Invention for Medical apparatus for testing medical conditions, including Zika and pregnancy

Invented by Jovan Hutton Pulitzer, Henry Joseph Legere, Iii, Reliant Immune Diagnostics LLC

The market for medical apparatus for testing medical conditions, including Zika and pregnancy, has witnessed significant growth in recent years. With advancements in technology and increasing awareness about the importance of early diagnosis, the demand for accurate and reliable medical testing devices has surged. One of the key factors driving the market growth is the rising prevalence of medical conditions such as Zika and pregnancy-related complications. The Zika virus, which emerged as a global health concern in 2015, has created a need for effective diagnostic tools to identify and monitor infected individuals. Similarly, the need for accurate pregnancy testing devices has grown due to the increasing number of women seeking early confirmation of their pregnancy status. The development of innovative medical apparatus has revolutionized the way medical conditions are diagnosed and monitored. Rapid advancements in molecular biology and genetic testing have led to the emergence of highly sensitive and specific diagnostic tools. For instance, nucleic acid amplification tests (NAATs) have become the gold standard for Zika virus detection, offering high accuracy and quick results. These tests detect the presence of viral RNA in blood, urine, or other bodily fluids, enabling early diagnosis and timely intervention. In the case of pregnancy testing, traditional methods such as urine-based tests have been widely used. However, technological advancements have led to the introduction of more sophisticated and accurate devices. Home pregnancy test kits now offer digital results, eliminating the need for interpretation of faint lines. Additionally, some devices can detect pregnancy hormones even before a missed period, providing women with early confirmation and peace of mind. The market for medical apparatus for testing medical conditions, including Zika and pregnancy, is highly competitive, with numerous players vying for market share. Established companies, as well as startups, are investing heavily in research and development to introduce innovative products that cater to the evolving needs of healthcare professionals and patients. Furthermore, the COVID-19 pandemic has further accelerated the demand for medical testing apparatus. The need for rapid and accurate diagnostic tools to detect the virus has highlighted the importance of investing in advanced medical testing technologies. Many companies have diversified their product portfolios to include COVID-19 testing kits, further driving the growth of the medical apparatus market. However, challenges such as stringent regulatory requirements and high costs associated with developing and commercializing medical testing devices can hinder market growth. Obtaining regulatory approvals and ensuring compliance with quality standards can be time-consuming and expensive. Additionally, the high cost of advanced testing devices may limit their accessibility, particularly in low-income regions. In conclusion, the market for medical apparatus for testing medical conditions, including Zika and pregnancy, is witnessing robust growth due to increasing prevalence of these conditions and advancements in technology. The demand for accurate and reliable diagnostic tools has fueled innovation in the industry, leading to the development of highly sensitive and specific testing devices. However, challenges such as regulatory requirements and cost constraints need to be addressed to ensure widespread accessibility and affordability of these medical apparatus.

The Reliant Immune Diagnostics LLC invention works as follows

The system provides results of multiple immunoassay tests. It includes a testing device with an alignment target, a plurality immunoassay strips that each include a sample pad for receiving a biological sample, a conjugate strip containing particles to conjugate with antibodies or antigens in the biologic samples, and an membrane strip that has a test and control line. Both the test and control lines are visible.

Background for Medical apparatus for testing medical conditions, including Zika and pregnancy

When testing for pregnancy, there are many other health issues at stake. What is needed, then, is a method and system for testing for pregnancy which also gives accurate information on other health issues.

In one aspect, the system provides results of immunoassay tests for multiple medical conditions. The system includes a testing device with an alignment target, as well as a plurality immunoassay strips. Each immunoassay strip comprises a sample pad for receiving a biological sample, a conjugate pads containing particles that can be conjugated to antibodies or antigens in the biologic samples, and a membrane having a viewable test line and control line. The system also comprises a mobile phone with a camera and a viewing screen and a software program stored on it. The software program provides executable instructions for initiating operation of a camera on the mobile phone, presenting on the screen an alignment graphic that is to be aligned to the alignment target on the testing device. It can then detect when the alignment has occurred.

Referring to the drawings wherein like numbers are used to designate similar elements throughout, various views and embodiments for an arbovirus-indicative birth defect risk test, as well as other possible embodiments, are illustrated and described. Figures are not drawn to scale and some drawings may be exaggerated or simplified for illustration purposes. The following examples will allow anyone with ordinary knowledge of the art to appreciate the various applications and variations.

