Produkte/Klinische Chemie/Kontrollen/Kontrollseren/Co-Oximetry CONTROL (Radiometer)
Co-Oximetry CONTROL (Radiometer)

PH5005

INTENDED USE
BGT Co-Oximetry Controlis intended to monitor the performance of Radiometer ABL 500, ABL 600, and OSM3 series equipment in measuring total hemoglobin, oxyhemoglobin, saturated oxyhemoglobin, carboxyhemoglobin, and methemoglobin.  These control 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.

PRODUCT DESCRIPTION
BGT Co-Oximetry Controls 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 Controls 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 Control, 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 3 levels provided in this  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: 
info@biogentechnologies.de

EXPECTED VALUES
The reference ranges for each parameter were assigned by multiple determinations performed on different Radiometer brands and models.  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 (OSM3 / 500 / 600 Series)
Total Hemoglobin (tHb) g/dL
L1 L2L3 
5.5 - 7.5 12.5 - 14.519 - 21 
Oxyhemoglobin (HbO2) %
L1 L2L3
60 - 64 58 - 6253 - 58 
Saturated Oxyhemoglobin (HbO2SAT) %
L1 L2L3 
70 -76 72 - 7892 - 98 
Carboxyhemoglobin (COHb) %
L1 L2L3 
0 - 2 10 - 123 - 5 
Methemoglobin (METHb) %
L1 L2L3 
4.5 - 6 10 - 1314 - 16 

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, instrument accuracy, 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. 

LIMITATIONS
BGT Co-Oximetry Controls are 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. 



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img/page/needfull/ce-zeichen.gif Hersteller:

Guenter Keul GmbH
Günter Keul GmbH
Von-Langen-Weg 10
D-48565 Steinfurt
Tel.: 02551/2097  Fax.: 02551/80883
Web: www.keul.de



 



 
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