Answering your daily challenges in ASO detection Anti-Streptolysin O rheumajet ASO I NFECTIOU S DI SEASES
I N F E C T I O U S D I S E A S E S Anti-streptolysin O Anti-Streptolysin O (ASO) antibodies appear against an exotoxin produced by the Group A Beta-hemolytic Streptococcus. An infection with Beta-hemolytic streptococcus usually causes an acute infection of throat and skin, but non treated infections can become chronic, generating glomerulonephritis, pericarditis or rheumatic fever. Diagnosis Diagnosis of Group A Beta-hemolytic Streptococcus does not predict whether complications will occur following a Streptococcus infection, but a correct diagnosis allows antibiotic treatment, avoiding possible chronic effects. Intended Use rheumajet ASO is a latex where the latex particles in suspension are coated with the ASO antigen. Positive samples, containing abnormally high levels of anti-streptolysin-o, will react against the latex particles, and agglutination will be visible. Performance The test has a high sensitivity, detecting positive samples with 200 IU/ml of anti-streptolysin O. Semiquantitative tests can be performed to calculate the antibody titer, expressing the result in IU/ml of anti-streptolysin O, based on the WHO International Standards. Main features Product name Method Assay Format Coating Sample Type Sample Volume Assay time rheumajet ASO Latex agglutination Qualitative / Semiquantitative Recombinant Streptolysin-O proteins Serum 50 µl 2 min Ordering Information rheumajet ASO 100 Tests Cod. 3000-7010 T3100-9701 R01 MAY-2016 Living Immunoassay Excellence
Answering your daily challenges in Rheumatoid arthritis diagnosis Rheumatoid Factor rheumajet RF I NFECTIOU S DI SEASES
I N F E C T I O U S D I S E A S E S Rheumatoid arthritis Rheumatoid arthritis (RA) is a common systemic autoimmune disease affecting up to 2% of the general population. Rheumatoid arthritis occurs when your immune system attacks the synovium, the lining of the membranes that surround the joints. In some people, the condition also can damage a wide variety of body systems, including the skin, eyes, lungs, heart and blood vessels. The resulting inflammation thickens the synovium, which can eventually destroy the cartilage and bone within the joint.it is characterized by chronic joint inflammation and destruction of bone and cartilage that produces joint pain and reduction of motility. Diagnosis Rheumatoid arthritis can be difficult to diagnose in its early stages because the early signs and symptoms mimic those of many other diseases. Diagnosis of reumathoid arthritis is based in the detection of Rheumatoid factor (RF), an autoantibody that recognises the Fc portion of all the IgG. During the disease, the rheumatoid factor are present in high levels and react against other antibodies. The immunocomplexes can precipitate in the joints, contributing to the disease process.. A variety of tests are available for the determination of RF, being agglutinations the most widely used. Intended Use rheumajet RF is a latex where the latex particles in suspension are coated with human IgG antibodies exposing the Fc portion. Positive samples, containing abnormally high levels of RF, will react against the latex particles, and agglutination will be visible. Performance rheumajet RF has a high sensitivity, detecting positive samples with 10 IU/ml of rheumatoid factor. Semiquantitative tests can be performed to calculate the analyte concentration, and the results are expressed in IU/ml of RT, based on the WHO International Standards Main features Product name Method Assay Format Coating Sample Type Sample Volume Assay time rheumajet RF Latex agglutination Qualitative / Semiquantitative Human IgG Serum 50 µl 2 min Ordering Information rheumajet RF 100 Tests Cod. 3000-7033 T3100-9702 R01 MAY-2016 Living Immunoassay Excellence
Answering your daily challenges in CRP detection C-Reactive Protein rheumajet CRP I NFECTIOU S DI SEASES
