For In Vitro Diagnostic Use.
MagMAX™ Dx Prefilled Viral/Pathogen Nucleic
Acid Isolation Kit
USER GUIDE
Catalog Numbers A52076
Publication Number MAN0025460
Revision B.0
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Revision history: Pub. No. MAN0025460
Revision Date Description
B.0 01 February 2022 Correcting "Limited product warranty" section to remove phone number.
A.0 10 August 2021 New manual.
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Contents
■CHAPTER 1 Product information .................................................. 4
Intended use ................................................................... 4
Product information ............................................................. 4
Contents and storage ............................................................ 5
Required materials not supplied ................................................... 5
■CHAPTER 2 Methods ............................................................... 7
Procedural guidelines ............................................................ 7
Guidelines for saliva collection ................................................ 7
Guidelines for oropharyngeal and nasopharyngeal swabs ........................ 8
Before you begin ................................................................ 8
Before each use of the kit .................................................... 8
Warnings and precautions ................................................... 8
Prepare samples for extraction .................................................... 9
Prepare raw saliva samples .................................................. 9
Prepare preserved saliva samples ............................................. 9
Prepare swab samples for extraction .......................................... 9
Perform viral nucleic acid isolation ............................................... 10
Set up the instrument ...................................................... 10
Prepare the Sample Plate, then process samples on the instrument .............. 10
■APPENDIX A Troubleshooting .................................................... 12
■APPENDIX B Safety ............................................................... 14
Chemical safety ................................................................ 14
Biological hazard safety ......................................................... 15
■APPENDIX C Documentation and support ...................................... 16
Customer and technical support ................................................. 16
Limited product warranty ........................................................ 16
MagMAX™ Dx Prefilled Viral/Pathogen Nucleic Acid Isolation Kit User Guide 3
Product information
WARNING! Read the Safety Data Sheets (SDSs) and follow the handling instructions. Wear
appropriate protective eyewear, clothing, and gloves. Safety Data Sheets (SDSs) are available from
thermofisher.com/support.
Intended use
The MagMAX™ Dx Prefilled Viral/Pathogen Nucleic Acid Isolation Kit is a magnetic bead technology-
based nucleic acid purification kit intended for isolation and purification of viral RNA and DNA from
human saliva, nasopharyngeal and oropharyngeal swabs for the detection of SARS-CoV-2 virus,
adenovirus, and influenza virus by real-time PCR method.
The kit is intended for use by qualified and trained clinical laboratory personnel specifically instructed
and trained in the techniques of automated magnetic bead purification and in vitro diagnostic
procedures.
Product information
The Applied Biosystems™ MagMAX™ Dx Prefilled Viral/Pathogen Nucleic Acid Isolation Kit (Cat. No.
A52076) is specifically designed for scalable, rapid purification of high-quality total nucleic acid from
easy-to-lyse virus in saliva or transport media. The kit utilizes MagMAX™ magnetic-bead technology,
ensuring reproducible recovery of high-quality nucleic acid for a range of downstream applications
such as sequencing and qPCR. This protocol guides users through automated isolation of RNA and
DNA from raw and stabilized saliva samples and transport media using the KingFisher™ Flex Magnetic
Particle Processor.
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4MagMAX™ Dx Prefilled Viral/Pathogen Nucleic Acid Isolation Kit User Guide
Contents and storage
Reagents that are provided in each kit support 192 reactions.
IMPORTANT! On receipt, store all plates and reagents in an upright position at room temperature.
Table 1 MagMAX™ Dx Prefilled Viral/Pathogen Nucleic Acid Isolation Kit
Component Quantity Storage
96 deep-well plate filled with Binding Solution (samples will be added
to this plate) 2
Store upright at
15°C to 25°C.
96 deep-well plate filled with Magnetic Beads 2
96 deep-well plate filled with Wash I Solution 2
96 deep-well plate filled with Wash II Solution 2
96 deep-well plate filled with Elution Solution 2
96 deep-well tip comb 2
Proteinase K Solution 1 vial
MicroAmp™ Clear Adhesive Film 2
Required materials not supplied
Unless otherwise indicated, all materials are available through thermofisher.com. MLS: Fisher
Scientific (fisherscientific.com) or another major laboratory supplier.
