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News Article | October 31, 2016
Site: globenewswire.com

MEDFORD, N.Y., Oct. 31, 2016 (GLOBE NEWSWIRE) -- Chembio Diagnostics, Inc. (NASDAQ:CEMI), which develops, manufactures, markets and licenses point-of-care diagnostic tests, announced today that the Company will release financial results for the third quarter of 2016, before the opening of the market on Thursday, November 10, 2016. The Company’s 10-Q and earnings press release will be available at 9:15 a.m. ET on its website. John J. Sperzel, Chembio's President and Chief Executive Officer, will host an investment community conference call beginning at 10:00 a.m. ET on Thursday, November 10, 2016, to discuss these results and to answer questions. He will be joined by Richard Larkin, Chembio's Chief Financial Officer. To participate on the conference call, please dial (877) 407-0778 from the U.S. or (201) 689-8565 from outside the U.S. In addition, following the completion of the call, a telephone replay will be accessible until November 17, 2016 at 11:59 p.m. ET by dialing (877) 481-4010 from the U.S. or (919) 882-2331 from outside the U.S. and entering conference ID: 10129.  The conference call may also be accessed via the internet at http://www.investorcalendar.com/IC/CEPage.asp?ID=175428.  An archive of the webcast will be available for 90 days on the Company's website at www.chembio.com. Those interested in listening to the conference call live via the internet may do so by visiting the Investor Relations section of Chembio's website at www.chembio.com. To listen to the live call, please go to the website 15 minutes prior to its start to register, download, and install the necessary audio software. A replay will be available on the website for a limited time. Chembio Diagnostics, Inc. develops, manufactures, licenses and markets proprietary rapid diagnostic tests in the growing $8.0 billion point-of-care testing market. Chembio markets its DPP® HIV 1/2 Assay, HIV 1/2 STAT-PAK® Assay and SURE CHECK® HIV 1/2 Assay, with these Chembio brand names, in the U.S. and internationally both directly and through third-party distributors. SURE CHECK® HIV 1/2 Assay previously has been sold in the U.S. exclusively as Clearview® Complete HIV 1/2 Assay. Outside the U.S., Chembio markets its SURE CHECK® HIV 1/2 Assays through distributors. Chembio has developed a patented point-of-care test platform technology, the Dual Path Platform (DPP®) technology, which has significant advantages over lateral-flow technologies. This technology is providing Chembio with a significant pipeline of business opportunities for the development and manufacture of new products. Headquartered in Medford, NY, Chembio is licensed by the U.S. Food and Drug Administration (FDA) as well as the U.S. Department of Agriculture (USDA), and is certified for the global market under the International Standards Organization (ISO) directive 13485. Chembio Diagnostic Systems, Inc. is a wholly-owned subsidiary of Chembio Diagnostics, Inc. For more information, please visit: www.chembio.com. Statements contained herein that are not historical facts may be forward-looking statements within the meaning of the Securities Act of 1933, as amended.  Forward-looking statements include statements regarding the intent, belief or current expectations of the Company and its management.  Such statements, which are estimates only, reflect management's current views, are based on certain assumptions, and involve risks and uncertainties.  Actual results, events, or performance may differ materially from the above forward-looking statements due to a number of important factors, and will be dependent upon a variety of factors, including, but not limited to Chembio's ability to obtain additional financing and to obtain regulatory approvals in a timely manner, as well as the demand for Chembio's products.  Chembio undertakes no obligation to publicly update these forward-looking statements to reflect events or circumstances that occur after the date hereof or to reflect any change in Chembio's expectations with regard to these forward-looking statements or the occurrence of unanticipated events.  Factors that may impact Chembio's success are more fully disclosed in Chembio's most recent public filings with the U.S. Securities and Exchange Commission.