I N F E C T I O U S D I S E A S E S C-Reactive Protein C-Reactive Protein (CRP) is a positive protein in acute phase of inflammatory processes. The increase of CRP occurs in a non-specific way in different kinds of tissular aggressions, as for example in infectious states, rheumatic fever, rheumatoid arthritis, myocardic infarct, malignant tumour, abdominal abscess, peritonitis or burns. Diagnosis A high CRP concentration in serum lacks diagnostic value when the patient illness is not defined. Nevertheless, it is very useful for following-up and monitoring inflammatory processes, as well as for making differential diagnosis in certain cases. Intended Use rheumajet CRP is a latex where the latex particles in suspension are coated with the IgG fraction of anti-human CRP. Positive samples, containing highly abnormal concentration of CRP, are visible due to the latex agglutination. Performance rheumajet CRP has a very good sensitivity, and can detect positive samples with a cut-off of 6 mg/l of CRP in serum. Semiquantitative tests can be done to calculate the concentration of CRP. The results are expressed in mg/l of CRP based on the International Reference Material for Measurement. Main features Product name Method Assay Format Coating Sample Type Sample Volume Assay time rheumajet CRP Latex agglutination Qualitative / Semiquantitative IgG fraction of anti-human CRP Serum 50 µl 2 min Ordering Information rheumajet CRP 100 Tests Cod. 3000-7051 T3100-9703 R01 MAY-2016 Living Immunoassay Excellence
Answering your daily challenges in Rheumatoid arthritis diagnosis Rheumatoid Factor celarkit AR I NFECTIOU S DI SEASES
I N F E C T I O U S D I S E A S E S Rheumatoid arthritis Rheumatoid arthritis (RA) is a common systemic autoimmune disease affecting up to 2% of the general Rheumatoid arthritis occurs when your immune system attacks the synovium the lining of the membranes that surround the joints. In some people, the condition also can damage a wide variety of body systems, including the skin, eyes, lungs, heart and blood vessels. The resulting inflammation thickens the synovium, which can eventually destroy the cartilage and bone within the joint. It is characterized by chronic joint inflammation and destruction of bone and cartilage that produces joint pain and reduction of motility. Diagnosis Diagnosis of RA is based in the detection of Rheumatoid factor (RF), an autoantibody that recognises the Fc portion of all the IgG. When reacting, the antibody immunocomplex precipitates and contributes in the disease progression. A variety of tests are available for the determination of RF, being agglutinations the most widely used. Intended Use celarkit AR is a hemagglutination test where the reagent is a suspension of sheep reed blood cells stabilized and sensitized with rabbit gammaglobulins. Gammaglobulins expose the Fc fraction that will react and agglutinate in presence of RF in the serum Performance The test has a high sensitivity, detecting positive samples with 5 IU/ml of rheumatoid factor. Semiquantitative tests can be performed to calculate the analyte concentration, and the results are expressed in IU/ml of RT, based on the WHO International Standards. Main features Product name Method Assay Format Coating Sample Type Sample Volume Assay time celarkit AR Hemagglutination Qualitative / Semiquantitative Rabbit gammaglobulin Serum 50 µl 2 min Ordering Information celarkit AR 50 Tests Cod. 3000-1020 T3100-9704 R01 MAY-2016 Living Immunoassay Excellence
Answering your daily challenges in Syphillis diagnosis Treponema pallidum RPR reditest I NFECTIOU S DI SEASES
Syphillis I N F E C T I O U S D I S E A S E S Syphilis is believed to have infected 12 million people in 1999 with greater than 90% of cases in the developing world. It affects between 700,000 and 1.6 million pregnancies a year resulting in spontaneous abortions, stillbirths, and congenital syphilis. The global prevalence was estimated in around 36.4 million people in 2008. Caused by the bacterium Treponema pallidum, syphilis is commonly acquired as an STD, but it also can be transmitted vertically by expectant mothers. Routine maternal screening and treatment for syphilis is critical to avoid serious perinatal consequences. Without screening around 69% of vertical transmissions result in adverse outcomes. Screening may reduce mortality attributable to congenital syphilis by up to 50%. Diagnosis Diagnosis of syphilis can be done through the identification of specific antibodies against Treponema pallidum (treponemal test) or the detection of heterophile antibodies produced during Treponema pallidum active infection (nontreponemal test). Even most laboratories use treponemal tests as a initial test screening, nontreponemal tests are essencial to differenciate between past or present syphilis, and only positive patients for nontreponemal test will be treated. Non-treponemal tests detect heterophile antibodies produced during Treponema pallidum infection, that even they are not specific for treponema antigens, are always related to an active syphilis disease. Nontreponemal + TPHA or other treponemal test TPHA + syphilis likely Traditional algorithm Nontreponemal