US 2004/0106212 A1 · Test strip qualification system

Abstract

In connection with a fluidic medical diagnostic device that permits measurement of the coagulation time of blood, software, methods and associated devices for quality control are disclosed. The fluidic device preferably comprises a test strip with one end having a sample port for introducing a sample and a bladder at the other end for drawing the sample to a measurement area. A channel carries sample from the sample port to an assay measurement area and first and second control measurement areas. Preferably a stop junction, between the measurement areas and bladder, halts the sample flow for measurement. If results from measurements taken for each control fall within a predetermined zone or defined limits, the assay measurement is qualified. If not, an error is registered and the test strip is counted as unfit.

Claims14

Dependent claims

A method of test strip qualification, said method comprising:

providing a test strip comprising an assay reaction area, a first control reaction area and a second control reaction area;
obtaining PT results for each reaction area;
comparing results from said first control area to a first control qualification criteria and results from second control area to a second control qualification criteria, wherein said first control qualification criteria comprises an upper limit and a lower limit, said first control upper limit being about 1.9 INR and said first control lower limit being about 0.60 INR;
and
outputting a message to a user indicating test strip reliability.

2 more elements

Dependencies are inferred from the claim text.

Test strip qualification system

Life of this patent

Test strip qualification system

Life of this patent

Abstract

Claims14