Instructions for Use

MagDEA® Dx SV
Version 2.2
Content: 30 Apr. 2024
This reagent is designed for automation system. Please surely read and understand thisdocument and operation manual of the system prior to usage. geneLEAD and magLEAD series
are applied as automated systems.
This new revision of the Instruction for Use (IFU) contains the following changes:- Added target specimen to the Intended use section.
Composition, use and performance of the product are unchanged.

E1300

Precision System Science Co., Ltd.
88 Kamihongou, Matsudo-shi, Chiba, 271-0064 JapanMagDEA® Dx SV
Version 2.21 / 12Precision System Science Co., Ltd.

Index
1. Symbols....................................................................................................................................... 3
2. Abstract of product ...................................................................................................................... 4
2.1. Introduction ............................................................................................................................. 4
2.2. Intended use ............................................................................................................................ 4
2.3. Extraction principle（Magtration® Technology） ....................................................................... 5
2.4. Kit contents .............................................................................................................................. 5
2.5. Warnings and precautions specific for the components.............................................................. 6
2.6. Process time............................................................................................................................. 7
2.7. Storage condition ..................................................................................................................... 8
3. How to use this product ............................................................................................................... 8
3.1. Safety instructions .................................................................................................................... 8
3.2. Operation procedure ................................................................................................................ 8
4. Reagent performance ................................................................................................................... 94.1. Linearity test of extracts from various sample matrices, spiked with M13 DNA bacteriophage..... 94.2. Genomic DNA from human whole blood ................................................................................. 10
5. Trouble shooting .........................................................................................................................11MagDEA® Dx SV
Version 2.2

2 / 12Precision System Science Co., Ltd.

1.

Symbols
In vitro diagnostic medical device
Authorized Representative in the European Community
CautionBatch code/lot number
Catalog number
Contents
Unique Device Identification
Temperature limitation
Sufficient for
Do not reuse
Consult instructions for use
Manufacturer
Use byAcute toxicity

Acute aquatic toxicity

Flammable

Health hazard

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2.

Abstract of product2.1. Introduction
MagDEA® Dx SV is the nucleic acid extraction reagent for the fully automated extraction – diagnostics
system. (geneLEAD and magLEAD series are applied as automated systems.) The system is based on theMagtration® Technology and it is possible to use up to 200 µL samples and 400 µL samples. Extracted nucleic
acid can be used for real time PCR or RT-PCR analysis, and it is possible to use this specific reagent kit by asimple procedure. PSS automated extraction system is based on the Magtration® Technology and magnetic
particles, and there is no need for centrifugation or spin column steps. The use of MagDEA® Dx SV
significantly reduce the risk of contamination from outside. Another advantage is that this procedure
extracts high quality nucleic acid in less time compare with a manual process.
2.2. Intended use«MagDEA Dx SV» is a ready-to-use cartridge containing reagents for the extraction and purification ofnucleic acids (NA). This reagent is used in combination with magLEAD and geneLEAD systems.
The NA isolation protocol is based on magnetic beads and is designed for automated preparation ofhighly pure (human, bacterial and viral) genomic DNA and viral genomic RNA from the following humanclinical samples.
The performance of this product has been established through performance evaluation using following
sample types.
: Whole blood collected in EDTA or citrate, plasma collected in EDTA or citrate, serum, urine,
cerebrospinal fluid (CSF), sputum, stool, and respiratory swabs (nasal swab, throat swab).

Caution⚫

Regulation (EU) 2017/746 Annex VIII CLASSIFICATION RULES As a result of evaluationaccording to Rule 1-5, this product is Class “A” because it corresponds to Rule 5 (a).

⚫

The performance of MagDEA Dx SV kit has been established by performance evaluation using
above mentioned sample matrices for extraction of nucleic acid.
The kit validation is limited to sample matrices above mentioned in Intended use.
No guarantee is issued with sample is used different from these validated by Precision SystemScience Co., Ltd. The user is responsible to validate the performance of the product if usedwith assays different from those sample.

⚫

Inform your PSS representative and your local competent authority about any serious
incidents which may occur when using this product.

⚫

The user is responsible to validate the performance of the product if used with assays different
from those validated by PSS as reported in the instructions for use.

⚫

This product must be handled by personnel qualified competent and trained in molecularbiology techniques, such as extraction, amplification and detection of nucleic acids, to avoid
incorrect results with potentially serious consequences for the patient in subsequent steps ofthe analysis performed on the extracted nucleic acids.

