AmoyDx KRAS/NRAS Mutations Detection Kit

Size: px
Start display at page:

Download "AmoyDx KRAS/NRAS Mutations Detection Kit"

Transcription

1 AmoyDx KRAS/NRAS Mutations Detection Kit Detection of 19 KRAS mutations (exons 2, 3 and 4) and 13 NRAS mutations (exons 2, 3 and 4) Instruction for Use Instruction Version: P1.0 Revision Date: September 2014 Store at -20±5 Address: 5th Floor, No.4 Plant, Kechuang Center Building, 289 Wengjiao Road, Xinyang Street, Haicang District, Xiamen,

2 Background RAS protein is a GTPase and one of the key molecules in the downstream signaling pathway of epidermal growth factor receptor (EGFR). RAS protein transduces signals from membrane-bound receptors via multiple downstream effector pathways and thereby affects fundamental cellular processes, including proliferation, apoptosis, and differentiation. In total, activating KRAS and NRAS mutations occur in 20~50% and 1~6% of colorectal cancer respectively, mainly in exons 2, 3 or 4. The mutation status of the RAS gene is relevant to the primary drug resistance of colorectal cancers treated with tyrosine kinase inhibitors. Patients with wild-type KRAS and NRAS gene could benefit from Erbitux (Cetuximab) or Vectibix (Panitumumab), whereas, the patients with mutant KRAS or NRAS gene show poor response to this treatment. The NCCN Clinical Practice Guideline in Oncology for colorectal cancers and European Drug Administration Organization suggest the employment of KRAS and NRAS gene mutation detection prior to the use of targeted medicines Erbitux and Vectibix in the treatment of metastatic colorectal cancer. As a result, KRAS and NRAS mutations detection supplies evidence for targeted clinical therapy of tumor patients, which decreases cost and time of treatment. The AmoyDx KRAS/NRAS Mutations Detection Kit is a real-time PCR test intended for qualitative detection of 19 KRAS mutations (exons 2, 3 and 4) and 13 NRAS mutations (exons 2, 3 and 4). Our company s patented technology allows detection of 1~5% mutant DNA in a background of 95~99% normal DNA at 10 ng sample DNA amount, while ensuring that false negatives are minimized. The purpose of the kit is to aid doctors to identify lung cancer or colorectal cancer patient carrying mutations in KRAS/NRAS gene. Intended Use The AmoyDx KRAS/NRAS Mutations Detection Kit is a highly sensitive test designed to accurately identify 19 KRAS mutations (exons 2, 3 and 4) and 13 NRAS mutations (exons 2, 3 and 4) in human tissue samples. Kit Contents This kit contains sufficient reagents to carry out 6 tests (Table 1). Table 1 Kit Contents Contents KN PCR Reaction Mix KN Enzyme Mix KN Positive Control Volume 8 strips 45μL 250 μl One 12-tube strip is employed for each sample (Table 2). Table 2 Mutation information for each strip Tube No. Mutation Name Volume (μl) Channel KN Reaction Mix 1 35 FAM, HEX/VIC KN Reaction Mix 2 35 FAM, HEX/VIC KN Reaction Mix 3 35 FAM, HEX/VIC KN Reaction Mix 4 35 FAM, HEX/VIC KN Reaction Mix 5 35 FAM, HEX/VIC KN Reaction Mix 6 35 FAM, HEX/VIC 1/8

3 KN Reaction Mix 7 35 FAM, HEX/VIC KN Reaction Mix 8 35 FAM, HEX/VIC KN Reaction Mix 9 35 FAM, HEX/VIC KN Reaction Mix FAM, HEX/VIC KN Reaction Mix FAM, HEX/VIC KN External Control Reaction Mix 35 FAM Note: Distinguish Tube from Tube according to the trapezoid end of strip edge, described as follows. Equipment and Reagents Not Supplied With Kit 1. The compatible PCR instruments are: Stratagene Mx3000P /Mx3005P, ABI7500, ABI7900HT and LightCycler480. (1) This kit is compatible with LightCycler480 II instrument. Fluorescence calibration is required for LightCycler480 I instrument. If the fluorescence crossover occurs in the LightCycler480 II instrument, the fluorescence calibration is also needed prior to the operation. To run the assay on a LightCycler machine, please use the Roche 480 adaptor, available from BIOplastics, Cat No. B It s essential to place a 12-tube strip on the first row (Row A) of the adaptor. (2) For ABI instruments please set up as follows: Reporter Dye: FAM, VIC; Quencher Dye: TAMRA; Passive Reference: NONE. (3) To run the assay on ABI 7500 machine, please use the 96-well plate adaptor. (4) To run the assay on ABI7900HT machine, please use the ABI7900 adaptor, available from BIOplastics, Cat No. B7900RAN. (5) For ABI7900HT, please set up as follows: Instrument: Standard. Ramp speed: Standard. Reaction volume: 40 μl. (6) For Stratagene Mx3000P /Mx3005P, if there s low net fluorescence signal (dr) but high background signal (R), please reduce the signal gain setting of instrument properly. (7) We recommend that all PCR instruments in use should be conducted fluorescence calibration once a year. 2. Sterile, nuclease-free tubes. 3. Dedicated pipettes and filtered pipette tips for handling DNA. 4. Sterile, nuclease-free H 2 O. Shipping and Storage The kit requires cold-chain-transportation. All contents of the kit should be stored immediately upon receipt at -20±5. Avoid unnecessary freezing and thawing of the contents of the kit. Do not use the reagent after five freeze-thaw cycles. Once opened, this reagent is stable at -20±5 until the expiry. Stability The shelf-life of the kit is 8 months when stored under the recommended conditions and in the original packaging. Do not use the kit after the stated expiry date. 2/8

4 Specimen Material Human genomic DNA should be extracted from tissue or formalin-fixed paraffin-embedded (FFPE) samples and stored at -20±5 prior to use. The FFPE samples should be made and stored following proper procedures. The slides should preferably be less than 3 years. Before extraction of DNA, it is very important to make sure that there is at least 30% tumor cells in the tissue samples. If the extracted DNA is not used immediately, it should be stored at below -20 for no more than 6 months. Selection of high quality DNA extraction reagents is essential for the kit. We recommend use of DNA extraction kit (AmoyDx FFPE DNA Kit, Cat No. ADx-FF01, for paraffin embedded specimens; AmoyDx Tissue DNA Kit, Cat No. ADx-TI01, for tissue and pleural effusion specimens). The OD value of DNA samples should be measured using the spectrophotometer after extraction. Make sure A 260 /A 280 value between 1.8 and 2.0. Technological Principles The kit uses ADx-ARMS technology, which comprises novel, specific primers and fluorescent probes to detect mutations and reference gene in a real-time PCR assay. The mutant DNA is amplified accurately by the specific primers, and detected by the novel probes. Highly Specific primers and probes, and a highly validated procedure based on Taq DNA polymerase contribute to outstanding assay sensitivity and selectivity. Protocol 1. The reaction mix tubes contain the reaction buffer, dntps, specific oligos and probes. 2. The KN Reaction Mix 1~11 includes a mutation detection system and an internal control system. The mutation detection system is used to detect the mutation status of KRAS and NRAS gene (positive or negative). The internal control system is designed to detect the presence of inhibitors and monitor the accuracy of experimental operation, which may lead to false negative results. 3. The KN External Control Reaction Mix is used to assess the DNA quality, that is, to reveal the presence of PCR inhibitors or compromised DNA integrity that may lead to false negative results. 4. The KN Positive Control contains a recombinant gene with the 19 KRAS mutations, 13 NRAS mutations, and normal human genomic DNA. 5. The KN Enzyme Mix contains the Taq DNA polymerase for PCR amplification and uracil-n-glycosylase which works at room temperature to prevent PCR amplicon carryover contamination. Experimental Procedure 1. Thaw KN Positive Control at room temperature. When the reagents completely thawed, mix the reagents by inverting the tube 10 times and centrifuge briefly to collect the contents at the bottom of the tube. 2. Centrifuge KN Enzyme Mix prior to use. 3. Add 4.2 μl KN Enzyme Mix into the following solutions individually: 65.8 μl DNA sample (see following for DNA sample concentrations), 65.8 μl KN Positive Control (PC) and 65.8 μl no-template controls (sterile water, NTC). 4. Mix each solution thoroughly by inverting 10 times and then centrifuge briefly. (1) According to different sources, samples can be divided into two groups: paraffin embedded and non-paraffin embedded specimens. (2) Non-paraffin embedded specimens include fresh tissue, frozen pathological sections, non-heparin anticoagulant plasma, serum and non-heparin anticoagulant blood. a) For non-paraffin embedded samples, the recommended DNA amount in each PCR tube is 1.88 ~ 4.7 ng 3/8