Table 2 For biofluid or transport media sample protocols
Item Source
Instrument
KingFisher™ Flex Magnetic Particle Processor 96DW with 96 Deep-well Head 5400630
KingFisher™ Flex 96 Deep-Well Heating Block (do not use a standard heating
block) 24075430
Equipment
Single and multichannel adjustable pipettors (1.00 µL to 1,000.0 µL) MLS
Laboratory mixer, vortex, or equivalent MLS
Cold block or ice MLS
Tubes, plates and other consumables
PBS (1X), pH 7.4 (without calcium and magnesium)[1] 10010023
Chapter 1 Product information
Contents and storage 1
MagMAX™ Dx Prefilled Viral/Pathogen Nucleic Acid Isolation Kit User Guide 5
Table 2 For biofluid or transport media sample protocols (continued)
Item Source
MicroAmp™ Adhesive Film Applicator 4333183
Non-stick, RNase-free microcentrifuge tubes (1.5 mL and 2.0 mL)[2] thermofisher.com/plastics
Sterile aerosol barrier (filtered) pipette tips[2] thermofisher.com/
pipettetips
[1] For saliva only.
[2] Also available at fisherscientific.com.
Chapter 1 Product information
Required materials not supplied
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6MagMAX™ Dx Prefilled Viral/Pathogen Nucleic Acid Isolation Kit User Guide
Methods
Procedural guidelines
•The plates provided in this kit are single use plates only. Do not reuse the plates.
•Ensure plates are stored upright for 24 hours before opening.
•Perform all steps at room temperature (15–25°C) unless otherwise noted.
•Yellowing of the Binding and Wash I Solution is normal and will not impact buer performance.
Guidelines for saliva collection
•Saliva samples must be collected, transported, and stored using appropriate procedures and
conditions. Improper handling of samples decreases performance and sensitivity for detecting the
target sequences.
•Extraction of nucleic acid from clinical samples must be performed according to the specified
methods listed in this procedure. Other extraction approaches and preprocessing systems have not
been evaluated.
•Positive and negative test controls must be included to accurately interpret patient test results.
•Ensure that there was no eating, drinking, smoking, chewing tobacco, chewing gum, brushing
teeth, or use of mouthwash for at least 30 minutes before giving a saliva sample.
•At least 30 minutes before saliva collection, rinse the mouth with water by swishing water for 10
seconds and swallowing the water to rid mouth of debris.
•Use the passive drool technique to pool saliva in the mouth, then drool into a collection device.
•Ensure only saliva is collected by using the passive drool technique, with no coughing or collection
of phlegm.
•For saliva collection volume, follow the saliva collection device manufacturers instructions for use.
•For raw saliva, collect a minimum of 1 mL.
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MagMAX™ Dx Prefilled Viral/Pathogen Nucleic Acid Isolation Kit User Guide 7
Guidelines for oropharyngeal and nasopharyngeal swabs
•Oropharyngeal and nasopharyngeal samples must be collected, transported, and stored using
appropriate procedures and conditions. Improper handling of samples decrease performance and
sensitivity of the assay to detect the target sequences.
•Extraction and amplification of nucleic acid from clinical samples must be performed according
to the specified methods listed in this procedure. Other extraction approaches and preprocessing
systems have not been evaluated.
•Patient samples must be collected according to appropriate laboratory guidelines. Only synthetic
fiber swabs with thin plastic or wire shafts should be used. Other types of swabs may contain
substances inhibitory to molecular tests.
•Positive and negative test controls must be included to accurately interpret patient test results.
Before you begin
Before each use of the kit
•Gently mix reagents in vials before use. Avoid creating bubbles.
•Examine the plate containing the beads prior to opening. Ensure that the beads are at the bottom
of each well. Hold the plate by the narrow end and sharply swing the sealed plate in a downward
motion 5 times. Hold the plate on the opposite side and repeat.
•To remove seals from prefilled plates, place the prefilled plate squarely onto the benchtop, secure
the plate with one hand and grasp the seal at the lower left corner with the other hand. Using a
gentle but steady motion, peel the seal o of the plate diagonally toward the upper right corner
without jostling the contents.
•If required by your assay, designate one well of the Sample Plate for a negative extraction control.
