REAL-TIME PCR KITS FOR DIAGNOSIS

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1 REAL-TIME PCR KITS FOR DIAGNOSIS 483

2 Reproducible, Sensitive and Precise Analysis Real Time PCR (qpcr) has revolutionized biological and medical sciences by providing quantitative detection of specific nucleic acid sequences. Today, Real Time PCR is one of the primary choices of the clinicians and laboratory professionals for the diagnosis of the pathological diseases. Efficient extraction of the viral nucleic acid from the sample, separately detected internal controls, specifically designed primers and probes, WHO calibrated external standards and consequently; reliable amplification system and analysis are all the critical parameters to get the confidential results for the detection of the specific viral nucleic acid sequences. RTA Real Time PCR Kits are the outcome of an in-depth research. They are designed for the detection of HIV-1, HBV, HCV and CMV nucleic acids in serum or plasma samples with highly accurate quantification. For your reproducible, sensitive and precise analysis; we offer you to benefit from the experience and knowledge we put in our products. Certification In Vitro Diagnostic Medical Devices Directive (98/79/EC) is a CE marking directive comprising the regulatory requirements that must be followed by in vitro diagnostic medical device manufacturers. The aim of the directive is to ensure that only safe and functional products meeting the identical quality and purity requirements are sold in diagnostic market. The quality and the compliance of RTA Real-Time PCR Kits to this directive is certified and marked with CE-IVD by MDC Medical Device Certification Notified Body (483) in Stuttgart/Germany together with the confirmation of Paul Ehrlich Institute of Germany.

3 HEPATITISB Hepatitis B Virus DNA Detection RTA HBV Real-Time PCR Kit is an in vitro nucleic acid amplification assay for the quantitation of Hepatitis B Virus RNA in human serum or plasma samples. The kit is designed to be used as an aid in the management of patients with chronic HBV infection undergoing anti-viral therapy to assess response to treatment in conjunction with all relevant clinical and laboratory finding. RTA HBV Real-Time PCR Kit provides you everything needed for a reliable and efficient detection: Very high sensitivity of detection (as few as 11.8 IU/ml) Extended linear range Complete specificity for all eight HBV genotypes Whole process check by adding the internal control during extraction 4 external quantitation standards calibrated against the WHO standards Compatibility with widely used thermal cyclers 98/79/EC EU IVD Directive compliance RTA HBV Real-Time PCR Kit is perfectly designed to amplify and detect a highly conserved region within the HBV genome by Real Time PCR. It is possible to monitor the nucleic acid amount on-line, during the reaction utilizing hydrolysis probe method in which fluorescence emission increases proportionally to the DNA amount. Sample Preparation: Nucleic acid extraction is a decisive step prior to qpcr since; providing high yields of nucleic acid and removal of PCR inhibitors in turn improve the amplification efficiency and critical for avoiding false negative PCR results. RTA HBV Real-Time PCR Kit has been validated for use with RTA Viral DNA Isolation Kit or RTA Viral Nucleic Acid Isolation Kit for its best performance. Analytical sensitivity Specificity Genotype detection Linear range Compatible RT PCR Instruments 11.8 IU/ml %1 All eight HBV genotypes 21 IU/ml 1x1 9 IU/ml Inceptra 484/964/966 Stratagene Mx3p/Mx35p Light Cycler 1.5/2. BioRad CFX96 Flourescence QS 1 QS 2 QS 3 QS 4 NC Figure 1. Detection of the quantitation standards in BioRad CFX96. NC: Negative Control Cycle number

4 HEPATITISC Hepatitis C Virus RNA Detection RTA HCV Real-Time PCR Kit is an in vitro nucleic acid amplification assay for the quantitation of Hepatitis C Virus RNA in human serum or plasma samples. The kit is designed to be used as an aid in the management of patients with chronic HCV infection undergoing anti-viral therapy to assess response to treatment in conjunction with all relevant clinical and laboratory finding. RTA HCV Real-Time PCR Kit provides you everything needed for a reliable and efficient detection: Very high sensitivity of detection (as few as 9.5 IU/ml) Extended linear range Complete specificity for all seven HCV genotypes One-step real time reverse transcription PCR Whole process check by adding the internal control during extraction 4 external quantitation standards calibrated against the WHO standards Compatibility with widely used thermal cyclers 98/79/EC EU IVD Directive compliance RTA HCV Real-Time PCR Kit is perfectly designed to amplify and detect a highly conserved region within the HCV genome by Real Time PCR. It is possible to monitor the nucleic acid amount on-line, during the reaction utilizing hydrolysis probe method in which fluorescence emission increases proportionally to the RNA amount. Sample Preparation: Nucleic acid extraction is a decisive step prior to qpcr since; providing high yields of nucleic acid and removal of PCR inhibitors in turn improve the amplification efficiency and critical for avoiding false negative PCR results. RTA HCV Real-Time PCR Kit has been validated for use with RTA Viral RNA Isolation Kit or RTA Viral Nucleic Acid Isolation Kit for its best performance. Analytical sensitivity Specificity Genotype detection Linear range Compatible RT PCR Instruments 9.5 IU/ml %1 All seven HCV genotypes 9.5 IU/ml 1x1 9 IU/ml Inceptra 484/964/966 Stratagene Mx3p/Mx35p Light Cycler 1.5/2. BioRad CFX96 Flourescence QS 1 QS 2 QS 3 QS 4 NC Figure 1. Detection of the quantitation standards in BioRad CFX96. NC: Negative Control Cycle number

