Thermo Fisher Scientific MagMAX Instruction Manual
INSTRUCTIONS FOR USE
MagMAX™ Viral/Pathogen II Nucleic Acid Isolation Kit,
High‑Throughput
Magnetic bead technology‑based nucleic acid purif ication for high‑throughput workf lows
REF.
A50884
Pub. No. MAN0019941 Rev. A.0
WARNING! Read the Safety Data Sheets (SDSs) and follow the handling instructions. W
clothing, and gloves. Safety Data Sheets (SDSs) are available from thermofisher.com/support.
ear appropriate protective eyewear,
Intended use
Applied Biosyst
of viral nucleic acid from human respiratory specimens. The magnetic bead technology‑based nucleic acid purification reagents have
been validated for the following workflows:
• Automated, high‑throughput workflows—for isolation and purification of RNA from nasal and nasopharyngeal specimens
• Manual and semi‑automated workflows—for isolation and purification of RNA and DNA from nasopharyngeal specimens
The MagMAX™ Viral/Pathogen II Nucleic Acid Isolation Kit, High‑Throughput is intended for use by qualified and trained clinical laboratory
personnel specifically instructed and trained in the techniques of magnetic bead purification, either manual or automated, and in vitro
diagnostic procedures. The MagMAX™ Viral/Pathogen II Nucleic Acid Isolation Kit, High‑Throughput is intended for use in a qualified
laboratory environment according to the sample type.
ems™ MagMAX™ Viral/Pathogen II Nucleic Acid Isolation Kit, High‑Throughput is intended for the isolation and purification
Product information
MagMAX™ Viral/Pathogen II Nucleic Acid Isolation Kit, High‑Throughput (REF. A50884) is specifically designed to recover nucleic acid
from viral particles contained in viral transport media (VTM). The kit utilizes MagMAX™ magnetic-bead technology, ensuring reproducible
recovery of high-quality RNA.
MagMAX™ Viral/Pathogen II Nucleic Acid Isolation Kit, High‑Throughput is intended for in vitro diagnostic use and includes the following
features:
• Automated, high‑throughput workflow using the Amplitude™ Platform to allow for up to 8,000 samples to be processed in a 24‑hour
period
• No requirement for carrier RNA
• Elution volume of 50 µL
Note: Protocol options also support a manual workflow or a semi‑automated workflow, accommodating sample volume inputs from
200 to 400 μL of VTM. Semi‑automated workflows using the KingFisher™ Flex Magnetic Particle Processor with 96 Deep-Well Head allow
for 96 nasopharyngeal swab specimens to be processed in <30 minutes.
For product information on manual or semi‑automated protocols, see the MagMAX™ Viral/Pathogen II Nucleic Acid Isolation Kit
Instructions For Use (Pub. No. MAN0019746).
Contents and storage
MagMAX™ Viral/Pathogen II Nucleic Acid Isolation Kit, High‑Throughput (REF. A50884) is compatible with the Amplitude™ Platform. The
reagents are supplied in 2 distinct modules that are designed to align with Amplitude™ Platform Module 1 and Module 2:
• MagMAX™ MVPII HT Module 1 Sample Prep (Cat. No. A50770)
• MagMAX™ MVPII HT Module 2 Sample Prep (Cat. No. A50771)
The MagMAX™ Viral/Pathogen II Nucleic Acid Isolation Kit, High‑Throughput contains sucient reagents for 20,000 reactions.
For In Vitro Diagnostic Use.
Table 1 MagMAX™ Viral/Pathogen II Nucleic Acid Isolation Kit, High‑Throughput (REF. A50884)
Amplitude
Platform Module
MagMAX™ MVPII HT Module 1 Sample Prep (Cat. No. A50770)
Module 1
MagMAX™ MVPII HT Module 2 Sample Prep (Cat. No. A50771)
™
MagMAX™ MVPII HT Binding Solution B32430F4 3 800 mL
MagMAX™ MVPII HT Binding Beads 109‑00‑502F4 3 30 mL
MagMAX™ MVPII HT Proteinase K EO2180F4 3 20 mL
Component REF. Quantity Amount Storage
15°C to
25°C
Module 2
MagMAX™ MVPII HT Wash Solution B32440F4 3 1,500 mL
MagMAX™ MVPII HT Elution Solution B29880F9 1 700 mL
15°C to
25°C
Required materials not supplied
Unless otherwise indicated, all materials are available through thermofisher.com. "MLS" indicates that the material is available from
fisherscientific.com or another major laboratory supplier.
