Title of Invention

"TWIN WELL STATION DEVICE"

Abstract A Twin well station device comprising a conjugate well (1) adjacent to the wash well (2)to form one unit, a hollow base (3) and a gap provided between the said conjugate (1) and said wash well (2) , each of the well having a seat (5) to provide proper alignment and positioning of test strip, a strip holder (7) provided on the inner side adjacent wall of the conjugate well, a result monitor provided on diagonally opposite side of the strip holder.
Full Text FIELD OF INVENTION:
This invention relates to a twin well station device with diagnostic malaria stix to be used for the qualitative differential detection of parasites such as P. falciparum and P .vivax for testing of malaria .
More particularly, the present invention relates to twin well station device Comprising of two well namely conjugate well and wash well with an Immunoassay device to be used for qualitative differential detection of parasites for testing of malaria.
BACKGROUND OF THE INVENTION
It is known that malaria is a serious; sometimes fatal, parasitic disease Characterized by fever, chills, and anemia and is caused by a parasite that is Transmitted from one human to another by the bite of infected Anopheles Mosquitoes. The disease occurs in more than 90 countries world wide, and it is Estimated that there are over 500 million clinical cases and 2.7 million malaria-Caused deaths per year.
It has been found that there are four kinds of parasites that can infect humans: Plasmodium falciparum, plasmodium vivax, plasmodium ovale, and plasmodium Malaria Conventionally, to detect whether the patient is infect by any of the Above parasites a blood sample is taken from the patient and malaria is Diagnosed microscopically by looking for the parasites in a drop of blood. In the Other existing methodsused for detecting the presence of malarial parasite in the blood sample the test is carried out in small cap, which has nothing to hold the strip, and is not very convenient to use.
A number of devices are in use for qualitative detection of different types of Parasites. Some of the devices are also available with test kits. The devices
Used for qualitative and quantitative analyses are of various types and different Methods are used for carrying out the detection test.
CA Patent no. 1334932 describes a disposable, pre-packaged device Particularly suitable for conducting diagnostic procedures based on Immunological reactions using specimens gathered in the absorbent tip of a Swab. The device is made up of an elongated hold member which includes Structure for supporting and positioning a swab, another holder member hingedly Mounted at one end of the swab holder member and which carries a capture Media element assemblage suitable for conducting an immunoassay test. The Device also includes a cover member hingedly mounted on the opposite end of The swab holder member The cover member includes structure positioned for Pressed the swab tip against the capture element when the device is operated. Thus the liquid in the swab tip is squeezed and the test fluid is expressed There from and brought into intimate contact with the capture element. The results of the test are visually observable by simply swinging the member. Which carries the capture element away from the swab holder member
GB patent no. 2114738 describes an apparatus for use in clinical test procedures comprising in combination a holder bearing a number of inserts and a Tray having a main recessS for the holder and its inserts and a plurality of wells arranged in a pattern complementary to the pattern of a plurality of the Inserts, so that several of the inserts can be introduced at once into the Corresponding wells. The holder and the tray may have complementary locating Means to allow insertion of the inserts in a desired orientation into the wells, and to prevent incorrect insertion in inverse orientation. Preferably the inserts bear a Specific sensitization, e.g. an immunological sensitization, reagents for the assay Reaction are dosed and stabilised in the wells, and a sealing cover retains the Reagents in stable form in storage before use.
US Patent no. 49112034 describes an apparatus provided for use in an immunoassay for the detection of a target analyte in a liquid sample, comprising a porous reactive filter, having an upper surface and a lower surface, to which is Bound an antibody specific for the target antigen: a holder affixed to the porous Filter, wherein the upper surface and lower surface of the reactive filter are Accessible for passage of liquids through the reactive filter; and an absorbent Container capable of being detachably attached to the holder; and an absorbent material contained within the container so as contact the lower surface of the porous filter when the absorbent container is attached to the holder. A prefilter assembly can optionally be attached to the holder so that the prefilter contacts the upper surface of the reactive fiter. The prefilter assembly, if present, and the absorbent container can readily be detached from the holder to avoid problems of back flow and to allow ease of storage of the disassembled holder and reactive filter for analysis and comparison with related assays, optionally a series of assays run at different times.
U.S. Patent no.5827681 describes a test kit for malaria comprising a slide Incubation chamber, which permits rapid detection of malaria in wet blood samples using a regular transmitted light microscope to detect opaque hemozoin particles
The disturbing rate at which malaria parasites are becoming resistant to ant malarial drugs emphasizes the need for a standardized test. Which can be Readily used by medical and laboratory personnel to determine the parasite's susceptibility to various drugs. The present invention utilizes a method based on chromatographic detection of presence of P. falciparum and P.vivax in the given blood sample and assesses a drug sensitivity upto 99.8% and specificity upto 99.6%. The malaria stix used with the twin well station device has a substantially good shelf life and is economical to produce.
The object of the present invention is to provide a visual, rapid and sensitive immunoassay for the qualitative differential detection of falciparum and P. vivax for malaria.
The invention will be descried in short with reference to the accompanying
Drawings.
Brief Description of the Accompanying Drawings
Fig. 1 shows the top view of the twin well station device.
Fig 2 shows the perspective cross sectional view of the twin well station device. It is the constructional view of the product.
Fig.3 is the cross sectional view of the twin well station device.
Fig. 4 shows the back view of the twin well station device.
Fig. 5 shows the cross sectional view of the twin well station device showing the tapered view of the two wells.
Detailed Description of the invention
The present invention relates to the twin well station device comprising of two wells namely- conjugate well(1) and wash well (2) both casted together to form one unit. There is a hollow base(3) and gap provided between the two wells to avoid shrinkage.
Fig. 1 shows top view of the device showing that both the well conjugate (1) as well as the wash well (2) have circular top and slanting bottom. There is a notch/ groove (4) provided at one end of the wash well to monitor result and a seat (5) is provided on diagonally opposite side of the result monitor for holding the strip in conjugate well. Each well is provided with a seat or groove for proper alignment or positioning of the diagnos malaria stix as well as to hold the stix in the respective wells.