Warnings and precautions
The MagMAX™ Dx Prefilled Viral/Pathogen Nucleic Acid Isolation Kit workflow should be performed by
qualified and trained sta to avoid the risk of erroneous results. Use separate areas for the preparation
of patient specimens and controls to prevent false positive results. Specimens and reagents must be
handled under a laminar airflow hood or biological safety cabinet.
•Specimens 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 specimens.
•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 reagents, protocols, or instrumentation are not permitted, and are in violation of
the In Vitro Diagnostic Directive 98/79/EC.
Chapter 2 Methods
Before you begin
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8MagMAX™ Dx Prefilled Viral/Pathogen Nucleic Acid Isolation Kit User Guide
•Do not use the kit after the expiration date.
•Dispose of waste in compliance with the local regulations.
•Safety Data Sheets are available upon request.
•Reagents must be stored and handled as specified in “Contents and storage” on page 5.
Prepare samples for extraction
Prepare raw saliva samples
1. Upon receipt of samples for extraction, dilute the raw saliva sample 1:1 by adding an equal volume
of 1X PBS pH 7.4 (without calcium or magnesium) to the tube and vortex well at maximum speed
for 1 minute.
2. Let the diluted raw saliva samples sit and settle for at least 30 minutes at 20°C to 25°C.
Note: Gradually, 2 fractions will form. Do not disturb the layers.
3. (Optional) Centrifuge the diluted raw saliva sample at 1,500 x g (3,000 rpm) for 5 minutes to
separate the large debris.
4. Transfer 200 µL from the top fraction of the diluted raw saliva sample to the Sample Plate.
Note: Pipet slowly to avoid large debris and precipitants from the lower fraction.
Proceed to “Prepare the Sample Plate, then process samples on the instrument” on page 10.
Prepare preserved saliva samples
1. Upon receipt of samples for extraction, let the preserved saliva samples sit and settle for at least
30 minutes at 20°C to 25°C.
Note: In some cases, large debris may start to settle to the bottom. A clear separation may not
always be visible.
2. (Optional) Centrifuge the preserved saliva sample at 1,500 x g (3,000 rpm) for 5 minutes to
separate the large debris.
3. Transfer 200 µL from the top fraction of the preserved saliva sample to the Sample Plate.
Note: Pipet slowly to avoid large debris and precipitants from the lower fraction.
Proceed to “Prepare the Sample Plate, then process samples on the instrument” on page 10.
Prepare swab samples for extraction
1. Upon receipt of samples, vortex the sample.
2. Transfer 200 µL of transport media to the sample plate.
Proceed to “Prepare the Sample Plate, then process samples on the instrument” on page 10.
Chapter 2 Methods
Prepare samples for extraction 2
MagMAX™ Dx Prefilled Viral/Pathogen Nucleic Acid Isolation Kit User Guide 9
Perform viral nucleic acid isolation
Viral nucleic acid isolation is performed using the KingFisher™ Flex Magnetic Particle Processor with
96 Deep-Well Head and the MagMAX™ Dx Prefilled Viral/Pathogen Nucleic Acid Isolation Kit with a
specimen volume of 200 µL.
IMPORTANT! Do not attempt to process more than the maximum volume allowed for each sample
type. Yields and quality will be reduced.
Set up the instrument
1. Ensure that the instrument is set up with the proper magnetic head and the proper heat block, as
indicated in the following table.
Component Type
Magnetic head 96 deep-well magnetic head
Heat block 96 deep-well heat block
IMPORTANT! Failure to use the proper magnetic head and heat block results in lower yields.
2. Ensure that the proper program (MVPIIDX_Ready_200_Flex_v1) has been downloaded from the
product page and loaded onto the instrument.
Prepare the Sample Plate, then process samples on the instrument
1. Remove the Sample Plate and the vial of Proteinase K from the product box.
2. Remove the sealing film of the Sample Plate, then add 5 µL of Proteinase K to each well.
Chapter 2 Methods
Perform viral nucleic acid isolation
2
10 MagMAX™ Dx Prefilled Viral/Pathogen Nucleic Acid Isolation Kit User Guide
3. Confirm the KingFisher™ Flex instrument deck positions with the following table.
Note: Place the pre-filled plate as per the protocol and check the deck position number. Deck
positions are also denoted on labels on the short and long ends of the plate.
