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1 NEWS BK NEWS # 378 /MKT DATE : 16022016 TITLE : New Bioelisa reagents Brochures Dear colleagues, We are

1 1 NEWS BK NEWS # 378 /MKT DATE : TITLE : New Bioelisa reagents Brochures Dear colleagues, We are pleased to present the new Bioelisa reagents Brochures, which are a very useful marketing and selling tool to promote these excellent reagents. These brochures include the following relevant information: General information about the disease and the diagnosis Intended use Performance of the reagent Main features Ordering information

2 2 The available brochures are listed below: T Flyer HBsAg 3.0 T Flyer antihbc T Flyer HCV 4.0 T Flyer HIV12 Ag/Ab T Flyer HTLVIII 5.0 T Flyer Syphilis 3.0 T Flyer Chagas Please find attached the Bioelisa reagents brochures in PDF (low resolution), please contact us if you are interested in receiving these materials in another format. We remain at your disposal for any further information you may require. Best regards, Ernest Mas Marketing Manager BIOFLASH Product Manager/Clinical Lab Jordi Gómez OEM Business Manager Joaquín Ortiz Product Manager/Blood Bank Sales Support LatAm David Padrosa OEM Account Manager Biokit Marketing Team Ricard Forns Marketing Vice President Montse Armengol Marketing Assistant Sandra Roselló Sales Support Manager Sales Support EEMEAI Joan Vilà Werfen Business Manager Sales Support NOA & WE Carlos Fernández Product Manager Instrumentation Sales Support APAC Veronica Vocero Product Specialist/Blood Bank Biokit Phone: Biokit Mktg Fax:

3 Answering your daily challenges in Hepatitis B diagnosis Hepatitis B Virus HBsAg 3.0 I NFECTIOU S DI SEASES

Hepatitis B I N F E C T I O U S D I S E A S E S Hepatitis B is a liver infection produced by the Hepatitis B Virus (HBV) that represents a major global health concern.

4 Hepatitis B I N F E C T I O U S D I S E A S E S Hepatitis B is a liver infection produced by the Hepatitis B Virus (HBV) that represents a major global health concern. It causes a number of liver diseases, ranging from acute and chronic hepatitis to cirrhosis and primary liver cancer. During the viral infection many serological markers appear. One of these markers is the Hepatitis B surface antigen (HBsAg). HBsAg is a complex of antigenic determinants found on the surface of HBV and it is the earliest indicator of acute infection and is also indicative of chronic infection if its presence persists for more than 6 months. The measurement of HBsAg is used to screen blood or blood products to prevent transmission of HBV as well to diagnose suspected HBV infection or to follow the status of infected individuals. Hepatitis B serologic testing involves measurement of HBV specific antigens and/or antibodies. Different serologic markers are used to identify the phases of HBV infection and to determine whether a patient has acute or chronic HBV infection or is immune to HBV as a result of prior infection or vaccination Acute Acute HBV Resolving early late Immune vaccination past infection Chronic Chronic HB Chronic HB. HBeAG neg HBV Antigens HBsAg HBeAg / HBV DNA antihbv antibodies AntiHBC IgM total antihbe antihbs / / / / / Titer Acute Hepatitis B virus infection with Recovery Typical Serologic Course HBeAg Symptoms Weeks after exposure HBsAg IgM anthbc antihbe antihbs Total antihbc Intended Use HBsAg 3.0 is a immunoenzymatic method for the detection of surface antigen of HBV. The presence of the antigen in serum or plasma constitutes the most important indicator for the diagnosis of HBV infection. Performance The performance of HBsAg 3.0 in samples from hospitalized patients is 100% sensitivity and 99.5% specificity, while in blood bank samples is 99.5% sensitivity and 99.94% specificity. The test has an analytical sensitivity of 0.1 units/ml for ad and ay subtypes using standards of Paul Ehrlich Institute, and IU/ml for adw2 subtype using the standard of World Health Organization. The use of polyclonal antibodies in both solid phase and conjugate helps in the detection of possible virus mutations. Main features Product Name HBsAg 3.0 Method EIA Assay Format Qualitative Coating Guinea pig antihbs antibodies Sample Type Serum / Plasma Sample Volume 100 µl (Direct) Time of reaction 2h T R01 JAN2016 Ordering Information HBsAg 96 Tests Cod HBsAg 480 Tests Cod Living Immunoassay Excellence

