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The PAQ test cassette is moulded, assembled, and packaged in the Czech Republic by contract manufacturer Wilden AG. |
A haemotology testing system designed for in-office use by practitioners is being readied for market launch in Europe and will be available soon in the United States. The eXpress Blood Counter (XBC), developed by Chempaq a/s (Copenhagen, Denmark), allows point-of-care testing that produces results in a matter of minutes. Wilden AG (Regensburg, Germany) collaborated in the development of the Particle Analyzer and Quantifier (PAQ) testing cassettes used with the XBC. It has announced that it will ramp up serial production of the devices at its facility in the Czech Republic.
About the size of a desk telephone, the XBC device determines total leucocytes, lymphocytes, monocytes, and granulocytes as well as the haemoglobin value in blood samples. A drop of blood is deposited on a PAQ test cassette, which is inserted into the XBC for analysis. The cassette contains all of the reagents. Once the cassette is inserted in the analyzer, a valve on the cassette opens, releasing the dilutive reagent from its chamber and allowing it to contact the blood sample. The liquids are mixed in another chamber, and the diluted blood sample is directed through an aperture into the final chamber. Within three minutes, test results appear in the XBC’s display.
Wilden is responsible for moulding, assembling, and packaging PAQ test cassettes. Given the complexity of the project, the firm encountered a number of challenges during the development and design for manufacture phases. Finding a way to grease the cassettes’ rotating valve, filling cassettes with the dilutive reagent, and ultrasonically welding a very thin film are among the milestones cited by the firm. It also was called upon to engineer an exceptionally clean production process to prevent contaminants from blocking the opening of the aperture through which the diluted blood sample flows. Even a minute blockage in the 40-µm orifice could result in an erroneous test result.
The cassettes measure 13 × 61 × 41 mm and weigh 20 g. The products’ body, top, and bottom parts, as well as the rotating valve, are injection moulded. Two-shot moulding is used to manufacture the valve to ensure 100% impermeability. Ten additional parts are sourced externally. The entire production and assembly process is carried out under cleanroom conditions. Prior to shipping, each cassette is sealed in an aluminium bag to ensure maximum protection from contaminants. Currently, the finished products are delivered to Chempaq. However, logistics are in place that would allow Wilden to ship the packaged devices directly to end-users.
For additional information, contact Wilden AG, Bischoff-von-Henle-Str. 2B, 93051 Regensburg, Germany; phone: +49 941 7058140; fax: +49 941 7058146; Internet: www.wilden.com.
