Test device and method for its use

• US 4,235,601 A
• Filed: 01/12/1979
• Issued: 11/25/1980
• Est. Priority Date: 01/12/1979
• Status: Expired due to Term

• Current Assignee: Marshall Diagnostics Incorporated
• Original Assignee: Thyroid Diagnostics Incorporated
• Inventors: Deutsch, Marshall E., Mead, Louis W.
• Primary Examiner(s): Turk, Arnold
• Application Number:
  US06/003,076
• Time in Patent Office: 683 Days
• Field of Search: 23/230 R, 23/230 B, 23/230.3, 23/230.6, 422/55, 422/56, 422/71, 195/103.5 R
• US Class Current: 436/514
• CPC Class Codes: G01N 33/54388 based on lateral flow
• CPC Class Codes: G01N 33/558 using diffusion or migration of antigen or antibody immunochromatographic test strips G01N33/54387
• CPC Class Codes: Y10S 436/805 Optical property
• CPC Class Codes: Y10S 436/81 Tube, bottle, or dipstick
• CPC Class Codes: Y10S 436/815 Test for named compound or class of compounds

Abstract

Test device for determining a characteristic of a sample, particularly for determining substances in fluid samples. The device comprises a strip element which is composed of a material capable of transporting a developing fluid therealong by capillarity and which has a portion at a predetermined location on the strip element for receiving the test sample and portions at predetermined locations on the strip element incorporated with reagent means for providing a detectable response sensitive to the characteristic under determination. The beginning end portion of the strip element is immersed in the developing fluid which, as a result, traverses the length of the strip element, thereby promoting appropriate contact between the test sample and the reagent means resulting in the disposition of a detectable response at a predetermined location on the strip element, which response is a function of the characteristic under determination. The test device is particularly suited for performing binding assays, in particular those wherein a radioisotope is used as a label, such as radioimmunoassays.

Claims

1. A method of determining a characteristic of a sample comprising the steps of:

(a) providing a strip element composed of a material capable of transporting a developing liquid therealong by capillarity having a beginning end portion and a terminal end portion and having a plurality of zones positioned between said beginning and terminal end portions, a first zone for receiving said sample, a portion of said sample capable of being moved along said strip by said developing liquid, a second zone having a first reagent incorporated therein, and capable of being moved along said strip by said developing liquid, a third zone having a second reagent incorporated therein, said second reagent capable of interacting with said first reagent to form a product and a measuring location at or downstream of said third zone, said measuring location being spaced upstream of said terminal end portion a distance preselected to assure that, when transport of said developing liquid along the strip element is terminated by the leading front thereof reaching said terminal end portion, substantial separation of said product and said first reagent has occurred at said measuring location, the amount of said product and of said separated first reagent being related to the amount of said sample characteristic;

(b) depositing the sample on said first zone;

(c) immersing the beginning end portion of the strip element in the developing liquid; and

(d) measuring the characteristic to be determined, when liquid transport is terminated, by detecting the presence of said product or said separated first reagent at said measuring location.

2. The method of claim 1 wherein step (d) comprises placing said strip element in instrument means for measuring said characteristic.

3. The method of claim 2 wherein at least some portions of said strip element other than said measuring location are masked from said instrument means.