5 Answering your daily challenges in Hepatitis B diagnosis Hepatitis B Virus antihbc I NFECTIOU S DI SEASES

6 Hepatitis B I N F E C T I O U S D I S E A S E S Hepatitis B is a liver infection produced by the Hepatitis B Virus (HBV) that represents a major global health concern. It causes a number of liver diseases, ranging from acute and chronic hepatitis to cirrhosis and primary liver cancer. During the viral infection many serological markers appear. One of these markers is the antibody anti core protein (antihbc). AntiHBc can usually be detected in the blood just after the detection of HBsAg and before the onset of clinically apparent hepatitis. In acute hepatitis B with recovery, antihbc is the only serological marker of infection in the period between HBsAg clearance and the appearance of antihbs. The antihbc antibodies may persist for life while the antibodies antihbs in some patients can became negative. In chronic hepatitis B the antihbc is detected with HBsAg, but in some individuals this antigen can become undetectable. Hepatitis B serologic testing involves measurement of HBV specific antigens and/or antibodies. Different serologic markers are used to identify the phases of HBV infection and to determine whether a patient has acute or chronic HBV infection or is immune to HBV as a result of prior infection or vaccination. Acute Acute HBV Resolving early late Immune vaccination past infection Chronic Chronic HB Chronic HB. HBeAG neg HBV Antigens HBsAg HBeAg / HBV DNA antihbv antibodies AntiHBC IgM total antihbe antihbs / / / / / Titer Acute Hepatitis B virus infection with Recovery Typical Serologic Course Symptoms HBeAg Weeks after exposure HBsAg IgM anthbc antihbe antihbs Total antihbc Intended Use antihbc is a competitive immunoenzymatic method for the determination of antibodies to core antigen from HBV. The incubation of the sample is done at the same time than the conjugate antibodies against HBcAg, obtaning results in 1h 30min. Performance The performance of antihbc was evaluated in comparative studies with other commercial assays. In total, near 6000 samples were analyzed, obtaining 100% sensitivity and 99.92% specificity. Main features Product Name Method Assay Format Coating Sample Type Sample Volume Time of incubations antihbc EIA Qualitative Recombinant HBcAg Serum / Plasma 50 µl (Direct) 1h 30 min T R01 JAN2016 Ordering Information antihbc 96 Tests Cod Living Immunoassay Excellence

7 Answering your daily challenges in Hepatitis C diagnosis Hepatitis C Virus HCV 4.0 I NFECTIOU S DI SEASES

Hepatitis C I N F E C T I O U S D I S E A S E S Hepatitis C is a viral infection of the liver which had been referred to as parenterally transmitted "nona, nonb hepatitis" until identification of the