News Article | February 27, 2017
Site: globenewswire.com

MEDFORD, N.Y., Feb. 27, 2017 (GLOBE NEWSWIRE) -- Chembio Diagnostics, Inc. (NASDAQ:CEMI), which develops, manufactures, markets and licenses point-of-care diagnostic tests, announced today that it will report financial results for 2016 on March 7, 2017 after market close.  John J. Sperzel, Chembio's President and Chief Executive Officer, and Richard Larkin, Chembio’s Chief Financial Officer will host a conference call and webcast at 4:30 p.m. ET to discuss the financial results for 2016 and review recent corporate developments. The Company’s 10-K and earnings press release will be available after 4:00 p.m. ET on Chembio’s web site. To participate on the conference call, please dial (877) 407-0778 from the U.S. or (201) 689-8566 from outside the U.S.  To listen live via the Internet, please visit the Investor Relations section of Chembio's website at www.chembio.com. To listen to a replay of the call, which will be accessible until March 14, 2017 at 11:59 p.m. ET, please dial (877) 481-4010 from the U.S. or (919) 882-2331 from outside the U.S., and enter conference ID #:10255.  An archive of the webcast will be available for 90 days on the Company's website at www.chembio.com. Chembio Diagnostics, Inc. develops, manufactures, licenses and markets proprietary rapid diagnostic tests in the growing $8.0 billion point-of-care testing market. Chembio markets each of its DPP® HIV 1/2 Assay, HIV 1/2 STAT-PAK® Assay, and SURE CHECK® HIV 1/2 Assay, with these Chembio brand names, in the U.S. and internationally both directly and through third-party distributors. The Company's SURE CHECK® HIV 1/2 Assay previously has been exclusively sold in the U.S. as Clearview® Complete HIV 1/2 Assay. Chembio has developed a patented point-of-care test platform technology, the Dual Path Platform (DPP®) technology, which has significant advantages over lateral-flow technologies. This technology is providing Chembio with a significant pipeline of business opportunities for the development and manufacture of new products. Headquartered in Medford, NY, Chembio is licensed by the U.S. Food and Drug Administration (FDA) as well as the U.S. Department of Agriculture (USDA), and is certified for the global market under the International Standards Organization (ISO) directive 13485. Chembio Diagnostic Systems, Inc. is a wholly-owned subsidiary of Chembio Diagnostics, Inc. For more information, please visit: www.chembio.com. Statements contained herein that are not historical facts may be forward-looking statements within the meaning of the Securities Act of 1933, as amended.  Forward-looking statements include statements regarding the intent, belief or current expectations of the Company and its management.  Such statements, which are estimates only, reflect management's current views, are based on certain assumptions, and involve risks and uncertainties.  Actual results, events, or performance may differ materially from the above forward-looking statements due to a number of important factors, and will be dependent upon a variety of factors, including, but not limited to Chembio's ability to obtain additional financing and to obtain regulatory approvals in a timely manner, as well as the demand for Chembio's products.  Chembio undertakes no obligation to publicly update these forward-looking statements to reflect events or circumstances that occur after the date hereof or to reflect any change in Chembio's expectations with regard to these forward-looking statements or the occurrence of unanticipated events.  Factors that may impact Chembio's success are more fully disclosed in Chembio's most recent public filings with the U.S. Securities and Exchange Commission.