5 (concentration 0.4~1 ng/μl). (3) For paraffin embedded samples, we recommend use of 7.05~14.1 ng template DNA (concentration 1.5~3 ng/μl) in each PCR tube depending on storage times. a) Use 7.05 ng template DNA (concentration 1.5 ng/μl) for samples with less than 3 months storage time. b) Use 9.4 ng template DNA (concentration 2 ng/μl) for samples with storage time between 3 months and 1 year. c) Use 11.75~14.1 ng template DNA (concentration 2.5~3 ng/μl) with storage time between 1 year and 3 years. d) Avoid use DNA for samples with more than 3 years storage time. Note: We recommend use of TE (ph = 8.0) for extracted DNA dilution. Suggest using at least 5 μl DNA for dilution within ten-fold series, to ensure the accuracy of final concentration. Since Enzyme Mix is viscous, please pay attention to the centrifugation and pipetting process. Minimize the contact interface between the pipette tip and Enzyme Mix to avoid adding excess enzyme. Avoid vortexing solutions with Enzyme Mix. 5. Take out the KN PCR Reation Mix strips and centrifuge the strips if there are any reagent droplets in the caps of the PCR tubes. Then briefly uncover the caps prior to use. 6. Transfer 5 μl of the above mixed solution to each PCR tube of 12-tube strip. Add the solution to the side of the tube wall above the reagents in the tube, and then seal the strips. 7. Spin or centrifuge the PCR tubes in order to collect the reagents at the bottom of wells. Note: this spin or centrifuge step is essential for proper mixing of the reagents. 8. Place the PCR tubes into the real-time PCR instrument. A recommended plate layout is shown in Table 3. Note: place the PCR tubes into the real-time PCR instrument and start to run immediately. If not, please store the PCR tubes at 4 for no more than 12 hours. Table 3 Suggested PCR Plate Layout Well A Sample 1 Sample 1 Sample 1 Sample 1 Sample 1 Sample 1 Sample 1 Sample 1 Sample 1 Sample 1 Sample 1 Sample 1 B Sample 2 Sample 2 Sample 2 Sample 2 Sample 2 Sample 2 Sample 2 Sample 2 Sample 2 Sample 2 Sample 2 Sample 2 C Sample 3 Sample 3 Sample 3 Sample 3 Sample 3 Sample 3 Sample 3 Sample 3 Sample 3 Sample 3 Sample 3 Sample 3 D Sample 4 Sample 4 Sample 4 Sample 4 Sample 4 Sample 4 Sample 4 Sample 4 Sample 4 Sample 4 Sample 4 Sample 4 E Sample 5 Sample 5 Sample 5 Sample 5 Sample 5 Sample 5 Sample 5 Sample 5 Sample 5 Sample 5 Sample 5 Sample 5 F Sample 6 Sample 6 Sample 6 Sample 6 Sample 6 Sample 6 Sample 6 Sample 6 Sample 6 Sample 6 Sample 6 Sample 6 G PC PC PC PC PC PC PC PC PC PC PC PC H NTC NTC NTC NTC NTC NTC NTC NTC NTC NTC NTC NTC 9. Carry out real-time PCR using the cycling conditions described in Table 4. Note: The reaction volume is 40 μl per well. Please pack the post-pcr tubes with two disposable gloves and discard properly. Do NOT open the post-pcr tubes to avoid contamination. 4/8

6 Table 4 Cycling Parameters Sample Data Analysis Stage Temperature Time Cycles min /8 25s 20s 20s 25s 35s Data collection of FAM and HEX/VIC 1. The FAM signals of tubes 1~11 indicate the mutation status of the sample. The HEX/VIC signals indicate the internal control status. The internal control amplifies and detects a region of genomic DNA adjacent to the KRAS/NRAS gene. 2. Ensure the calibration fluorescence is unselected, and select single mutation detection for each tube accordingly. It is necessary to choose the reaction wells for positive control, no-template control and sample simultaneously. Then users could adjust the threshold of FAM amplification curve, and obtain the Ct value of mutant group. 3. The threshold at which the signal is detected above background fluorescence is called the Cycle threshold (Ct). The Ct values used to determine if a sample is positive or negative are based on extensive validation. If the Ct value falls within the appointed range, the sample is classed as positive. If the Ct value is outside the appointed range, the sample is classed as negative or below the detection limit of the kit. 4. Assess each NTC Ct value to ensure that there is no positive amplification, if the NTC has positive amplification, the data must be discarded as there is contamination. If the HEX/VIC signal of Tube 1~11 and FAM signal of Tube 12 occasionally rises, further analysis could be carried out. 5. The KN Positive Control FAM Ct value should be less than 20, but variation may occur due to different threshold settings on different instruments. 6. If the HEX/VIC signals of a sample fail but the FAM signal works well, continue with the analysis. If both the HEX/VIC and FAM signals fail, the obtained data must be discarded and the experiment should be repeated. 7. Check the FAM signal of the external control assay: (1) Ct value should be between 15~21. (2) If the requirements of item (1) are satisfied, further analysis shall be carried out. However, if Ct value is less than 15, it indicates the DNA is overloaded, so the amount of DNA should be reduced. If all the results of 11 tubes (1~11) are negative, the sample is classified as negative. (3) If the external control assay fails, it shows that the DNA template contains PCR inhibitors, indicating that the DNA needs to be re-extracted. If the sample FAM Ct value in any of the 11 tubes (1~11) is less than 26, the sample is classified as positive. 8. Analysis of mutation assay results (see Table 5): Check the FAM Ct value for each sample. Based on different mutant Ct values, the detection results are divided into strong positive, weak positive or negative. (1) Strong Positive: if the sample FAM Ct value is less than 26, the sample is classified as strong positive. (2) Weak Positive: if the sample FAM Ct value is in the range shown in the Weak Positive in Table 5, the 20s 15 31

7 sample is provisionally classified as weak positive. a) If the FAM Ct value is in the Weak Positive range, the Ct of the reaction tube is calculated to confirm the result. If the Ct value is less than the corresponding Ct Cut-off value, the sample is confirmed as weak positive. If the Ct value is greater than the Ct Cut-off value, the sample is classified as negative or below the limits of the kit. b) The calculation of Ct: Ct = mutant FAM Ct value external control FAM Ct value. The mutant FAM Ct value indicates the Ct value of the mutant FAM signal from a sample. The external control FAM Ct value indicates the Ct value of the FAM signal in external control tube of that sample. (3) Negative: if the sample FAM Ct value is greater than or equal to the critical negative value shown in the Negative in Table 5, the sample is classified as negative or below the detection limit of the kit. Table 5 Results Determination Strong Positive Weak Positive Negative Tube No Mutant Ct Value Ct <26 Ct <26 Ct <26 Ct <26 Ct <26 Ct <26 Ct <26 Ct <26 Ct <26 Ct <26 Ct <26 Mutant Ct Value 26 Ct <28 26 Ct <29 26 Ct <29 26 Ct <29 26 Ct <29 26 Ct <29 26 Ct <28 26 Ct <29 26 Ct <29 26 Ct <28 26 Ct <29 Ct Cut-off value Mutant Ct Value Ct 28 Ct 29 Ct 29 Ct 29 Ct 29 Ct 29 Ct 28 Ct 29 Ct 29 Ct 28 Ct The sample may contain two or more mutations simultaneously. Performance Characteristics The performance characteristics of this kit were validated on Stratagene Mx3000P /Mx3005P, ABI7500, ABI7900HT and LightCycler Sensitivity: (1) For Stratagene Mx3000P /Mx3005P, the kit allows detection of 1% mutant DNA in a background of 99% normal DNA at 10 ng sample DNA amount. (2) For other PCR instruments, the kit allows detection of 1% mutant DNA in a background of 99% normal DNA at 10 ng sample DNA amount. Except: the sensitivity of NRAS-M1, NRAS-M2 and NRAS-M12 mutations are 2% at 10 ng sample DNA amount, the sensitivity of KRAS-M22 and KRAS-M23 mutations are 5% at 10 ng sample DNA amount. 2. Productivity: the kit can be used to analysis 6 samples maximum. (see Table 6) Table 6 Sample Qty detected with the Kit PCR Run(s) Control Qty Total samples can be detected 1 run 2 (2 controls/run * 1) 6 2 runs 4 (2 controls/run * 2) 4 3. Accuracy: Accuracy of the kit was established by testing 32 mutant positive reference controls and 10 negative reference controls, the detection concordance rate are 100%. 4. Precision: Precision of the kit was established by performing a certain mutant positive reference control for 10 repeats; all the controls can be detected. Warnings and Precautions 1. Please read the instruction carefully and become familiar with all components of the kit prior to use. 2. The product specified above does not contain any virus, reagent by-product of the same or metabolic 6/8