test, e.g. RPR Nontreponemal -syphilis unlikely but retest if early syphilis suspected TPHA - syphilis unlikely EIA/CLIA+ Reverse sequencial algorithm EIA or CLIA Nontreponemal test, e.g. RPR EIA/CLIA - syphilis unlikely but retest if early syphilis suspected Nontreponemal+ Syphilis likely Nontreponemal - TPHA or other treponemal test TPHA + syphilis likely TPHA - syphilis unlikely Intended Use RPR reditest is a nontreponemal test for the rapid detection of syphilis.the reagent is based in a cardiolipin suspension that are detected by reagines (heterophiles antibodies) present in a positive sample. When the reaction antigen-antibody take place, the charcoal particles present in the reagent start a flocculation process together with the antigen-antibody complexes, allowing visual reading. T3100-9705 R01 MAY-2016 Performance Compared with the standard RPR and the VDRL test from Centre for Disease Control, RPR reditest has demonstrated 92.3% sensitivity and 99.3% specificity in serum samples and 100% sensitivity and 99.4% specificity in plasma samples. Main features Product name Method Assay Format Coating Sample Type Sample Volume Assay time Ordering Information Living Immunoassay Excellence RPR reditest Charcoal flocculation Qualitative / Semiquantitative Cardiolipin Serum / Plasma 50 µl 8 min RPR reditest 100 Tests Cod. 3000-5511 RPR reditest 500 Tests Cod. 3000-5550
Answering your daily challenges in Syphillis diagnosis Treponema pallidum syphagen TPHA syphagen TPHA AUTO I NFECTIOU S DI SEASES
Syphillis I N F E C T I O U S D I S E A S E S Syphilis is believed to have infected 12 million people in 1999 with greater than 90% of cases in the developing world. It affects between 700,000 and 1.6 million pregnancies a year resulting in spontaneous abortions, stillbirths, and congenital syphilis. The global prevalence was estimated in around 36.4 million people in 2008. Caused by the bacterium Treponema pallidum, syphilis is commonly acquired as an STD, but it also can be transmitted vertically by expectant mothers. Routine maternal screening and treatment for syphilis is critical to avoid serious perinatal consequences. Without screening around 69% of vertical transmissions result in adverse outcomes. Screening may reduce mortality attributable to congenital syphilis by up to 50%. Diagnosis Diagnosis of syphilis can be done through the identification of specific antibodies against Treponema pallidum (treponemal test) or the detection of heterophile antibodies produced during Treponema pallidum active infection (nontreponemal test). For syphilis diagnosis, both tests are needed, combinen in diferent algorithms. Treponema Pallidum Screening algorithms Nontreponemal + TPHA or other treponemal test TPHA + syphilis likely Traditional algorithm Nontreponemal test, e.g. RPR Nontreponemal -syphilis unlikely but retest if early syphilis suspected TPHA - syphilis unlikely EIA/CLIA+ Reverse sequencial algorithm EIA or CLIA Nontreponemal test, e.g. RPR EIA/CLIA - syphilis unlikely but retest if early syphilis suspected Nontreponemal+ Syphilis likely Nontreponemal - TPHA or other treponemal test TPHA + syphilis likely TPHA - syphilis unlikely Intended Use syphagen TPHA and syphagen TPHA AUTO reagents are composed by a solution of stabilized chicken erythrocytes sensitized with an antigen extract of Treponema pallidum. syphagen TPHA is a manual method and syphagen TPHA AUTO is adapted for Olympus PK7200 or PK7300 instruments. Performance syphagen TPHA In different evaluations, syphagen TPHA has demonstrated sensitivity between 99.6% and 100%, and specificity between 97.8% and 100%. syphagen TPHA AUTO syphagen TPHA AUTO has 99.97% sspecificity, evaluated in 205.204 samples. T3100-9706 R01 MAY-2016 Main features Product name Method Assay Format Coating Sample Type Sample Volume Assay time Ordering Information Living Immunoassay Excellence syphagen TPHA Hemagglutination Qualitative and Quantitative Inactivated virus antigen Serum/Plasma 25 µl (Dil. 1/80) 60 min syphagen TPHA 200 Tests Cod. 300615700 syphagen TPHA AUTO 5000 Tests Cod. 3000-5705 syphagen TPHA AUTO Hemagglutination Qualitative Inactivated virus antigen Serum/Plasma 25 µl (Dil. 1/80 in plate) 60 min
Answering your daily challenges in Toxoplasmosis diagnosis Toxoplasma gondii toxocell latex I NFECTIOU S DI SEASES
