8.2.3 - Temperature correction
The assayed values are based on an 60 minutes ESR, with dilution and
. Therefore,
the measured ESR value should be compared with the expected value
using temperature correction. The
calculation of a 30 minute measurement to a 60 minute ESR result with temperature correction influences
the QC result due to rounding.
See chapter
for more information.
8.2.4 - Usage options
Starrsed Control can be used in two ways:
1. With original Starrsed barcode label:
The Starrsed software maintains internal QC history and sends an error message when test results are
out of range.
2. With user barcode label:
The user can use his own ID labels (hereafter called "Lab ID"). Existing QC procedures and LIMS interface
settings can be maintained without any changes. The Lab ID is linked within the Starrsed software to the
original Starrsed Control barcode.
An external barcode reader can be used to read the 10-character QC barcode labels on the tube or the
package insert to create the link. The barcode symbology is "Code 39".
When Starrsed Control label or a linked user barcode label is used:
▪
The Starrsed software recognises the Starrsed Control sample by the structure of the barcode, which
contains the following information: Level A or N, the expected mean value and range and the expiry date.
▪
The history of QC results is maintained internally. Error messages are generated when the QC results
are outside the acceptable range.
▪
QC samples can be optionally requested by the LIMS and QC results can be send to the LIMS.
Starrsed Control can be used on Starrsed analysers in EDTA or in Citrate mode. Quality Control sampling can
be performed at any time during the normal ESR procedure, depending on users Quality Control schedule.
Quality Control scheduling is the responsibility of the user. The Starrsed software does not provide Quality
Control scheduling functionality.
8.2.5 - Quality control procedure
Starrsed Control is provided in ready-to-use sample tubes and is used in the same manner as patient
samples. Starrsed Control is to be used for the Westergren method with dilution only as prescribed by the
"ICSH review of the measurement of the ESR" (2011) and the "CLSI Procedures for the ESR Test; Approved
standard; H02-A5" (2011).
Citrate mode: When the Starrsed analyzer is used in the Citrate mode, the Starrsed Control material must be
diluted manually by transferring the necessary amount of material into a pre-citrated ESR blood collection
tube. Immediately after re-suspending, transfer the necessary amount of material into a pre-citrated tube
according instructions of the tube manufacturer. Close the tube with the mixture and invert at least 12 times,
then place the sample into the analyzer.
Quality control
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