Special Section Technical Briefs

Development of a Novel Positive Control for the Standard Test Method for the Platelet Leukocyte Assay: An In Vitro Hemocompatibility Assessment of Blood-Contacting Medical Devices1

[+] Author and Article Information
Steven Deline, Tim Schatz, Kent Grove, Sarah Howard, Mark Smith

American Preclinical Services,
Minneapolis, MN 55433

DOI: 10.1115/1.4033118Manuscript received March 1, 2016; final manuscript received March 16, 2016; published online May 12, 2016. Editor: William Durfee.

J. Med. Devices 10(2), 020909 (May 12, 2016) (2 pages) Paper No: MED-16-1058; doi: 10.1115/1.4033118 History: Received March 01, 2016; Revised March 16, 2016

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ASTM, 2013, “ Standard Test Method for Platelet Leukocyte Count—An In-Vitro Measure for Hemocompatibility Assessment of Cardiovascular Materials (Active Standard),” ASTM International, West Conshohocken, PA, Standard No. ASTM F2888.


Grahic Jump Location
Fig. 1

The average platelet and leukocyte percentage of blank control from all the experiments. The platelet and leukocyte counts HDPE were not statistically different from the blank. The positive control platelet and leukocyte counts were statistically different from the positive control. P values for the two statistically significant comparisons were shown as 0.000 and were reported to three significant figures; the actual P value was below 0.0005.

Grahic Jump Location
Fig. 2

(a) Scanning electron microscopy (SEM) of the positive control material uncoated glass cover slip. (b) SEM image of the thrombin-coated glass cover slip at 250×. (c) SEM image of the thrombin-coated glass cover slip at 1000× prior to exposure to the blood with no cellular deposition. (d) Early exposure time point ∼10 min after addition of blood to the treated positive control material.

Grahic Jump Location
Fig. 3

A representative photo of all the positive control clots seen at the completion of the 1 hr exposure



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