8 Hepatitis C I N F E C T I O U S D I S E A S E S Hepatitis C is a viral infection of the liver which had been referred to as parenterally transmitted "nona, nonb hepatitis" until identification of the causative agent in The discovery and characterization of the hepatitis C virus (HCV) led to the understanding of its primary role in posttransfusion hepatitis and its tendency to induce persistent infection. The virus infects liver cells and can cause severe inflammation of the liver with longterm complications. HCV is a major cause of acute hepatitis and chronic liver disease, including cirrhosis and liver cancer. Globally, an estimated 170 million people are chronically infected with HCV and 3 to 4 million people are newly infected each year. Diagnostic tests for hepatitis C can be divided into two general categories: 1) serological assays (antihcv) a. screening tests: EIA or CLIA b. confirmatory tests: immunoblot 2) molecular assays The presence of antihcv antibodies cannot be confirmed until some weeks after exposure creating a window period of seronegativity and potential infectivity. For this reason it is very important the early detection of the HCV antibodies in order to ensure the maximum sensitivity of the assay. Bioelisa HCV 4.0 ensures an outstanding diagnostic sensitivity during the seroconversion period because of its early detection of antibodies. Titre Months RNA RNA RNA RNA RNA Alanine transaminase Total AntiHCV antibody Years Intended Use HCV 4.0 is an immunoenzymatic method for the detection of HCV infection. The wells are coated with four different antigens, representing epitopes Core, NS3, NS4 and NS5, giving the test a very good sensitivity. Performance The sensitivity of the test, evaluated in two studies of 200 and 723 samples is 100%. The specificity is between 99.63% and 99.8%, evaluated in two studies with 5,187 and 1,019 samples respectively. Main features Product Name HCV 4.0 Method Assay Format Coating Sample Type Sample Volume Time of incubation EIA Qualitative Recombinant Core HCV antigen Recombinant NS3 HCV antigen Recombinant NS4 HCV antigen Recombinant NS5 HCV antigen Serum / Plasma 10 µl (Dil ½ 0 in plate) 2h T R01 JAN2016 Ordering Information HCV Tests Cod HCV Tests Cod Living Immunoassay Excellence

9 Answering your daily challenges in the AIDS diagnosis HIV HIV 12 Ag/Ab I NFECTIOU S DI SEASES

10 AIDS I N F E C T I O U S D I S E A S E S Acquired immune deficiency syndrome (AIDS) is considered the most important global pandemic. AIDS is a disease of the human immune system caused by infection with human immunodeficiency virus (HIV). According to World Health Organization (WHO), there were approximately 35 million people living with HIV at the end of 2013 and 2.1 million people newly infected every year. HIV is transmitted via unprotected sexual intercourse, contaminated blood transfusions, hypodermic needles or from mother to child during pregnancy, delivery, or breastfeeding. The pandemic is not homogeneous within regions, and there are wide variations in infection levels between different areas. The number of people infected with HIV continues to rise in most parts of the world, despite the implementation of prevention strategies. Due to the lack of vaccination, an early diagnosis and a mandatory screening of blood bank samples are very important for prevention. Screening and diagnosis can be done using different methods: Antibody tests Designed for routine diagnostic testing and screening of HIV Test Comments ELISA CLIA Blot Screening test for detection of antibodies to HIV1 and HIV2. High sensitivity Screening test for detection of antibodies to HIV1 and HIV2. High sensitivity Confirmatory tests All HIV tests require high sensitivity and specificity to ensure a correct diagnosis. Most of the traditional tests have evolved to decrease the eclipse period and be able to detect a positive patient early after the exposure. The sensitivity of each test in the early stages of the infection can be estimated with the analytical sensitivity, as it fixes the minimum concentration of p24 antigen that can be detected. Intended Use The HIV 12 Ag/Ab is a fourth generation enzyme immunoassay for the simultaneous qualitative detection of HIV p24 antigen and antibodies to HIV1 (groups M and O) and HIV2. Two monoclonal antibodies against p24 allow the detection of low concentrations of p24, giving this test the best analytical sensitivity compared with similar tests. HIV Infection HIV RNA (plasma) HIV1 p24 Antigen HIV Antibody Days Eclipse Period Viral Detection Nucleic acid Acute HIV Infection Antibody Detection 3rd generation test Immunoassay Viral Detection 4th generation Immunoassay Seroconversion window Antibody Detection 2nd generation Immunoassay Antibody Detection 1st generation Immunoassay Established HIV Infection T R01 NOV2015 Performance HIV12 Ag/Ab has a sensitivity of 100% and the specificity is between 99.79% to 99.87% in a total of 6,465 unselected blood donors samples. The analytical sensitivity of the test is the best of the market, detecting positive samples with a concentration below 0.5 IU/ml in the WHO p24 antigen test, and below 12.5 pg/ml in the AFSAPSS standard. In the analysis of 16 seroconversion panels HIV12 Ag/Ab showed excellent sensitivity to detect positive samples earlier than similar tests. Main features Product Name HIV12 Ag/Ab Method EIA Assay Format Qualitative Coating HIV1 gp41, recombinant antigen HIV2 gp36, synthetic peptide Anti p24 Ag, two monoclonal antibodies Ordering Information HIV 12 Ag/Ab 96 Tests Cod HIV 12 Ag/Ab 480 Tests Cod Living Immunoassay Excellence Sample Type Sample Volume Time of reaction Serum / Plasma 100 µl (Dil ½ in plate) 2h 30 min

