The introduction of the IVD directive and the ethical question of using patients as controls emphasise the importance of accreditation and quality control in transfusion laboratories
In order to achieve accreditation status laboratories must be able to demonstrate the use of quality control material in routine testing.
In many transfusion laboratories there is often a reliance on the use of 'known' patients due to the lack of suitable commercial controls.
The introduction of the IVD directive and the ethical question of using patients as controls emphasise this issue.
With the Albacheck range from Alpha Laboratories several new products will help address these concerns.
Sensitivity Controls can help to confirm that the techniques and technologies employed in routine testing are capable of detecting weak IgG antibodies.
The controls, derived from a pool of donations containing either weak anti-Fya or anti-c, have been validated for use by conventional tube methods, Diamed ID gel cards, Ortho Biovue and Zenyx Qasar.
Packaged in a convenient 5ml dropper bottles, unopened vials are stable for one year at 2-8C.
These reagents can also be used as a test of operator proficiency for staff training.
For use with automated blood grouping instruments, Whole Blood Controls in a ready to use format are available to check ABO and D grouping.
The selection of groups in four separate samples has performed in consultation with laboratories to offer the most suitable combination.
Proficiency Test offers a set of 20 randomly selected tubes containing weak blood group antibodies, the specificity of each will be available on disk.
This can help laboratories to assess the ability of either an individual or of a particular technology in detecting weak positives.
Unopened vials are stable for one year at 2-8C.
