CoaguCheck Test Strip Recall

Thanks to Ali Sadeghi-Khomami PhD, Precision BioLogic, and Joan Polancic, MS MLS, Denver Health, for the heads-up on this announcemment: Roche Diagnostics, the manufacturer of CoaguChek meters and test strips, is recalling the CoaguChek XS PT Test Strips due to inaccurate INR test results, when compared to laboratory results. Roche re-calibrated the CoaguChek XS PT […]

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Anticoagulant Therapy

Aug 31 2018

george

Reference Intervals

I recently became reacquainted with colleague Madeline Ducate, PhD, who supports pharmaceutical houses with the laboratory needs for international clinical trials. Madeline is occasionally confronted with a lack of laboratory reference intervals in under-resourced countries, where cultural norms or the lack of funding limit specimen collection and processing from healthy subjects. In vitro diagnostics companies […]

Bleeding Disorders

Coag Test Utilization

While visiting the University of Texas Medical Branch campus in Galveston, George had the opportunity to become acquainted with Mayukh Sarkar, PhD, Medical Laboratory Scientist in the Division of Hematopathology, Laboratory Services. Dr. Sarkar recently published Sarkar MK, Botz CM, Laposata M. An assessment of overutilization and underutilization of laboratory tests by expert physicians in […]

Specimen Management

Minimally Prolonged PT

George visited the University of Texas Medical Branch in Galveston on Thursday, August 9 to discuss the American Society for Clinical Laboratory Science partnership with the American Board of Internal Medicine Choosing Wisely initiative. A great day with Eddie Salazar, PhD and the Clinical Laboratory Science faculty. Our afternoon included a coagulation diagnostic management team […]

Events

January, 2018 Quick Question: RIs

Here are the results of our January, 2018 Quick Question, How do you establish a coag factor reference interval? A. Use a published RI from an article or textbook: 3 votes, 7% B. Validate manufacturer’s RI using ~ 20 locally collected aliquots: 16 votes, 39% C. Validate manufacturer’s RI using ~30 locally collected aliquots: 11 […]

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Quick Question Archive

Jan 1 2018

george

Yet More on Reference Intervals

This is a follow-up comment from Bob Gosselin on Griselle Font-Bonet’s December 31 post about reference intervals. The original post drew many thoughtful and provocative comments from Dave McGlasson, and Drs. Ali Sadeghi-Khomami and Emmanuel Favaloro; consequently, it became so long that an add-on comment would make it unwieldly. Bob says these “last thoughts”… Lest […]

Bleeding Disorders

Reference Intervals

From Griselle Font-Bonet: We are having problems establishing the reference ranges for the intrinsic coagulation factors VIII, IX, and X. We are using normal plasmas from volunteers, but we are getting results above the upper limit of the manufacturer range (60-150%). Calibration and QC values are good. Does anyone have a recommendation?From George: Hello, and […]

Validation

Multi-site Reference Intervals

While attending the September 12–15, 2017 Mayo Medical Laboratory conference, Bleeding and Thrombosing Diseases George spoke with Susan Hollister and Jennifer Rider from Sanford Health in Fargo. Susan and Jen are developing reference intervals for their coagulation laboratory services throughout Sanford’s system and are looking for a reasonable approach that combines satellite resources with the […]

Validation

Medical Decision Points

Odetta Hanna from Sekisui Diagnostics asked, “Do you have a good resource to obtain the medical decision points for coagulation assays?” From George, yes, the text I find most helpful for clinical decision-making is Kitchens CS, Kessler CM, Konkie BA. Consultative Hemostasis and Thrombosis, Third Edition, 2013, Elsevier, Philadelphia. Also, if you pardon the self-promotion, […]

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Global Hemostasis Assays

Sep 12 2016

george

How Many QC Repetitions?

From Heather DeVries at Indiana University Health. Hello George! In a system meeting recently, our procedure for evaluating new lot calibrator material was discussed. Currently, we require sites to run 5 points of QC after calibrating with a new lot. If the mean of those 5 points is within 20% of the established mean, we […]

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Validation

Validation

CoaguCheck Test Strip Recall

Reference Intervals

Coag Test Utilization

Minimally Prolonged PT

January, 2018 Quick Question: RIs

Yet More on Reference Intervals

Reference Intervals

Multi-site Reference Intervals

Medical Decision Points

How Many QC Repetitions?

George Fritsma MS MLS

Cheat Sheets from George

Questions or Comments?

Quick Question