Innovation in Diagnostics. ToRCH. A complete line of kits for an accurate diagnosis INFECTIOUS ID DISEASES

Transcription

1 Innovation in Diagnostics ToRCH A complete line of kits for an accurate diagnosis INFECTIOUS ID DISEASES EN

2 TOXOPLASMOSIS Toxoplasmosis is a parasitic disease caused by with the obligate intracellular protozoan Toxoplasma gondii. Although the are usually either asymptomatic or associated with self-limited symptoms in adults (e.g., fever, malaise and lymphadenopathy), in pregnant women can cause serious health problems in the fetus if the parasites are present. The diagnosis of Toxoplasma gondii may be established by serologic tests, amplification of specific nucleic acid sequences (PCR), histological demonstration of the parasite and/or its antigens or by isolation of the organism. The use of serologic tests for demonstration of specific antibody to Toxoplasma gondii is the initial and primary method of diagnosis. Serological screening relies on IgG and IgM antibody determinations. The presence of elevated levels of Toxoplasma specific antibodies indicates has occurred at some point, but does not distinguish between an acquired recently and one acquired in the distant past. In acute, IgG and IgM antibodies generally rise 1 to 2 weeks of. Detection of Toxoplasma specific IgM antibodies is so used as an aid in determining the time of, but it is critical to remind that IgM antibodies have been reported to persist for up to 18 post. To differentiate between a recently acquired and a past, IgM and IgG positive specimens should be tested for IgG avidity. A high avidity index for IgG antibodies is a strong indication that an took place more than 4-5 ago. TGS TA TOXO The TGS TA TOXO IgG kit and the TGS TA TOXO IgG Avidity kit employ an indirect two-step immunological method while the TGS TA TOXO IgM kit employs a capture two-step immunological method. Both methods are based on the principle of chemiluminescence. Low Avidity IgM Negative (positive) IgG IgM Avidity Diagnosis Negative Negative No (susceptible) IgM IgG Past Negative Positive Not applicable Very early Positive Positive Low Positive Positive High Past (long lasting IgM) Positive Negative High Past INNOVATION IN DIAGNOSTICS

3 FEATURES EASY HANDLING Full automation. All reagents are ready to use. ACCURACY Highly purified proteins ensure an accurate determination of the specific antibodies preventing the interference from other infectiuous agents. FLEXIBILITY Patient specific test profiles and various operation modes: random access, Batch, STAT. EFFICIENCY Compact, quick and walk-away system. High analytical output. First results in 25 minutes. On board storage of refrigerated reagents. RELIABILITY Accurate and reproducible results thanks to the CLIA (Chemiluminescence immunoassay) method, which uses coated micro-particles with large and consistent coating area. RUBELLA Rubella is a mild exanthematous and moderately contagious disease caused by Rubella virus, which is the sole member of the Rubivirus genus of the Togavirus family. Rubella antibody testing are the main diagnostic tool available to either establish a previous exposure to Rubella or Rubella vaccination or a current /re- with Rubella. A primary acute Rubella is associated with an elevated IgM antibody response to the Rubella virus; Rubella virus specific IgM are detectable after the incubation period and usually disappear after approximately 8 weeks, although in rare cases they may be present a year or more after natural or vaccination and after asymptomatic re. Rubella virus specific IgGs appear immediately after IgMs and they show a greater-than-fourfold rise in their titer and persist for life. In addition to IgM and IgG determinations immunoglobulin G avidity testing has been shown to be useful for differentiating recent from past Rubella, investigating suspected Rubella in pregnant women and congenital Rubella syndrome. TGS TA RUBELLA The TGS TA RUBELLA IgG kit and the TGS TA RUBELLA IgG Avidity kit employ an indirect two-step immunological method while the TGS TA RUBELLA IgM kit employs a capture two-step immunological method. Both methods are based on the principle of chemiluminescence. Low Avidity IgM Negative (positive) IgG IgM Avidity Diagnosis Negative Negative No (susceptible) IgM IgG Past Negative Positive Not applicable Very early Positive Positive Low Positive Positive High Past (long lasting IgM) Positive Negative High Past

