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Test strip qualification system

  • US 6,835,570 B2
  • Filed: 11/12/2003
  • Issued: 12/28/2004
  • Est. Priority Date: 03/14/2002
  • Status: Expired due to Term
First Claim
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1. A method of test strip qualification comprising:

  • providing a test strip comprising an assay reaction area, a first control reaction area and a second control reaction area;

    obtaining prothrombin (PT) results for each reaction area; and

    comparing results from said first control reaction area to control qualification criteria comprising an upper limit and a lower limit, wherein said upper limit is dependent upon assay reaction area PT results at or below about a 2.0 International Normalized Ratio (INR) and is independent of assay reaction area PT results at or above about a 2.0 INR, wherein said test strip is qualified if said results fall below within said lower limit and said upper limit.

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