Fig.2 shows the constructional view of the device. The conjugate well (1) as well as wash well (2) are cylindrical in shape and tapering towards bottom. The height of the conjugate well (1) varies from 0.2cm to 0.8cm when the height of the wash well (2) is 1cm. The diameter of the bottom of the well is ¼ of the diameter of the top end of the well. The height of the wash well is 2.5- 3.5 times greater than the conjugate well. The wells (1,2) are standardized for carrying out the test easily and conveniently. Two of the sides of the wells are flat. On one side of the wash well result monitor (6) is provided.
Fig3 shows the cross sectional view of the device. The strip holder (7) is shown on the inner side of the wash well.
Fig 4 shows the result monitor. The result monitor (6) is a vertical groove adjacent to the wash well (2) where the test strip is placed after conducting the test. Te results can be monitored easily and clearly when the strip is placed vertically.
Fig 5 shows both the wells (1,2) have a slanting base. The angle of the slant of each base varies from 5 to 20 degrees. The sla ntiong base of the device is to direct reagent flow to a particular direction so that even if there is a little quantity of the blood sample the test can be carried on.
The conjugate well (1) is coated with a layer of conjugate. The twin well station device is made up of polystyrene or the like non - toxic material with crystal transparent look enabling clear visualization of reagent volumes in the wells.the coating has to be optimized.
During use of the device 4 to 10 microliter of blood along with the reagent are put in conjugare well and they are allow to mix. Some times a drop of assay buffer is dispensed in the conjugate well before putting the sample. Six drops of the assay buffer are dispensed in the wash well. A test strip to test the malaria is
placed in the said well at least for 5 to 10 minutes till the blood and reagent are soaked by the strip by the capillary action. The strip is taken out and placed in the wash well for ten minutes. The strip is taken out from the wash well and is placed on the result monitor. The results are then monitored.
The subject application is a statement of invention, wherein various alterations and modification are possible without deviating from the scope of the claimed invention; hence the same should not be construed to restrict the scope of the
invention.




















