Bio-Rad Laboratories. The Best Protection Whoever You Are. Congenital and Pediatric Disease Testing

Transcription

1 Bio-Rad Laboratories I N F E C T I O U S D I S E A S E T E S T I N G The Best Protection Whoever You Are Congenital and Pediatric Disease Testing

2 Bio-Rad Laboratories I N F E C T I O U S D I S E A S E T E S T I N G The Best Protection

3 Whoever You Are

4 Bio-Rad Laboratories I N F E C T I O U S D I S E A S E T E S T I N G Platelia ToRCH Assays Bio-Rad proposes a complete range of fully standardized and high-level performance assays for serodiagnosis of ToRCH infections (Toxoplasma, Rubella virus, Cytomegalovirus, Herpes virus). This new generation of tests provides laboratories with high quality standards and improved practicability. Congenital and Neonatal Infectious Diseases Infections with Toxoplasma gondii, Rubella virus, Cytomegalovirus, Herpes Simplex viruses and Parvovirus B19 are common and often asymptomatic, but can lead to severe damage to neonates when acquired during pregnancy. Diagnosis is primarily done using serological tests which provide a valuable tool for monitoring pregnant women for acquisition of a primary infection.

5 Bio-Rad is committed to improving diagnosis of antenatal, perinatal and post-natal infectious diseases Toxoplasma gondii Primary infections with T. gondii acquired during pregnancy can cause stillbirth or congenital abnormalities, including blindness, encephalomyelitis, impaired brain functions and convulsions in the newborn. In case of congenital toxoplasmosis, the main factor influencing disease severity is gestational age at infection with higher severity during the first trimester. Toxoplasmosis can be treated with antibiotics but early detection of the disease is crucial for effective therapy. Cytomegalovirus CMV is the leading cause of congenital viral infection. CMV can be transmitted to the fetus during pregnancy after maternal primary infection or eventually the recurrence of a latent virus. Transmission will result in a generalized infection with severe complications (hepatosplenomegaly, microcephaly, hydrocephaly, low birth weight, prematurity, mental retardation or fetal death). Some fetal infections are asymptomatic but neonates will present delayed complications like deafness, blindness or mental retardation. Rubella virus Rubella virus poses a serious risk when transmitted from a mother to her developing baby. If the mother is infected within the first 20 weeks of pregnancy, the child may be born with Congenital Rubella Syndrome, which includes a range of severe birth defects (heart, brain, ear or eye malformations, deafness, microcephaly, mental retardation or fetal death). Aggressive immunization of pre-school children has greatly reduced the incidence of rubella epidemics, but a need still exists for accurate monitoring of the immune status, especially for women of child-bearing age. Herpes Simplex virus Neonates are particularly vulnerable to infections caused by HSV-1 or HSV-2. In most cases, the infection is the result of vertical transmission during the peripartum period, and more rarely in utero or postpartum. Women with primary infections are 10 to 20 times more likely to transmit the virus to their infants than women with recurrent infections. Without prompt initiation of treatment, more than 70% of infected infants will progress to disseminated or central nervous system diseases.

6 Bio-Rad Laboratories offer a continually expanding and comprehensive menu for infectious disease screening, including reagent kits, controls and instrumentation Standardized Protocols The Platelia ToRCH assays use parallel protocols with common reagents. Using the same pre-dilution, washing solution, substrate, stop solution, incubation times and other processing steps allows testing of different assays in parallel and even combining several assays on the same microplate. The Pediatric assay line similarly uses standardized protocols for determination of the immune status. Improving Lab Workflow Specificity Sensitivity Platelia Toxo IgG 100.0% 100.0% Platelia Toxo IgM 99.9% 100.0% Platelia Rubella IgG 100.0% 100.0% Platelia Rubella IgM 99.4% 98.8% Platelia CMV IgG 100.0% 98.7% Platelia CMV IgM 99.2% 95.0% Platelia HSV1 IgG 99.3% 98.8% Platelia HSV2 IgG 96.9% 99.5% Performances of the Platelia ToRCH panel assays Better Practicability Protocol standardization and improved reagent handling dramatically enhance the turnaround time of samples and improve workflow streams and lab organization. Increasing Lab Efficiency Comprehensive ID Menu With over 60 different proprietary methods available, Bio-Rad offers an unsurpassed menu range for infectious disease testing, including traditional and innovative assays. Working with the Leader Complete Automated Solution Bio-Rad Laboratories offer a complete line of assays and analyzers for total automation of infectious disease testing. Platelia ToRCH and Pediatric assays are fully validated on Bio-Rad Systems: EVOLIS and EVOLIS Twin Plus. Consolidating ID Testing Accuracy and Reliability Immunocapture format for IgM assays, careful selection of antigens and antibodies and Bio-Rad expertise are essential for the development of highly specific and sensitive assays, and better service to clinicians and patients. Using Gold Standard Assays EVOLIS Twin Plus System