News Article | November 10, 2016
Site: globenewswire.com

MEDFORD, N.Y., Nov. 10, 2016 (GLOBE NEWSWIRE) -- Chembio Diagnostics, Inc. (Nasdaq:CEMI), a leader in point-of-care (“POC”) diagnostic tests for infectious diseases, today reported financial results for the three and nine months ended September 30, 2016. John J. Sperzel III, Chief Executive Officer, stated, “The Company made important advances in multiple areas during the third quarter of 2016, intended to prepare the Company for growth: commercialization, regulatory approvals, product development grants, and equity financing.  With respect to Chembio's commercial infrastructure, the Company appointed two seasoned executives to build our worldwide sales and marketing capabilities, with immediate focus on the United States, Latin America, Asia Pacific and Africa. The Company expanded its distribution network by appointing Isla Lab, the largest distributor of diagnostic products in the Caribbean, as its exclusive distributor in that region. “Chembio recently secured two important regulatory approvals. In July 2016, the Company obtained a CE mark for the DPP® Zika IgM/IgG Assay and DPP® Micro Reader, allowing the products to be marketed and sold in 17 European countries, including the United Kingdom, Germany, and France, as well as a majority of the Caribbean nations. In late October 2016, the Company received approval by Brazil’s health regulatory agency, Agência Nacional de Vigilância Sanitária (ANVISA) for DPP® Zika IgM/IgG Assay. These regulatory achievements follow the milestone which occurred at the end of the second quarter of 2016, when Chembio’s DPP® HIV 1/2 Assay was accepted for the World Health Organization (WHO) list of prequalified in vitro diagnostics. “In August 2016, Chembio completed an equity financing which provided gross proceeds of approximately $13.8 million, which provides the Company with capital needed to advance its product development programs and invest in the sales and operational infrastructure needed to support sustained growth. Also in August 2016, Chembio was awarded a contract for up to $13.2 million in total funding from the U.S. Department of Health and Human Services (HHS); Office of the Assistant Secretary for Preparedness and Response (ASPR); Biomedical Advanced Research and Development Authority (BARDA) to develop and commercialize the Company’s DPP® Zika IgM/IgG Assay and Zika-related products. “Subsequent to the 2016 third–quarter end, Chembio entered into an agreement to acquire RVR Diagnostics Sdn Bhd (RVR), a Malaysian, privately-held manufacturer and distributor of POC diagnostic tests for infectious diseases. Subject to satisfaction of conditions to closing, completion of the RVR acquisition will provide the Company with a strategically located and cost-effective manufacturing facility, an additional revenue source, and the potential to accelerate important product registrations in Southeast Asia, which we believe will be important in serving a number of global markets.” Addressing the company’s financial results, Mr. Sperzel commented, “Despite reporting a decrease in product sales for both the second and third quarters of 2016, a quarter-over-quarter analysis shows sales growth with total revenues for the third quarter of 2016 up 15% and product sales for the third quarter of 2016 up 23%, as compared to the second quarter of 2016.  In the United States, sales of the HIV 1/2 STAT-PAK® Assay increased 44% as compared to the third quarter of 2015, and increased 21% as compared to the second quarter of 2016. This growth provides strong evidence that we are effectively rebuilding the U.S. HIV STAT-PAK® business, since we took back the U.S. distribution rights to this product in June 2014. We are also seeing encouraging U.S. sales of the HIV 1/2 SURE CHECK® Assay since we took back distribution rights to this product at the end of May 2016. Through the Company’s achievements in strengthening commercial infrastructure, securing regulatory approvals, improving its balance sheet, obtaining a multi-million dollar grant from the U.S. Government, and establishing operations in the growing Asian market, we believe Chembio is on a path to establish a global operation with potential for growth in several important markets.” Selected Summary Financial Information comparing the 2016 third quarter to the 2015 third quarter: Selected Summary Financial Information comparing the first nine months of 2016 to the first nine months of 2015: Third Quarter: Total revenues in the 2016 third quarter of $3.75 million decreased 45.6% compared with $6.89 million in the prior-year period. Product sales in the 2016 third quarter of $2.50 million decreased 59.7% compared with $6.21 million in the prior-year period.  R&D milestone, and grant and royalty revenues in the 2016 third quarter of $1,244,000 increased 83.4% compared with $678,000 in the prior-year period. Gross margin dollars in the 2016 third quarter of $1.95 million decreased 32.9% compared with $2.91 million in the prior-year period, due primarily to decreased product revenues. Product gross margin dollars in the 2016 third quarter of $0.71 million decreased 68.3% compared with $2.23 million in the prior-year period, which also was primarily due to the decreased product revenues. R&D expenses in the 2016 third quarter of $2.26 million increased 44.2%, compared with $1.57 million in the prior-year period. This increase is due primarily to increased clinical trial expenses as well as R&D activities for projects and grants. Selling, general and administrative expenses in the 2016 third quarter of $1.83 million decreased 4.5% compared with $1.92 million in the prior-year period, largely due to decreased commissions, which were due to decreased sales in Brazil, as well as decreases in stock-based compensation, travel, entertainment and trade shows, consulting, and other expenses, which were partially offset by increases in wages and related costs, marketing materials, professional fees and investor relations expenses. Operating loss in the 2016 third quarter was $2,144,000, compared with an operating loss of $579,000 in the prior-year period. Net loss in the 2016 third quarter was $2,138,000, or $0.19 per diluted share, compared with net loss of $437,000, or $0.05 per diluted share, in the prior-year period. First Nine Months: Total revenues in the 2016 first nine months of $13.61 million decreased 31.4% compared with $19.83 million in the prior-year period. Product sales in the 2016 first nine months of $10.45 million decreased 42.4% compared with $18.15 million in the prior-year period.  