8 by-product of Hepatitis A, B, C, D or HIV. 3. Do not exchange and mix up the kit contents with different batches. 4. The kit and its contents cannot be resold or modified for resale without the written approval of manufacturer. 5. Using other sources of reagents is not recommended. Strictly distinguish the reagents from Positive Control to avoid contamination. Otherwise, false positive may be produced. 6. Do the experiments with attention to prevent exogenous DNA contamination to reagents. It is recommended that, use separate, dedicated pipettes and filtered pipette tips to add DNA template during the preparation of reagents. 7. To optimize the activity and performance, mixtures should always be protected from light to avoid photo bleaching. 8. All the chemicals are potential hazard, only trained professionals could use this kit. Please wear suitable lab coat and disposable gloves. The used kit should be disposed properly. 9. The kits can t detect KRAS and NRAS mutations other than those listed in Appendix I. 10. Wipe down the work area, spray down the pipettes and equipment with 75% ethanol or 10% hypochlorous acid. 11. The flow of tubes, racks, pipets and other equipment used should be from pre-amplification to post-amplification, and never backwards. Notes 1. Symbol for "AUTHORISED REPRESENTATIVE IN THE EUROPEAN COMMUNITY" 2. Symbol for "IN VITRO DIAGNOSTIC MEDICAL DEVICE" 3. Symbol for "KEEP DRY" 4. Symbol for "THIS WAY UP" 5. Symbol for "FRAGILE HANDLE WITH CARE" Information of European Authorised Representative Wellkang Ltd t/a Wellkang Tech Consulting Suite B, 29 Harley Street, London W1G 9QR United Kingdom References 1. Douillard JY, Oliner KS, Siena S, et al Panitumumab-FOLFOX4 Treatment and RAS Mutations in Colorectal Cancer. The New England Journal of Medicine, 369 (11): Di M, Pietrantonio F, Perrone F, et al Lack of KRAS, NRAS, BRAF and TP53 mutations improves outcome of elderly metastatic colorectal cancer patients treated with cetuximab, oxaliplatin and UFT. Targeted Oncology, Roock WD, Claes Bart, Bernasconi D, et al Effects of KRAS, BRAF, NRAS, and PIK3CA mutations on the efficacy of cetuximab plus chemotherapy in chemotherapy-refractory metastatic colorectal cancer: a retrospective consortium analysis. Lancet Oncol, 11: /8

9 Appendix I KRAS and NRAS Mutations detected with the Kit Tube No. Reagent Supplied Exon Mutation Base change Cosmic ID Name 1 KN Reaction Mix 1 KRAS 2 G12S 34G>A 517 KRAS-M4 G12D 35G>A 521 KRAS-M1 G12C 34G>T 516 KRAS-M6 G12R 34G>C 518 KRAS-M5 2 KN Reaction Mix 2 KRAS 2 G12V 35G>T 520 KRAS-M3 G12A 35G>C 522 KRAS-M2 G13C 37G>T 527 KRAS-M14 3 KN Reaction Mix 3 KRAS 2 G13D 38G>A 532 KRAS-M7 4 KN Reaction Mix 4 KRAS 3 A59T 175G>A 546 KRAS-M25 Q61K 181C>A 549 KRAS-M19 Q61L 182A>T 553 KRAS-M15 5 KN Reaction Mix 5 KRAS 4 Q61R 182A>G 552 KRAS-M16 Q61H 183A>C 554 KRAS-M17 Q61H 183A>T 555 KRAS-M18 K117N 351A>C KRAS-M20 K117N 351A>T KRAS-M21 6 KN Reaction Mix 6 KRAS 4 Al46T 436G>A KRAS-M22 A146V 437C>T KRAS-M23 A146P 436G>C KRAS-M24 7 KN Reaction Mix 7 NRAS 2 G12D 35G>A 564 NRAS-M3 G12S 34G>A 563 NRAS-M10 8 KN Reaction Mix 8 NRAS 2 G13D 38G>A 573 NRAS-M4 G13R 37G>C 569 NRAS-M6 G12C 34G>T 562 NRAS-M7 9 KN Reaction Mix 9 NRAS 2 G12V 35G>T 566 NRAS-M9 G12A 35G>C 565 NRAS-M11 G13V 38G>T 574 NRAS-M14 Q61R 182A>G 584 NRAS-M1 10 KN Reaction Mix 10 NRAS 3 Q61K 181C>A 580 NRAS-M2 Q61L 182A>T 583 NRAS-M5 Q61H 183A>C 586 NRAS-M8 11 KN Reaction Mix 11 NRAS 4 A146T 436G>A NRAS-M12 8/8

AmoyDx KRAS/NRAS/BRAF Mutations Detection Kit

AmoyDx KRAS/NRAS/BRAF Mutations Detection Kit AmoyDx KRAS/NRAS/BRAF Mutations Detection Kit Detection of 17 KRAS mutations (exons 2, 3 and 4), 13 NRAS mutations (exons 2, 3 and 4) and six BRAF V600 mutations (exon 15) Instruction for Use Instruction

More information

AmoyDx PIK3CA Five Mutations Detection Kit

AmoyDx PIK3CA Five Mutations Detection Kit AmoyDx PIK3CA Five Mutations Detection Kit Detection of five mutations in PIK3CA gene Instruction for Use Instruction Version: B2.2 Revision Date: June 2016 Store at -20±5 Background For: ADx-PI01 Phosphatidylinositol

More information

AmoyDx KRAS/NRAS Mutations Detection Kit

AmoyDx KRAS/NRAS Mutations Detection Kit AmoyDx KRAS/NRAS Mutations Detection Kit Detection of 19 KRAS mutations (exons 2, 3 and 4) and 13 NRAS mutations (exons 2, 3 and 4) Instruction for Use 8.01.25402W006A 6 tests For Stratagene Mx3000P, ABI7500

More information

AmoyDx PIK3CA Five Mutations Detection Kit

AmoyDx PIK3CA Five Mutations Detection Kit AmoyDx PIK3CA Five Mutations Detection Kit Detection of five mutations in PIK3CA gene Instruction for Use Instruction Version: B 1.0 Revision Date: May 2013 Store at -20±2 Manufacturer: Amoy Diagnostics

More information

AmoyDx JAK2 Mutation Detection Kit

AmoyDx JAK2 Mutation Detection Kit AmoyDx JAK2 Mutation Detection Kit Detection of V617F mutation in the JAK2 oncogene Instruction for Use For Research Use Only Instruction Version: B2.6 Revision Date: October 2013 Store at -20±5 Xiamen,