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2.3. Extraction principle（Magtration® Technology）
The Magtration® Technology is based on magnetic particles located inside of a tip, to segregate theparticles from the liquid. (1) Sample is prepared. (2) Protein in sample is lysed using Proteinase K and lysis
solution. (3) Nucleic acid is absorbed to magnetic particles with hydrophilic surface using chaotropic ion andalcohol. (4) Magnetic particles are recovered from reaction buffer by Magtration® Technology. (5) Magneticparticles are washed using wash buffer containing alcohol. (6) Magnetic particles are recovered from washbuffer by Magtration® Technology. (7) Nucleic acid is eluted using hot water as elution buffer, and eluate isrecovered to collection tube.

2.4. Kit contents
The kit contains 48 unitary prefilled Nucleic Acid extraction cartridges
Each Nucleic acid extraction cartridge contains:

Nucleic acid extraction reagent
cartridge
Well 8Well 1
2D-codeMagDEA® Dx SV
Version 2.2

Well No.

Reagent name

Quantity1Lysis solution

400 µL

2PK solution

80 µL

3Carrier solution

80 µL

4

Magnetic particles

200 µL

5Binding buffer

1000 µL

6Wash buffer 11200 µL

7Wash buffer 2700 µL

8Distilled water

1200 µL

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2.5. Warnings and precautions specific for the components
The following components of the MagDEA Dx SV contain hazardous reagents.
For further information, please, see Material Safety Data Sheets.
GHS Hazard and Precautions statements of components:
Lysis Solution
Contains Hexadecyl trimethylammonium chloride and Guanidinium chloride
Danger
H302:
H315:
H319:
H335:
H400:
H410:

Harmful if swallowed.
Causes skin irritation.
Causes serious eye irritation.
May cause respiratory irritation.
Very toxic to aquatic life.
Very toxic to aquatic life with long lasting effects.

P261:
Avoid breathing dust/fumes/gas/mist/vapours/spray.
P264:
Wash the hands thoroughly after handling.
P270:
Do not eat, drink, or smoke when using this product.
P271:
Use only outdoors or in a well-ventilated area.
P273:
Avoid release to the environment.
P280:
Wear protective gloves/protective clothing/eye protection/face protection.
P301+P312:
IF SWALLOWED: Call a POISON CENTER or a doctor if you feel unwell.
P302+P352:
IF ON SKIN: Wash with plenty of water.
P304+P340:
IF INHALED: Remove person to fresh air and keep comfortable for breathing.
P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if
present and easy to do. Continue rinsing.
P312:
Call a POISON CENTER or a doctor if you feel unwell.
P321:
Specific treatment.
P330:
Rinse mouth.
P332+P313:
If skin irritation occurs: Get medical advice/attention.
P337+P313:
If eye irritation persists get medical advice/attention.
P362:
Take off contaminated clothing.
P391:
Collect spillage.
P403+P233:
Store in a well-ventilated place. Keep container tightly closed.
P405:
Store locked up.
P501:
Dispose of contents/container according to national regulation.
Binding Buffer Wash Buffer 1, and Wash Buffer 2
Contains 2-propanol.
DangerMagDEA® Dx SV
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Precision System Science Co., Ltd.

H225:
H319:
H335:
H361:
H370:
H372:
H373:
P201:
P202:
P210:

Highly flammable liquid and vapour.
Causes serious eye irritation.
May cause respiratory irritation.
Suspected of damaging fertility or the unborn child.
Causes damage to organs.
Causes damage to organs through prolonged or repeated exposure.
May cause damage to organs through prolonged or repeated exposure.
Obtain special instructions before use.
Do not handle until all safety precautions have been read and understood.
Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. Nosmoking.
P233:
Keep container tightly closed.
P240:
Ground/bond container and receiving equipment.
P241:
Use explosion-proof electrical/ventilating/lighting equipment.
P242:
Use only non-sparking tools.
P243:
Take precautionary measures against static discharge.
P260:
Do not breathe dust/fumes/gas/mist/vapours/spray.
P261:
Avoid breathing dust/fume/ gas/mist/vapours/spray.
P264:
Wash the hands thoroughly after handling.
P270:
Do not eat, drink, or smoke when using this product.
P271:
Use only outdoors or in a well-ventilated area.
P280:
Wear protective gloves/protective clothing/eye protection/face protection.
P303+P361+P353: IF ON SKIN (or hair): Take off immediately all contaminated clothing. Rinse skin withwater/shower.
P304+P340:
IF INHALED: Remove person to fresh air and keep comfortable for breathing.
P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if
present and easy to do. Continue rinsing.
P308+P311:
If exposed or concerned: Call a POISON CENTER or a doctor.
P308+P313:
If exposed: Call a POISON CENTER or a doctor.
P312:
Call a POISON CENTER or a doctor if you feel unwell.
P314:Get medical advice/attention if you feel unwell.
P321:
Specific treatment.
P337+P313:
If eye irritation persists: Get medical advice/ attention.
P370+P378:
In case of fire: use carbon dioxide, foam, dry chemical, and water fog to extinguish.
P403+P233:
Store in a well-ventilated place. Keep container tightly closed.
P403+P235:
Store in a well-ventilated place. Keep cool.
P405:Store locked up.
P501:
Dispose of contents/container according to national regulation.