R&D milestone, and grant and royalty revenues in the 2016 first nine months of $3,161,000 increased 87.2% compared with $1,689,000 in the prior-year period. Gross margin dollars in the 2016 first nine months of $6.70 million decreased 22.3% compared with $8.62 million in the prior-year period, due primarily to the decrease in product sales. The amount of product gross margin in the 2016 first nine months of $3.54 million decreased 48.9% compared with $6.93 million in the prior-year period. R&D expenses in the 2016 first nine months of $6.27 million increased 27.6%, compared with $4.91 million in the prior-year period. This increase is due primarily to increased R&D activities for projects and grants. Selling, general and administrative expenses in the 2016 first nine months of $5.43 million decreased 10.3%, compared with $6.06 million in the prior-year period, largely due to decreased commissions on sales in Brazil, decreased wages and related costs, stock-based compensation, consulting and travel, entertainment and trade shows, which were partially offset by increases in marketing materials, investor relations expenses and professional fees. Operating loss in the 2016 first nine months was $4,998,000, compared with an operating loss of $2,352,000 in the prior-year period. Net loss in the 2016 first nine months was $10,789,000, or $1.06 per diluted share, compared with net loss of $1,748,000, or $0.18 per diluted share, in the prior-year period.  The net loss in the 2016 period includes a tax provision for the recording of a valuation allowance on the Company's deferred tax asset of $5,801,000. Valuation Allowance The Company elected, based on accounting guidance, to record a full Valuation Allowance ("VA") on its Deferred Tax Asset ("DTA").  Chembio's DTA was primarily based on the Company's Net Operating Loss (NOL) carryforwards.  Based primarily on the fact that the Company believes, given information available to it at this time, that it is more likely than not that the deferred tax asset will not be realized in the foreseeable future, the Company concluded that it was appropriate to record a full VA against its DTA.  This resulted in a tax provision in the second quarter of 2016 of $5.96 million and for the nine months ended September 30, 2016 of $5.80 million.  This VA does not affect the Company's ability to use its NOLs in the future. Balance Sheet Highlights: The Company had cash and cash equivalents of $12.17 million as of September 30, 2016, compared with $5.38 million as of December 31, 2015. The increase was primarily due to net cash raised in the sale of common stock, partially offset by cash used in operating activities for the nine months of 2016. Our working capital increased by $8.06 million from $9.48 million as of December 31, 2015 to $17.54 million. In early August 2016, the Company sold 2,300,000 common shares for a total of $13.8 million, which after expenses resulted in approximately $12.5 million in net funds to the Company. Conference Call To participate on the conference call, please dial (877) 407-0778 from the U.S. or (201) 689-8565 from outside the U.S. In addition, following the completion of the call, a telephone replay will be accessible until November 17, 2016 at 11:59 p.m. ET by dialing (877) 481-4010 from the U.S. or (919) 882-2331 from outside the U.S. and entering conference ID: 10129.  The conference call may also be accessed via the internet at http://www.investorcalendar.com/IC/CEPage.asp?ID=175428.  An archive of the webcast will be available for 90 days on the Company's website at www.chembio.com. Those interested in listening to the conference call live via the internet may do so by visiting the Investor Relations section of Chembio's website at www.chembio.com. To listen to the live call, please go to the website 15 minutes prior to its start to register, download, and install the necessary audio software. A replay will be available on the website for a limited time. About Chembio Diagnostics Chembio Diagnostics, Inc. develops, manufactures, licenses and markets proprietary rapid diagnostic tests in the growing $8.0 billion point-of-care testing market. Chembio markets each of its DPP® HIV 1/2 Assay, HIV 1/2 STAT-PAK® Assay, and SURE CHECK® HIV 1/2 Assay, with these Chembio brand names, in the U.S. and internationally both directly and through third-party distributors.  The Company's SURE CHECK® HIV 1/2 Assay previously has been exclusively sold in the U.S. as Clearview® Complete HIV 1/2 Assay. Chembio has developed a patented point-of-care (POC) test platform technology, the Dual Path Platform (DPP®) technology, which has significant advantages over lateral-flow technologies. This technology is providing Chembio with a significant pipeline of business opportunities for the development and manufacture of new products. Headquartered in Medford, NY, Chembio is licensed by the U.S. Food and Drug Administration (FDA) as well as the U.S. Department of Agriculture (USDA), and is certified for the global market under the International Standards Organization (ISO) directive 13485. Chembio Diagnostic Systems, Inc. is a wholly-owned subsidiary of Chembio Diagnostics, Inc. For more information, please visit: www.chembio.com. Forward-Looking Statements Statements contained herein that are not historical facts may be forward-looking statements within the meaning of the Securities Act of 1933, as amended. Forward-looking statements include statements regarding the intent, belief or current expectations of the Company and its management. Such statements, which are estimates only, reflect management's current views, are based on certain assumptions, and involve risks and uncertainties. Actual results, events, or performance may differ materially from the above forward-looking statements due to a number of important factors, and will be dependent upon a variety of factors, including, but not limited to Chembio's ability to obtain additional financing and to obtain regulatory approvals in a timely manner, as well as the demand for Chembio's products. Chembio undertakes no obligation to publicly update these forward-looking statements to reflect events or circumstances that occur after the date hereof or to reflect any change in Chembio's expectations with regard to these forward-looking statements or the occurrence of unanticipated events. Factors that may impact Chembio's success are more fully disclosed in Chembio's most recent public filings with the U.S. Securities and Exchange Commission.


