Key result
Interlaboratory testing links identical instruments and lots to clinically significant heparin therapeutic range variation.
Observational
Yes
BACKGROUND: Monitoring of unfractionated heparin therapy by activated partial thromboplastin time using the ex vivo method for determining the heparin therapeutic range (HTR) is the standard of practice. Many extrinsic and intrinsic factors influence accuracy of the HTR. This study investigates the affect of instrumentation and laboratory site on the accuracy of the ex vivo HTR method. METHODS: Patients on unfractionated heparin are used to determine the HTR by published guidelines. Various instruments and different laboratories are compared to investigate the affect of these variables on the HTR. RESULTS: The HTR is the same when the same model of instrument or even different models (same methodology) are used in the same laboratory. However, a significant clinical difference is observed when different hospital laboratories using same lot and instrument model are compared. CONCLUSIONS: The ex vivo method for HTR is the best protocol currently available. The HTR should be determined and averaged on all of the same method instruments used in the laboratory. However, determination of the HTR in different laboratories should not be shared.
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Marlar et al. (2012) conducted an observational in Patients on unfractionated heparin therapy. Different hospital laboratories and instruments vs. Same laboratory and/or same instrument model was evaluated on Heparin therapeutic range (HTR). Different hospital laboratories using the same lot and instrument model showed significant clinical differences in the determined heparin therapeutic range compared to within-laboratory determinations.
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