A new reference material is primarily intended for use in calibrating procedures and devices for the determination of C-reactive protein (CRP) in human serum. It can also be used for value-assignment of in-house calibrator solutions and control materials.
C-reactive protein (CRP) is a biomarker for inflammation due to infections or other medical conditions (e.g. rheumatoid arthritis or lupus). The NIST team produced the certified reference material of pure CRP for the intended purpose of calibrating diagnostic tools and procedures that measure these low levels of CRP with greater accuracy, precision and traceability to SI units.
Ideally, all clinical diagnostic tests would be traceable to a ‘higher-order’ reference material to ensure the validity of the test results. Many common diagnostic tests currently lack suitable higher-order reference materials, and NIST plays an important role in filling this gap. In-vitro diagnostic companies as well as research laboratories may use SRM® 2924 to develop calibrator solutions and control materials at low CRP concentrations. The NIST researchers will also use SRM® 2924 as a ‘higher-order’ reference material to produce a follow-on SRM® for CRP in serum, that will directly feed into the measurement traceability chain for CRP in clinical laboratories everywhere.