Grant
Agency: Department of Health and Human Services | Branch: | Program: SBIR | Phase: Phase II | Award Amount: 2.43M | Year: 2011

DESCRIPTION (provided by applicant): Tuberculosis is a chronic infectious disease caused by Mycobacterium tuberculosis with an estimated two billion people currently infected worldwide and over nine million new cases detected annually worldwide. This is the largest killer of patients with HIV/AIDS. Current methods of diagnosis are complex, time-consuming, unreliable or unaffordable for most countries where the disease presents a significant public health threat. New diagnostics are critically needed to address the global tuberculosis burden and improve control programs. Our Phase I studies have clearly demonstrated the feasibility of developing a rapid and accurate test for tuberculosis. In collaboration with the Infectious Disease Research Institute, scientists at Chembio Diagnostic Systems, Inc. have identified a set of novel seroreactive antigens, designed several highly performing polyepitope fusion proteins, and applied the selected antigens in the Chembio's innovative immunoassay format, the Dual Path Platform (DPP(R)), with proven high accuracy of rapid serodiagnosis. We found that a DPP test prototype had a sensitivity of 81% and specificity of 95% in evaluations with serum samples obtained from culture-confirmed patients with active pulmonary tuberculosis from endemic regions in Brazil and Indonesia. In this Phase II application we propose to complete development and evaluation of the rapid diagnostic test for tuberculosis which will have required performance and operational characteristics. The specific aims are to: 1) optimize assay design, 2) determine diagnostic test performance, and 3) validate test production protocols in preparation for regulatory approval. We expect that the proposed DPP assay will demonstrate improved sensitivity and specificity over the existing rapid tests and will be applicable for expedited diagnosis of tuberculosis worldwide. PUBLIC HEALTH RELEVANCE: Tuberculosis remains one of the leading causes of mortality due to infectious disease worldwide. The current methods for diagnosis of tuberculosis are time-consuming, complex and laborious, and/or too expensive for routine use in resource-limited settings where most of patients live. The delayed or missed diagnosis leads to spreading of infection, progression of disease,and increased mortality. The research proposed here aims at developing a simple and rapid (20 minutes) point-of-care diagnostic test that would improve control programs by helping accurately detect new cases of tuberculosis, enabling timely antibiotic therapy, and preventing disease transmission. In addition to the visual reading, there will be an option for automated readout of the test result. The proposed assay will be fully validated and evaluated with serum samples from six countries representing various geographical areas and epidemiological setting associated with tuberculosis. These studies will demonstrate superior sensitivity and specificity as well as improved operational characteristics over the existing technologies.


Patent
Chembio Diagnostic Systems, Inc. | Date: 2015-02-25

Test devices are provided for determining the presence of a first ligand in a sample. In some embodiments depletion conjugates are used to deplete the ligands different from but related to the first ligands from the sample. In some embodiments, interim binding agents are used to enhance the test signal.


Patent
Chembio Diagnostic Systems, Inc. | Date: 2015-02-25

Methods are provided for determining the presence of a first ligand in a sample. In some embodiments depletion conjugates are used to deplete the ligands different from but related to the first ligands from the sample. In some embodiments, interim binding agents are used to enhance the test signal.


Grant
Agency: Department of Agriculture | Branch: | Program: SBIR | Phase: Phase II | Award Amount: 599.78K | Year: 2016

