Stool DNA Extraction Kit

Transcription

1 Stool DNA Extraction Kit Instructions For Use (IFU) English English

2 IVD REF Store at C 96 DiaSorin Ireland Ltd. Unit 13/14 Holly Avenue Stillorgan Industrial Park Blackrock Co. Dublin Ireland Page 2

3 INDEX 1 SYMBOLS AND ABBREVIATIONS INTENDED USE SUMMARY AND EXPLANATION STOOL DNA PROCEDURE REAGENTS INSTRUMENT FOR AUTOMATION OF THE PROCEDURE Arrow/LIAISON IXT Use of Instrument Installation Procedures and Principle of Operation Operating Instructions Calibration Procedures Operational Precautions and Limitations Hazards Service and Maintenance Information Contamination Controls Technical Support SAMPLE COLLECTION AND PREPARATION PROCEDURE Procedure Stool DNA Isolation Select protocol and elution volume Load pump with tip Load cartridge Pierce cartridge Load sample Load elution tube Start the protocol Remove the eluate from the instrument Cleaning after the run Arrow/LIAISON IXT Waste Handling Sample Waste Handling Shutting down the Arrow/LIAISON IXT at the End of a Working Day Troubleshooting PERFORMANCE DATA Introduction Reproducibility and Repeatability Extraction of DNA from 82 Stool Samples Collected for Analysis of CRC Detection of Bacterial Species in Stool Samples LIMITATIONS OF THE PROCEDURE EXPECTED VALUES SPECIFIC PERFORMANCE CHARACTERISTICS QUALITY CONTROL PRODUCT LIST NOTES Page 3

4 1 SYMBOLS AND ABBREVIATIONS IVD In Vitro Diagnostic Medical Device REF Catalogue number LOT Lot number To be used by <yyyy-mm> Temperature limitations Legal manufacturer <N> Content is sufficient for <N> tests Consult instructions for use Xn Harmful Flammable NA NAT RT IVD Nucleic Acid Nucleic Acid Technology Room Temperature, +15 C C In Vitro Diagnostic Page 4

5 2 INTENDED USE The Stool DNA kit is designed for automated and rapid isolation of PCR-quality DNA from a variety of stool sample sources including humans, birds, rats, mice, cattle, etc. The Stool DNA kit yields high quality genomic, bacterial, and viral DNA from stool, ready to use in PCR and other downstream enzymatic reactions. The Stool DNA kit has been validated with human stool samples for the extraction of human DNA (see section 9 Performance data). It can be used on both the NorDiag Arrow instrument and the LIAISON IXT instrument. The product is intended used by professional users, trained in molecular techniques and on the use of Arrow/ LIAISON IXT and respective kits. Any diagnostic result following purification with the Stool DNA kit should be interpreted with regards to other laboratory or clinical findings. 3 SUMMARY AND EXPLANATION The Stool DNA kit is a generic system based on magnetic beads, and various buffer solutions that enable the efficient extraction of DNA from stool samples. The Arrow/ LIAISON IXT instrument automates the purification of DNA.This reduces the hands-on time and enables greater sample throughput as well as reduced inhibition in the downstream analysis systems. The isolated DNA is intended for qualitative analyses. The automated protocol is fast and easy to setup with all reagents present in prefilled cartridges. Up to12 fecal samples can be completed in less than 50 minutes. Page 5

6 4 STOOL DNA PROCEDURE The Stool DNA kit is based on magnetic bead technology. The paramagnetic particles are used to capture DNA in solution. The DNA on the magnetic beads is washed and thereafter eluted from the magnetic beads into a solution for further use (fig.1). 1. Stool is mixed into the stool stabilizer, homogenized and centrifuged to remove particular matter. 2. The supernatant is used as sample in the instrument. 3. The sample is treated with a lysis solution. 4. Magnetic beads are added to bind the DNA in the solution. 5. After DNA binding to the magnetic beads, several washes are performed with magnetic separation between each wash. 6. The magnetic bead/dna complex is re-suspended in warm elution buffer, and after a magnetic separation the purified DNA is transferred to the elution tube. 7. DNA is now ready for further analysis. Figure 1: Principle of the procedure.. Page 6