7 Congenital and Pediatric Disease Testing Pediatric Infectious Diseases Platelia Pediatric Assays Bio-Rad proposes a comprehensive range of diagnostic assays for detection of IgG and IgM antibodies to Measles, Mumps and Varicella-Zoster viruses. Along with Parvovirus B19 IgG and IgM assays, it will help in accurately detecting and preventing some of the most important viral illnesses in children. Despite successful vaccine immunization programs, Measles, Mumps and Varicella Zoster still remain a major issue in certain population categories (immunocompromised patients, people with limited access to vaccination and neonates). No vaccine is available for preventing Parvovirus B19 infections in young children. Serodiagnosis is used to determine the immune status and to detect early or recent infection. Measles Also known as rubeola, it is a highly contagious disease characterized by fever, cough, coryza and a typical generalized maculopapular erythematous rash. It is usually self-limited but severe complications such as encephalomyelitis may occur. In developed countries, most children are immunized as part of the vaccination programs. According to the World Health Organization, however, measles remains a leading cause of vaccine-preventable childhood mortality. Mumps Painful swelling of the salivary glands and fever is the most typical presentation of mumps infection. While symptoms are usually not severe in children, inflammation may involve ovaries and testis in adults and result in infertility, although still rare in absolute terms. The central nervous system and various organs can also be affected. Women may be at risk for spontaneous abortion if infected during the first trimester. Vaccination has dramatically reduced the incidence of the disease. Varicella Zoster Primary infection with Varicella Zoster virus (VZV) results in chickenpox, which may rarely lead to complications such as encephalitis or pneumonia. After the primary infection, VZV remains latent in the nervous system and will reactivate in 10-20% of cases, producing herpes zoster (shingles). Infection during pregnancy may lead to spontaneous abortion, fetal demise and embryopathy. Neonatal infections occur in 10-20% of neonates whose mothers became acutely infected a few days before or after delivery. Parvovirus B19 Parvovirus is responsible for Fifth Disease or erythema infectiosum. It commonly infects children and typically causes a mild rash that may resemble a slapped-cheek and various symptoms (anemia, arthralgia, fever or a flu-like syndrome). When affecting healthy children or adults, no lasting effects are observed. When contracted during pregnancy, however, transmission from mother to fetus can have serious implications such as fetal anemia and intra-uterine death.

8 Bio-Rad Laboratories I N F E C T I O U S D I S E A S E T E S T I N G Congenital and Neonatal Assay Panel Ordering Information Catalog No. Description Platelia Toxo IgG tests Platelia Toxo IgM tests Platelia Toxo IgG Avidity tests Platelia Toxo IgA tests Platelia Rubella IgG tests Platelia Rubella IgM tests Platelia CMV IgG tests Platelia CMV IgM tests Platelia CMV IgG Avidity tests Platelia HSV 1 IgG tests Platelia HSV 2 IgG tests Platelia HSV 1/2 IgM tests Pediatric Assay Panel Ordering Information Catalog No. Description Platelia Measles IgG tests Platelia Measles IgM tests Platelia Mumps IgG tests Platelia Mumps IgM tests Platelia VZV IgG tests Platelia VZV IgM tests Platelia Parvovirus B19 IgG * tests Platelia Parvovirus B19 IgM * tests * under development Bio-Rad Laboratories For further information, please contact the Bio-Rad office nearest you or visit our website at Bio-Rad, S.N.C. au capital de , Locataire-Gérant, RCS Nanterre N Intracommunautaire FR Siret Clinical Diagnostics Group Website Australia Austria Belgium Brazil Canada China Czech Republic Denmark Finland France Germany +49-(0) Greece Hong Kong Hungary India Israel Italy Japan Korea Mexico +52 (55) The Netherlands New Zealand Norway Poland Portugal Russia Singapore South Africa Spain Sweden Switzerland Thailand United Kingdom +44-(0) Bio-Rad Rev D 10/2013