I N F E C T I O U S D I S E A S E S Toxoplasmosis Toxoplasma gondii is an obligate intracellular protozoan parasite that is capable of infecting a variety of intermediate hosts including humans. Infected definitive hosts (cats) shed oocysts in feces that rapidly mature in the soil and become infectious. Toxoplasmosis is acquired by humans through ingestion of food or water contaminated with cat feces or through eating undercooked meat containing viable oocysts. Vertical transmission of the parasite through the placenta can also occur, leading to congenital toxoplasmosis. Following primary infection, Toxoplasma gondii can remain latent for the life of the host and the risk for reactivation is highest among immunosuppressed individuals. Diagnosis The detection of Toxoplasma-specific antibodies is the primary diagnostic method to confirm a recent infection with Toxoplasma gondii or determine whether a person has immunity against it. Although toxoplasmosis is usually asymptomatic, causing a mild, flu-like illness few weeks after exposure, in people with weakened immune systems, such as people with AIDS, may become occasionally fatal. In pregnant women, the infection with Toxoplasma gondii during pregnancy can expose the fetus to a congenital infection, causing physical and neurological abnormalities. Detection of antibodies in blood samples can differentiate women with immunity against Toxoplasma gondii. The lack of antibodies indicates a lack of immunity, and some precautions need to be taken to avoid infection during pregnancy. Intended Use toxocell latex is a latex agglutination test specific for the detection of antibodies to Toxoplasma gondii. The reagent is made with a suspension of latex particles coated with inactivated virus antigen. The high experience of Biokit in fabrication of the inactivated Toxoplasma antigens gives the test a very good performance. Performance The global sensitivity and specificity of toxocell latex are 100% and 84.2% respectively for general population, and 100% and 95.4% for pregnant population. The performance of the test allows detecting positive samples with a cut-off of 10 IU/ml. The results obtained after semiquantification analysis are expressed in IU/ml according to the WHO 3rd International Standard. Main features Product name Method Assay Format Coating Sample Type Sample Volume Assay time toxocell latex Latex agglutination Qualitative / Semiquantitative Inactivated virus antigen Serum 50 µl 5 min T3100-9708 R01 MAY-2016 Ordering Information toxocell latex 100 Tests Cod. 3000-4525 Living Immunoassay Excellence
Answering your daily challenges in Rubella diagnosis Rubella Virus rubagen I NFECTIOU S DI SEASES
I N F E C T I O U S D I S E A S E S Rubella Rubella is a highly contagious viral disease, spread through contact with discharges from the nose and throat of an infected person. Although rubella causes only mild symptoms of low fever, swollen glands, joint pain, and a fine red rash in most children and adults, it can have severe complications for women in their first trimester of pregnancy. These complications include severe birth defects or death of the fetus. Diagnosis A blood test is done to check for rubella antibodies. When the body is infected with the rubella virus, it produces both immunoglobulin G (IgG) and immunoglobulin M (IgM) antibodies to fight the infection. Once IgG exists, it persists for a lifetime, but the special IgM antibody usually wanes over six months. A blood test can be used either to confirm a recent infection (IgG and IgM) or determine whether a person has immunity to rubella (IgG only). The lack of antibodies indicates that a person is susceptible to rubella. All pregnant women should be tested for rubella early in pregnancy, whether or not they have a history of vaccination. If the woman lacks immunity, she is counseled to avoid anyone with the disease and to be vaccinated after giving birth. Intended Use rubagen is a latex agglutination test specific for the detection of IgG and IgM antibodies to Rubella virus. Using serial dilutions of the samples it is possible to obtain semiquantitative results with a high concordance with the real concentration of antibodies. The reagent is made with a suspension of latex particles coated with inactivated virus antigen. The high experience of Biokit in fabrication of the inactivated Rubella antigens gives the test a very good performance. Performance The global sensitivity and specificity of rubagen evaluated in 178 characterized samples are 100% and 98.1% respectively. In the analysis of five seroconversion panels before and after vaccination, rubagen detected correctly all the samples. The high sensitivity of the test allows detecting positive samples with a cut-off of 10 IU/ml. The results obtained after semiquantification analysis are expressed in IU/ml according to the WHO International Standard. Main features Product name Method Assay Format Coating Sample Type Sample Volume Assay time rubagen Latex agglutination Qualitative / Semiquantitative Inactivated virus antigen Serum 50 µl (dil. 1/4, 1/5 or 1/6.7) 8 min T3100-9709 R01 MAY-2016 Ordering Information rubagen 100 Tests Cod. 3000-4001 Living Immunoassay Excellence