Item
Amplitude™ Platform Module 1 and Module 2 equipment
80% Ethanol
Silicone oil
Amplitude™ High‑Throughput Consumable Package 3 Plastics
(Optional) Extraction control, if required for your assay
[1]
See also “Module 1 Required samples, reagents, and consumables” on page 4 and “Module 2 Required sample input, reagents, and consumables” on page 8.
See the user guide for the Amplitude™ Platform
(Pub. No. MAN0019842)
Source
[1]
Product limitations
• The system performance was established using nasal and nasopharyngeal swab samples only. Specimen types other than nasal and
nasopharyngeal swab should not be tested with this kit.
• Samples must be collected, transported, and stored using appropriate procedures and conditions. Improper collection, transport, or
storage of specimens may hinder the ability of the assay to detect the target sequences.
• Chemical inactivation and other known clinically relevant interfering substances and techniques can lead to inappropriate primary
samples and interfere with test results.
• The Amplitude™ Platform workflow must be performed according to the specified methods described in the user guide for the
system.
• The quality of the biological samples is essential for the quality of the results generated with this kit.
• False-negative results may arise from:
– Improper sample collection
– Degradation of the SARS-CoV-2 RNA during shipping/storage
– Specimen collection after SARS-CoV-2 RNA can no longer be found in the specimen matrix
– Using unauthorized extraction or assay reagents
– Failure to follow instructions for use
• False-positive results may arise from:
– Cross contamination during specimen handling or preparation
– Cross contamination between patient samples
– Specimen mix-up
– RNA contamination during product handling
2 MagMAX
™
Viral/Pathogen II Nucleic Acid Isolation Kit, High‑Throughput Instructions for Use
Warnings and precautions
The reagents should only be used in a qualified laboratory environment according to the sample type by qualified and trained sta to
avoid cross-contamination and the risk of erroneous results. For information about operator roles and requirements, see the user guide for
your system.
• Before using this product, read and understand the information provided in this guide and the user guide for your system.
• Read and understand the Safety Data Sheets (SDSs) provided by the chemical manufacturer before you store, handle, or work with
any chemicals or hazardous materials. To obtain SDSs, see the "Documentation and Support" section in this document.
• Samples and controls should always be treated as if infectious and/or biohazardous in accordance with safe laboratory procedures.
• Follow necessary precautions when handling specimens. Use personal protective equipment (PPE) consistent with current guidelines
for the handling of potentially infectious samples.
• Always use pipette tips with aerosol barriers. Tips that are used must be sterile and free from DNases and RNases.
• Do not eat, drink, smoke, or apply cosmetic products in the work areas.
• Modifications to assay reagents, assay protocol, or instrumentation are not permitted.
• Reagents must be stored and handled as specified in “Contents and storage” on page 1.
• Do not use system consumables or reagents after the indicated expiry date.
• Dispose of waste in compliance with local, state, and federal regulations.
Sample collection, transport, and storage
CAUTION! Handle all samples and controls as if they are capable of transmitting infectious agents.
• Patient samples must be collected according to appropriate laboratory guidelines. The Amplitude™ Platform can be used with patient
samples collected via nasopharyngeal or nasal swab.
• Store samples at 2–8°C for up to 72 hours after collection. If a delay in testing is expected, store samples at ≤-70°C.
Guidelines for sample tubes
• Only use sample tubes meeting the specifications listed in the table below:
Tube runner type
13 mm, 32‑position 12 mm 14 mm 140 mm Skirted, internal conical only
16 mm, 26‑position 15 mm 17 mm 140 mm Skirted, internal conical only
17 mm, 24‑position 16 mm 18 mm 140 mm
Tube diameter range
Minimum Maximum
IMPORTANT!