More information

Super-ARMS KRAS/NRAS/BRAF Mutations Detection Kit

Super-ARMS KRAS/NRAS/BRAF Mutations Detection Kit Super-ARMS KRAS/NRAS/BRAF Mutations Detection Kit Detection of 18 KRAS mutations (exons 2, 3 and 4), 15 NRAS mutations (exons 2, 3 and 4) and one BRAF mutation (exon 15) Instruction for Use 8.01.25404X024E

More information

AmoyDx TM PIK3CA Five Mutations Detection Kit

AmoyDx TM PIK3CA Five Mutations Detection Kit AmoyDx TM PIK3CA Five Mutations Detection Kit Detection of five mutations in PIK3CA gene Instructions For Use Instructions Version: B1.3 Date of Revision: April 2012 Store at -20±2 1/5 Background Phosphatidylinositol

More information

SuperARMS EGFR T790M Mutation Detection Kit

SuperARMS EGFR T790M Mutation Detection Kit SuperARMS EGFR T790M Mutation Detection Kit Detection of EGFR T790M mutation in plasma sample Instruction for Use Instruction Version: B1.0 Revision Date: May 2016 Store at -20±5 Background Due to its

More information

AmoyDx TM KRAS Seven Mutations Detection Kit

AmoyDx TM KRAS Seven Mutations Detection Kit AmoyDx TM KRAS Seven Mutations Detection Kit Detection of seven mutations in KRAS codons 12 and 13 Instructions For Use Instructions Version: B1.0 Date of Revision: May 2012 Store at -20±2 o C 1/7 Background

More information

AmoyDx JAK2 Mutation Detection Kit

AmoyDx JAK2 Mutation Detection Kit AmoyDx JAK2 Mutation Detection Kit Detection of V617F mutation in the JAK2 oncogene Instructions For Use For Research Use Only and For Reference Only Instructions Version: B1.2 Date of Revision: June 2016

More information

AmoyDx JAK2 Mutation Detection Kit

AmoyDx JAK2 Mutation Detection Kit AmoyDx JAK2 Mutation Detection Kit Detection of V617F mutation in the JAK2 oncogene Instruction for Use For Research Use Only and For Reference Only 8.01.20801X024E 24 tests For Rotor-Gene Q/6000 (72 Wells)

More information

AmoyDx TM JAK2 V617F Mutation Detection Kit

AmoyDx TM JAK2 V617F Mutation Detection Kit AmoyDx TM JAK2 V617F Mutation Detection Kit Detection of V617F mutation in the JAK2 oncogene Instructions For Use Instructions Version: B1.0 Date of Revision: July 2012 Store at -20±2 o C -1/5- Background

More information

AmoyDx Human Papillomavirus (HPV) Genotyping Detection Kit

AmoyDx Human Papillomavirus (HPV) Genotyping Detection Kit AmoyDx Human Papillomavirus (HPV) Genotyping Detection Kit Detection of 19 High-risk HPVs and 2 low-risk HPVs Instruction for Use Instruction Version: P1.2 Revision Date: August 2015 Store at -20±5 Background

More information

AmoyDx TM RRM1 Gene Expression Analysis Kit

AmoyDx TM RRM1 Gene Expression Analysis Kit AmoyDx TM RRM1 Gene Expression Analysis Kit Instructions For Use Instructions Version: B2.1 Date of Revision: April 2012 Store at -20±2 o C -1/5- Background RRM1 is one of the targets of Gemcitabine, and

More information

AmoyDx EGFR Three Mutations Detection Kit

AmoyDx EGFR Three Mutations Detection Kit AmoyDx EGFR Three Mutations Detection Kit Detection of 3 mutations in exons 19 and 21 Instructions For Use Instructions Version: B1.1 Date of Revision: August 2012 Store at -20 1 / 6 Background Due to

More information

AmoyDx TM RET 14 Mutations Detection Kit

AmoyDx TM RET 14 Mutations Detection Kit For: ADx-RE0 AmoyDx TM RET Mutations Detection Kit Detection of rearrangement mutations of RET gene Instructions For Use Instructions Version: B. Date of Revision: April 0 Store at -0± o C Website:www.amoydx.com/en

More information

AmoyDx BRAF V600 Mutations Detection Kit

AmoyDx BRAF V600 Mutations Detection Kit AmoyDx BRAF V600 Mutations Detection Kit Detection of V600 Mutations in the BRAF oncogene Instruction for Use 8.01.20302X024F 24 tests For Rotor-Gene Q/6000 (72 Wells) Amoy Diagnostics Co., Ltd. 39 Dingshan

More information

AmoyDx EGFR 29 Mutations Detection Kit

AmoyDx EGFR 29 Mutations Detection Kit AmoyDx EGFR 29 Mutations Detection Kit Detection of 29 mutations in exons 18-21 Instruction for Use Instruction Version: B1.1 Revision Date: August 2013 Store at -20±2 Background Due to its association

More information

AmoyDx TM EGFR 29 Mutations Detection Kit

AmoyDx TM EGFR 29 Mutations Detection Kit AmoyDx TM EGFR 29 Mutations Detection Kit Detection of 29 mutations in exons 18-21 Instructions For Use Instructions Version: P2.2 Date of Revision: April 2012 Store at -20±2 o C : :: : 1 / 8 Background

More information

AmoyDx TM EGFR 29 Mutations Detection Kit

AmoyDx TM EGFR 29 Mutations Detection Kit AmoyDx TM EGFR 29 Mutations Detection Kit Detection of 29 mutations in exons 18-21 Instructions For Use Instructions Version: B2.2 Date of Revision: April 2012 Store at -20±2 o C 1 / 8 Background Due to

More information

AmoyDx EGFR 29 Mutations Detection Kit

AmoyDx EGFR 29 Mutations Detection Kit AmoyDx EGFR 29 Mutations Detection Kit Detection of 29 mutations in exons 18-21 Instruction for Use 8.01.20201X024F 24 tests For Rotor-Gene Q/ 6000 (72 wells) Amoy Diagnostics Co., Ltd. 39 Dingshan Road,

More information

AmoyDx Human Papillomavirus (HPV) Genotyping Detection Kit

AmoyDx Human Papillomavirus (HPV) Genotyping Detection Kit AmoyDx Human Papillomavirus (HPV) Genotyping Detection Kit Detection of 19 High-risk HPVs and 2 low-risk HPVs Instruction for Use 8.01.25803W048A 48 tests For Stratagene Mx3000P, ABI 7500, 8.01.25803W048B

More information

myt KRAS qpcr primers for detection of seven human KRAS codon 12/13 mutations:

myt KRAS qpcr primers for detection of seven human KRAS codon 12/13 mutations: myt KRAS qpcr primers for detection of seven human KRAS codon 12/13 mutations: KRAS G12D: Gly12Asp (GGT>GAT) KRAS G12A: Gly12Ala (GGT>GCT) KRAS G12V: Gly12Val (GGT>GTT) KRAS G12S: Gly12Ser (GGT>AGT) KRAS

More information

AmoyDx High-risk Human Papillomavirus (HPV) Detection Kit

AmoyDx High-risk Human Papillomavirus (HPV) Detection Kit AmoyDx High-risk Human Papillomavirus (HPV) Detection Kit Detection of 19 High-risk Human Papillomavirus Instruction for Use 8.01.25802X048E 48 tests For Stratagene Mx3000P, ABI 7500, LightCycler 480,

More information

AmoyDx HPV 6/11/16/18 Detection Kit

AmoyDx HPV 6/11/16/18 Detection Kit AmoyDx HPV 6/11/16/18 Detection Kit Detection of two high-risk HPVs (16/18) and two low-risk HPVs (6/11) Instruction for Use 8.01.25801X048E 48 tests For Stratagene Mx3000P, ABI 7500, LightCycler 480,

More information

HELINI Hepatitis B virus [HBV] Real-time PCR Kit (Genotype A to H)

HELINI Hepatitis B virus [HBV] Real-time PCR Kit (Genotype A to H) HELINI Hepatitis B virus [HBV] Real-time PCR Kit (Genotype A to H) Quantitative In vitro diagnostics Instruction manual Cat. No: 8001-25/50/100 tests Compatible with: Agilent, Bio-Rad, Applied Bio systems

More information

Ultra-Sensitive BRAF Mutation Detection Kit. User Manual

Ultra-Sensitive BRAF Mutation Detection Kit. User Manual Ultra-Sensitive BRAF Mutation Detection Kit User Manual Catalog Number: BRAF0001-20 BRAF0001-50 Size: 20 tests/kit 50 tests/kit Intended Use: For Research Use Only Doc. No.: Revision: 100-BRAF0001 Rev.