Referring to Figure 1, it is shown that an immunoassay test strip 100 has been modeled in one embodiment. 1. One embodiment of an immunoassay strip 100 is shown. The test strip is usually housed within a device that collects a biological analyte from the user and directs it onto the strip 100. It is understood, however, that a biological can be applied to a strip without it needing a testing device. The test strip 100 has a backing 102. The test strip is composed of several sections that are arranged on the backing 102. On one end of strip 100 is a sample pad 104 for collecting the biological analyte. The biological analyte can be urine, blood or saliva. It could also be stool, sweat or any other biologic that is needed to perform the immunoassay. The user may receive the necessary biologic in a variety of forms, including vials, containers and dilutants. A few drops of blood can be collected from a fingerstick using a finger-prick device. This blood analyte can be either blood mixed with a sufficient amount of buffered solutions to create sample analyte 106, or blood that has not been diluted or otherwise altered, in which the blood is the only analyte.

The biological analyte, upon contact with the pad of sample 104, starts to migrate along the strip 100, by capillary effect, and comes into contact with various sections. Between the sample pad and the test line 110, a particle conjugate pad is placed. The conjugate pad may contain reagents that are associated with an antigen such as a viral, allergen or bacteria. These reagents can be antibodies, enzymes or other reagents required to diagnose a specific condition. The conjugate pad may contain particles such as colored latex beads or colloid gold. As the analyte migrates through conjugate pad, antibodies in the sample analyte will complex with reagents on the conjugate pads 108. This immune complex will then migrate to the test area or test line 110.

The test line 110 (T), for example, can be coated with an antigen of interest, such as a virus or allergen. This allows the detection and quantification of antibodies that are associated with this antigen. The immune complex formed when the analyte passes through the conjugate pads 108 is captured on the antigen found on the test lines 110. The test line 110 may produce a qualitative reaction on the strip, such as color. In some embodiments the test line 110 is not a straight line but can be another shape or symbol, such as plus sign. No reaction will occur in the test line if there are no antigen-antigen complexes in the analyte.

After passing through the test line 110, the analyte migrates further along the strip to reach a control line 112, where excess anti-antibody-colloidal gold or latex conjugates get bound. The control line 112 may show a qualitative response, indicating the sample has migrated as intended across the membrane or substrate. The control line 112 may not be required to run the test and can be removed, but it does serve as a comparison for the user. In embodiments that provide a colored qualitative answer, the controlline 112 may appear in an overly saturated colour, such as dark or bright red, when the sample reaches it. This saturated color can be used to compare the qualitative response on the testline 110. If the qualitative response on the line 110 is much lighter than the line 110, then it could be that there was very little reaction at the line. If no response appears at the test-line 110, then no reaction occurred. “A strong reaction can be indicated if the qualitative response on the test line is similar to that of the control line 112.

The strip 100 need not be continuous. The various sections of strip 100 can be separated from one another, but still adhered to backing 102. As shown in FIG. As shown in FIG. Both the test line or zone 100 and the control zone 112 are disposed on a nitrocellulose strip 114. The nitrocellulose strip 114 adheres to the backing 102 but is separate from the sample pad and conjugate pad. As shown in FIG. As shown in FIG. The end of the conjugate membrane strip 114 adjacent to that of the conjugate membrane pad 104 may also lie on top of the end adjacent to that of the conjugate membrane pad. The analyte can then be easily deposited on each section of strip 100, as it migrates along the strip 100. The analyte comes in contact with the wick 116 after it has migrated across the nitrocellulose strip 114 and therefore across the test line and control line 112. This allows the analyte to be collected and absorbed. As shown in FIG., the end of the analyte 106 adjacent to the membrane strip 114 can be placed over the adjacent end. 1.

Several flow immune assays have been developed to identify proteins, molecules of interests, and even immunoglobulins IgG IgA and IgM. IgE (immunoglobulin) is an antibody that circulates freely in the blood until it enters the tissue. It then binds to mast cells via the FcERI receptor (F-CepsilonR-one), also known as the high-affinity IgE receptor. “There is a small amount IgE bound on IgE receptors in the blood, tissues, and eosinophils.

Many assay systems are designed to detect infectious proteins. The tests mentioned above use non-human antibodies, usually of the IgG type, e.g. goat IgG antibodies, to detect the target protein in the sample (blood or urine, saliva or sweat). The antibody forms a complex with the protein of interest, which travels through the membrane to reach the test zone. The test zone contains an IgG antibody that is directed against IgG of the animal species. As further described herein, the present detecting apparatus and method use human (patient/consumer-derived) antibodies from the sample and the test zone that contains a humanized antibody directed against the protein of interest that is preconjugated to a detecting substance that results in a visual change.

Summary Antigen Target:

Immune assay to detect specific IgE

Immune assay to detect total IgE (not concerned about specific IgE:

Referring to FIG. In Figure 2, one embodiment of a immunoassay 200 is shown, where an analyte is tested on a number of test strips. Each of the test strips 204 can be designed to test for a specific antigen. One strip could be used to test for streptococcal (strep throat), another for peanut allergy testing, and so on. Each strip can also test multiple antigens. As shown in FIG. Multiple testing panels or lines may be included. Each line can be for an antigen. As shown in Figure. As shown in FIG. “A strip for testing allergens can have a panel to test for grass allergies at testline 210 (CH3), for cat allergy at testline 208 (CH2) or for peanut allergy at testline 206 (CH1).