For each Module 1 run, all 376 sample tubes must be within the same diameter range. Individual tube heights can vary, but should
·
not exceed 140 mm.
For each Module 1 run, all 376 sample tubes must be loaded in the same type of tube runner. Tube runner types cannot be mixed
·
within a run.
• Ensure that you have the minimum volume of sample required for the sample tube size.
Maximum tube
height
Tube bottom type
Non‑skirted, external conical
or
Skirted, internal conical
Sample tube size
12–14 mm 0.5 mL
15–17 mm 1 mL
16–18 mm 1 mL
• All sample tubes must be barcoded with a unique ID. For sample tube barcode requirements, see the user guide for your system.
Note: The Amplitude™ Platform does not perform sample accessioning. If required, perform sample accessioning according to
guidelines established by your laboratory prior to processing the samples on Module 1. After testing, the results can be ported into
your laboratory system.
MagMAX™ Viral/Pathogen II Nucleic Acid Isolation Kit, High‑Throughput Instructions for Use 3
Minimum volume required
• For sample collection devices containing swabs, the swabs must be removed from sample tube before loading into the tube runners.
Alternatively, the sample can be transferred to a fresh, barcoded sample tube that is then loaded into an appropriate runner type.
• The Amplitude™ Platform cannot run fewer than 376 samples at a time. If you have fewer than 376 sample tubes, you must include
additional empty, barcoded tubes to fill any empty positions in the tube runners.
Guidelines for sample inactivation
Follow the sample inactivation guidelines and requirements established by your laboratory and local regulatory bodies. If your laboratory
inactivates samples, do so before you begin the Module 1 workflow.
Chemical inactivation is not recommended and may interfere with test results.
In‑use reagent stability
Table 2 In-use reagent stability
Reagent
MagMAX™ MVPII HT Binding Solution Store capped at 15°C to 25°C long‑term.
MagMAX™ MVPII HT Binding Beads Store capped at 15°C to 25°C long‑term.
Binding Bead Mix (prepared by customer)
MagMAX™ MVPII HT Proteinase K
Purified sample nucleic acid
Once the MagMAX™ MVPII HT Binding Solution and MagMAX™ MVPII HT Binding Beads
are combined, the mix is stable for 24 hours after preparation. Store capped at 15°C to
25°C.
Once placed in the Tecan™ Fluent™ 1080 Automation Workstation reagent carrier (15°C to
25°C), the reagent has long‑term stability.
Once extracted, purified sample nucleic acid is stable at 4°C for 48 hours.
For long term storage, store according to the guidelines established by your laboratory.
Stability information
Perform a Module 1 run
Module 1 overview
Module 1 operation is controlled by the Tecan™ FluentControl™ Software, via the Tecan™ Fluent™ 1080 Automation Workstation
touchscreen. For more information, see the user guide for the Amplitude™ Platform (Pub. No. MAN0019842).
During Module 1 operation:
• Technicians load prepared sample tube runners, reagents, and consumables on the Tecan™ Fluent™ 1080 Automation Workstation
deck and start runs.
• The instrument prepares 4 sample extraction plates containing the following components:
– 200 µL of sample from the sample tubes
– MagMAX™ MVPII HT Proteinase K
– Extraction control and assay control as required by the assay that is used in combination with MagMAX™ Viral/Pathogen II
Nucleic Acid Isolation Kit, High‑Throughput
– Binding Bead Mix
– Silicone oil
• The Tecan™ Fluent™ 1080 Automation Workstation scans the barcodes on sample tubes and sample extraction plates, then registers
the information with the SampleManager LIMS™ Software for sample tracking.
Module 1 Required samples, reagents, and consumables
For a complete list of required samples, reagents, and consumables, see the user guide for the Amplitude™ Platform
(Pub. No. MAN0019842).
Required samples, reagents, and consumables
Sample input
Barcoded sample tubes in sample carrier racks 376 samples per run
4 MagMAX
™
Viral/Pathogen II Nucleic Acid Isolation Kit, High‑Throughput Instructions for Use
Usage
(Reload frequency)
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