Deck
position Prefilled plate Contents Prefilled volume
1
MagMAX™Virus Binding Buer PF
(Sample Plate)
(Cat. No. 100104740)
Binding Solution
+ Proteinase K
(+extraction control if
needed) + sample
Proteinase K: 5 μL
Sample: 200 μL
Binding Buer: 265 μL
2
MagMAX™ DNA/RNA Binding
Beads PF (Bead Plate)
(Cat. No. 100104744)
Magnetic Beads in
diluent buer
Magnetic beads: 10 μL
Diluent buer: 190 μL
3
MagMAX™ Virus Wash Buer I PF
(Wash I)
(Cat. No. 100104741)
Wash I Wash Buer I: 500 µL
4
MagMAX™ Virus Wash Buer II PF
(Wash II)
(Cat. No. 100104742)
Wash II (80% EtOH) Wash Buer II: 1,000 µL
5
MagMAX™ Virus Elution Buer PF
(Elution Plate)
(Cat. No. 100104743)
Elution Solution Elution Buer: 65 µL
4. Select the MVPIIDX_Ready_200_Flex_v1 program on the instrument.
5. Click Start. Peel o the sealing film of each pre-filled deep-well plate, input the tip comb into the
Wash Buer II plate, then place each plate into the corresponding deck position.
6. After the program runs for ~25 minutes, immediately remove the Elution plate. The extraction is
now complete.
IMPORTANT! If not used for immediate processing, seal the plate containing the eluate to
prevent evaporation. Place the Elution Plate on ice for immediate use in real-time RT‑PCR.
Note: If bead carryover is observed, place the elution plate on a magnetic stand to pellet the
beads, then pipette the eluate to a new 96-well plate for use in real-time PCR. Review the real-time
PCR results to determine if re-extraction is required.
To ensure reliable performance of the KingFisher™ Flex Magnetic Particle Processor, perform
preventative maintenance as instructed by the manufacturer.
Chapter 2 Methods
Perform viral nucleic acid isolation 2
MagMAX™ Dx Prefilled Viral/Pathogen Nucleic Acid Isolation Kit User Guide 11
Troubleshooting
Observation Possible cause Recommended action
Low or inconsistent yield Plates were stored incorrectly. Store plates in an upright position at room
temperature. Examine the plate or row
containing the beads before removing the seal
for an indication of how to proceed.
For plates that have been inverted, store them
upright for at least 24 hours, then check that
the beads form a tight dark pellet in the center
of the bottom of the well before unsealing the
plate.
For plates without beads in that were not
stored correctly, flick the plates in a fast
downward motion to ensure that the materials
are in the well and not on the seal before
unsealing.
For plates that were stored inverted, the
beads are dry and uneven in the bottom
of the wells and or not fully resuspended.
Flick the plate in a fast downward motion
to remove the fluid from the seal, then
gently vortex to resuspend the beads before
unsealing. A gentle brief centrifugation can
be performed after resuspension but is not
always necessary.
After removing the seal, there
were some wet or dry beads
on the seal.
For wet beads, carefully pipet the liquid from
the seal back to its proper well.
For dry beads, resuspend the dry beads in
Nuclease-Free water, then carefully pipet the
liquid from the seal back to its proper well.
There were bubbles in the
wells.
Centrifuge the plates to remove the bubbles
before use.
The wells were blocked. Remove any seal covering well openings and
blocking tip comb access. Seal remnants on
the plate edge will not interfere with tip comb
access and do not have to be removed.
If the seal has delaminated and left a
transparent seal over the well then rotate plate
180 degrees and peel diagonally from the
corner that is now on the bottom left. If the
problem persists, call technical support.
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12 MagMAX™ Dx Prefilled Viral/Pathogen Nucleic Acid Isolation Kit User Guide
Observation Possible cause Recommended action
Low or inconsistent yield
(continued)
Heat block was installed
incorrectly.
Install the correct deep well heat block.
Sample input limits were
below or above recommended
amounts.
Consult user guide for recommended sample
input ranges.
Appendix A Troubleshooting
Perform viral nucleic acid isolation A
MagMAX™ Dx Prefilled Viral/Pathogen Nucleic Acid Isolation Kit User Guide 13
Safety
WARNING! GENERAL SAFETY. Using this product in a manner not specified in the user
documentation may result in personal injury or damage to the instrument or device. Ensure that
anyone using this product has received instructions in general safety practices for laboratories and
the safety information provided in this document.