Answering your daily challenges in Infectious Mononucleosis diagnosis Epstein-Barr Virus monogen I NFECTIOU S DI SEASES
I N F E C T I O U S D I S E A S E S Infectious mononucleosis Infectious mononucleosis (IM) is an acute infectious disease caused by Epstein-Barr virus (EBV). The most frequent symptoms are fever, sore throat, fatigue and headache. Complications of IM as enlargement of the spleen or liver affections may be more serious than the disease itself. EBV can cause much more serious illness in people who have impaired immune systems, such as people with HIV infection or people taking drugs to suppress immunity after an organ transplant. Diagnosis Diagnosis based on symptoms is common in IM disease, but numerous cases of misidentification with other non-related viral and bacterial diseases have been cited, and serologic tests are now necessary to ensure a correct diagnosis. When an infection with EBV occurs, the patient develops specific antibodies against EBV antigens and heterophile antibodies against glycoproteins from red cell membrane (Paul-Bunnell antigens). Heterophile antibodies appear earlier and in higher titer than specific antibodies, it is why it is the first choice of diagnosis. Intended Use monogen is a latex agglutination test specific for the detection of heterophile antibodies produced by the human immune system in response to EBV infection. The reagent is made with a suspension of latex particles coated with highly purified Paul-Bunnell antigen from bovine red cell membranes. The degree of purity of the antigen is such that monogen only react with IM hererophile antibodies, obtaining very high specificity. Performance In a study with 220 samples, monogen obtained a relative sensitivity and specificity of 93% and 94% respectively, if compared with with hemagglutination test against Paul-Bunnell antigen. Compared with specific Epstein-Barr antigen, the relative specificity of the test remains in 93% and the relative sensitivity increases to 99%. Main features Product name Method Assay Format Coating Sample Type Sample Volume Assay time monogen Latex agglutination Qualitative / Semiquantitative Paul-Bunnell antigen Serum / Plasma 50 µl 3 min T3100-9710 R01 MAY-2016 Ordering Information monogen 50 Tests Cod. 3000-1001 monogen 100 Tests Cod. 3000-1002 Living Immunoassay Excellence
Answering your daily challenges in Infectious Mononucleosis Epstein-Barr Virus color-mono I NFECTIOU S DI SEASES
I N F E C T I O U S D I S E A S E S Infectious mononucleosis Infectious mononucleosis (IM) is an acute infectious disease caused by Epstein-Barr Virus (EBV). The most frequent symptoms are fever, sore throat, fatigue and headache. Complications of IM as enlargement of the spleen or liver affections may be more serious than the disease itself. EBV can cause much more serious illness in people who have impaired immune systems, such as people with HIV infection or people taking drugs to suppress immunity after an organ transplant. Diagnosis Diagnosis based on symptoms is common in IM disease, but numerous cases of misidentification with other non-related viral and bacterial diseases have been cited, and serologic tests are now necessary to ensure a correct diagnosis. When an infection with EBV occurs, the patient develops specific antibodies against EBV antigens and heterophile antibodies against glycoproteins from red cell membrane (Paul-Bunnell antigens). Heterophile antibodies appear earlier and in higher titer than specific antibodies, it is why it is the first choice of diagnosis. Intended Use Color-mono is a hemagglutination test specific for the detection of heterophile antibodies produced by the human immune system in response to EBV infection. The reagent is a specially treated suspension of stabilized horse red blood cells that will be recognized by heterophile antibodies agains EBV. Performance In a study of 318 serum samples, color-mono obtained 100% sensitivity and 100% specificity compared against a latex agglutination test coated with highly purified Paul-Bunell antigen. Main features Product name Method Assay Format Coating Sample Type Sample Volume Assay time color-mono Hemagglutination Qualitative / Semiquantitative Horse red cells Serum / Plasma 50 µl 1 min T3100-9711 R01 MAY-2016 Ordering Information color-mono 50 Tests Cod. 3000-1005 Living Immunoassay Excellence