11 Answering your daily challenges in the diagnosis of HTLV infection HTLV HTLVIII 5.0 I NFECTIOU S DI SEASES

HTLV infection I N F E C T I O U S D I S E A S E S Human Tcell Lymphotropic Viruses (HTLVs) are pathogenic retroviruses that may cause severe hematological and neurological diseases, including some

12 HTLV infection I N F E C T I O U S D I S E A S E S Human Tcell Lymphotropic Viruses (HTLVs) are pathogenic retroviruses that may cause severe hematological and neurological diseases, including some kinds of Leukemia, in infected individuals. The virus incorporates itself into human DNA, and can remain in the body throughout life without causing any harm at all, but about 1 person in 20 will develop. HTLVI associated diseases, as Adult Tcell Leukaemia/Lymphoma (ATLL) or HTLVIassociated myelopathy (HAM). The most important families are HTLVI and HTLVII, that can be transmitted through sexual contact, contaminated blood products and from mother to child. Especially in areas where HTLV is endemic, as Japan, Caribbean, South America, some parts of Africa, and lately Europe and United States, HTLV screening in blood bank samples has become mandatory to ensure no transmission through blood transfusion. Intended Use HTLVIII 5.0 is a direct sandwich immunoassay that utilizes a combination of recombinant proteins and a trifusion recombinant protein labeled with peroxidase. This format assures simultaneous detection of IgG and IgM antibodies against HTLVI and HTLVII. Performance The sensitivity of the test, evaluated in 515 samples, is 100% for detection HTLVI and HTLVII, and 72.7% for HTLVIII. The specificity is 99.82% for blood donor samples, obtained in an evaluation of 5000 samples, and 100% in clinical samples, evaluated in 306 pathological samples non positive for HTLV. This performance makes the test a perfect option for maintaining blood bank safety and for HTLV diagnosis. Main features Product Name HTLV Method Assay Format Coating Sample Type Sample Volume Time of reaction EIA Qualitative gp21, recombinant antigen gp46, recombinant antigen HTLVI gp46, recombinant antigen HTLVII Serum / Plasma 50 µl (Dil ½ in plate) 1h 30 min T R01 JAN2016 Ordering Information HTLVIII Tests Cod Living Immunoassay Excellence

13 Answering your daily challenges in Syphillis diagnosis Treponema pallidum SYPHILIS 3.0 I NFECTIOU S DI SEASES

14 Syphilis 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 Caused by the bacterium Treponema pallidum, syphilis is commonly acquired as an STD, but it also can be transmitted vertically by expectant mothers or by the transfusion of contaminated blood or the transplantation of contaminated organs. 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%. Serologic tests like the Syphilis assay are the method of choice for detection of Treponema pallidum infections. 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 Many automated tests detect both IgM and IgG antibodies to treponemalspecific antigen, allowing detection of primary infection. Seeing advantages to automation, many laboratories are adopting a reverse algorithm, employing a treponemal test to detect infection, followed by a nontreponemal test to assess active disease. Intended Use The SYPHILIS 3.0 is a third generation enzyme immunoassay for the simultaneous qualitative detection of IgG and IgM antibodies to Treponema pallidum. Besides immunodominant recombinant antigens p15, p17 and p47, this assay incorporates an additional recombinant protein that enhances the sensitivity of the test. Performance The global relative sensitivity of the SYPHILIS 3.0 assay evaluated in characterized positive samples is 99.4% 100%. The specificity is 99.8% for samples from blood donors and 100% for hospitalized patients. The high analytical sensitivity of the test makes possible to detect as positive samples with concentrations lower than 0.03 IU/ml of the World Health Organization (WHO) 1st international standard for syphilitic serum. T R01 JAN2016 Main features Product Name Bioelisa SYPHILIS 3.0 Method EIA Assay Format Qualitative Coating p15, recombinant antigen p17, recombinant antigen P47, recombinant antigen patent pending recombinant antigen Ordering Information SYPHILIS Tests Cod SYPHILIS Tests Cod Living Immunoassay Excellence Sample Type Sample Volume Time of reaction Serum / Plasma 50 µl (Dil 1/2 in plate) 2h