7 5 REAGENTS Each Stool DNA kit contains: o 96 Cartridges for the Stool isolation procedure o 96 ml Stool stabilizer (Ammonium chloride <25%) o 98 Pumps o 96 Tips o 1 Instructions for use Table 1: Contents of Stool DNA cartridges. Each Cartridge contains: Magnetic Beads with NaN 3 1 x 300 µl Lysis Solution 1 x 1600 µl Guanidine thiocyanate GTC (<50%) Triton (<25%) Wash Solution 1 x 2600 µl Tris (< 10%) Isopropanol Wash Solution 1 x 900 µl Tris (< 10%) Ethanol Elution buffer 1 x 2600 µl Isopropanol 1 x 500 µl Materials required but not provided 2 ml microtube for sample preparation (optional brand) Sample tubes (see Table 2) Elution tubes (optional brand) NAT detection system Gloves Pipettes with filter tips Commercial liquid household bleach, 5.25% hypochlorite solutions or equivalent for sterilization of instrument. Centrifuge capable of 6000g Vortexer Page 7

8 Table 2: Recommended sample tubes for use with Arrow/LIAISON IXT. The table only lists the tubes tested at DiaSorin. Brand Compatible tubes Incompatible tubes Axygen Microtubes (MCT-series) Screw cap microtubes (ST-series) Corning Microtubes Costar Snap Cap (e.g. 3620) Corning Eppendorf Microtubes Standard, Safe-Lock, LoBind None determined Qiagen Collection tubes (1.5 and 2.0 ml) None determined Sarstedt Microtubes (e.g ) and screw cap microtubes (e.g ) None determined Storage The Stool DNA kits are shipped at room temperature. All reagents and buffers should be stored at room temperature (15 25 C). Do NOT freeze the reagent cartridges, and do NOT expose to direct sunlight. Warnings and precautions For In Vitro Diagnostics (IVD) use: These reagents are to be used for the automated purification of NA. Use only the DiaSorin piercing tool for piercing of cartridges. Do not add bleach directly to the sample-preparation waste in the used cartridge. The waste contains guanidine thiocyanate, which can form highly reactive compounds when combined with bleach. Only DiaSorin approved plastic consumables for the instruments should be used, as any other plastic consumables may not work with the system. For sample collection, preparation and storage, see section 7. When working with chemicals, always wear a protective lab coat, disposable gloves and protective goggles. Biological waste from the Arrow/ LIAISON IXT must be discarded according to local safety regulations. Every new application or combination of applications with other systems should be validated by the user for the specific use. Use established laboratory routines for disposal of sample material and any plastics that have been in contact with sample material. Page 8

9 6 INSTRUMENT FOR AUTOMATION OF THE PROCEDURE 6.1 Arrow/LIAISON IXT The Arrow/LIAISON IXT pipetting instrument (fig. 2) is an IVD approved NA isolation device with protocol for the Stool DNA kit. A piercing tool for opening of cartridges is required and provided with the instrument. Sample tubes and elution tubes are required but not provided (see section 5 Reagents and table 2: Recommended sample tubes for use with Arrow/LIAISON IXT). Figure 2: The Arrow instrument and LIAISON IXT instrument (the colour of the Arrow instrument may vary from that shown in the picture) 6.2 Use of Instrument The instrument is to be used by professionals that are trained in molecular techniques and specifically on the use of the Arrow/LIAISON IXT instrument. 6.3 Installation Procedures and Principle of Operation Please refer to the Installation Manual and the Operator s Manual of the instrument for information. 6.4 Operating Instructions See Section 8 Procedure, and Operator s Manual for Arrow/LIAISON IXT 6.5 Calibration Procedures The instrument can be calibrated by qualified personnel when appropriate (see the Installation Manual). 6.6 Operational Precautions and Limitations This product is intended for use by professionals, trained in molecular biological techniques and in operating this automated instrument. The user is responsible for checking that any new application; new sample types, new targets or new downstream detection gives satisfactory performance prior to use. Diagnostic results generated using this sample purification procedure as a sample concentrator in conjunction with any downstream diagnostic assay should be interpreted with regard to other clinical or Page 9

