8
Quality control
8.1 - Control pipettes
The correct function of the hardware and software of the Interrliner measurement unit should be checked at
regular intervals with the aid of Mechatronics Control Pipettes (Order nr. QTST049000). More information can
be found in the Control Pipette User Manual (MRN-019).
8.2 - Monitoring measurement quality with Starrsed Control
Starrsed Control is an in-vitro diagnostic quality control material to monitor the accuracy and precision of
Erythrocyte Sedimentation Rate (ESR) instruments and procedures. This instruction is only applicable for
Starrsed Control, used on Mechatronics ESR Starrsed instruments.
Starrsed Control is available in:
- Abnormal range (Level A)
- Normal range (Level N)
The software can produce statistical data for further analysis for:
▪
Defining control limits (accept or reject patient results)
▪
Error detecting (systematic or random errors)
▪
Evaluation of QC results
8.2.1 - Limitations
Starrsed Control is to be used for Erythrocyte Sedimentation Rate testing only and shall not be used to
control any other hematology procedure.
Starrsed Control shall not be used as a standard.
Starrsed Control should not be used past the expiry date.
Mechatronics as supplier of the Starrsed Control shall not be liable for any claimed damages arising from
other than intended usage.
8.2.2 - Expected value range
Starrsed Control is assayed for Starrsed ESR analyzers. The software always calculates a temperature
corrected result because only temperature corrected results can be compared with the Assay mean value.
The assayed mean values, expected ranges and reference values are derived from validation measurements
on multiple instruments at different sites. All these values are mentioned on the product insert (the assayed
mean value encoded in the tubes barcode) and are lot-specific. The lab should establish its own acceptable
ranges. Whenever the Controls fail to perform consistently within the acceptable ranges, patient results
should be considered invalid. Contact your Starrsed instrument provider for assistance. The values from the
reference methods are only an indication for that method and not for comparison with the Assay mean
value.
If results vary outside the specified assay ranges, discard the tube and utilize a new tube. If difficulties
persist, contact your supplier for further assistance and/or instructions.
Quality control
MRN-164_2-EN Version 2.02 Interrliner
67
