REFERENCE RANGE CHANGES
On Wednesday, November 10, 2010, the following reference ranges are changing for 5374 Anticardiolipin Antibodies as follows:
Test Old Reference Range NEW REFERENCE RANGE
IgG 0.0 - 23.0 GPL 0.0 - 14.9 GPL
IgM 0.0 - 11.0 MPL 0.0 - 12.4 MPL
Please inform appropriate personnel and make the necessary changes to your systems. Please contact us with any questions. Thank you for your business!
On Wednesday, September 15, 2010, the Coagulation Laboratory will begin using a new lot of reagent used for both the Prothrombin (PT) and PT Mix assays. This new lot necessitates a change in the reference ranges for these assays. Effective September 15, 2010 the reference range for all patients being tested for a PT and/or PT Mix will change as follows:
Old Reference Range NEW REFERENCE RANGE
9.0 – 11.0 sec 9.8 – 11.5 sec
COAGULATION INSTRUMENTATION & REAGENTS UPGRADED
The ITxM-Diagnostics Laboratory recently converted from Siemen’s BCS to Siemen’s BCS-XP Coagulation Analyzers for all Factor testing and Lupus Anticoagulant assays. This upgrade under the direction of Andrea Cortese Hassett, Ph.D., Chief Science Officer, involved the main automated coagulation testing performed by the laboratory and also included the conversion to some new coagulation reagents. The newer instruments provide the laboratory with advanced computer technologies not available on the older models, faster processing potential and greater user control for new protocols.
In addition to upgrading the instrumentation, the ITxM-Diagnostics Coagulation Laboratory converted from Thromborel S® (Dade Behring) to Innovin® (Dade Behring) for Prothrombin (PT) and all PT-based assay, including the Extrinsic Factors (Factors II, V, VII, and X). Innovin® is used as an initiator of clotting via the extrinsic and common pathways in the global screening test, PT. Innovin® is a purified recombinant human tissue factor produced in E. coli, whereas Thromborel S® is produced from human tissues. Innovin® has a high ISI value, which is needed for calculating the INR from the PT. The high specificity of Innovin® derives from the fact that this reagent is manufactured through a recombinant process and does not contain any other clotting factors, such as prothrombin, Factor VII, or Factor X. The Innovin® reagent is not sensitive to Heparin. The major applications for the Innovin® reagent based upon the PT are (1) as a rapid screening test to detect deficiencies in the Extrinsic or Common Pathways (due to liver disease, vitamin K deficiency, hereditary/acquired defect); (2) as a sensitive monitoring tests for oral anticoagulant therapy; and (3) as an assay for specific coagulation factors.
There were five reference ranges that changed as a result of the implementation of these new instruments and reagents. These included the following:
Assay Normal Range
PT / PT-Mix 9.0-11.0 sec
APTT / APTT-Mix 30.0-42.0 sec
Factor VII 0.70-1.60 U/ml
Fibrinogen 150-400 mg/dL
Reptilase <20 sec
All other reference ranges remained the same. The new reference ranges went into effect on September 9, 2009.
While the older BCS units served the laboratory well for many years, the newer Siemen’s BCS-XP Coagulation Analyzers should provide improved technological instrumentation with less maintenance and repair problems for a number of years into the future. We want to thank all involved in this conversion, including those at Siemens, Kevin Young at Orchard Software Corporation, the entire laboratory staff of the ITxM-Diagnostics Coagulation Laboratory for their assistance, Karen Grasso and Sherri Kopko for computer interface assistance and Andrea Cortese Hassett, PhD, for leading this effort. For additional information or questions regarding this conversion, new ranges, new reagents or instrumentation, please contact Michael P. Meyer, Technical Supervisor, at 412-209-7353 or email at mmeyer@itxm.org.
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