More information

AmoyDx FFPE DNA Kit. (Spin Column) For purification of DNA from formalin-fixed, paraffin-embedded tissue sections. Instruction for Use

AmoyDx FFPE DNA Kit. (Spin Column) For purification of DNA from formalin-fixed, paraffin-embedded tissue sections. Instruction for Use AmoyDx FFPE DNA Kit (Spin Column) For purification of DNA from formalin-fixed, paraffin-embedded tissue sections Instruction for Use 8.0223501X036G 36 tests Amoy Diagnostics Co., Ltd. 39 Dingshan Road,

More information

AmoyDx FFPE RNA Kit. (Spin Column) For purification of total RNA from formalin-fixed, paraffin-embedded tissue sections. Instruction for Use

AmoyDx FFPE RNA Kit. (Spin Column) For purification of total RNA from formalin-fixed, paraffin-embedded tissue sections. Instruction for Use AmoyDx FFPE RNA Kit (Spin Column) For purification of total RNA from formalin-fixed, paraffin-embedded tissue sections Instruction for Use 8.02.24101X036G 36 tests Amoy Diagnostics Co., Ltd. 39 Dingshan

More information

HELINI White spot Syndrome virus [WSSV] Real-time PCR Kit

HELINI White spot Syndrome virus [WSSV] Real-time PCR Kit HELINI White spot Syndrome virus [WSSV] Real-time PCR Kit Instruction manual Cat. No: 6001-25/50/100 tests Compatible with: Agilent, Bio-Rad, Roche, Applied Bio systems [ABI], Rotor-gene, Cepheid, Bioer,

More information

HBV Quantitative & YMDD Mutation Real Time PCR Kit

HBV Quantitative & YMDD Mutation Real Time PCR Kit Revision No.: ZJ0002 Issue Date: Aug 7 th, 2008 HBV Quantitative & YMDD Mutation Real Time PCR Kit Cat. No.: HD-0003-01 For Use with LightCycler 1.0/LightCycler2.0/LightCycler480 (Roche) Real Time PCR

More information

AmoyDx BRCA1 and BRCA2 Gene Mutation Detection Kit (Next Generation Sequencing)

AmoyDx BRCA1 and BRCA2 Gene Mutation Detection Kit (Next Generation Sequencing) AmoyDx BRCA1 and BRCA2 Gene Mutation Detection Kit (Next Generation Sequencing) Instruction for Use 8.06.27201W024I 24 tests For Illumina MiSeq Amoy Diagnostics Co., Ltd. 39 Dingshan Road, Haicang District,

More information

AmoyDx TM EGFR 29 Mutations Detection Kit

AmoyDx TM EGFR 29 Mutations Detection Kit For: ADx-EG07 ADx-EG08 ADx-EG09 AmoyDx TM EGFR 29 Mutations Detection Kit Detection of 29 mutations in exons 18-21 Instructions For Use Instructions Version: B2.2 Date of Revision: April 2012 Store at

More information

HBV Quantitative & YMDD Mutation Real Time PCR Kit

HBV Quantitative & YMDD Mutation Real Time PCR Kit Revision No.: ZJ0002 Issue Date: Aug 7 th, 2008 HBV Quantitative & YMDD Mutation Real Time PCR Kit Cat. No.: HD-0003-02 For Use with LightCycler2.0/LightCycler480 (Roche) Real Time PCR Systems For In Vitro

More information

(Spin Column) For purification of DNA and RNA from formalin-fixed, paraffin-embedded tissue sections. Instruction for Use

(Spin Column) For purification of DNA and RNA from formalin-fixed, paraffin-embedded tissue sections. Instruction for Use AmoyDx FFPE DNA/RNA Kit (Spin Column) For purification of DNA and RNA from formalin-fixed, paraffin-embedded tissue sections Instruction for Use Instruction Version: B1.3 Revision Date: September 2015

More information

CTNNB Mutation Analysis Kit

CTNNB Mutation Analysis Kit CTNNB1 32-37 Mutation Analysis Kit For quantitative detection of mutations in codons 32-37 in the CTNNB1 gene by qpcr 50 tests For research use only. Developing Innovative, Noninvasive cfdna tests for

More information

AmoyDx EGFR/ALK/ROS1 Mutations Detection Kit

AmoyDx EGFR/ALK/ROS1 Mutations Detection Kit AmoyDx EGFR/ALK/ROS1 Mutations Detection Kit Detection of 24 EGFR mutations (exons 18-21), 21 ALK gene fusions and 13 ROS1 gene fusions Instruction for Use 8.01.25501W008A 8 tests For Stratagene Mx3000P,

More information

Mitochondrion DNA site Mutation Real Time PCR Kit

Mitochondrion DNA site Mutation Real Time PCR Kit Revision No.: ZJ0003 Issue Date: Aug 7 th, 2008 Mitochondrion DNA site 11778 Mutation Real Time PCR Kit Cat. No.: GD-0027-01 For use with LightCycler2.0/ LightCycler480 (Roche) real time PCR systems. For

More information

Precipio, Inc. Instructions for Use. EGFR Exon 12 Mutation Enrichment using ICE COLD-PCR

Precipio, Inc. Instructions for Use. EGFR Exon 12 Mutation Enrichment using ICE COLD-PCR Precipio, Inc. Instructions for Use EGFR Exon 12 Mutation Enrichment using ICE COLD-PCR Table of Contents Manufacturer 2 Intended Use 2 Reagent Preparation 2 Kit Components and Storage Conditions 2 Optional

More information

myt BRAF - Ultra qpcr Primers for Ultra-sensitive Detection of Human BRAF V600E/K For Research Use Only

myt BRAF - Ultra qpcr Primers for Ultra-sensitive Detection of Human BRAF V600E/K For Research Use Only myt BRAF - Ultra qpcr Primers for Ultra-sensitive Detection of Human BRAF V600E/K For Research Use Only Swift Biosciences, Inc. All rights reserved Version 1112 2 Notice to Purchaser: Limited License This

More information

Precipio, Inc. Instructions for Use. PIK3CA Exon 9 Mutation Analysis using ICE COLD-PCR for Detection with High Resolution Melting

Precipio, Inc. Instructions for Use. PIK3CA Exon 9 Mutation Analysis using ICE COLD-PCR for Detection with High Resolution Melting Precipio, Inc. Instructions for Use PIK3CA Exon 9 Mutation Analysis using ICE COLD-PCR for Detection with High Resolution Melting Table of Contents Manufacturer 2 Reagent Preparation 2 Kit Components and

More information

Precipio, Inc. Instructions for Use. EGFR Exon 18 Mutation Enrichment using ICE COLD-PCR

Precipio, Inc. Instructions for Use. EGFR Exon 18 Mutation Enrichment using ICE COLD-PCR Precipio, Inc. Instructions for Use EGFR Exon 18 Mutation Enrichment using ICE COLD-PCR Table of Contents Manufacturer 2 Intended Use 2 Reagent Preparation 2 Kit Components and Storage Conditions 2 Optional

More information

Varicella Zoster Virus Real Time PCR Kit

Varicella Zoster Virus Real Time PCR Kit Revision No.: ZJ0001 Issue Date: Aug 28th, 2007 Varicella Zoster Virus Real Time PCR Kit Cat. No.: OD-0024-01 For use with LightCycler2.0/ LightCycler480 (Roche) real time PCR systems For in vitro Diagnostic

More information

Quantidex DNA Assay. Protocol. For Research Use Only. Not for use in diagnostic procedures.