Bovine tuberculosis (TB), a zoonotic disease caused by Mycobacterium bovis, continues to plague the cattle industry in the United States (US) and worldwide. Current diagnostic methods are inadequate; therefore, improved tests are urgently needed for disease control/eradication. The goal of the proposed research is to develop a simple, rapid, accurate, animal-side and cost-effective blood test for bovine TB in cattle. The assay will use Chembio proprietary Dual Path Platform (DPP) technology and rationally designed antigens of M. bovis to detect specific antibodies within 20 minutes under field conditions.Phase I studies have demonstrated the technical feasibility of the proposed approach. Several seroreactive antigens were identified which, when combined in our DPP assay, provided a diagnostic accuracy of ~95%. Proposed Phase II work has three technical objectives: 1) develop DPP BovidTB Assay, 2) evaluate test performance, and 3) validate the product in preparation for regulatory approval. Key antigen screening out of >100 novel M. bovis proteins will lead to designing efficient polyepitope fusion reagents for improved antibody detection. The DPP assay will be fully optimized and evaluated with extended panels of well-characterized serum specimens from cattle with confirmed M. bovis infection and from TB-free herds collected in the US, Brazil, the United Kingdom, and South Africa. Large-scale antigen production and DPP product manufacturing protocols will be validated. Portable optical readers will be evaluated to generate accurate quantitative data for objective DPP assay interpretation. Test performance evaluation results will be collected and analyzed to support regulatory submission.Upon successful completion of the Phase II work, Chembio will bring the new product to the US and international markets. The proposed research will be translated into significant commercial applications worldwide. The Chembio manufacturing facility in Medford, NY, is registered with FDA and licensed by USDA. The company has an extensive track record of new diagnostic product commercialization, including DPP VetTB Assay for captive cervids and elephants, and an established network of international distributors. A new blood test with superior performance and practical features will improve bovine TB control/eradication programs. Thus, the proposed research will meet the goals of the USDA Program Priorities and Societal Challenge Areas related to animal production and protection, and it will satisfy the public interest to increase food security and promote exports of agricultural biotechnology.


Grant
Agency: Department of Agriculture | Branch: | Program: SBIR | Phase: Phase I | Award Amount: 99.65K | Year: 2015

Bovine tuberculosis (TB), a zoonotic disease caused by Mycobacterium bovis, continues to plague the cattle industry in the United States (US) and worldwide. Current diagnostic methods are inadequate; therefore, improved tests are urgently needed for disease control/eradication. The goal of the proposed research is to develop a simple, rapid, accurate, and cost-effective blood test for bovine TB in cattle. The assay will use proprietary Dual Path Platform (DPP) technology and rationally selected antigens of M. bovis to detect specific antibodies animal-side within 15-20 minutes under field conditions.Phase I has two technical objectives: 1) identify key antigens, and 2) develop a DPP test prototype. Novel M. bovis antigens will be screened out of a large panel of recombinant candidates using serum samples from M. bovis-inoculated cattle. Novel polyepitope fusions will be designed for highly sensitive multi-antigen cocktails providing >90% serodiagnostic accuracy. DPP test prototype will be evaluated with extended panels of well-characterized serum samples. Phase II studies will focus on product development, validation, and field evaluation in preparation for regulatory approval.The proposed research will be translated into significant commercial applications. The Chembio manufacturing facility in Medford, NY, is registered with FDA and licensed by USDA. The company has an extensive track record of new diagnostic product commercialization and an established network of international distributors. A new blood test with superior performance and practical features will improve bovine TB control/eradication programs. Thus, the proposed research will meet the goals of the USDA Program Priorities and Societal Challenge Areas related to animal production and protection, and it will satisfy the public interest to increase food security and promote exports of agricultural biotechnology.


Patent
Chembio Diagnostic Systems, Inc. | Date: 2015-03-02

A test device for use with a liquid solution includes a housing that houses a plurality of sorbent strips. At least one strip has a location for receiving the solution. The housing defines at least an opening in said housing wherein said opening is aligned with the location for receiving the solution. The device includes a sealed reservoir filled with the liquid solution, the sealed reservoir being disposed in alignment with the opening and coupled to the housing. The device includes an opener coupled to the housing. The opener is arranged to rotate from a first position, in which the opener is not in contact with the sealed reservoir, to a second position, in which the opener causes the sealed reservoir to effect a release of the solution from the reservoir and into the opening and onto the sorbent strip housed within the housing.


Patent
Chembio Diagnostic Systems, Inc. | Date: 2014-10-27

A single-use multiplex, or assay, screening test for the detection of one or more of a plurality of unrelated febrile illnesses is provided. The febrile illnesses for which the test is designed are unrelated, in that the illnesses may be caused, by way of example, by infection from viruses, bacterium and/or parasites; by infection from viruses, bacterium, parasites or other contagions that are animal borne; by infection from viruses, bacterium, parasites, or other contagions that can be aerosolized for transmission; by infection from viruses, bacterium, parasites or other contagions that are transmitted from direct contact; by infection from viruses, bacterium, parasites or other contagions that are generally transmitted in the tropics and/or subtropics; and/or by infection from a virus, bacteria, parasite sharing one or more related feature and which causes a febrile illness. The assay test provides rapid results to a point of care center or other facility requiring such results to facilitate treatment and or containment of the illnesses.

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