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Test ID: POC ACT-LR
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Hemochron Signature Elite - ACT-LR
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Point of Care Test
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Useful For
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This procedure provides instructions for performing whole blood coagulation test, Activated Clotting Time (ACT) using fresh whole blood on HEMOCHRON Signature Elite at Point-Of-Care Testing (POCT) sites.
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Method name and description
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HEMOCHRON Signature Elite is a portable system. It utilizes a mechanical endpoint clotting mechanism which is monitored optically.
After adding the whole blood sample, the HEMOCHRON Signature Elite precisely measures 15 microliters of blood and automatically moves it into the test channel in the Cuvette. Sample/reagent mixing, and test initiation are automatic, requiring no operator interaction. After mixing with the reagent, the sample is moved back and forth within the test channel and monitored for clot formation.
Clot detection utilizes a series of LED optical detectors aligned with the test channel of the Cuvette. The speed at which the blood sample moves between the detectors is measured. As the clot formation begins, blood flow is impeded, and the movement slows. The instrument recognizes that the clot endpoint has been achieved when the movement decreases below a predetermined rate. Electronic optical detection of a fibrin clot in the sample automatically terminates the test causing the instrument’s timer to display the coagulation time in seconds.
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Clinical information
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ACT (Activated Clotting Time) is used to MONITOR heparin therapy during; cardiac surgery, cardiac catheterization, hemodialysis and cardiopulmonary bypass surgery.
ACT-LR: Monitor low to moderate heparin doses (up to 2.5 units/ml)
The POCT HEMOCHRON Signature Elite ACT test is classified as Non-Waived Moderate Complex Test by Clinical Laboratory Improvement Amendments (CLIA).
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Specimen type / Specimen volume / Specimen container
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Specimen Type: Fresh Whole Blood
Sample Volume: 1 big drop, approximately 0.2 cc
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Collection instructions / Special Precautions / Timing of collection
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Blood samples for testing should NOT be collected until the instrument indicates: “ADD SAMPLE….PRESS START”
Blood sample should be added immediately to the test cuvette without delay once the countdown started.
Testing should be done immediately.
Universal precautions must be observed when handling blood specimens. All blood specimens must be handled as potentially infectious.
PPE must be used when handling any biological samples.
All sharps should be disposed properly in a leak-proof sharp box.
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Storage and transport instructions
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Blood sample should be added immediately to the test cuvette without delay
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Specimen Rejection Criteria
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1. Clotted sample
2. Insufficient quantity
3. Improper collection procedure
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Biological reference intervals and clinical decision values
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Test
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Reference Interval
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Analytical Measuring
Range
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Out of Range
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Reporting Units
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ACT-LR
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80-160 Sec**
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Up to 400*
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- Results over 400 sec. are displayed as:
“Out of range-Hi”
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Seconds
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Factors affecting test performance and result interpretation
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Error
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Effect
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How to avoid
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Wrong patient ID/ Wrong sequence in Data Entry
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Mix-Up / loss patient’s Cerner results record
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Use 2 identifiers; patient’s full name and valid HC number and follow the correct sequence of Data Entry
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Collecting sample before countdown started
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Blood sample might get clotted
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Blood samples be collected only when instrument indicates: “ADD SAMPLE….PRESS START”
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Air bubbles in
Sample/ clotted sample
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Test will show error/ result will be displayed 0 sec.
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Processing sample immediately and remove air bubbles by tapping the syringe
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Turnaround time / Days and times test performed / Specimen retention time
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The sample is processed in the device immediately and the result depends on the patient clotting time.
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