Quantidex DNA Assay. Protocol. For Research Use Only. Not for use in diagnostic procedures. Quantidex DNA Assay Protocol For Research Use Only. Not for use in diagnostic procedures. 49539 100 Asuragen, Inc. 2170 Woodward St. Austin, TX 78744 1840 USA +1.512.681.5200 PC 0235 v1 Effective Date:

More information

Maize CaMV promoter & NOS terminator (GMO)

Maize CaMV promoter & NOS terminator (GMO) PCRmax Ltd TM qpcr test Maize CaMV promoter & NOS terminator (GMO) Maize CaMV promoter & NOS terminator 150 tests For general laboratory and research use only 1 Introduction to Maize CaMV promoter & NOS

More information

BRCA MAQ USER GUIDE Version 1.0

BRCA MAQ USER GUIDE Version 1.0 BRCA MAQ USER GUIDE Version 1.0 For Copy Number Analysis Assays IFU604 v170797 www.multiplicom.com 2012 Multiplicom NV, all rights reserved Table of Contents Introduction to Multiplex Amplicon Quantification...2

More information

Precipio, Inc. Instructions for Use. BRAF Exon 15 Mutation Enrichment using ICE COLD-PCR

Precipio, Inc. Instructions for Use. BRAF Exon 15 Mutation Enrichment using ICE COLD-PCR Precipio, Inc. Instructions for Use BRAF Exon 15 Mutation Enrichment using ICE COLD-PCR Table of Contents Manufacturer 2 Intended Use 2 Reagent Preparation 2 Kit Components and Storage Conditions 2 ICE

More information

HDV Real Time RT-PCR Kit

HDV Real Time RT-PCR Kit Revision No.: ZJ0002 Issue Date: Aug 7 th, 2008 HDV Real Time RT-PCR Kit Cat. No.: HR-0010-01 For Use with LightCycler 1.0/LightCycler2.0/LightCycler480 (Roche) Real Time PCR Systems (Pls ignore the Internal

More information

Love Bird (Agapornis) Sexing Sex chromosome specific spindlin gene. Advanced Kit. 150 tests. For general laboratory and research use only

Love Bird (Agapornis) Sexing Sex chromosome specific spindlin gene. Advanced Kit. 150 tests. For general laboratory and research use only Love Bird (Agapornis) Sexing Sex chromosome specific spindlin gene 150 tests Advanced Kit For general laboratory and research use only Introduction to Love Bird (Agapornis) Sexing Specificity MAX MIN The

More information

HBV Genotype B&C Real Time PCR Kit

HBV Genotype B&C Real Time PCR Kit Revision No.: ZJ0002 Issue Date: Aug 7 th, 2008 HBV Genotype B&C Real Time PCR Kit Cat. No.: HD-0006-03 For use with PE5700/ MJ-Opticon etc. Single Color Systems Real-Time PCR system. User Manual For In

More information

FMV 35S promoter (GMO) Advanced Kit. FMV 35S promoter. 150 tests. For general laboratory and research use only

FMV 35S promoter (GMO) Advanced Kit. FMV 35S promoter. 150 tests. For general laboratory and research use only FMV 35S promoter (GMO) FMV 35S promoter 150 tests Advanced Kit For general laboratory and research use only Introduction to FMV 35S promoter (GMO) The kit provides a method for detecting gene insertion

More information

HPV 16&18 Real Time PCR Kit

HPV 16&18 Real Time PCR Kit HPV 16&18 Real Time PCR Kit Cat. No.: TD-0030-02 For use with ABI Prism 7000/7300/7500/7900; Smart CyclerII; icycler iq 4/iQ 5; Rotor Gene 2000/3000; Mx3000P/3005P; MJ-Option2/Chromo4 real time PCR systems

More information

Brucella Real Time PCR Kit

Brucella Real Time PCR Kit Revision No.: ZJ0003 Issue Date: Aug 7 th, 2008 Brucella Real Time PCR Kit Cat. No.: ZD-0071-02 For use with ABI Prism 7000/7300/7500/7900; Smart CyclerII; icycler iq 4/iQ 5; Rotor Gene 2000/3000; Mx3000P/3005P;

More information

M. tuberculosis_mpb64/is611. genesig Advanced Kit. 150 tests. Primerdesign Ltd. For general laboratory and research use only

M. tuberculosis_mpb64/is611. genesig Advanced Kit. 150 tests. Primerdesign Ltd. For general laboratory and research use only TM Primerdesign Ltd M. tuberculosis_mpb64/is611 0 genesig Advanced Kit 150 tests For general laboratory and research use only 1 Introduction to M.tuberculosis_MPB64/IS6110 2 Specificity MAX MIN The Primerdesign

More information

Simplexa EBV Quantitation Standards

Simplexa EBV Quantitation Standards Simplexa EBV Quantitation Standards REF MOL2410 Rev. C Simplexa EBV Quantitation Standards are intended to establish a standard curve with the Simplexa EBV assay on the 3M Integrated Cycler. For in vitro

More information

ViroReal Kit African Swine Fever Virus

ViroReal Kit African Swine Fever Virus ViroReal Kit African Swine Fever Virus For use with the ABI 7500 (Fast) Mx3005P LightCycler 480 For veterinary use only DVEV02011, DVEV02013 100 DVEV02051, DVEV02053 50 Arsenalstr.11 1030 Vienna, Austria

More information

HBV Quantitative Real Time PCR Kit

HBV Quantitative Real Time PCR Kit Revision No.: ZJ0002 Issue Date: Aug 7 th, 2008 HBV Quantitative Real Time PCR Kit Cat. No.: HD-0002-02 For use with ABI Prism 7000/7300/7500/7900; Smart CyclerII; icycler iq 4/iQ 5; Rotor Gene 2000/3000;

More information

Super-ARMS EGFR Mutation Detection Kit

Super-ARMS EGFR Mutation Detection Kit Super-ARMS EGFR Mutation Detection Kit Detection of 41 mutations in exons 18-21 Instruction for Use 8.01.20213X024E 24 tests For Stratagene Mx3000P, ABI7500, LightCycler 480 II, SLAN-96S Amoy Diagnostics

More information

Transfusion-transmitted Virus(TTV) Real Time PCR Kit

Transfusion-transmitted Virus(TTV) Real Time PCR Kit Revision No.: ZJ0003 Issue Date: Aug 7 th, 2008 Transfusion-transmitted Virus(TTV) Real Time PCR Kit Cat. No.: HD-0013-02 For use with ABI Prism 7000/7300/7500/7900; Smart CyclerII; icycler iq 4/iQ 5;

More information

Techne qpcr test. Pisum sativum. Ribosomal protein S12 (rps12) gene. 100 tests

Techne qpcr test. Pisum sativum. Ribosomal protein S12 (rps12) gene. 100 tests Techne qpcr test Pisum sativum Ribosomal protein S12 (rps12) gene 100 tests For general laboratory and research use only Introduction to Pisum sativum 1 2 Specificity The Techne Kit for Pisum sativum (P.sativum)

More information

Pistacia vera. Introduction to Pistacia vera. 100 tests. Techne qpcr test. For general laboratory and research use only

Pistacia vera. Introduction to Pistacia vera. 100 tests. Techne qpcr test. For general laboratory and research use only Techne qpcr test Pistacia vera 100 tests For general laboratory and research use only Introduction to Pistacia vera 1 2 Specificity The Techne Kit for Pistacia vera (P.vera) genomes is designed for the

More information

Escherichia coli_o104: H4

Escherichia coli_o104: H4 PCRmax Ltd TM qpcr test Escherichia coli_o104: H4 150 tests For general laboratory and research use only 1 Introduction to Escherichia coli_o104:h4 2 Specificity MAX MIN The PCR Max qpcr Kit for Escherichia

More information

EpiQuik Quantitative PCR Fast Kit Base Catalog # P-1029

EpiQuik Quantitative PCR Fast Kit Base Catalog # P-1029 EpiQuik Quantitative PCR Fast Kit Base Catalog # PLEASE READ THIS ENTIRE USER GUIDE BEFORE USE Uses: The EpiQuik Quantitative PCR Fast Kit is designed for quantitative real time analysis of DNA samples

