CRP including hsCRP

Purpose:
The Programme aims to assess the performance of organisations utilising the standard C – reactive protein (CRP) test as a marker of infection and for those using hsCRP in the assessment of risk for Cardiovascular Disease (CVD).

The standard (CRP) test is a well-established marker for inflammation and infection. The measuring range being approximately 10 to 1000 mg/L.

However, low but persistent levels of inflammation is often associated with CVD. A high sensitivity CRP (hsCRP) test has been proposed as a marker to assess the individual’s risk of CVD. The hs-CRP test accurately detects much lower levels of the protein than the standard CRP test, range from 0.5 to 10 mg/L.

Scope:
Three liquid human serum samples are distributed monthly with a minimum of 36 samples distributed over the year covering a wide clinically relevant range. The samples consist of endogenous samples from normal volunteers and patients to cover the clinical range for the (hs) CRP methods used for CVD risk assessment. The samples for the standard assay consist of endogenous patient samples along with a panel of linearly related samples produced from donations from healthy volunteers spiked with a highly purified source of human CRP to provide an extended clinical range. The programme assesses both laboratory and method performance, including bias, within and between batch imprecision and linearity.