For in vitro diagnostic use. Others LightMix in-vitro diagnostics kit Polyomaviruses JC and BK IVD LightMix® in-vitro diagnostics kit Polyomaviruses JC and BK 100 1377683945183 This product is not a Roche product, Roche Global Customer Support is not offering any Support. For any additional information and support please ONLY contact TIB MolBiol directly. Furthermore we can not guarantee that all available information for this product is up to date. TIBMOLBIOL-0205 Detection of JCV and BKV genomic DNAfor use with the Roche Diagnostics LightCycler® Instruments 06 295 100 001 6 295 100 001 06295100001 6295100001 06295100001 LightMix Polyomavirus JC BK LightMix Polyomavirus JC BK 04260159332155 Reagents, kits 40-0206-32 96 reactions Not Available false This product is an in-vitro nucleic acid amplification test for the detection and quantification of genomic DNA from Polyomavirus BK from nucleic acid extracts obtained from human plasma, serum, blood or urine. This product allows also to detect Polyomavirus JC and to estimate the quantities. This kit product does not detect Polyomaviruses KI or WU.The amount of virus in these body fluids is an indication for reactivation of virus in immune incompetent patients, in particular in renal transplant patients.This test is intended to be used to monitor polyoma virus amounts in blood or urine (viral load) in kidney transplant patients who are at risk of developing Polyomavirus Nephropathy (PVAN). The test result shall inform the clinician about an impending damage of the kidney.This test is not intended to identify viral subtypes.Results are reported as virus copies/ml of sample.Polyomaviruses are widespread in the population and commonly asymptomatic in healthy individuals. Detection of virus in urine from healthy subjects is no indication for a disease requiring treatment.The present diagnostic device must be used by qualified personnel only.Note: The performance of the assay can be guaranteed only when used with LightCycler® Instruments.One kit contains reagents for 96 reactions performed in a 20 μl volume.Each run requires including two standards and one negative control.The table below summarizes some features of the kit :LightCycler®InstrumentSoftwareVersion(or higher)Total PCRRun Time(approx.)MaximumSamplesper run (2)MaximumProductivityof the kit(3)MinimumProductivityof the kit (4)LC 1.24.10 (1)70 min29 + 3 ctrl.7521LC 1.54.10 (1)70 min29 + 3 ctrl.7521LC 2.04.0570 min29 + 3 ctrl.7521LC480 II (6) (96 wells)1.5100 min93 + 3 ctrl.8121LC480 II (6) (384 wells)1.5100 min381(5) + 3 ctrl.8121z 480 (open channel)1.5100 min93 + 3 ctrl.8121Running the test with the LightCycler® 1.2 or 1.5 Instruments with the software version 3.5 yields comparable results. Instruction for programming, data analysis and interpretation of results are not described in this manual. Upgrade to version 4.10 or higher when possible.Each run must include two standards and one No-Target Control (NTC) for a total of 3 control reactions.The first run of the kit requires including 15 controls (instead of 3) to teach the quantification module. The maximum number of samples that can be processed is reduced accordingly.Calculated considering a single clinical sample analyzed in each run.It requires using four kits.LightCycler® 480 “first version” cannot be used with this kit. en This device detects a fragment of the Polyomaviruses JC and/or BK genome in a nucleic acid extract obtained from blood or urine.This device does not detect Polyomavirus KI (Allander et al., 2007)6 or WU (Gaynor et al., 2007)7. Pathogenicity and prevalence are not known; WU virus has been found in particular in patients with acute respiratory tract infection.A 172-175 bp long fragment of the Small t-Antigen gene is amplified with specific primers and detected with a universal fluorescein donor probe and virus specific probes labeled with LightCycler® Red 690 for JCV and 640 for BKV, similar to the assay described by Narayanan et al., 20074.After every PCR cycle the probes bind during the annealing step to the PCR generated target and bring the fluorophores in close proximity. The donor fluorophore fluorescein is excited by light, part of the energy is transferred to the acceptor dye and detected. The fluorescence intensities are plotted against the cycle number, giving a picture of the amplification and to calculate a crossing point (Cp) which is related to the log of the concentration of target in the sample.Hybridization Probes can be used to identify the PCR product in a melting curve analysis in order to verify that the right product has been formed. The melting point (Tm) is dependent on length and G+C content, but also upon the degree of homology to the sensor probe. In this device the Tm is not used for virus discrimination; slight temperature shifts are acceptable as the shape of curve depends also on the amount of product. However, a significant decrease in the Tm is an indication of a sequence variation, explaining an eventual lower signal level in the quantification plot and may give cause for a subsequent analysis of the sample by DNA sequencing (please contact us at: [email protected]).The supplied control DNA allows comparison with unknown patient samples.4.Narayanan M, Szymanski J, Slavcheva E, Rao A, Kelly A, Jones K, Jaffers G. BK virus associated renal cell carcinoma: case presentation with opti-mized PCR and other diagnostic tests. Am J Transplant 7(6):1666-71 (2007).6. Allander et al., 2007 Identification of a Third Human Polyomavirus. J Virol 81: 4130–41367.Gaynor et al. 2007 Identification of a Novel Polyomavirus from Patients with Acute Respiratory Tract Infections. PLoS Pathogens 3 (5): e64 en

LightMix^® in-vitro diagnostics kit Polyomaviruses JC and BK

Detection of JCV and BKV genomic DNA
for use with the Roche Diagnostics LightCycler^® Instruments

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LightMix^® in-vitro diagnostics kit Polyomaviruses JC and BK

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