More information

TruSeq Custom Amplicon Dx FFPE QC Kit

TruSeq Custom Amplicon Dx FFPE QC Kit TruSeq Custom Amplicon Dx - FFPE QC Kit FOR IN VITRO DIAGNOSTIC USE Catalog # 20006259: 1-4 uses, up to 48 Samples Intended Use The Illumina TruSeq Custom Amplicon Dx FFPE QC Kit is a set of reagents used

More information

M. tuberculosis_mpb64/is61 10 genesig Standard Kit

M. tuberculosis_mpb64/is61 10 genesig Standard Kit TM Primerdesign Ltd M. tuberculosis_mpb64/is61 10 genesig Standard Kit 150 tests For general laboratory and research use only 1 Introduction to M.tuberculosis_MPB64/IS6110 2 Specificity MAX MIN The Primerdesign

More information

User Manual. NGS Library qpcr Quantification Kit (Illumina compatible)

User Manual. NGS Library qpcr Quantification Kit (Illumina compatible) NGS Library qpcr Quantification Kit (Illumina compatible) User Manual 384 Oyster Point Blvd, Suite 15 South San Francisco, CA 94080 Phone: 1 (888) MCLAB-88 Fax: 1 (650) 872-0253 www.mclab.com Contents

More information

ViroReal Kit HHV-6A, B

ViroReal Kit HHV-6A, B ViroReal Kit HHV-6A, B For Research Use Only DHUV00653 50 reactions ingenetix GmbH Arsenalstraße 11 1030 Vienna, Austria T +43 (0)1 36 198 0 198 F +43 (0)1 36 198 0 199 office@ingenetix.com www.ingenetix.com

More information

AFP mrna Expression in Peripheral Blood Real Time RT-PCR Kit

AFP mrna Expression in Peripheral Blood Real Time RT-PCR Kit Revision No.: ZJ0003 Issue Date: Aug 7 th, 2008 AFP mrna Expression in Peripheral Blood Real Time RT-PCR Kit Cat. No.: TR-0029-01 For Use with LightCycler 1.0/LightCycler2.0/LightCycler480 (Roche) Real

More information

NOS terminator (GMO) genesig Advanced Kit. NOS terminator. 150 tests. Primerdesign Ltd. For general laboratory and research use only

NOS terminator (GMO) genesig Advanced Kit. NOS terminator. 150 tests. Primerdesign Ltd. For general laboratory and research use only TM Primerdesign Ltd NOS terminator (GMO) NOS terminator genesig Advanced Kit 150 tests For general laboratory and research use only 1 Introduction to NOS terminator (GMO) The kit provides a method for

More information

Epstein Barr Virus (Human Herpes virus 4)

Epstein Barr Virus (Human Herpes virus 4) PCRmax Ltd TM qpcr test Epstein Barr Virus (Human Herpes virus 4) nonglycosylated membrane protein (BNRF1) gene 150 tests For general laboratory and research use only 1 Introduction to Epstein Barr Virus

More information

For in vitro Veterinary Diagnostics only. Real-Time RT-PCR Detection Kit for Avian Hepatitis E Virus

For in vitro Veterinary Diagnostics only. Real-Time RT-PCR Detection Kit for Avian Hepatitis E Virus For in vitro Veterinary Diagnostics only. Real-Time RT-PCR Detection Kit for Avian Hepatitis E Virus DIRECTION FOR USE Art. No. 31100 / 31101 Kylt Avian Hepatitis E Real-Time RT-PCR Detection Kit for Avian

More information

Campylobacter Jejuni Real Time PCR Kit

Campylobacter Jejuni Real Time PCR Kit Revision No.: ZJ0003 Issue Date: Aug 7 th, 2008 Campylobacter Jejuni Real Time PCR Kit Cat. No.: DD-0040-01 For Use with LightCycler 1.0/LightCycler2.0/LightCycler480 (Roche) Real Time PCR Systems (Pls

More information

For in vitro Veterinary Diagnostics only. Kylt Avian Nephritis Virus. Real-Time RT-PCR Detection.

For in vitro Veterinary Diagnostics only. Kylt Avian Nephritis Virus. Real-Time RT-PCR Detection. For in vitro Veterinary Diagnostics only. Kylt Avian Nephritis Virus Real-Time RT-PCR Detection www.kylt.eu DIRECTION FOR USE Kylt Avian Nephritis Virus Real-Time RT-PCR Detection A. General Kylt Avian

More information

Techne qpcr test. A graveolens. NADPH-dependent mannose 6- phosphate reductase (m6pr) 100 tests

Techne qpcr test. A graveolens. NADPH-dependent mannose 6- phosphate reductase (m6pr) 100 tests Techne qpcr test A graveolens NADPH-dependent mannose 6- phosphate reductase (m6pr) 100 tests For general laboratory and research use only Introduction to A graveolens 1 2 Specificity The Techne Kit for

More information

Human Papillomavirus 16

Human Papillomavirus 16 TM Primerdesign Ltd Human Papillomavirus 16 E6 gene genesig Advanced Kit 150 tests For general laboratory and research use only 1 Introduction to Human Papillomavirus 16 Papillomaviruses are a diverse

More information

For in vitro Veterinary Diagnostics only. Kylt Avian Hepatitis E. Real-Time RT-PCR Detection.

For in vitro Veterinary Diagnostics only. Kylt Avian Hepatitis E. Real-Time RT-PCR Detection. For in vitro Veterinary Diagnostics only. Kylt Avian Hepatitis E Real-Time RT-PCR Detection www.kylt.eu DIRECTION FOR USE Kylt Avian Hepatitis E Real-Time RT-PCR Detection A. General Kylt Avian Hepatitis

More information

For in vitro Veterinary Diagnostics only. Kylt Brachyspira spp. Real-Time PCR Detection.

For in vitro Veterinary Diagnostics only. Kylt Brachyspira spp. Real-Time PCR Detection. For in vitro Veterinary Diagnostics only. Kylt Brachyspira spp. Real-Time PCR Detection www.kylt.eu DIRECTION FOR USE Kylt Brachyspira spp. Real-Time PCR Detection A. General Kylt Brachyspira spp. products

More information

For in vitro Veterinary Diagnostics only. Kylt Influenza A - H9. Real-Time RT-PCR Detection.

For in vitro Veterinary Diagnostics only. Kylt Influenza A - H9. Real-Time RT-PCR Detection. For in vitro Veterinary Diagnostics only. Kylt Influenza A - H9 Real-Time RT-PCR Detection www.kylt.eu DIRECTION FOR USE Kylt Influenza A - H9 Real-Time RT-PCR Detection A. General Kylt Influenza A - H9

More information

Human Papillomavirus 16

Human Papillomavirus 16 TM Primerdesign Ltd Human Papillomavirus 16 E6 gene genesig Standard Kit 150 tests For general laboratory and research use only 1 Introduction to Human Papillomavirus 16 Papillomaviruses are a diverse

More information

For in vitro Veterinary Diagnostics only. Real-Time RT-PCR Detection Kit for Avian Nephritis Virus

For in vitro Veterinary Diagnostics only. Real-Time RT-PCR Detection Kit for Avian Nephritis Virus For in vitro Veterinary Diagnostics only. Real-Time RT-PCR Detection Kit for Avian Nephritis Virus DIRECTION FOR USE Art. No. 31098 / 31099 Kylt Avian Nephritis Virus Real-Time RT-PCR Detection Kit for

More information

Vibrio Vulnificus Real Time PCR Kit

Vibrio Vulnificus Real Time PCR Kit Revision No.: ZJ0002 Issue Date: Jan 2 nd, 2008 Vibrio Vulnificus Real Time PCR Kit Cat. No.: DD-0129-01 For use with LightCycler2.0/ LightCycler480 (Roche) real time PCR systems For In Vitro Diagnostic

More information

Human Papillomavirus 33

Human Papillomavirus 33 PCRmax Ltd Human Papillomavirus 33 E6 gene TM qpcr test 150 tests For general laboratory and research use only 1 Introduction to Human Papillomavirus 33 Papillomaviruses are a diverse group of DNA-based

