Adenoviruses have been implicated in a wide range of clinical diseases affecting mainly the respiratory, ocular and the gastrointestinal systems of the human. Respiratory illnesses include the acute febrile pharyngitis, pharyngoconjuctival fever, pneumonia and the acute respiratory disease. Ocular adenoviral infections have three basic modes of presentation: epidemic keratoconjuctivitis, pharyngoconjuctival fever and nonspecific follicular conjunctivitis.  In addition, some adenoviruses are enteric and have emerged as a major source of pediatric gastroenteritis.

There are 41 known human adenoviruses, differentiated primarily by serological and DNA analysis. Many serotypes are known to cause specific syndromes in humans. Morphologically, the adenoviruses are non-enveloped icosahedral structures about 80 nm in diameter. The antibodies used in this test utilize the recognition of group specific antigens present in the 41 types of adenoviruses.

The antibodies we use in the kit react with the following serotypes:1, 2, 3, 4, 5, 6, 7, 8,  9, 10, 11, 12, 14, 16, 18, 19, 20, 26, 31, 34, 35, 36, 37, 40 and 41. The antibodies haven't been tested against the other serotypes, but there is no particular reason to think that they would not be recognized as well.

The One Step AdenoStick 1-Step Test (Cat. No R-5188) is a rapid test for the qualitative detection of various adenovirus types present in eye swabs, nasal and pharyngeal secretions, fecal material and cell culture supernatant. This test is for professional use.

Latex agglutination tests are very popular in clinical laboratories. These tests have been applied to the detection of over 100 infectious diseases, and many other applications are currently available.

The first description of a test based in latex agglutination was the Rheumatoid Factor Test proposed by Singer and Plotz in 1956. Since then, tests to detect microbial and viral infections, autoimmune diseases, hormones, drugs and serum proteins have been developed and marketed by many companies worldwide. New latex applications and technologies are still being devised and applied to new analyses.

In latex agglutination procedures, an antibody (or antigen) coates the surface of latex particles (sensitized latex). When a sample containing the specific antigen (or antibody) is mixed with the milky-appearing sensitized latex, it causes visible agglutination.

The degree of agglutination plotted as a function of agglutinant concentration follows a bell-shape curve similar to the precipitin one. Latex particles are used to magnify the antigen - antibody complex.

Many of the latex agglutination tests developed are performed manually and the agglutination is detected by visual observation.

Although quite useful in the laboratory and cheap due to the absence of equipment needs, these manual assays suffer from lack of consistency in endpoint readouts. It has been established that about 100 clumps must be seen to determine agglutination, and that these clumps must be of about 50 pm in size to be seen by eye.

Respiratory syncytial virus (RSV) is the most important cause of pneumonia and bronchiolitis in infants and small children. RSV causes a range of respiratory illness, the most common being a cold with profuse rhinorrhea. Of infants infected for the first time, 25-40% develops some lower respiratory tract disease. Between 1 and 2% of infected infants require hospitalization. Because of its high infectivity and because hospital staff as well as patients are susceptible, RSV has emerged as the most frequent cause of nosocomial infections on pediatric wards. RSV belongs to the family Paramyxoviridae and the genus Pneumovirus. It is morphologically similar to other paramyxoviruses with the exception that the diameter of its helical nucleocapsid is smaller, 13 to 14 nm rather than 18 nm. RSV is an antigenically heterogeneous species, with strain differences, which are due primarily to differences in one of the two antigenically active surface components. These differences between strains are probably of little or no practical importance from a diagnostic point of view, since available reagents, including monoclonal antibodies, react equally with all clinical isolates.

The One Step RSVStick Assay (Catalog Number R-5198) is a rapid immunochromatographic test for use in the qualitative screening of human nasopharyngeal samples for detection of the presence of respiratory syncytial virus (RSV) antigen.

Helicobacter pylori are gram-negative bacteria that infect gastric mucosa. Infection with H. pylori may lead to chronic gastritis and predispose to gastric and duodenal ulcers. Infection with H. pylori is very common and has been estimated to occur in 40-50% of the population in developed countries and 80-90% of the population in developing regions.

The One-Step H. pylori Fecal Antigen Assay (Cat.No. R-5180) is a rapid, visual immunochromatographic assay for the qualitative detection of Helicobacter pylori antigen in fecal samples. This test is intended as an aid in the diagnosis of H. pylori infection, and is recommended for professional use.

Rotaviruses are one of the major causes of pediatric gastroenteritis and diarrhea. Untreated, rotavirus infection may result in severe illness with dehydration and disturbances of the body's normal electrolyte balance, especially in babies and preschool children. Rotavirus is the cause of up to 50% of the hospitalized cases of diarrheal illness in infants and young children. Rotavirus induced dehydration is a major cause of infant morbidity in both developed and underdeveloped countries, and a major cause of infant mortality in the latter regions. 

The highest prevalence of the disease is experienced in temperate climates during the cooler months of the year. In tropical climates rotavirus infection can occur year round. The age groups most susceptible to the disease are that of infants and children.

Adenoviruses have been implicated in a wide range of clinical diseases affecting mainly the respiratory, ocular and the gastrointestinal systems of the human. Some adenovirus serotypes are enteric and have emerged as a major source of pediatric gastroenteritis.

Diagnosis of rotavirus and adenovirus gastroenteritis is based on the identification of virus particles in the feces. These particles, shed in large numbers during infection, may be observed by electron microscopy (EM) or detected by immunological methods, such as the immunochromatographic method used in the Rota/Adeno CombiStick assay.

 The One Step Rota/Adeno CombiStick (Cat. No. R-5192) is a rapid immunochromatographic test for use in the qualitative screening of human fecal samples for detection of the presence of rotavirus or adenovirus antigen.