10 laboratory findings. A negative test result should not exclude the possibility of a positive sample because test results may be affected by several factors, such as substances present in the specimen that may interfere with the test, incorrect specimen collection, specimen mix-up, or technical problems. Verify that all components, e.g. cartridges, pumps and tips, sample tubes and elution tubes are correctly positioned in the rack. Take care to choose the correct protocol for the cartridge that is used in your run. If the instrument was moved, please refer to the Installation Manual and the Operator`s Manual for information about the installation checks that need to be performed. Keep the instrument clean (see section Cleaning after the run). Regular preventative maintenance is necessary to ensure that the instrument is working properly, and to avoid unnecessary stops during testing. This must be performed by trained personnel. 6.7 Hazards Always wear protective clothing according to laboratory regulations, such as gloves and safety goggles, when using the kit. Do not add bleach directly to the sample-preparation waste in the used cartridge. The waste contains guanidine hydrochloride, which can form highly reactive compounds when combined with bleach. A separate MSDS is available on request. Never pierce cartridges outside of the instrument (see section 8.1.4). Do not wash the piercing tool with bleach directly after piercing (see section for cleaning of the piercing tool). Remove used cartridges, pump-tips, samples, and elution tubes after each run. Treat all sample material (including waste from the instrument) as hazardous, and handle in accordance with laboratory guidelines. 6.8 Service and Maintenance Information Annual service is recommended for the instrument to function properly. The surface on the instrument should always be kept clean. Clean the surface with either a detergent or alcohol depending on what has been spilt. Please refer to the Operators Manual for further information on cleaning and decontamination of the instrument Contamination Wear gloves when placing and piercing the cartridges. Make sure that the piercing tool is clean, and free of RNase if required (see section Pierce cartridge). Always use filter tips when pipetting sample Controls To control the sample preparation process, it is recommended to prepare a confirmed positive sample and include it in the purification process along with the other samples. To detect and minimize irregularities in diagnostic results, adequate controls should also be used according to the instruction for use for the applicable downstream detection method Technical Support If an instrument problem occurs, first consult section 8.5 Troubleshooting. Make notes of any unusual observations or error messages, prior to mailing support. Please use customercare@ie.diasorin.com as your first line of reporting support issues. The instrument should be connected to an uninterruptible power supply (UPS) to prevent sudden stops of the instrument during a run (in case of a power failure in the electrical system in the building where it is located). Page 10

