Looking for breakthrough ideas for innovation challenges? Try Patsnap Eureka!

Hematology linearity control composition system and method of use

A compositional and linear technology, applied in scientific instruments, biological tests, reference solutions, etc., can solve problems such as time-consuming and measurement errors

Active Publication Date: 2009-09-16
BECKMAN COULTER INC
View PDF36 Cites 6 Cited by
  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Not only does this require further time spent preparing the control composition prior to instrumental testing, but it also introduces additional error into the measurement

Method used

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
View more

Image

Smart Image Click on the blue labels to locate them in the text.
Viewing Examples
Smart Image
  • Hematology linearity control composition system and method of use
  • Hematology linearity control composition system and method of use
  • Hematology linearity control composition system and method of use

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0043] Examples 1 and 2 provide exemplary procedures for preparing leukocyte analogs for use in the linear control compositions of the invention. In Example 1, the leukocyte analog was a monocyte analog when measured by impedance as described in US Patent No. 4,704,364 (Carver et al.). In Example 2, the leukocyte analog is a lymphocyte analog as measured by the VCS measurement as described in US Patent No. 5,320,964 (Young et al.). Example 3 provides an exemplary process for preparing platelet analogs for use in linear control compositions. Additionally, Example 5 provides an exemplary process for preparing stabilized red blood cells that can be used in linear control compositions.

[0044] It was found that linear control compositions of the present invention containing high concentrations of leukocyte analogs, stabilized red blood cells, and optionally platelet analogs as described above exhibited both open vial stability and closed vial stability, which was essentially Th...

Embodiment 6

[0058] Example 6 provides an exemplary process for preparing a linear control system. As indicated, after all individual line control compositions were prepared and packaged into control vials, the control vials were labeled to show their levels in the line control system. The assay parameters were then assigned to the linear control composition at each level. As used herein, the term "measurement parameter" includes measured values ​​and target ranges. Typically, measured values ​​are presented as a single quantity with a margin of error; and target ranges are presented as acceptable upper and lower limits. For example, the WBC assay parameter at level 8 for the linear control system shown in Table 2 may either be an assay value of 290 ± 21.6, or a target range with an upper limit of 311.60 and a lower limit of 268.4.

[0059] Standard procedures known in the art for assay value assignment of hematological controls were used for the linear control system. For each batch, t...

Embodiment 7

[0076] Example 7 provides an exemplary procedure for determining the linearity of white blood cell, red blood cell, and platelet counts, and hemoglobin measurements using a linear control system. As shown therein, the control vials were mixed by hand following a procedure that clinical laboratories have used for many years to process a baseline control containing cell particles equivalent to the concentration of cell particles in a normal blood sample. By using this procedure, the control vials were mixed gently by hand within tens of seconds without any vigorous mixing. Additionally, all levels of the control composition were used directly on the instrument without further dilution by the operator.

[0077] After obtaining the reported values ​​for WBC, RBC, Hgb, and Plt for each level of the linear control system, and obtaining the average of the reported values ​​for each of these four parameters, each of these reportable parameters The linearity of a measurement can be de...

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
Login to View More

PUM

No PUM Login to View More

Abstract

A linearity control system includes a series of linearity control compositions; each thereof includes white blood cell analogs and stabilized red blood cells in a suspension medium. The concentration of the white blood cell analogs in the series of control compositions increases from 0.2x103 to 800x103 analogs per microliter, and the concentration of the white blood cell analogs in at least one control composition is greater than 120x103 analogs per microliter. The stabilized red blood cells facilitate mono-dispersion of the white blood cell analogs in the suspension medium by gently mixing. The control compositions further include platelet analogs, or additionally include reticulocyte and / or nucleated red blood cell analogs. The linearity control system allows the verification of the reportable measurement range and linearity of the measurements of hematology analyzers for white blood cells, red blood cells and platelets in extended concentration ranges.

Description

[0001] Cross References to Related Applications [0001] This application claims priority under 35 U.S.C. § 119(e) to U.S. Provisional Patent Application Serial No. 60 / 865,661, filed November 14, 2006, which is hereby incorporated in its entirety as a reference. technical field [0002] The present invention relates to a linear reference control composition and a linear control system capable of verifying the reportable assay range and linearity of measurement of white blood cells, red blood cells and platelets by a hematology analyzer over an extended concentration range. Background technique [0003] In clinical hematology, quality control has always been a necessary and routine procedure. Accuracy in various types of blood cell counts depends in part on the availability of adequate control products and the method by which the control products are used. With the many models of equipment currently available for particle counting, quality control through the use of control...

Claims

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
Login to View More

Application Information

Patent Timeline
no application Login to View More
Patent Type & Authority Applications(China)
IPC IPC(8): G01N33/49
CPCG01N2496/10G01N33/96G01N15/12G01N2015/1006Y10T436/101666Y10T436/10
Inventor 内里·奥尔蒂斯西奥多·J·盖鲁洛
Owner BECKMAN COULTER INC
Who we serve
  • R&D Engineer
  • R&D Manager
  • IP Professional
Why Patsnap Eureka
  • Industry Leading Data Capabilities
  • Powerful AI technology
  • Patent DNA Extraction
Social media
Patsnap Eureka Blog
Learn More
PatSnap group products

Browse by: Latest US Patents, China's latest patents, Technical Efficacy Thesaurus, Application Domain, Technology Topic, Popular Technical Reports.

© 2024 PatSnap. All rights reserved.Legal|Privacy policy|Modern Slavery Act Transparency Statement|Sitemap|About US| Contact US: help@patsnap.com