2.6. Process time
Operation time depends on protocol.
Protocol200 µL protocol400 µL Whole Blood Protocol

400 µL Other matrix Protocol

Process time

Approx. 25 min.

Approx. 40 min.

Approx. 30 min.

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2.7. Storage condition
Please keep the extraction reagent kit at 10-30 oC. Do not freeze and keep the reagent away from hightemperature including humidity or vibration. To prevent the reagent kit from exposure under direct sunlight,
please keep the reagents in external boxes for storage after usage.
Always store the kit cartridges with the sealing on the upper side and not under tilting conditions.

3.

How to use this product3.1. Safety instructions
Please confirm following items prior to use.

・ This extraction reagent kit is dedicated for automation system only. Therefore, please read carefully theinstrument operation manual prior to use.
・ In case of instrument error messages, please refer to the instrument operation manual.
Notes for safety usage
・ Reagent inside of prepack cartridge include toxic or flammable material, please refer to hazard andprecautionary statements of Material safety data sheet (MSDS) and pay attention to the safety handlingparagraph.
・ Follow the laboratory safety guidance and pay attention to infection risks.
・ Do not drink or smoke close to the test area.
・ Wear protective gloves, coat and eye protection gear when using the kit.
・ Dispose the gloves and clean your hands carefully after use.
Notes for dispose
・ When disposing reagent or consumables, handle them as infection risk. Refer to MSDS and follow yourregional regulation for disposables.
・ The reagents include iso-propyl alcohol so keep away from fire or explosive items when disposing.
Notes for reagent performance
・ Do not use when the cartridge or aluminum seal is damaged or leaks.
・ Do not use expired reagent kit.
・ Do not re-use extraction cartridge or tip rack.
・ Do not damage or dirt 2D code.
・ Prior to use, if the reagent stick on the wall inside the cartridge well, vibrate/flick briefly for the drops
to fall down without creating any bubbles.
・ The elution consists of distilled water however the final elution volume may vary due to remaining’s on
the magnetic particles, tip surface or due to evaporation.
・ Do not leave the reagent for too long time on the instrument before start.
・ It is recommended to use controls for PCR, such as internal control or positive control, to get reliablediagnostic results.
3.2. Operation procedure
Prior to use, please read carefully the operation procedure about automation system in the operationmanual.
Consumable kit sold separately is necessary.
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1. Power ON the instrument.
2. Select functions from Graphic user interface (GUI).
3. Prepare extraction reagent cartridge, tip set included in consumable kit sold separately and sample by
GUI guidance. Prior to use, if the reagent sticks inside the wall of the cartridge well, vibrate briefly forthe drops to fall down without creating any bubbles.
Consumption of one sample are as follows. Prepare the reagent and the consumables according toGUI of instrument.
Nucleic acid extraction cartridge MagDEA® Dx SV
1 pc
Tip set
1 pc
Collection tube
1 pc
Sample tube
1 pc
4. Select protocol with help of GUI of instrument or PC.
5. Make sure to set MagDEA® Dx SV, Sample tube or Sonication tube, (if needed Sonication cap), collection
tube for elution, Tip rack and PCR cartridges properly based on the GUI guidance.
6. Close the front cover of the instrument.
7. Push Start button to start the nucleic acid extraction process.
8. After process completion, open front cover by GUI guidance.

4.

Reagent performance

The performance tests were validated using geneLEAD XII plus of PSS. PCR result of the extract isdepended on the PCR condition and the amplification system.
4.1. Linearity test of extracts from various sample matrices, spiked with M13 DNA bacteriophage
M13 DNA bacteriophage, using 10 µL and 7 different concentrations, were added to 200 µL of following
human body fluid samples; Serum, plasma (EDTA-2Na), plasma (ACD), swab (throat), swab (nasal),
cerebrospinal fluid (CSF) and urine. Those samples were prepared to final numbers of 1×10 2, 3, 4, 5, 6 7 and 8copies/extraction (5 replicates). DNA was extracted using MagDEA® Dx SV on geneLEAD XII plus, and theextracts were PCR amplified using ABI 7500 Dx fast (M13 specific TaqMan probe). 100 copies/extraction
were detected in all tests. Slopes, coefficient of determination (R2), PCR efficiency and y-intercept werecalculated using the Ct values obtained from samples between 1x102-8 copies/extraction (Table 1). No
differences were observed between the sample species. PCR amplification curve and Linearity plot graphusing serum is shown in Figure 1.
Table 1.