11 7 SAMPLE COLLECTION AND PREPARATION It is recommended that stool samples are collected from the surface of the stool and stored in the Stool stabilizer buffer. If this buffer is not available during collection of the stool sample, the stool should be kept frozen until extraction is scheduled and Stool stabilizer can be added. The sample preparation procedure is as follows: 1. In a 2 ml sample tube, add 1 ml Stool stabilizer reagent to ~120 mg or less of fresh or frozen stool sample collected. 2. Let the sample solution rest at room temperature for at least 15 minutes with vigorous vortexing every 5 minutes. 3. Make sure the stool samples are thoroughly homogenized. Note: The samples may be frozen after this step for later DNA extraction. After thawing of such frozen samples, a vortexing step is necessary for rehomogenization. 4. Centrifuge the samples at ~6000 g for 5 minutes. 5. Transfer 500 µl stool supernatant to a new clean 1,5 ml screw cap tube (see Table 2) for extraction on the Arrow/LIAISON IXT instrument. Often there is a fatty layer on top of the stool supernatant. Pierce through this layer with the pipette tip and aspirate slowly the 500 µl solution needed while avoiding transfer of any particles. 8 PROCEDURE 8.1 Procedure Stool DNA Isolation The running and cleaning procedures on the instrument are as follows: 1. Select protocol and elution volume 2. Load pump with tip 3. Load cartridge 4. Pierce cartridge 5. Load sample 6. Load elution tube 7. Start the protocol 8. Remove the eluate from the instrument. 9. Cleaning after the run Loading instructions 2, 3, 5, and 6 appear on the instrument screen after the protocol has been selected. Details of all steps are given below: Select protocol and elution volume a. Turn the Arrow/LIAISON IXT power button at the left back side on, and then push the ON button on the front left side (See Operator`s Manual for further instructions). b. Press `Continue` on the first screen to let the instrument initialize. c. Press `START PROTOCOL` on the main menu. d. Select the Stool DNA protocol. e. Choose elution volume (100 or 200 µl) Page 11

12 8.1.2 Load pump with tip a. Assemble pump and tip Hold the pump and press it down into the tip while the tip is in the tip box (fig.3). Press down until the pump and tip are well connected and sealed. The physical distance between the pump and the rim of the tip must be in the range 0-3 mm (fig.4). Take a pump Push pump into tip Assembled pump-tip is placed in instrument Figure 3: How to assemble pump and tip. OK Not OK The physical distance between the pump and the rim of the tip must be 0-3 mm. Figure 4: Correct and incorrect pump-tip assembly. Page 12

13 b. Load the assembled pump-tip Place the pump with tip in the instrument according to fig Insert the pump upwards first. Open tip holder clip and insert the tip. The rim of the tip must be onto the top of the metal edge, see fig Close tip holder clip. Figure 5: Pump-tip positioning and tip clip. The rim of the tip is in direct contact with the metal edge. Figure 6: Correct positioning of tip. The rim of the tip is too high above the metal edge. Figure 7: Incorrect positioning of tip. Page 13

14 8.1.3 Load cartridge Place the cartridge into the Arrow/LIAISON IXT rack. Press the cartridge firmly in place such that the entire longitudinal edge (fig.8) is in direct contact with the rack. The cartridge hole in the rack is intentionally close-fit to ensure that the cartridge stays in place during the run. Make sure that the front is secured by the lock on the cartridge (fig.8). Position the cartridges according to table 3. Front Cartridge lock Longitudinal edge Figure 8: Stool DNA cartridge, with front lock and longitudinal edge. Table 3: Positioning of cartridges in the Arrow/LIAISON IXT. Example is shown for the first 6 samples. Number of samples Positioning in the instrument (track number) , 6 3 5, 6, 7 4 5, 6, 7, 8 5 5, 6, 7, 8, 9 6 4, 5, 6, 7, 8, 9 Page 14

15 8.1.4 Pierce cartridge The piercing tool (fig.9) is used to pierce holes in the cartridge foil while the rack with the cartridge is positioned in the instrument (fig.13). a. Piercing procedure Pierce from the back to the front of the cartridge, with the piercing tool oriented according to figure 9. A complete piercing is best obtained by resolute and continuous movements throughout the procedure. Resolutely pierce the back well (figure 10), and, without pausing, roll the tool through the remaining wells (figure 11). This 2-step procedure should take approximately 1 second per cartridge. If piercing is not complete, roll the tool back to the starting point (figure 12). b. Piercing tool cleaning procedure Immediately after piercing has been completed, clean the piercing tool by rinsing the tool under tap water. Leave to dry until next use. In cases where further cleaning is desirable (e.g. with ethanol, or RNaseAway ), ensure that the piercing tool has become dry before use*. Treatment with chemicals such as RNaseAway necessitates a subsequent thorough rinse in nuclease-free water. The piercing tool may be autoclaved. *WARNING: If ethanol is used for cleaning, and piercing is performed before the tool has become completely dry, then remaining ethanol will dissolve the print ink on the cartridge foil, with a subsequent risk of contaminating the reagents with ink. Figure 9: Piercing tool and its orientation with regard to the cartridge. Page 15

