Test device for detecting analyte in liquid sample

1 . A test device for detecting an analyte in a liquid sample, the test device comprising:

a label pad, containing a label;

a lateral flow testing element, having a nitrocellulose membrane in a testing area;

a housing, having an upper housing and a lower housing; and

a diversion element, including a liquid outlet end;

wherein the label pad includes an end overlapping on the nitrocellulose membrane, the lateral flow testing element is located between the upper housing and the lower housing, the housing includes a housing end including a housing end opening, the diversion element includes a diversion element part located in the housing end opening, and the liquid outlet end of the diversion element is in contact with the label pad on the lateral flow testing element in the housing so that the liquid sample from the diversion element is capable of directly flowing to a label area;

wherein the lower housing includes a groove, the diversion element includes a diversion element surface, the lateral flow testing element is located in the groove, and the upper housing comprises a liquid retention chamber configured to receive a part of the liquid sample from the diversion element surface;

wherein the liquid retention chamber has a liquid retention chamber opening, the diversion element has a diversion element upper surface for receiving the liquid sample, and the liquid retention chamber opening is covered by the diversion element upper surface;

wherein the housing includes a housing inner surface, the liquid retention chamber is composed of compartment chambers formed by protruding plastic press strips set on the housing inner surface, and each of the press strips includes a press strip surface being in contact with the diversion element upper surface;

wherein the liquid outlet end includes a liquid outlet end portion, the test device further comprises a blocking element for reducing an amount and a flow rate of the liquid sample at the liquid outlet end portion flowing to the label area, wherein the blocking element is disposed in the housing, and the liquid outlet end portion is in contact with the blocking element.

2 . The device according to claim 1 , wherein the liquid retention chamber comprises one or more non-capillary grooves or non-capillary chambers.

3 . The device according to claim 1 , wherein the liquid retention chamber includes a liquid retention chamber end portion, the blocking element is disposed at the liquid retention chamber end portion, so as to reduce the amount and the flow rate of the liquid sample on the diversion element directly flowing to the label pad on the lateral flow testing element and to allow the liquid sample from the liquid outlet end to flow to the liquid retention chamber.

4 . The device according to claim 3 , wherein the blocking element is disposed on the upper housing, the lower housing is provided with a recess, the label pad includes a label pad part, the recess is provided with a blank area for disposing the label pad part, the diversion element includes a diversion element end portion, and the diversion element end portion is located on the blank area and in direct contact with the blank area.

5 . The device according to claim 4 , wherein when the upper housing and the lower housing are assembled together, the blocking element is inserted into the recess and in contact with the diversion element end portion.

6 . The device according to claim 4 , wherein the lateral flow testing element further comprises a sample application pad partially overlapped on the blank area on the label pad, the diversion element part covers the sample application pad, and the diversion element has an aperture or texture configured to allow the flow rate of the liquid sample on the diversion element to be greater than that of the liquid sample on the sample application pad.

7 . The device according to claim 4 , wherein the lateral flow testing element further comprises a sample application pad partially overlapped on the blank area on the label pad, and the diversion element part is overlapped on the sample application pad, wherein a part of the liquid sample from the diversion element flows into the sample application pad, and another part of the liquid sample from the diversion element directly flows to the label pad; and time when the liquid sample from the diversion element directly flows to the label pad is earlier than time when the liquid sample from the sample application pad flows to the label pad.

8 . The device according to claim 5 , wherein the label pad comprises a first label pad and a second label pad, wherein the first label pad is located upstream of the second label pad, and the liquid outlet end of the diversion element is overlapped on the first label pad.

9 . The device according to claim 8 , wherein the first label pad comprises a first label-free blank area and a first label-containing area, the second label pad comprises a second label-free blank area and a second label-containing area, and the diversion element end portion is overlapped on the first label-free blank area.

10 . The device according to claim 9 , wherein the nitrocellulose membrane comprises a test result area comprising a second antibody immobilized in the test result area and for specifically binding to the analyte, and each of the first label-containing area and the second label-containing area comprises a first antibody conjugated with latex particles or gold particles or both, and the first antibody is capable of specifically binding to the analyte.

11 . The device according to claim 10 , wherein the label pad composed of the first label pad and the second label pad has a label pad length, the label pad length is 15 mm, the liquid outlet end of the diversion element is spaced from the label area of the first label pad by 2 mm, and the second label pad is spaced from the testing area by 7 mm.

12 . The device according to claim 11 , wherein the second antibody specifically captures an HCG antigen, the first antibody specifically binds to the HCG antigen, and the liquid sample is a urine sample.

13 . The device according to claim 12 , wherein the label on the first label pad is the first antibody that is conjugated with gold particles and binds to HCG in urine, and the label on the second label pad is the first antibody that is conjugated with latex particles and specifically binds to HCG in urine.

14 . The device according to claim 11 , wherein the diversion element has a diversion element length, the diversion element length is 40 mm, the length of the diversion element located in the housing is 13 mm, the diversion element has a diversion element thickness, and the diversion element thickness is 3 mm.

15 . The device according to claim 7 , wherein the label pad comprises a first label pad and a second label pad, wherein the first label pad is located upstream of the second label pad, and the liquid outlet end of the diversion element is overlapped on the first label pad.

16 . The device according to claim 15 , wherein the first label pad comprises a first label-free blank area and a first label-containing area, the second label pad comprises a second label-free blank area and a second label-containing area, and the diversion element end portion is overlapped on the first label-free blank area.