Harmonizing factor assay-related testing performed in a large laboratory network

Area of Science:

• Clinical Chemistry
• Haemostasis Diagnostics
• Laboratory Medicine

Background:

• Coagulation factor testing is crucial for diagnosing bleeding disorders and investigating prolonged clotting times.
• Standardization of testing procedures and normal reference ranges (NRRs) is essential for accurate haemostasis laboratory results.
• Harmonization is needed across laboratory networks to ensure consistent patient care.

Purpose of the Study:

• To harmonize procedures and establish normal reference ranges (NRRs) for coagulation factor testing.
• To evaluate the performance of ACL TOP 50 family instruments and HemosIL reagents in a large laboratory network.
• To assess the comparability and factor sensitivity of new instrumentation against established methods.

Main Methods:

• Comparative evaluation of ACL TOP 550/750 instruments with HemosIL reagents against existing Stago and Siemens systems.
• Assessment of coagulation factor sensitivity in prothrombin time (PT) and activated partial thromboplastin time (APTT) assays.
• Establishment of coagulation factor NRRs using normal plasma samples.

Main Results:

• HemosIL factor assays demonstrated good comparability with reference methods (correlation coefficient R > 0.9).
• Coagulation factor sensitivity for PT and APTT assays was found to be acceptable, around 30 U/dl.
• Harmonized NRRs were successfully established across the laboratory network.

Conclusions:

• The ACL TOP 50 Family instruments and Werfen reagents provide acceptable performance for coagulation factor testing.
• The evaluation enabled the harmonization of coagulation factor testing procedures and NRRs within a large laboratory network.
• Standardized testing improves diagnostic accuracy and consistency for bleeding disorder assessment.