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Co-Oximetry Linearity Test Set (Bayer 800)
BGT Co-Oximetry Linearity Test Set is intended to monitor the performance of Bayer Diagnostics (Ciba-Corning / Chiron) Rapidlab 800 series medical analyzers in measuring total hemoglobin, oxyhemoglobin, carboxyhemoglobin, and methemoglobin. These calibration verification materials are intended for in vitro diagnostics use only.
SUMMARY & PRINCIPLE
The measurement of total hemoglobin and hemoglobin fractions is frequently used by critical care units in determining the effects of metabolic and toxicological factors upon patients' oxygen transport of blood. Instruments that measure these co-oximetry parameters must meet stringent requirements for accuracy and precision. BGT Co-Oximetry Linearity Test Set (when used as a part of a total control system) will assist clinicians in the documentation of instrumentation linearity, calibration verification and verification of linear range required by many inspection agencies.
BGT Co-Oximetry Linearity Test Sets are sealed in ampules containing a formulated blend of certified dyes in the FD&C and D&C primary class, and are considered non-toxic colorants. Each test set prepared is formulated into 5 distinct levels, with 5 ampules per level, and 2mL per ampule.
STORAGE & STABILITY
BGT Co-Oximetry Linearity Test Sets are stable at room temperature for 36 months (from date of manufacture). Please avoid storing the product for prolonged periods at extreme temperatures or in direct sunlight. Freezing of product will cause ampules to crack and / or affect product reliability. The lot number and expiration date are stamped on the ampules, package, and insert sheet.
DIRECTIONS FOR USE
Before using BGT Co-Oximetry Linearity Test Set, please ensure that your Co-Oximeter has been calibrated according to manufacturer instructions. To prepare for actual sampling, hold ampule by the top and shake gently. Then with light tapping, restore all liquid to the bottom. Break open carefully to avoid cutting of fingers - using the complimentary ampule snapper provided with this test set. Aspiration of liquid into the analyzer may be performed directly, through a syringe, or via capillary techniques.
CALCULATION OF RESULTS
Duplicate or triplicate runs are advised when obtaining a mean recovered value for each of the 5 levels provided in this test set. Once a mean recovered value is obtained, plot results on standard linear graph paper using "Expected" as the X-axis and "Recovered" as the Y-axis. ‘Expected' values for this test set are included as part of this insert.
Users may also avail themselves of BGT free data reduction service. By performing all of their calculations for them at no cost, we are able to save clinicians valuable time. Simply enter data into our customized MS Excel spreadsheets, and email them to the address provided. These sheets can be obtained by contacting us at the following address:
The reference ranges for each parameter were assigned by multiple determinations performed on Rapidlab 800 Series analyzers. The assigned values are determined with the product sampled at room temperature. If the instruments are properly calibrated, test data obtained while using our linearity test set should fall within expected ranges:
|Analyte Ranges (Rapidlab 800 Series)|
|Total Hemoglobin (tHb) g/dL|
|6 - 7||7 - 9||14 - 16||19 - 21||25 - 28|
|Oxyhemoglobin (O2Hb) %|
|39 - 43||57 - 61||22 - 27||24 - 28||48 - 52|
|Carboxyhemoglobin (COHb) %|
|32 - 36||0 -2||13 - 16||≤ 0||3 - 4|
|Methemoglobin (METHb) %|
|10 - 14||0 -1||2 -3||3 - 4||1 - 2|
While each lot of product is manufactured in such a way that it will test the analytical measurement range of your instrument, actual results obtained may vary depending upon analyzer and methodology used. Results may also depend upon the accuracy of the instrument and reagent calibration. The degree of acceptable non-linearity is an individual judgment based upon a test analyte's methodology, clinical significance and medical decision levels.
BGT Co-Oximetry Linearity Test Set is sensitive to extreme temperatures and prolonged exposure to direct light. It is intended for use in evaluating the performance of laboratory instruments. It is not intended for use as a calibration standard, nor is it a substitute for other aspects of a complete quality control program.
| Hersteller: |
Günter Keul GmbH
Tel.: 02551/2097 Fax.: 02551/80883