RECORDING ASSAY DEVICE

• US 20110236914A1
• Filed: 05/23/2011
• Published: 09/29/2011
• Est. Priority Date: 03/19/1997
• Status: Active Grant

• Current Assignee: Smartsensor Telemed Limited
• Original Assignee: Smartsensor Telemed Limited
• Inventors: Jackson, James Richard
• Granted Patent: US 8,163,568 B2
• Time in Patent Office: Days
• US Class Current: 435/7.92
• CPC Class Codes: G01N 33/528 Atypical element structures, e.g. gloves, rods, tampons, toilet paper
• CPC Class Codes: G01N 33/5302 Apparatus specially adapted for immunological test procedures
• CPC Class Codes: G01N 33/54366 Apparatus specially adapted for solid-phase testing
• CPC Class Codes: Y10S 435/81 Packaged device or kit
• CPC Class Codes: Y10S 436/807 Apparatus included in process claim, e.g. physical support structures
• CPC Class Codes: Y10T 436/25 including sample preparation

Abstract

A method for assaying a sample involves an assessment device having an assay part and a detachable recording part, which are disposed on separable portions of a substrate. The sample to be assayed is received in a sample application well on the assay element, where it contacts a measuring element, generally after being mixed with an assay reagent. Assay information relating to the sample is transferred from the measuring element to data recording element on the recording part. After the information transfer, the assay part and the recording are separated, so that the assay part can no longer transfer information to the data recording element.

Claims

1. A method for assaying a sample, comprising the steps of:

providing an assessment device having an assay element and a data recording element arranged on a substrate and connected by way of a communication conduit;

receiving a sample within a sample application well on the assay element;

mixing the sample with an assay reagent;

detecting assay information relating to the sample;

transmitting, by way of the communication conduit, the assay information from the assay element to the data recording element;

recording the assay information within the data recording element; and

separating, irreversibly, the communication conduit after the recording step.

2. The method of claim 1, wherein:

the separating step is accomplished by breaking the substrate irreversibly into first and second portions, with the assay element on the first portion and the data recording element on the second portion.

3. The method of claim 2, further comprising the step of:

providing an actuating signal to an indicator upon completion of the recording step.

4. The method of claim 1, further comprising the step of:

providing an actuating signal to an indicator upon completion of the recording step.

5. The method of claim 1, further comprising the step of:

downloading the assay information electronically from the data recording element to a processing facility after the separating step.

6. The method of claim 2, further comprising the step of:

downloading the assay information electronically from the data recording element to a processing facility after the separating step.

7. The method of claim 3, further comprising the step of:

downloading the assay information electronically from the data recording element to a processing facility after the separating step.

8. The method of claim 4, further comprising the step of:

downloading the assay information electronically from the data recording element to a processing facility after the separating step.

9. The method of claim 1, wherein:

the separating step is accomplished by;

inserting the assessment device in a casing; and

breaking the substrate of the assessment device irreversibly into first and second portions, with the assay element on the first portion and the data recording element on the second portion, using a separation line defined by the casing.

10. The method of claim 9, further comprising the step of:

providing an actuating signal to an indicator upon completion of the recording step.

11. The method of claim 10, further comprising the step of:

downloading the assay information electronically from the data recording element to a processing facility after the separating step.

12. The method of claim 9, further comprising the step of:

downloading the assay information electronically from the data recording element to a processing facility after the separating step.

13. A method for assaying a sample, comprising the steps of:

depositing the sample into a sample application well of an assessment device, the assessment device comprising a substrate having first and second portions, with an assay element, which includes the sample application well, arranged on the first portion, a data recording element arranged on the second portion and means, arranged on the substrate, for communicating data from the assay element to the recording element;

producing an assay product from the sample in the assay element;

detecting assay information relating to the assay product;

transmitting, by the data communicating means, the assay information from the assay element to the data recording element;

recording the assay information within the recording element; and

disrupting, irreversibly, the data communicating means after the assay information is recorded.