16 A complete piercing is best obtained by firm and continuous movements throughout the procedure. Figure 10: Firmly pierce the back well. The 2-step procedure should take approximately 1 second per cartridge. Figure 11: Without pausing, roll the tool through the remaining wells. Figure 12: If piercing is not complete, roll the tool back to the starting point. Page 16

17 8.1.5 Load sample Put the sample tube into the adapter position (fig.13). See section 5 (Table 2) for tube brand, and section 7 for sample preparation. Please note that adapters for the sample tubes (fig.14) are included with the instrument. Both types of adapter can be used for microtubes Load elution tube Put the elution tube (optional brand) into the elution tube position (fig.13). Cartridges Front Cartridge lock Sample tubes Elution tube snap cap holder (optional to use) Elution tubes Position 1, 2, 3, 4, etc. Figure 14: Adapters for sample tube Figure 13: A loaded rack Start the protocol Close the door and press `START` Remove the eluate from the instrument When `Protocol finished` is displayed on the screen, the eluate is ready for downstream analysis. Page 17

18 8.1.9 Cleaning after the run After the protocol has been run, remove and discard the sample preparation waste, including the pump-tips and cartridges. WARNING: Do not add bleach directly to the sample preparation waste in the used cartridge. The waste contains guanidine thiocyanate, which can form highly reactive compounds when combined with bleach. If necessary, clean the instrument as follows: 1. Run the UV decontamination protocol. 2. Remove the rack (fig. 15) from the instrument. 3. Remove the magnet (fig. 16). 4. If required, the heating block (fig. 17) can be lifted for cleaning. NOTE: The heating block is connected to the instrument with a cable and cannot be removed entirely. 5. Clean the rack, the magnet and the inside of the instrument with detergent or alcohol depending on the material spilt. 6. See the Operator s Manual for further cleaning instructions. Figure 15: The Arrow/ LIAISON IXT rack Figure 16: The magnet Figure 17: The heating block 8.2 Arrow/LIAISON IXT Waste Handling Make sure there are no used cartridges or pumps left in the instrument prior to starting a new run. Discard the waste according to the laboratory safety routines (see also section 6.7 Hazards). 8.3 Sample Waste Handling Treat all sample materials as hazardous, and handle according to laboratory guidelines. 8.4 Shutting down the Arrow/LIAISON IXT at the End of a Working Day Remove and discard remaining cartridges and plastics from the instrument. Clean the instrument in accordance with instructions in section Turn the instrument off by pressing `TURN OFF` on the main menu. When the instrument has shut down, the instrument can also be turned off at the back. Page 18

19 8.5 Troubleshooting Problem Low or zero eluate volume Comments The cartridge might not have been firmly in place in the rack during the run. For detailed instructions of cartridge loading, see section Load cartridge. The calibration settings could be out of range. Calibrate the instrument (see the Installation Manual). If the eluate volume is low or zero despite satisfactory calibration settings, check the used cartridge against the photo below. If there is poor match, photograph the used cartridge from the top and the side and it to for further troubleshooting. Stool DNA cartridge post-run Inhibition in downstream analysis When collecting stool samples, collect from the surface of the stool as there is a higher concentration of inhibitors in the interior of the stool. Reduce the amount of stool sample added to the stool stabilizer. With some stool samples it might be necessary to reduce the amount of stool to 30 mg pr ml stool stabilizer. Use 200 ul elution volume to avoid inhibition. Visible amounts of beads in the eluate The presence of beads will affect absorbance readings, but not PCR or most other downstream analyses. To avoid bead influenced absorbance readings, remove beads by placing samples onto a magnet. Non-responsive instrument screen Disconnect the power cord, then reconnect to let the instrument re-initialize. If this does not help, contact DiaSorin at customercare@ie.diasorin.com. Instrument error message See the Arrow/ LIAISON IXT Operator s Manual Page 19