·Before using an instrument or device, read and understand the safety information provided in the
user documentation provided by the manufacturer of the instrument or device.
·Before handling chemicals, read and understand all applicable Safety Data Sheets (SDSs) and use
appropriate personal protective equipment (gloves, gowns, eye protection, and so on). To obtain
SDSs, see the “Documentation and Support” section in this document.
Chemical safety
WARNING! GENERAL CHEMICAL HANDLING. To minimize hazards, ensure laboratory personnel
read and practice the general safety guidelines for chemical usage, storage, and waste provided
below. Consult the relevant SDS for specific precautions and instructions:
·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.
·Minimize contact with chemicals. Wear appropriate personal protective equipment when handling
chemicals (for example, safety glasses, gloves, or protective clothing).
·Minimize the inhalation of chemicals. Do not leave chemical containers open. Use only with
sucient ventilation (for example, fume hood).
·Check regularly for chemical leaks or spills. If a leak or spill occurs, follow the manufacturer
cleanup procedures as recommended in the SDS.
·Handle chemical wastes in a fume hood.
·Ensure use of primary and secondary waste containers. (A primary waste container holds the
immediate waste. A secondary container contains spills or leaks from the primary container.
Both containers must be compatible with the waste material and meet federal, state, and local
requirements for container storage.)
·After emptying a waste container, seal it with the cap provided.
·Characterize (by analysis if needed) the waste generated by the particular applications, reagents,
and substrates used in your laboratory.
·Ensure that the waste is stored, transferred, transported, and disposed of according to all local,
state/provincial, and/or national regulations.
·IMPORTANT! Radioactive or biohazardous materials may require special handling, and disposal
limitations may apply.
B
14 MagMAX™ Dx Prefilled Viral/Pathogen Nucleic Acid Isolation Kit User Guide
Biological hazard safety
WARNING! BIOHAZARD. Biological samples such as tissues, body fluids, infectious agents,
and blood of humans and other animals have the potential to transmit infectious diseases.
Conduct all work in properly equipped facilities with the appropriate safety equipment (for example,
physical containment devices). Safety equipment can also include items for personal protection,
such as gloves, coats, gowns, shoe covers, boots, respirators, face shields, safety glasses, or
goggles. Individuals should be trained according to applicable regulatory and company/ institution
requirements before working with potentially biohazardous materials. Follow all applicable local,
state/provincial, and/or national regulations. The following references provide general guidelines when
handling biological samples in laboratory environment.
·Laboratory biosafety manual, fourth edition. Geneva: World Health Organization; 2020 (Laboratory
biosafety manual, fourth edition and associated monographs)
www.who.int/publications/i/item/9789240011311
·U.S. Department of Health and Human Services, Biosafety in Microbiological and Biomedical
Laboratories (BMBL), 6th Edition, HHS Publication No. (CDC) 300859, Revised June 2020
https://www.cdc.gov/labs/pdf/CDC-BiosafetymicrobiologicalBiomedicalLaboratories-2020-
P.pdf
WARNING! Potential Biohazard. If you use the kit with the automated nucleic extraction workflow,
the surface of the KingFisher™ purification system may be considered a biohazard. Use appropriate
decontamination methods when working with biohazards.
Appendix B Safety
Biological hazard safety B
MagMAX™ Dx Prefilled Viral/Pathogen Nucleic Acid Isolation Kit User Guide 15
Documentation and support
Customer and technical support
Visit thermofisher.com/support for the latest service and support information.
•Worldwide contact telephone numbers
•Product support information
–Product FAQs
–Software, patches, and updates
–Training for many applications and instruments
•Order and web support
•Product documentation
–User guides, manuals, and protocols
–Certificates of Analysis
–Safety Data Sheets (SDSs; also known as MSDSs)
Note: For SDSs for reagents and chemicals from other manufacturers, contact the
manufacturer.
Limited product warranty
Life Technologies Corporation and/or its aliate(s) warrant their products as set forth in the Life
Technologies' General Terms and Conditions of Sale at www.thermofisher.com/us/en/home/global/
terms-and-conditions.html. If you have any questions, please contact Life Technologies at india-
info@thermofisher.com.
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16 MagMAX™ Dx Prefilled Viral/Pathogen Nucleic Acid Isolation Kit User Guide
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