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| HUMAN PRODUCTS | VETERINARY PRODUCTS | NEW TECHNOLOGIES |
| Diagnostic Products for Humans: |
| HIV1/2 STAT-PAK® ASSAY | HIV 1/2 STAT-PAK® DIPSTICK | HIV1/2 SURE CHECK® | SICKLE-STAT | TB STAT-PAK®II |
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Chagas STAT-PAK® Assay
Product Information
Recognized as one of the world’s neglected diseases, Chagas is a major public health concern in Latin America and is a growing concern in the United States and regions of Europe as the number of infected immigrants increase. It is estimated that 16 to 18 million people are infected with the disease with nearly 100 million people at risk in 21 countries. This includes approximately 25% of the population of Latin America. An estimated 50,000 deaths occur annually. In Latin America, an estimated 65 million people inhabit endemic areas where there is risk of infection. Approximately 15 to 20 million inhabitants of rural and urban areas are thought to be infected with T. cruzi.
Chagas is transmitted by Trypanosoma cruzi, a protozoan parasite of the hematophagous triatomine insect. Infection occurs when the insect bites its mammalian host and releases infective trypomastigotes in its excreta while feeding. Alternatively, infection can occur through blood transfusions, organ transplantation, ingestion of contaminated food and congenitally. Prevalence of congenital infection is 10% in children born to chagastic mothers.
The disease manifests itself in stages. The initial acute phase may cause illness and death, especially in young children. However, more commonly, 90% of infected individuals enter the chronic stage of infection that may last several months to years. Among them about 30% are characterized by cardiomyopathy and/or megasyndromes involving the esophagus or colon. The leading manifestation of chagas is chronic myocarditis resulting in high morbidity and mortality.
Treatment administered during the acute stage of infection is usually effective. Once Chagas has progressed to the chronic stage, there is no effective treatment. Therefore, early detection and treatment, especially in young children, can have a significant impact on both patient outcome and health care costs.
The incidence of Chagas is highest in rural areas where some serological tests (ELISA, PCR, IHA and IFA) are impractical to perform due to requirements for specialized instrumentation, cold storage and interpretation by a trained clinician.
Recombinant antigens provide a convenient tool to improve current methods of serological diagnosis of chagas disease. Several assays such as immunofluorescence, hemagglutination, complementation fixation, radioimmunoassay and ELISA are available for diagnosis. However, these assays may be impractical to perform in rural areas due to requirements for laboratory instrumentation to perform or interpret the tests. Most also require cold storage.
Chembio Diagnostic Systems, Inc.’s Chagas STAT-PAK® rapid assay is easy-to-perform, requires no cold chain storage, uses a minimal sample size and provides visual detection of antibodies to T. cruzi.
Convenient & Cost Effective
- Ideally suited for field and point-of-care testing
- Minimal sample size required—10 µl whole blood, 5 µl serum or plasma
- Room temperature storage
- Long shelf life
Time & Labor Saving
- Simple, two-step procedure
- Total test time of 15 minutes
- No special equipment required
Reliable Results
- Built-in IgG procedural control
- Highly sensitive and specific
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Chagas STAT-PAK Assay |
20 Tests |
CG101 |
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HIV 1 /2 STAT-PAK® Assay |
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HIV 1 /2 STAT-PAK® Dipstick Assay |
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| HIV 1 /2 STAT-PAK® Dipstick Assay |
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SURE CHECK® HIV 1/ 2 Assay |
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HIV 1 /2 STAT-PAK® Assay
HIV 1 /2 STAT-PAK® Dipstick Assay
SURE CHECK® HIV 1/ 2 Assay
Product Information
By the end of 2005 there were approximately 40.3 million people living with HIV/AIDS including 17.5 million women and 2.3 million children under the age of 15. Nearly 5 million people were newly infected with HIV/AIDS. In the same year, 3.1 million people died of HIV/AIDS-related causes.
HIV/AIDS is caused by infection with Human Immunodeficiency Virus, HIV 1 or HIV 2. HIV 1 is the most frequently found strain worldwide. Infection with HIV 2 is found primarily in West Africa, although infections have been identified in other areas of the world.
HIV is spread by sexual contact with an infected person, by sharing needles and/or syringes (primarily for drug injection) with someone who is infected, or, less commonly (and now very rarely in countries where blood is screened for HIV antibodies), through transfusions of infected blood or blood clotting factors. Babies born to HIV infected women may become infected before or during birth or through breast-feeding after birth. Patients with HIV/AIDS and HIV/AIDS related diseases usually have a high level of the antibody to the viruses.
 The standard screening test for antibodies to HIV is the enzyme immunoassay (EIA) or ELISA which is widely used in the United States and around the world. This test requires two visits to a clinic or medical facility; one to receive pretest counseling and to have blood drawn for HIV testing, and the second to receive test results and additional counseling and if needed referrals. Rapid, point-of-care (POC) tests have been developed which produce results within 20 minutes or less and allows testing, counseling and referrals to be accomplished in one visit. Rapid tests are less costly for testing agencies to perform due to the fewer outreach visits required to deliver results. Patients receive counseling, test results and referrals (if warranted) in one visit. Also, studies have shown that rapid tests are as sensitive and specific as conventional immunoassays.