Other examples of the configurations can include, but aren’t limited to, 1) food 5: peanut, milk, soya, wheat, eggs; 2) nut and seed panel: almonds, cashews, hazelnuts, peanuts, pecans, walnuts, sesame seeds, sunflower seeds; 3) fish: crab, lobsters, shrimps, salmon, tuna ; 4) pets: cat and dog; 5) indoor allergens : dust mites and mold mix (alternaria “Other examples of configurations for the testing panels can be, but are not limited to: 1) Food 5: Peanut, milk, soy, wheat, egg; 2) Nut and seed panel: almond, cashew, hazelnut, peanut, pecan, walnut, sesame seed, sunflower seed; 3) seafood – crab, lobster, shrimp, salmon, tuna; 4) Pets – cat, dog. 5) Indoor allergens – dust mites, mold mix (alternaria

The panels can be used to test for other non-allergens such as strep (hCG detection), Zika (hCG detection), flu (anthrax), cancer (HPV), Lyme disease (mono), mononucleosis, or other diseases. Some embodiments allow testing for arboviruses. Arboviruses (viruses transmitted by arthropods) are commonly spread by mosquitos. Vectors are organisms which transfer the virus to a host. In the case of mosquitoes, a parasite that has infected a host can infect other hosts when it feeds again on an uninfected one. Arboviruses that are well-known include Dengue, Japanese encephalitis, Rift Valley Fever, West Nile, Yellow fever, Chikungunya and Zika viruses. Arbovirus testing can be done using urine, blood, saliva, and other biologics.

Certain antigens or conditions can be logically paired. A testing device could include a strip to detect pregnancy as well as a zika test strip, since the Zika virus is known to cause birth defect in babies born to women who are Zika-infected. Combining these two tests in a single device or kit will alert a pregnant woman of a possible Zika infection at the same time as she discovers that she is pregnant. This allows her to seek immediate medical attention. It is a significant improvement over previous Zika testing where women were required to wait for weeks before the results from a laboratory after her biologic was collected by their physician. This may result in a woman passing a state-mandated abortion cutoff, like 24 weeks for some states. The combination of a Zika test and a prenatal test, which physically links the two tests and allows a woman determine her Zika risk when taking a test for pregnancy, where a test can be taken up to six days after conception. This allows the woman to act much earlier than the state-mandated cutoff point and waiting for laboratory results.

Various test devices may include the test strips 100 or strips, such as a slides that support the test strip, a cassette-based diagnostic test or a dipstick. In various embodiments, the test results may take on a form such as a visual qualitative test, a semiquantitative visual format, or a reader quantitative test format. A digital implementation is also possible, whereby the result of the test is displayed on a screen within the apparatus and visible to the end user.

The apparatus and the method of detection can be a one-step approach from sample to reading without sample dilution or other sample manipulation. The sample is not diluted or subjected to any other manipulation. The sample can be diluted, or undergo other sample manipulations. For example, the blood sample will be diluted using a buffer.

Referring to FIG. A diagrammatic representation is shown in Figure 3 of an embodiment of a test device 300. The body of the device is formed by a housing 302. The housing 302 can be made from plastic, metal or any other durable material that is suitable for shipping and handling by an end user. The housing 302 can be hollow to allow for a plurality test strips 304 and a biologic to be placed within. The testing device may also include a plurality 306 of windows, each associated with a particular test strip 304. This allows a user the ability to see at least that section of the nitrocellulose 114 membrane strip where the test lines 110 and 112 are located. The windows 306 can be covered by plastic, glass or other materials to allow the user to view the strips 304. On the surface of the housing 302, a sample well 308 can be placed to allow the user to deposit the biologic in the housing 302. The sample well 308 is disposed near or over the sample pad or pads 104 on the test strip 100. The embodiment of FIG. In FIG. 3, there is a single well 308 for collecting a single type biologic for testing. Each of the plurality strips 304 are suited to test for antigens with that specific biologic sample type. If the device 300 is a combined Zika and pregnancy test with both a Zika and pregnancy strip, then a urine sample can be placed into the well 308, which will cause the urine to contact the sample pads 104 of both the Zika and pregnancy strips. Both of these tests can also be done with blood samples.

The crosshair symbol 310 can be placed on the surface the housing of the testing device 300 to serve as an alignment target. This symbol can be a graphic that is printed on the testing device or adhered. The crosshair symbol is used to align a testing device for taking an image using a camera of a mobile phone, in order to use the mobile application described herein. Other embodiments may use other symbols such as simple shapes (circle or square). Other images (such a a medical symbol cross, an arrow etc.) or any other type of image can be used as the crosshair symbol 310. “Any other type of picture.

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