Can Quotient demonstrate metrological traceability of the Anti-D quantitation value to a recognised standard?

Quotient manufacture products designed to test the sensitivity of immunohaematology test systems  which contain Anti-D at  a level of <0.1IU/mL as recommended in BCSH Guidelines for pre transfusion compatibility procedures in blood transfusion laboratories. 

The products are prepared from pooled human plasma containing Anti-D which undergoes quantitation to determine the antibody concentration in IU/mL.   Based on the quantitation result the anti-D is then accurately diluted to achieve a level of <0.1 IU/mL in the final product. 

Quantitation is carried out prior to the final dilution of the plasma to ensure that the concentration of the antibody is within the linear range of the quantitation assay to allow accurate measurement. Levels of Anti-D at or below 0.1 IU/mL are not considered to be within the linear range of the assay and therefore are not measured directly.

Quantitation of the Anti-D is carried out by an accredited laboratory which utilises a standard curve prepared from the British Working Standard Anti-D (73/515) and therefore Quotient sensitivity control products containing Anti-D below 0.1IU/mL are metrologically traceable to 73/515 Anti-D  British Working Standard (NIBSC).

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