
        B.     Original certification should remain on the unit in personnel folder and a copy should be sent to
               your site‟s POC Office Clinical Laboratory.
        C.     Must be recertified after 6 months and annually thereafter. See training skills checklist.
               Recertification consists of reviewing the current revision of the policy and procedure, successfully
               passing the knowledge based quiz, and demonstrating the test performance to an approved
               trainer.
        D.     Each clinical area performing Point of Care Cardiac Markers will test proficiency samples.
               Samples are to be rotated among the staff. Reported results will be submitted for analysis by the
               administering agency (NYS DOH or College of American Pathologists).


VII.    Documentation – N/A


VIII.   References

        Alere Triage Cardiac package insert
        Alere Triage Cardio ProfilER package insert
        Alere Point of Care Summit, Boston, MA, June 7, 2007
Title: Triage Cardiac Panel/Profile                                                 Date             Page              Policy #
                                                                                    Issued:          8 of 8            LB-POC.20
                                                                                    3/3/08


          Biomarkers of Acute Coronary Syndromes and Heart Failure, Christenson, R., editor, NACB Laboratory
          Medicine Practice Guidelines, American Association for Clinical Chemistry, 2007.


Kaleida Health developed these policies and procedures in conjunction with administrative and clinical departments. These documents were
designed to aid the qualified health care team in making clinical decisions about patient care. These policies and procedures should not be
construed as dictating exclusive courses of treatment and/or procedures. No health care team member should view these documents and
their bibliographic references as a final authority on patient care. Variations of these policies and procedures in practice may be warranted
based on individual patient characteristics and unique clinical circumstances. Please contact the print shop regarding any associated forms.

				
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