20 9 PERFORMANCE DATA 9.1 Introduction Stool DNA performs with high reproducibility and repeatability (section 9.2). A total of 82 individual samples have been tested with regard to yield and purity of total DNA and hdna, as well as for the presence of PCR inhibitory substances (section 9.3). 9.2 Reproducibility and Repeatability Stool from twelve persons were prepared in stool stabilizer buffer to a concentration of ~120 mg stool pr ml of buffer. The stool solutions were then aliquoted to sample tubes and extracted five times on 3 different instruments with three different operators (fig. 18). The sample volume was 500 µl stool solution in stool stabilizer buffer. The obtained eluate volume was approximately 180 µl. 300 tdna yield (ng/ul) Run 1 Run 2 Run 3 Run 4 Run 5 0 x56-1 x56-2 x56-3 x56-4 x56-5 x56-6 x56-7 x56-8 x56-9 x56-10 x56-11 x56-12 Figure 18: Reproducibility and repeatability of Stool DNA. As expected, the total DNA varies extensively among individuals. The reproducibility and repeatability of Stool DNA is excellent (fig.18). 9.3 Extraction of DNA from 82 Stool Samples Collected for Analysis of CRC A total of 82 samples were randomly chosen from a large collection of stool samples previously collected from individuals with symptoms of colorectal cancer. Stool samples were collected directly in stool stabilizer by the patients themselves using a dedicated collection device and frozen in the laboratory at the time of arrival. Extraction of total DNA from 82 individuals shows a broad yield range of total DNA and hdna, across patients (fig. 19 and 20, respectively). Measurement of DNA quality using the OD 260/280 ratio shows that near all values are above 1.7 (fig.21). All samples yielded good results when analyzed using real-time PCR for quantification of human DNA and PCR inhibition (fig.22). Page 20

21 x75-01 x75-04 x75-07 x75-10 x75-13 x75-16 x75-19 x75-22 x75-25 x75-28 x75-31 x75-34 x75-37 x75-40 x75-43 x75-46 x75-49 x75-52 x75-55 x75-58 x75-61 x75-64 x75-67 x75-70 x75-73 x75-76 x75-79 x75-82 x75-01 x75-04 x75-07 x75-10 x75-13 x75-16 x75-19 x75-22 x75-25 x75-28 x75-31 x75-34 x75-37 x75-40 x75-43 x75-46 x75-49 x75-52 x75-55 x75-58 x75-61 x75-64 x75-67 x75-70 x75-73 x75-76 x75-79 x Total DNA Yield (ng/ul) Figure 19: Total DNA yield in stool samples from 82 individuals hdna pg/ul Figure 20: Quantification of a human single copy gene shows high variation in hdna. Page 21

22 x75-01 x75-04 x75-07 x75-10 x75-13 x75-16 x75-19 x75-22 x75-25 x75-28 x75-31 x75-34 x75-37 x75-40 x75-43 x75-46 x75-49 x75-52 x75-55 x75-58 x75-61 x75-64 x75-67 x75-70 x75-73 x75-76 x75-79 x75-82 x75-01 x75-04 x75-07 x75-10 x75-13 x75-16 x75-19 x75-22 x75-25 x75-28 x75-31 x75-34 x75-37 x75-40 x75-43 x75-46 x75-49 x75-52 x75-55 x75-58 x75-61 x75-64 x75-67 x75-70 x75-73 x75-76 x75-79 x DNA Quality: 260/280 ratio Figure 21: DNA quality measured by OD 260/280 ratio. 31 Inhibition - IPC Ct Figure 22: Internal PCR control (IPC) for 82 stool samples shows very limited PCR inhibition. Page 22