5 Human Immunodeficiency Virus-1 RNA Detection HIV-1 RTA HIV-1 Real-Time PCR Kit is an in vitro nucleic acid amplification assay for the quantitation of Human Immunodeficiency Virus RNA in human serum or plasma samples. The kit is designed to be used as an aid in the management of patients with chronic HIV-1 infection undergoing anti-viral therapy to assess response to treatment in conjunction with all relevant clinical and laboratory finding. RTA HIV-1 Real-Time PCR Kit provides you everything needed for a reliable and efficient detection: Very high sensitivity of detection (as few as 85 IU/ml) Extended linear range Complete specificity for all major nine HIV-1 genotypes One-step real time reverse transcription PCR Whole process check by adding the internal control during extraction 4 external quantitation standards calibrated against the WHO standards Compatibility with widely used thermal cyclers 98/79/EC EU IVD Directive compliance RTA HIV-1 Real-Time PCR Kit is perfectly designed to amplify and detect a highly conserved region within the HIV-1 genome by Real Time PCR. It is possible to monitor the nucleic acid amount on-line, during the reaction utilizing hydrolysis probe method in which fluorescence emission increases proportionally to the RNA amount. Sample Preparation: Nucleic acid extraction is a decisive step prior to qpcr since; providing high yields of nucleic acid and removal of PCR inhibitors in turn improve the amplification efficiency and critical for avoiding false negative PCR results. RTA HIV-1 Real-Time PCR Kit has been validated for use with RTA Viral Nucleic Acid Isolation Kit for its best performance. Analytical sensitivity Specificity Genotype detection Linear range Compatible RT PCR Instruments 85 IU/ml %1 All nine HIV-1 genotypes 85 IU/ml 1x1 9 IU/ml Inceptra 484/964/966 Stratagene Mx3p/Mx35p Light Cycler 1.5/2. BioRad CFX96 Flourescence QS 1 QS 2 QS 3 QS 4 NC Figure 1. Detection of the quantitation standards in BioRad CFX96. NC: Negative Control Cycle number

6 Cytomegalovirus DNA Detection CMV RTA CMV Real-Time PCR Kit is an in vitro nucleic acid amplification assay for the quantitation of Cytomegalovirus RNA in human serum or plasma samples. The kit is designed to be used as an aid in the management of patients with chronic CMV infection undergoing anti-viral therapy to assess response to treatment in conjunction with all relevant clinical and laboratory finding. RTA CMV Real-Time PCR Kit provides you everything needed for a reliable and efficient detection: Very high sensitivity of detection (as few as 13 IU/ml) Extended linear range Complete specificity for All relevant genotypes and subtypes Whole process check by adding the internal control during extraction 4 external quantitation standards calibrated against the WHO standards Compatibility with widely used thermal cyclers 98/79/EC EU IVD Directive compliance RTA CMV Real-Time PCR Kit is perfectly designed to amplify and detect a highly conserved region within the CMV genome by Real Time PCR. It is possible to monitor the nucleic acid amount on-line, during the reaction utilizing hydrolysis probe method in which fluorescence emission increases proportionally to the DNA amount. Sample Preparation: Nucleic acid extraction is a decisive step prior to qpcr since; providing high yields of nucleic acid and removal of PCR inhibitors in turn improve the amplification efficiency and critical for avoiding false negative PCR results. RTA CMV Real-Time PCR Kit has been validated for use with RTA Viral DNA Isolation Kit or RTA Viral Nucleic Acid Isolation Kit for its best performance. Analytical sensitivity Specificity Genotype detection Linear range Compatible RT PCR Instruments 13 IU/ml %1 All relevant genotypes and subtypes 85 IU/ml 1x1 9 IU/ml Inceptra 484/964/966 Stratagene Mx3p/Mx35p Light Cycler 1.5/2. BioRad CFX96 Flourescence QS 1 QS 2 QS 3 QS 4 NC Figure 1. Detection of the quantitation standards in BioRad CFX96. NC: Negative Control Cycle number

7 MASTER MIX DNA qpcr Probe Master Mix RTA DNA qpcr Master Mix Kit is a ready-to-use, master mix that contains all the reagents (except primers, probes and templates) needed for running quantitative, real-time DNA detection assays. Convenient use - minimizing pipetting steps High sensitivity of detection High stability and efficiency minimum variation between results RTA DNA qpcr Master Mix Kit is also convenient for several purposes including the analyzing of gene expression, microbial detection and the determination of viral load. Ordering List HBV DNA Real Time PCR Kit HCV RNA Real Time PCR Kit Test: 25 Catalog#: Test: 25 Catalog#: Test: 1 Catalog#: 9111 Test: 1 Catalog#: 9121 HIV-I RNA Real Time PCR Kit CMV Real Time PCR Kit Test: 25 Catalog#: Test: 25 Catalog#: Test: 1 Catalog#: 9131 Test: 1 Catalog#: 9141 DNA QPCR Master Mix Kit Test: 25 Catalog#: 9325 Test: 1 Catalog#: 931 Test: 5 Catalog#: 935

8 RTA.BR.3 Rev.Date/Rev.No: -/ Rta Laboratories Plastikçiler OSB (Geposb) Cumhuriyet Cad. No:3 414 Gebze / Kocaeli - Turkey T: F:

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