Manufacturing of Quality Control Sera for Immunoassays
Why control preparations are so important?
Quality Control should be a part of immunoassays to ensure that your results are reliable and informative. Each laboratory should maintain Quality Control system which includes measurement of control samples during each run and entering the results obtained on Levy-Jennings control charts to control run-to-run reproducibility.
Quality Control should be an integral part of Quality Assurance system which controls all the relevant procedures involved – from correct sampling and delivery of samples to a laboratory to their correct analyzing and correct and timely results output. It is highly recommended establishing a QA/QC program that involves the quality control sera preparations for your immunoassays.
What types of Quality Control Sera you should use?
Xema produces various reagents and kits for the immunoassays of tumor biomarkers, hormones, etc. To meet different requests from our customers, Xema provides the following types of quality control sera to meet your projects:
1) OmaQon (Tumor Markers): used for tumor biomarker immunoassay kits IFU
2) HormoQon (Hormones): used for hormones immunoassay kits IFU
3) AutoQon AT (autoantibodies to thyroid gland antigens): used for kits testing autoantibodies to thyroid gland. IFU
4) PrenaQon (prenatal screening markers): intended for kits measuring biomarkers used for calculation of risk of congenital pathology (Down syndrome, trisomy 18, intrauterine fetal growth retardation, Spina bifida). IFU
When or how often Quality Control Sera be used?
Quality control sera should be measured during each assay run. The results obtained are used to maintain Levy-Jennings charts which allow you to ensure precision of your analytical procedures – and thus, validity of your results.
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