23 Ct values 9.4 Detection of Bacterial Species in Stool Samples Stool from seven persons were prepared in stool stabilizer buffer and extracted on the Arrow/LIAISON IXT instrument. A set of selected bacterial groups were selected for detection with real-time PCR analysis (fig.23) Amplification of bacterial species Sample 1 Sample 2 Sample 3 Sample 4 Sample 5 Sample 6 Sample 7 Figure 23: Amplification of bacterial species in stool samples. Page 23

24 10 LIMITATIONS OF THE PROCEDURE See section 6.6 Operational Precautions and Limitations and the manufacturer s instructions for use for the applicable detection system. 11 EXPECTED VALUES The Stool DNA procedure only purifies the DNA from the sample to prepare for detection with another method. It does not give any values or diagnostic results as such. When using the Stool DNA procedure it is generally expected that the sensitivity of your analysis is the same or better than when using manual extraction methods. A low level of inhibition is also expected. 12 SPECIFIC PERFORMANCE CHARACTERISTICS The Stool DNA procedure has high reproducibility and repeatability, and yields DNA with very low occurrence of PCR inhibitory substances (see section 9 Performance Data). For performance characteristics of the detection system, please see manufacturers instructions for use for the applicable detection system. 13 QUALITY CONTROL To ensure consistent product quality, each lot of kits is released in accordance with DiaSorin Quality Control Procedure. Page 24

25 14 PRODUCT LIST Table 4: Product list for ordering Arrow/LIAISON IXT kits. Prod. Code Product Description Size Arrow Instrument, CE/IVD A compact, automated user-friendly solution for nucleic acid extractions, running 1-12 samples. 1 piece I0074 LIAISON IXT Instrument, CE/IVD A compact, automated user-friendly solution for nucleic acid extractions, running 1-12 samples. 1 piece DNA Extraction Kit RNA Extraction Kit CellSep Kit CellSep Advanced Kit BUGS n BEADS Kit, CE/IVD Stool DNA Extraction Kit, CE/IVD Blood DNA 200 Extraction Kit, CE/IVD Blood DNA 500 Extraction Kit, CE/IVD Viral NA Extraction Kit, CE/IVD Other Supporting Products For isolation of genomic DNA from cultured cells, tissue, buccal swab and saliva. Includes cartridges, 2 buffers, proteinase K, tips and pumps For isolation of intact RNA from cultured cells. Includes cartridges, 1 buffer, tips and pumps. For isolation of cells from whole blood or buffy coat. Includes cartridges, sample tubes, tips and pumps. For isolation of 1-3 cell types from whole blood or buffy coat. Includes cartridges, sample tubes, tips and pumps. For isolation of mainly bacterial NA from various sample types, such as cell culture, urine, swab and sputum. Includes cartridges, tips and pumps. For isolation of genomic, bacterial and viral DNA from human and animal stool. Includes cartridges, buffer, tips and pumps. For isolation of mainly genomic DNA from whole blood. Includes cartridges, tips and pumps. For isolation of mainly genomic DNA from whole blood and buffy coat. Includes cartridges, tips and pumps. For isolation of viral NA from serum, plasma, swabs, and blood. Includes cartridges, tips and pumps. 96 preps 96 preps 96 preps 96 preps 96 preps 96 preps 96 preps 96 preps 96 preps tips in box Extra box of 96 tips 1 x 96 tips pumps in plastic bag Extra bag of 98 pumps 1 x 98 pumps Piercing tool For piercing cartridges 1 piece Page 25

26 15 NOTES Page 26

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28 DiaSorin Ireland Ltd. Unit 13/14 Holly Avenue, Stillorgan Industrial Park, Blackrock, Co. Dublin, Ireland. Tel: Fax: info@ie.diasorin.com customercare@ie.diasorin.com Page 28