The linearity test analysis showing obtained Ct values from seven different human samplematrixes.
SerumPlasma

PlasmaSwabSwab(EDTA)(ACD)(Throat)(nasal)

CSF

Urine

Slope-3.447-3.406-3.415-3.369-3.391-3.361-3.397

coefficient of determination (R2)

0.995

0.997

0.998

0.999

0.999

0.996

0.998

PCR efficiency (%)

95.02796.59496.25398.06197.21598.40596.954y-intercept

41.86341.55641.78241.09741.46340.88341.052MagDEA® Dx SV
Version 2.2

9 / 12Precision System Science Co., Ltd.

Figure 1.

Linearity plot graph showing copy numbers and Ct values from M13 bacteriophage included
serum as typical data.

4.2. Genomic DNA from human whole blood
Genomic DNA was extracted from human EDTA-2Na (specimen A) or ACD (specimen B) whole blood
samples using MagDEA® Dx SV for total 6 days (6 replicates by each run). The white blood cell (WBC)numbers of specimen A and B were 6.4 and 9.2 k/µL respectively. The concentrations and purities of theextracts were measured using ND-1000 spectrometer (NanoDrop) (Figure 2). After 6 runs, there were no
significant variations between the two specimens.
Table 2.

The A260/280, and A260/230 of genomic DNA from whole blood sample.
A260/230

A260/280

Specimen A

1.70±0.11

1.88±0.06

Specimen B

1.85±0.17

1.89±0.05

7.00
6.00

Yield (µg)

5.00
4.00

Specimen A (wbc 6.4 k/uL)

3.00

Specimen B (wbc 9.2 k/uL)

2.00
1.00
0.00
Day 1
Figure 2.

Day 2

Day 3

Day 4

Day 5

Day 6

The yield of genomic DNA from whole blood sample.

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5.

Trouble shooting

In case of finding a general error, please follow the procedure below. Please follow the instrument
operation manual in case of an instrument error.
(1) Low extraction yield, not pure enoughRoot cause
CountermeasureSample status
Verify that the sample storage condition is appropriate or not.
Use fresh sample or sample stored under appropriate condition.
Extraction amount can vary from chilled or frozen sample.
Reagent status
Verify that the extraction reagent cartridge storage condition isappropriate. In case of kit storage in refrigerator, please place thereagent in room temperature prior to use.
Do not freeze the reagent, and prevent storage places with vibration.
Solid items remaining
Some specific sample extracts with solid items remaining inside may
cause tip stacking, and mixing process may not function properly.
The sample should contain a clear solution for smooth handling by
1000uL pipet. Do not use solid sample for extraction.
Contamination
Clean all instrument parts well after use, including all surfaces by using
0.1 % sodium hypochlorite, and then clean by 70 % ethanol.
Trouble of automation Refer the error code of automation system, and accordance with thesystemcountermeasure.
(2) RNA is solved
Root cause
Too much sample
amountElution storage too longtime
External RNase
contamination

MagDEA® Dx SV
Version 2.2

Countermeasure
In case of adding too high sample concentration, RNase cannot beinactivated. Reduce sample concentration.
Do not keep eluted sample for too long time in RT after extraction.
Tighten cap of elution tube as soon as possible, and keep samples at -80
oC condition.
Clean all instrument parts well after use, including all surfaces by using
0.1 % sodium hypochlorite, and then clean by 70 % ethanol. After use,clean all parts on the instrument surface carefully by using RNase
removal agent.

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Magtration® and MagDEA® are registered trademark owned by Precision System Science Co., Ltd.
These explanations are based on the status of 2023/4.
Please be noted information such as specification can be changed without information.

Produced by / sold by
Precision System Science Co., Ltd.
88 Kamihongou, Matsudo-shi, Chiba, 271-0064 Japan
Tel: +81 (0) 47-303-4801 Fax: +81 (0) 47-303-4811
URL : http://www.pss.co.jp
E-mail : service@pss.co.jp
Precision System Science USA, Inc.
5673 West Las Positas Blvd., Suite 202, Pleasanton, CA 94588, U.S.A.
E-mail : contact@pssbio.com
Precision System Science Europe GmbH
55122 Mainz, Mombacher Str. 93, Germany
E-mail : contact-psse@pss.co.jp

Emergo Europe
Westervoortsedijk 60 6827 AT Arnhem The Netherlands

MagDEA® Dx SV
Version 2.2

12 / 12Precision System Science Co., Ltd.