15 Answering your daily challenges in Chagas diagnosis Trypanosoma cruzi CHAGAS I NFECTIOU S DI SEASES

Chagas Diseases I N F E C T I O U S D I S E A S E S Chagas disease is a chronic parasitic infection caused by a flagellate protozoan, Trypanosoma cruzi.

cruzi can also be transmitted congenitally or by the transfusion of contaminated blood or the transplantation of contaminated organs. Chagas disease is endemic to Latin America.

cruzi, more than 25 million are at risk of being infected and more than 15000 are killed every year. The prevalence rates of antit. cruzii antibodies vary widely across the different endemic areas.

16 Chagas Diseases I N F E C T I O U S D I S E A S E S Chagas disease is a chronic parasitic infection caused by a flagellate protozoan, Trypanosoma cruzi. This parasite is normally transmitted to humans or other mammals by triatomine bugs, of the family Reduviidae. T. cruzi can also be transmitted congenitally or by the transfusion of contaminated blood or the transplantation of contaminated organs. Chagas disease is endemic to Latin America. According to the World Health Organization (WHO) an estimated 10 million people are currently infected with T. cruzi, more than 25 million are at risk of being infected and more than are killed every year. The prevalence rates of antit. cruzii antibodies vary widely across the different endemic areas. In 2005, the figures ranged from 0.01% in Ecuador and 0.09% in Costa Rica to 8.61% in Bolivia, three countries that report results obtained by confirmatory testing. The prevalence rates are decreasing over the time in all the endemic countries, but as consequence of the intense population migration and mobility of people to Europe (mainly Spain and Portugal) and North America, Chagas disease has spread and is now global. The diagnosis of infection with T. cruzi is complex, mainly during the chronic phase, due to the lack of symptoms and the low or intermitent parasitemia that leads to direct parasitological methods having a low sensitivity. For this reason, the diagnosis is based on serological methods, which detect the presence of specific antibodies against antigens of T. cruzi combined with clinical and epidemiological findings. Most assays use crude lysates of the parasite as antigen; however the use of recombinant proteins and/or synthetic peptides have been described to increase the specificity of the tests. SEROLOGY DIAGNOSTIC Acute and Chronic Phase Test Manual tests Screening Tests: Enzyme immunoassays Characteristics Latex agglutination Immunofluorescence Indirect hemagglutination (IHA) ELISA CLIA Intended Use The CHAGAS is an immunoenzymatic assay for the detection of IgG and IgM antibodies for Trypanosoma cruzi. The solid phase is coated with four recombinant antigens of T. cruzi as a capture method. The use of four different epitopes gives the test a higher sensitivity than similar assays. Performance The relative sensitivity of CHAGAS is 100% and the specificity obtained in different evaluation studies range from 97.4% to 99.5% in blood bank samples and from 98.2% to 99.5% in hospitalized patients. T R01 JAN2016 Main features Product Name CHAGAS Method EIA Assay Format Qualitative Coating Recombinant antigens (4 different epitopes) Sample Type Serum / Plasma Sample Volume 10 µl (Dil 1/20 in plate) Time of reaction 2h Ordering Information CHAGAS 96 Tests Cod Living Immunoassay Excellence

We are pleased to present the new Leaflet bioelisa Menu and Instrumentation, with reference

NEWS BK NEWS# 390/ MKT DATE : 13-07-2016 TITLE : New Leaflet bioelisa Menu and Instrumentation Dear colleagues, We are pleased to present the new Leaflet bioelisa Menu and Instrumentation, with reference