More information

ProNex DNA QC Assay Calibration Kit, 7500

ProNex DNA QC Assay Calibration Kit, 7500 TECHNICAL MANUAL ProNex DNA QC Assay Calibration Kit, 7500 Instructions for Use of Products NG1001 9/17 TM515 ProNex DNA QC Assay Calibration Kit, 7500 All technical literature is available at: www.promega.com/protocols/

More information

Epstein Barr Virus (Human Herpes virus 4)

Epstein Barr Virus (Human Herpes virus 4) TM Primerdesign Ltd Epstein Barr Virus (Human Herpes virus 4) nonglycosylated membrane protein (BNRF1) gene genesig Standard Kit 150 tests For general laboratory and research use only 1 Introduction to

More information

(Spin Column) For purification of DNA and RNA from formalin-fixed, paraffin-embedded. tissue sections. Instruction for Use. For Research Use Only

(Spin Column) For purification of DNA and RNA from formalin-fixed, paraffin-embedded. tissue sections. Instruction for Use. For Research Use Only AmoyDx FFPE DNA/RNA Kit (Spin Column) For purification of DNA and RNA from formalin-fixed, paraffin-embedded tissue sections Instruction for Use For Research Use Only Instruction Version: B1.0 Revision

More information

Primerdesign Ltd. High risk Human Papillomavirus. Multiplex screening kit. genesig kit. 100 tests. For general laboratory and research use only

Primerdesign Ltd. High risk Human Papillomavirus. Multiplex screening kit. genesig kit. 100 tests. For general laboratory and research use only Primerdesign Ltd High risk Human Papillomavirus Multiplex screening kit genesig kit 100 tests For general laboratory and research use only 1 Introduction to Human Papillomavirus Papillomaviruses are a

More information

Acinetobacter baumannii

Acinetobacter baumannii TM Primerdesign Ltd Acinetobacter baumannii hypothetical protein sequence gene genesig Standard Kit 150 tests For general laboratory and research use only 1 Introduction to Acinetobacter baumannii Acinetobacter

More information

Instruction manual for product # PNAC Version 1.4

Instruction manual for product # PNAC Version 1.4 PNAClamp KRAS Mutation Detection Kit (Ver. 2) For in vitro diagnostic use Instruction manual for product # PNAC-1002 Version 1.4 Store at -15 C to -20 C Instruction Version: Ver. 1.4 Date of Revision:

More information

Sansure Biotech. Wellkang Ltd Suite B, 29 Harley Street London W1G 9QR UNITED KINGDOM. For Professional Use Only

Sansure Biotech. Wellkang Ltd Suite B, 29 Harley Street London W1G 9QR UNITED KINGDOM. For Professional Use Only Wellkang Ltd Suite B, 29 Harley Street London W1G 9QR UNITED KINGDOM For Professional Use Only Reference Number S3002E Product Name Herpes Simplex Virus Type 2 DNA Fluorescence Diagnostic Kit (PCR-Fluorescence

More information

Schistosoma Japonicum Real Time PCR Kit. For In Vitro Diagnostic Use Only User Manual

Schistosoma Japonicum Real Time PCR Kit. For In Vitro Diagnostic Use Only User Manual Revision No.: ZJ0003 Issue Date: Aug 7 th, 2008 Schistosoma Japonicum Real Time PCR Kit Cat. No.: QD-0085-01 For Use with LightCycler 1.0/LightCycler2.0/LightCycler480 (Roche) Real Time PCR Systems (Pls

More information

Product Insert 1 1 Quantified RNA Standards are provided as 100 ng/µl, 10 ng/µl, 1 ng/µl, 100 pg/µl, 10 pg/µl and 1 pg/µl

Product Insert 1 1 Quantified RNA Standards are provided as 100 ng/µl, 10 ng/µl, 1 ng/µl, 100 pg/µl, 10 pg/µl and 1 pg/µl 3430 Schmon Parkway Thorold, ON, Canada L2V 4Y6 Phone: 866-667-4362 (905) 227-8848 Fax: (905) 227-1061 Email: techsupport@norgenbiotek.com Low Abundance RNA Quantification Kit Product # 58900 Product Insert

More information

Arachis hypogaea A.hypogaea. genesig Allergen detection Kit. 100 tests. Primerdesign Ltd. For general laboratory and research use only

Arachis hypogaea A.hypogaea. genesig Allergen detection Kit. 100 tests. Primerdesign Ltd. For general laboratory and research use only TM Primerdesign Ltd Arachis hypogaea A.hypogaea genesig Allergen detection Kit 100 tests For general laboratory and research use only 1 Introduction to Arachis hypogaea Peanut (Arachis hypogaea) belongs

More information

RealLine HPV 31 / 33 Str-Format

RealLine HPV 31 / 33 Str-Format Instructions for use A QUALITATIVE ASSAY KIT FOR THE DIFFERENTIAL DETERMINATION OF HUMAN PAPILLOMAVIRUS TYPE 31 AND 33 DNA BY REAL TIME PCR METHOD In vitro diagnosticum () VBD8471 96 Tests valid from May

More information

Precipio, Inc. Instructions for Use. EGFR Exon 20 Mutation Analysis using ICE COLD- PCR for Detection with High Resolution Melting

Precipio, Inc. Instructions for Use. EGFR Exon 20 Mutation Analysis using ICE COLD- PCR for Detection with High Resolution Melting Precipio, Inc. Instructions for Use EGFR Exon 20 Mutation Analysis using ICE COLDPCR for Detection with High Resolution Melting Table of Contents Manufacturer 2 Intended Use 2 Reagent Preparation 2 Kit

More information

NRAS Mutation Analysis Reagents (Codons 12 and 13)

NRAS Mutation Analysis Reagents (Codons 12 and 13) NRAS Mutation Analysis Reagents (Codons 12 and 13) User Manual V1.1 Cat No. GP18 32 reactions 1 CONTENTS Introduction 4 Overview of Mutector TM Assay 5 Materials Provided 6 Materials Required 7 Equipment

More information

Annex 6.2 CDC real-time measles RT-PCR protocol targeting measles N gene (75 nt region)

Annex 6.2 CDC real-time measles RT-PCR protocol targeting measles N gene (75 nt region) Annex 6.2 CDC real-time measles RT-PCR protocol targeting measles N gene (75 nt region) NOTE: This document is intended to provide basic test method details and is not an SOP. Laboratories need to develop

More information

Enteroinvasive E. Coil(EIEC) Real Time PCR Kit. For In Vitro Diagnostic Use Only User Manual

Enteroinvasive E. Coil(EIEC) Real Time PCR Kit. For In Vitro Diagnostic Use Only User Manual Revision No.: ZJ0003 Issue Date: Aug 7 th, 2008 Enteroinvasive E. Coil(EIEC) Real Time PCR Kit Cat. No.: DD-0093-01 For Use with LightCycler 1.0/LightCycler2.0/LightCycler480 (Roche) Real Time PCR Systems

More information

Human Herpes Virus 1 (Herpes simplex type 1)

Human Herpes Virus 1 (Herpes simplex type 1) TM Primerdesign Ltd Human Herpes Virus 1 (Herpes simplex type 1) Capsid assembly and DNA maturation gene genesig Advanced Kit 150 tests For general laboratory and research use only 1 Introduction to Human

More information

EGFR RGQ PCR Kit Handbook

EGFR RGQ PCR Kit Handbook July 2010 EGFR RGQ PCR Kit Handbook For qualitative measurement of 29 somatic mutations in the EGFR oncogene, for use with the Rotor-Gene Q 5plex HRM Instrument For research use only. Not for use in diagnostic

More information

For in vitro Veterinary Diagnostics only. Kylt Chicken Astrovirus. Real-Time RT-PCR Detection.

For in vitro Veterinary Diagnostics only. Kylt Chicken Astrovirus. Real-Time RT-PCR Detection. For in vitro Veterinary Diagnostics only. Kylt Chicken Astrovirus Real-Time RT-PCR Detection www.kylt.eu DIRECTION FOR USE Kylt Chicken Astrovirus Real-Time RT-PCR Detection A. General Kylt Chicken Astrovirus

More information