Rotaviruses are one of the major causes of pediatric gastroenteritis and diarrhea. Untreated, rotavirus infection may result in severe illness with dehydration and disturbances of the body's normal electrolyte balance, especially in babies and preschool children. 

Rotavirus is the cause of up to 50% of the hospitalized cases of diarrheal illness in infants and young children. Rotavirus induced dehydration is a major cause of infant morbidity in both developed and underdeveloped countries, and a major cause of infant mortality in the latter regions (up to 4% per year). 

The highest prevalence of the disease is experienced in temperate climates during the cooler months of the year. In tropical climates rotavirus infection can occur year round. The age groups most susceptible to the disease are that of infants and children and geriatric patients.

Diagnosis of rotavirus gastroenteritis is based on the identification of rotavirus particles in the feces. These particles, shed in large numbers during infection, may be observed by electron microscopy (EM) or detected by immunological methods, such as the immunochromatographic method used in the RotaStick assay.

The One Step RotaStick (Cat.No.R-5178) is a rapid immunochromatographic test for use in the qualitative screening of human fecal samples for detection of the presence of rotavirus antigen.

One-Step Test for Direct Determination of Group A Streptococcus

Among the beta-hemolytic streptococci causing infections in humans, the A, B, C and G groups figure most prominently. Group A streptococci continue to be a focus of interest not only because of their causal role in acute streptococcal pharyngitis and other pyogenic infections but also because of their association with post streptococcal sequelae, specifically acute rheumatic fever and acute glomerulonephritis. In order to properly treat the disease using antibiotic therapy, it is important to use an accurate diagnostic method to identify the pathologic agent. For the screening of group A streptococcal infection several methods are currently used including susceptibility of the organism to a bacitracin disc placed on a sheep blood agar plate, latex agglutination and enzyme immunoassay.

The One Step StrepAStick (Throat Swab) Assay is a rapid test to qualitatively detect the presence of Strep A antigen in throat swab specimens, providing results within 5 minutes. The test utilizes antibodies specific for whole cell Lancefield Group A Streptococcus to selectively detect Strep A antigen in a throat swab specimen.

Group B streptococci are most notable for their role in causing neonatal sepsis and meningitis. Two forms of neonatal infection have been recognized on clinical and epidemiological grounds:

(a) Early onset disease, which usually occurs within the first 10 days after delivery.

(b) Late onset disease, which usually, though not always, occurs 10 days after birth. Late onset disease may be due to nosocomial acquisition of the organism and is rarely associated with material or obstetric complications. Early onset disease is thought to be due to acquisition, perhaps by aspiration, of the organism from the mother's genital tract at the time of delivery. The incidence of Group B Streptococci range from 1 to 5% of live births with mortality rates from 22 to 80%.  In order to properly treat the disease using antibiotic therapy, it is important to use an accurate diagnostic method to identify the pathologic agent. Different methods are currently used for detection of Group B Streptococci including cellular culture, immunofluorescence, enzyme immunoassay, or latex agglutination.

The One Step Strep B Stick test (Cat. No. R-6015) is a rapid qualitative one step assay for the detection of Streptococcus Group B antigen from vagina swab specimens.

Tuberculosis (TB) remains an important socio-economical and medical problem throughout the world. In 1995, more people died of tuberculosis in the world than of any other infectious disease. According to the Centre for Disease Control, the incidence of TB is expected to increase from 7.5 million cases per year in 1995 to 11.9 million in 2005. The case fatality rate is estimated at 55% for untreated people and 15% for the treated patients.

The commonly used diagnostic tests for the tuberculosis such as sputum examination of acid fast bacilli, culture of sputum or other fluids, the tuberculin skin test and radiological investigations do not achieve the required diagnostic sensitivity.

Actually, the best assets for clinical and epidemiological work in the diagnosis of tuberculosis are serological tests such as haemagglutination, complement fixation, immunofluorescence, ELISA and radioimmunodiffusion techniques. But the highly qualified technicians and expensive material needed to perform tuberculosis tests using the above methods are a serious limitation in non developed countries.

 The One Step TB Antibody One-step Test (Cat.No.R-6017) is a rapid qualitative screening test for the detection of human antibodies to Koch's bacillus in serum, plasma, or whole blood. The test is able to specifically detect antibodies from patient in active phase of the disease. Samples from vaccinated people will not react with Novamed's TB Antibody One-step Test.

Human chorionic gonadotropin (hCG) is a glycoprotein hormone produced by the developing placenta shortly after fertilization. In normal pregnancy, hCG can be detected in both urine and serum as early as 7 to 10 days after conception. hCG levels continue to rise very rapidly, frequently exceeding 100 mIU/mL by the first missed menstrual period, and peaking in the 100,000-200,000 mIU/mL range about 10-12 weeks into pregnancy. The appearance of hCG in both urine and serum soon after conception, and its subsequent rapid rise in concentration during early gestational growth, make it an excellent marker for the early detection of pregnancy.

The One Step hCG One Step Pregnancy Test Device (Urine/Serum) is a rapid test that qualitatively detects the presence of hCG in urine or serum specimens at the sensitivity of 10 mIU/mL. The test utilizes a combination of monoclonal and polyclonal antibodies to selectively detect elevated levels of hCG in urine or serum. At the level of claimed sensitivity, the hCG One Step Pregnancy Test Device shows no crossreactivity interference from the structurally related glycoprotein hormones hFSH, hLH and hTSH at high physiological levels.

Novamed's hCG Pregnancy Test Device (Urine/Serum) is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine or serum to aid in the early detection of pregnancy. Two different formats of hCG Pregnancy Test Device (Urine/Serum) are available: Cat.No.R-6012-U with the cut off of 10 mIU/ml and Cat.No.R-6012 with the cut off of 25 mIU/ml.