4 CYTOMEGALOVIRUS Human Cytomegalovirus belongs to the herpes virus family. It s the most common agent of viral intrauterine and affects % of all live newborns in different parts of the world. In pregnant women, distinguishing the primary from non-primary HCMV is important. This is also true for immunocompromised patients, in whom primary s are often accompanied by symptoms, whereas reactivation is usually asymptomatic. The serological diagnosis of recently acquired HCMV is based on the detection of specific IgM antibodies, seroconversion or a significant increase in specific IgG antibody concentrations. Since seroconversion, the most dependable serological marker, and a rise in IgG titres are seldom demonstrable, the detection of HCMV IgM antibodies is the most frequently used serological procedure for diagnosing acute s. However, in some persons, IgM may be detected for many following primary and may also be produced following re or reactivation. Moreover, false positive HCMV results may occur with other herpesviruses and with some autoimmune disorders. In addition to IgM and IgG determinations immunoglobulin G avidity testing has been shown to be useful for differentiating recent from past cytomegalovirus and investigating suspected CMV in pregnant women. TGS TA CMV All the TGS TA CMV kits employ an indirect two-step immunological method based on the principle of chemiluminescence. The TGS TA CMV IgM kit requires a pre-treatment of samples with anti-igg antibody in order to eliminate human immunoglobulins G (IgG) and Rheumatoid Factor (FR). Low Avidity IgM Negative/Positive IgG IgM Avidity Diagnosi IgM Past IgG Negative Negative No Negative Positive Not applicable Very early Positive Positive Low Positive Positive High Reactivation / Past (long lasting IgM) Positive Negative High Past INNOVATION IN DIAGNOSTICS

5 HERPES SIMPLEX VIRUS Type 1 and 2 Herpes Simplex viruses (HSV 1, HSV 2) belong to the Herpesviridae family, in the Alphaherpesvirus subfamily and both are human pathogens. Diagnosis of primary s is based on detection of specific IgM class antibodies as well as to demonstrate seroconversion or a significant increase in the concentration between acute and convalescent sera. Many serological tests offered on the market use purified viral lysates. Given that the cross-reaction between the two HSV serotypes is highly significant, use of these viral lysates does not permit correct differentiation between HSV 1 and HSV 2. The use of recombinant membrane glycoproteins specific for the type of virus makes possible distinguish exactly the patient s immune status. The specific recombinant glycoproteins are gg1 for the type 1 virus and gg2 for the type 2 virus. They are used both to monitor the primary, by detecting the specific IgM antibodies, and the patient s immune status, by detecting the specific IgG antibodies. TGS TA HSV All the TGS TA HSV kits employ an indirect two-step immunological method based on the principle of chemiluminescence. The TGS TA HSV 1 / 2 IgM kit requires a pre-treatment of samples with anti-igg antibody in order to eliminate human immunoglobulins G (IgG) and Rheumatoid Factor (FR). IgG IgM Diagnosis HSV IgG Negative Negative No Primary Infection HSV IgM Reactivation Negative Positive Positive Positive Recent or Reactivation Positive Negative Past INNOVATION IN DIAGNOSTICS

6 INNOVATION IN DIAGNOSTICS Kit Antigen Number of Tests TGS TA Toxo IgG YB TGS TA Toxo IgM YB TGS TA Toxo IgG Avidity YB purified T. gondii antigens highly purified p30 purified T. gondii antigens Incubation Stability of Calibration Measuring Range IU/mL (I.S. 01/600) Throughput First Result Relative Sensitivity Relative Specificity 70 test/h 24 min 94.7% 99.3% 63 test/h 35 min 86.4% 93.3% Shelf Life Method CAPTURE test/h 35 min CLIA 3 Steps TGS TA Rubella IgG YB TGS TA Rubella IgM YB TGS TA Rubella IgG Avidity YB purified virus (E1, E2, Core) IU/mL (I.S. RUBI-1-94) test/h 24 min 98.3% 92.6% 63 test/h 35 min 96.6% 99.3% CAPTURE test/h 35 min CLIA 3 Steps TGS TA CMV IgG YB TGS TA CMV IgM YB TGS TA CMV IgG Avidity YB purified viral lysate AD test/h 24 min 98,6% 84,6% 38 test/h 45 min 97,0% 99,1% with Pre-treatment test/h 35 min CLIA 3 Steps TGS TA HSV 1 IgG YB TGS TA HSV 2 IgG YB TGS TA HSV 1/2 IgM YB gg1 Rec gg2 Rec gg1 Rec.+ gg2 Rec test/h 24 min 94,4% 97,3% 70 test/h 24 min 99,1% 94,1% 38 test/h 45 min 77,8% 97,7% with Pre-treatment Control Set TGS TA Toxo Control Set YB TGS TA Rubella Control Set YB TGS TA CMV Control Set YB TGS TA HSV 1 / 2 IgG Control Set YB TGS TA Toxo Av. Control Set YB TGS TA Rubella Av. Control Set YB TGS TA CMV Av. Control Set YB TGS TA HSV 1 / 2 IgM Control Set YB Patient specific test profiles. Operational modes: Random access, Batch, STAT. Continous loading and barcode identification of samples and reagents. On board storage of refrigerated reagents. TGS TA ANALYSER 0 Disposable cuvettes to avoid cross/reactions. 2-point recalibration mathod. First result: 24 minutes. Throughput: 70 test/h. Up to 15 different immunoassays on board. The TGS TA kits are available on IDS-iSYS Multi-Discipline Automated System too. Technogenetics Srl via Vanvitelli Milano, Italy info@technogenetics.it Vers.: 01/2015