Answering your daily challenges in the diagnosis of Rotavirus infection Rotavirus rotagen I NFECTIOU S DI SEASES
I N F E C T I O U S D I S E A S E S Rotavirus Rotavirus infections are the most common cause of diarrhea in infants and children worldwide. The virus spreads easily through hand-to-mouth contact throughout the moment the virus appears in faeces, even if the infected person does not have symptoms. Although rotavirus infections are unpleasant, most of them can be treated at home with extra fluids to prevent dehydration. Occasionally, severe dehydration requires intravenous fluids in the hospital. Dehydration is a serious complication of rotavirus and a major cause of childhood deaths in developing countries. Diagnosis Rotavirus are present in an infected person's stool several days before symptoms appear and for up to 10 days after symptoms subside. Diagnosis of the infection normally follows diagnosis of gastroenteritis as the cause of severe diarrhea. There is no specific treatment for a rotavirus infection. Antibiotics and antivirals will not help to eliminate the infection. Usually, the infection resolves within three to seven days. Diagnosis of rotavirus infection is important in order to discard bacterial infection, that should be treated with antibiotics. Intended Use rotagen is a latex where the latex particles are coated with rabbit antibodies against simian rotavirus SA-11. When a sample is positive for adenovirus, latex agglutination allow visual observation of teh antigen-antibody reaction. The kit includes a control reagent coated with nonimmune rabbit immunoglobulins to detect non-specific reactions. Performance The global sensitivity and specificity of rotagen were evaluated in total of 121 samples, obtaining 100% sensitivity and 96.3% specificity. Main features Product name Method Assay Format Coating Sample Type Sample Volume Assay time rotagen Latex agglutination Qualitative Rabbit anti-rotavirus antibodies Feces / Swab 50µl + 50µl 2 min Ordering Information rotagen 25 Tests Cod. 3000-8010 T3100-9712 R01 MAY-2016 Living Immunoassay Excellence
Answering your daily challenges in the diagnosis of Rotavirus and Adenovirus Rotavirus / Adenovirus biorapid ROTA-ADENO I NFECTIOU S DI SEASES
I N F E C T I O U S D I S E A S E S Rotavirus and Adenovirus Rotavirus and Adenovirus infections are the most common cause of diarrhea in infants and children worldwide. The virus spreads easily through hand-to-mouth contact throughout the moment the virus appears in faeces, even if the infected person does not have symptoms. Although gastrointestinal infections are unpleasant, most of them can be treated at home with extra fluids to prevent dehydration. Occasionally, severe dehydration requires intravenous fluids in the hospital. In developing countries, dehydration is a serious complication of rotavirus and adenovirus infections, and it is a major cause of childhood deaths. Diagnosis Rotavirus and Adenovirus are present in an infected person's stool several days before symptoms appear and for up to 10 days after symptoms subside. Diagnosis of the infection normally follows diagnosis of gastroenteritis as the cause of severe diarrhea. There is no specific treatment for a rotavirus or adenovirus infection. Antibiotics and antivirals will not help to eliminate the infection. Usually, the infection resolves within three to seven days. Diagnosis of rotavirus or adenovirus infection is important in order to discard bacterial infection, that should be treated with antibiotics. Intended Use biorapid ROTA-ADENO is an immunochromatographic assay that utilizes a combination of monoclonal and polyclonal antibodies. The test includes two distinct capture antibodies lines in the stationary antibody zone for the detection and differentiation of adenovirus (green line) and rotavirus (red line). Performance biorapid ROTA-ADENO, evaluated against a reference chromatographic test, demonstrated 99% concordance both in the detection of rotavirus and adenovirus. Main features Product name Method Assay Format Coating Sample Type Sample Volume Assay time biorapid ROTA-ADENO Immunochromatography Qualitative Anti-rotavirus mouse monoclonal antibodies Anti-adenovirus mouse monoclonal antibodies Feces / Swab 100µl 10 min T3100-9713 R01 MAY-2016 Ordering Information biorapid ROTA-ADENO 20 Tests Cod. 3000-1073 Living Immunoassay Excellence