Abbott Precision XceedPro Manual del operador Pagina 3

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Title (with LTR): Precision Xceed Glucose Procedure (LTR19678)
Last Approved: Gregory, Kimberly (Electronic Signature Timestamp: 8/11/2014 3:20:23 PM)
3
3. Additional information that must be retained for four years:
1. Testing personnel records
2. Quality control results
3. Product information (i.e. serial number, lot numbers, expiration dates, etc.), information on quality control
and any remedial action
4. QC charts, maintenance sheets, reference and critical ranges
4. Other
1. Universal precautions must be observed when handling any patient specimen.
2. A physician’s order or standing order is required prior to performing test.
3. The Hospital Hand Hygiene policy must be adhered to at all times.
Limitations/Interferences
1. The Precision XceedPro Test Strips are designed for use with fresh whole blood samples. DO NOT use serum
or plasma samples.
2. The Hematocrit range is 20 – 70%.
3. Reportable range: 20 – 500 mg/dL, sample size 0.6 ul, test time 20 seconds
4. Test results may be affected by various levels of severe hydration, severely hypotensive, in shock, or in a
hyperglycemic-hyperosmolar state (with or without ketosis). Similar observations have been reported in the
literature for other blood glucose monitoring systems.
Precautions
If the test fails to start, sufficient blood sample may not have been applied to the test strip.
Discard the current test strip and repeat with new strip.
Do not use during intravenous infusion of high-dose ascorbic acid or during xylose absorption testing.
Do not use test strips after their expiration date.
Do not use test strips that are wet, bent, scratched, or damaged in any way.
Do not re-use test strips.
Action Ranges
Patient Specimens
Based on the performance characteristics of the instruments, it is recommended that values less than 50 mg/dL or
greater than 400 mg/dL be verified by sending specimen to the laboratory and notifying the physician. Additionally, in
the neonatal population, refer to preprinted order sheets for ranges and protocols, and for diabetic patients, refer to
individualized sliding scale insulin orders.
Reference Range
The normal range reported for plasma glucose collected in a gray top tube in a fasting patient is reported to be 70-100
mg/dl. Plasma glucose values are compared to the reference range in the context of criteria of the American Diabetes
Association for the diagnosis of diabetes mellitus. However, we do not report a non-fasting glucose level, as this varies
widely depending on a variety of factors. Additionally, the sample collected for blood capillary glucose is a capillary
specimen, which differs from the corresponding values of a plasma sample. Therefore, the BCG test does not
correlate exactly with the plasma glucose level collected in a gray top tube. Furthermore, the CBCG test is designed
for monitoring known diabetic patients in the hospital setting and is not indicated for the diagnosis of diabetes mellitus
or related conditions. The BCG value should be evaluated in the context of the individual patient, their prior BCG
glucose values, underlying medical conditions, pharmacological interventions, and a variety of other patient-specific
criteria.
As a general guideline, the reference range values are:
Adult fasting, 70 - 140 mg / dL
Non-fasting, 70 - 200 mg / dL
Please refer to pediatric and neonatal protocols for reference ranges.
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