Chembio Diagnostic Systems, Inc.’s SURE CHECK® HIV 1 / 2, HIV 1/ 2 STAT-PAK® and HIV 1/ 2 STAT-PAK® Dipstick tests are easy-to-perform, single-use diagnostic tests for the rapid, visual detection of antibodies to HIV 1 and HIV 2.
Assay Features
Convenient & Cost Effective
- Ideally suited for field and point-of-care testing
- Minimal sample size required—5 µl (assay dependent) fingerstick orvenous whole blood, serum or plasma
- Room temperature storage
- Long shelf life
- No special laboratory equipment required
Time & Labor Saving
- Ready-to-Use Reagents
- Simple procedure
- Total test time of 10 to 15 minutes (assay dependent)
- No special equipment required
- Results are easy to interpret
Reliable Results
- Built-in IgG procedural control
- Highly sensitive and specific
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HIV 1 /2 STAT-PAK® Assay |
20 Tests |
HIV101 |
PDF |
PDF
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View Video |
| HIV 1 /2 STAT-PAK® Assay—FDA Approved |
20 Tests |
HIV102 |
PDF |
PDF
(coming Soon) |
View Video |
| HIV Rapid Test Control Pack |
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HIV104 |
PDF |
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HIV 1 /2 STAT-PAK® Dipstick Assay |
30 Tests |
HIV302 |
PDF |
PDF
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View Video |
| HIV 1 /2 STAT-PAK® Dipstick Assay |
30 Tests |
HIV303 |
PDF |
PDF |
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Disposable Rack |
30 Wells |
10-6048-0 |
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Test Tubes, 1 ml |
30 Tubes |
1-2012-0 |
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SURE CHECK® HIV 1/ 2 Assay |
25 Tests |
HIV201 |
PDF |
PDF
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View Video |
| SURE CHECK® HIV 1/ 2 Assay—FDA Approved |
25 Tests |
HIV202 |
PDF |
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View Video |
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Sickle-STAT
Sickle-STAT Hemoglobin Controls
Product Information
Sickle cell disease is an inherited blood disorder that is defined by the presence of hemoglobin S which occurs in either the homozygous (SS-sickle cell anemia) or heterozygous (AS-sickle cell trait) forms. The disease is characterized by chronic anemia, painful events and various complications associated with tissue and organ damage. The most common and well-known type of sickle cell disease is sickle cell anemia, also called SS disease which can be fatal prior to adolescence if not diagnosed. All types of sickle cell disease are caused by a genetic change in hemoglobin--the oxygen-carrying protein inside the red blood cells. The red blood cells of affected individuals contain a predominance of a structural variant of the usual adult hemoglobin (A). This variant hemoglobin, called sickle hemoglobin, has a tendency to polymerize into rod-like structures that alter the shape of red blood cells. The cells have a sickle shape and a shorter life span (10 to 20 days) than normally shaped red blood cells (120 days). This results in chronic anemia characterized by low levels of hemoglobin and decreased numbers of red blood cells. Sickle cells are also less flexible and more sticky than normal red blood cells and can become trapped in small blood vessels preventing blood flow. This compromises the delivery of oxygen which can result in pain and damage to associated tissues and organs. Carriers of the sickle cell gene are said to have sickle cell trait (AS). Unlike sickle cell disease, sickle cell trait does not cause health problems. However, persons with sickle cell trait can pass the gene to their children. Therefore, it is extremely important to test for hemoglobin SS (sickle cell disease) and AS (sickle cell trait) in high risk individuals so that these individuals can be identified and the resultant consequences of the disease reduced.
The prevalence of sickle cell disease (SS) in the United States is 0.2% among African Americans and 0.1% among Hispanic Americans. The prevalence of sickle cell trait (AS) is 10% among African Americans. Internationally the disease is most frequently found in sub-Saharan Africa. However, it is also found in regions of Sicily, Greece, southern Turkey, and India. Early diagnosis of sickle cell anemia is very important so that children who have the disease can receive proper treatment. Forty-four (44) States, the District of Columbia, Puerto Rico, and the Virgin Islands currently screen all newborns for sickle cell anemia. Screening is available by request in the other six (6) States. This screening includes a simple blood test for sickle cell anemia on all newborn infants and uses blood from the same blood samples as other routine newborn screening tests. If the first test shows that the sickle hemoglobin is present, a second blood test is done to confirm the diagnosis. These tests also tell whether the child carries the sickle cell trait.