We Claim
1. A twin well station device comprising two wells of different sizes:
a conjugate well (1) adjacent to another wash well (2) forming a single unit; a hollow base and gap provided between the said conjugate well (1) and said wash well (2), each of the well having a seat (5) to provide proper alignment and positioning of test strip; a strip holder (7) provided on the inner side of the wash well, a result monitor (6) provided on the back side of the strip holder (7) of the wash well, inner surface of both the wells are slightly slanted in the bottom side for holding the strip in position.
2. A twin well station device as claimed in claim 1 wherein the said wash well has circular top and bottom side with one flat side.
3. A twin well station device as claimed in claim 1 where in the conjugate well has circular in shape with one flat side.
4. A twin well station device as claimed in claim 1 where in the said wash well and the conjugate well are tapered towards the bottom end.
5. A twin well station as claimed in claim 1 wherein the height of the wash well is 2.5 to 3.5 times greater than the conjugate well.
6. A twin well station device as claimed in claim 1 where in the diameter of the bottom of each well is 1/4th of the top circumference of the well.
7. A twin well station as claimed in claim 1 where in the bottom of the wells are slightly slanted to keep the strip in position and to facilitate the proper migration of the solution on to the strip.
8. A twin well station device as claimed in claim 1 where in the bottom of each well has a slant of 5 to 20° angles.
9. A twin well station device as claimed in claim 1 where in seats are provided on each well of the strip to keep the strip in position.

10. A twin well station device as claimed in claim 1 where in the result monitor is provided on the back side of the device to read the result.
11. A twin well station device such as herein before described with reference to the accompanying drawings.

Documents:

1571-DEL-2004-Abstract-(29-09-2008).pdf

1571-del-2004-abstract.pdf

1571-DEL-2004-Claims-(29-09-2008).pdf

1571-del-2004-claims.pdf

1571-DEL-2004-Correspondence-Others-(29-09-2008).pdf

1571-del-2004-correspondence-others.pdf

1571-del-2004-correspondence-po.pdf

1571-DEL-2004-Description (Complete)-(29-09-2008).pdf

1571-del-2004-description (complete).pdf

1571-del-2004-description (provisional).pdf

1571-DEL-2004-Drawings-(29-09-2008).pdf

1571-del-2004-drawings.pdf

1571-del-2004-form-1.pdf

1571-del-2004-form-13-(13-06-2007).pdf

1571-del-2004-form-13.pdf

1571-del-2004-form-18.pdf

1571-DEL-2004-Form-2-(29-09-2008).pdf

1571-del-2004-form-2.pdf

1571-DEL-2004-Form-26-(29-09-2008).pdf

1571-del-2004-form-26.pdf

1571-DEL-2004-Form-3-(29-09-2008).pdf

1571-del-2004-form-3.pdf

1571-del-2004-form-5.pdf


Patent Number 225307
Indian Patent Application Number 1571/DEL/2004
PG Journal Number 46/2008
Publication Date 14-Nov-2008
Grant Date 07-Nov-2008
Date of Filing 23-Aug-2004
Name of Patentee J. MITRA & CO., LTD.,
Applicant Address A-180 OKHLA INDUSTRIAL AREA PHASE-1, NEW DELHI-110020.
Inventors:
# Inventor's Name Inventor's Address
1 LALIT MAHAJAN A-180, OKHLA INDUSTRIAL AREA PHASE-1, NEW DELHI-110020
PCT International Classification Number G01N 31/53
PCT International Application Number N/A
PCT International Filing date
PCT Conventions:
# PCT Application Number Date of Convention Priority Country
1 NA