The Chembio Sickle-STAT assay is a qualitative screening test for the detection of hemoglobin S in blood samples. The test is used in conjunction with other criteria for the diagnosis of sickle cell disease. |
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| Sickle-STAT Assay |
48 Tests |
SC901 |
PDF |
| Sickle-STAT Hemoglobin Controls |
4 x 1 ml vials |
SC903 |
PDF
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TB STAT-PAK® II
Product Information
Globally, tuberculosis (TB) causes more human deaths than any other single infectious disease, with approximately 95% of cases and 98% of deaths occurring in the developing world. It is estimated that over 2 billion people are infected with the M. tuberculosis bacterium, which is equal to one-third of the world’s population. TB is a chronic bacterial infection that is spread in humans through the air and usually infects the lungs, although other organs are sometimes involved. Most persons who are infected with TB are asymptomatic (i.e., latent TB), with a relatively small percentage subsequently developing symptoms of the disease – i.e., active TB. The World Health Organization (WHO) estimates that each year another 8 million people worldwide will develop active TB. Mortality is estimated at 3 million annually.
M. tuberculosis is the primary etiologic agent of TB in humans. In addition to humans, a broad range of animal species are susceptible to TB, usually resultant from infection with M. bovis. Though more rarely isolated in humans, the bacterium M. bovis is responsible for tuberculosis in domestic ungulates (e.g., cattle, goats, sheep, etc.) as well as wild animals (e.g., deer, elk, badgers, possums) and captive exotic animals (e.g., elephants, giraffes, and camels, among others). Humans infected with M. bovis who subsequently go on to develop TB exhibit clinical symptoms indistinguishable from M. tuberculosis-infected TB, the pathogeneses of which are identical. While animal-to-human M. bovis infection is well documented, evidence of human-to-human transmission of M. bovis is limited and largely anecdotal. In infected populations, M. bovis shows a high degree of virulence for both humans and animals.
The WHO estimates that human TB morbidity and mortality for the 1990’s was 88 million and 30 million, respectively, with similar predictions for the current decade unless policies and practices in detection and treatment are dramatically altered. Most cases of TB occur in developing countries, 22 of which (mostly in Southeast Asia and Africa) have been designated “high prevalence endemic countries”.
The economic effects of TB are devastating, both for individuals and communities. The disease tends to strike individuals in their most productive years of 15-50. The adverse financial impact due to the potential loss of family income coupled with the expense of transportation to get to often distant health facilities for treatment and the cost of administering and monitoring TB for 6-9 months of daily therapy (i.e., DOTS) all conspire against both the macro-economy (i.e., society as a whole) as well as the micro-economy (i.e., family or individual) of those developing countries least able to afford it. Yet with the right treatment TB can be cured for less than US$20 per patient. The worldwide annual cost of TB control is estimated to be $4 Billion.
As a highly contagious, air-borne disease, transmission of TB usually results from close or casual contact with infected persons. When an infected person sneezes, coughs, spits, or talks they disseminate TB microorganisms that can be inhaled. Once introduced into the lungs, TB is able to avoid being destroyed by the body’s macrophages or granulomas – specialized cells of the immune system that destroy many bacteria, viruses, and other foreign bodies. As a result, the bacteria are able to spread throughout the newly infected person’s body, multiply, survive, and remain dormant for years. This stage of TB is called Latent TB. Active TB occurs when the bacteria infiltrate organ systems, the most common being the lungs (pulmonary TB). Clinical symptoms of TB include severe coughing, chest pain, blood in the sputum, acute weight loss, fever, and chronic fatigue.
TB and HIV interact perniciously, especially in sub-Saharan Africa where in some countries it is estimated that more than 50% of the population is infected with HIV. Because HIV weakens the body’s immune system, persons with latent TB who are also HIV reactive are at significantly greater risk of converting to active TB than their HIV nonreactive counterparts. In these areas of the world, TB has become the leading cause of death among people with HIV/AIDS.
Despite the importance of TB as a global public health problem, diagnosis and treatment of the disease, while effective, still relies on highly inaccurate diagnostic procedures that are more than 100 years old. Currently, a diagnosis of TB most often relies on Acid Fast Bacillus (AFB) smear technology from multiple sputum samples, developed by Robert Koch in 1882. However, this test may not detect as many as 50% of TB cases. Use of culture technology is slow (taking 3-4 weeks or longer) and not readily available in large areas of the developing world. Additionally, its cost is generally prohibitive in most cases. Reliance on X-Ray technology is highly insensitive as the technology can’t differentiate TB from Cancer or other pneumonias. Newer technologies are on the horizon, but they are both technologically demanding and expensive.
Alternative technologies that may supplement smear screening and increase the overall detection rate of TB include serological tests. CHEMBIO Diagnostic Systems, Inc. is developing such an assay that is rapid, easy to use, doesn’t require sophisticated equipment (can be used by most technicians in remote rural clinic settings), and augments the accuracy of more traditional test strategies.
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HUMAN DIAGNOSTICS PRODUCTS :
ANIMAL / VETERINARY DIAGNOSTICS PRODUCTS
NEW TECHNOLOGIES
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