March 2024

NeuMoDx™ Cartridge
Instructions for Use
576

Version 1

For In Vitro Diagnostic Use with the NeuMoDx 288 and

NeuMoDx 96 Molecular Systems

℞ only
For prescription use only

100100

NeuMoDx Molecular, Inc.

1250 Eisenhower Place
Ann Arbor, MI
48108 USA

Emergo Europe B.V.

Westervoortsedijk 60
6827 AT Arnhem
The Netherlands

40600591_C
 For insert updates, go to: www.qiagen.com/neumodx-ifu

For detailed instructions, refer to the NeuMoDx 288 Molecular System Operator’s
Manual; P/N 40600108 [REF 500100]

For detailed instructions, refer to the NeuMoDx 96 Molecular System Operator’s

Manual; P/N 40600317 [REF 500200] or P/N 40600655 [REF 500201]

2 NeuMoDx Cartridge Instructions for Use (Handbook) 03/2024

Contents
Intended Use .............................................................................................................. 4

Summary and Explanation ........................................................................................... 4

Principles of the Procedure ........................................................................................... 4

Materials Provided ...................................................................................................... 5

Kit contents ...................................................................................................... 5

Materials Required but Not Provided ............................................................................ 6

Equipment ....................................................................................................... 6

Warnings and Precautions ........................................................................................... 7

Safety information ............................................................................................ 7

Emergency information ..................................................................................... 8

Disposal .......................................................................................................... 8

Product Storage, Handling, and Stability ....................................................................... 9

Specimen Collection, Transport, and Storage ................................................................. 9

Instructions for Use .................................................................................................... 10

Limitations ................................................................................................................ 11

Quality Control......................................................................................................... 11

References ............................................................................................................... 12

Symbols................................................................................................................... 13

Contact Information .................................................................................................. 15

Ordering Information ................................................................................................ 16

Document Revision History ......................................................................................... 17

NeuMoDx Cartridge Instructions for Use (Handbook) 03/2024 3

Intended Use
The NeuMoDx Cartridge is a proprietary consumable used for the efficacious extraction,
purification, amplification, and detection of nucleic acids on the NeuMoDx 288 and
NeuMoDx 96 Molecular Systems (NeuMoDx System(s)). The NeuMoDx Cartridge is
universally used for all tests processed on NeuMoDx Systems. For in vitro diagnostic use.

Summary and Explanation

Each NeuMoDx Cartridge contains twelve microfluidic circuits that enable the processing of
up to twelve samples once housed appropriately in the XPCR modules of the NeuMoDx System.
The NeuMoDx Cartridge also incorporates a chamber to contain all the liquid waste generated
while processing the samples.

Principles of the Procedure

The NeuMoDx Systems use a combination of heat and proprietary extraction reagents to
perform cell lysis, nucleic acid extraction and inactivation/reduction of inhibitors from
unprocessed clinical specimens prior to presenting the extracted nucleic acid for detection by
real-time polymerase chain reaction (PCR). An aliquot of the unprocessed specimen is mixed
with the appropriate NeuMoDx Lysis Buffer and subjected to lysis at predetermined
temperatures in the presence of lytic enzymes and paramagnetic particles.

The released nucleic acids are captured by paramagnetic particles and these particles (along
with the bound nucleic acids) are then loaded into the NeuMoDx Cartridge where the
unbound/non-specifically bound components are washed away using the NeuMoDx Wash
Reagent and the bound nucleic acid is eluted using the NeuMoDx Release Reagent.

The NeuMoDx Systems mix the released nucleic acid with assay specific primers, probe(s),
and the dried master mix contained in a NeuMoDx Test Strip. The System then dispenses the
prepared, PCR-ready mixture into the NeuMoDx Cartridge where real-time PCR occurs.

4 NeuMoDx Cartridge Instructions for Use (Handbook) 03/2024

Materials Provided
Kit contents

NeuMoDx Cartridge Units per Tests per Tests per

REF 100100 Package Unit Package

NeuMoDx Cartridge 48 12 576

NeuMoDx Cartridge Instructions for Use (Handbook) 03/2024 5

Materials Required but Not Provided
REF Contents

various NeuMoDx Lysis Buffer(s)

NeuMoDx Extraction Plate

100200
Dried paramagnetic particles, lytic enzymes, and sample process controls

400100 NeuMoDx Wash Reagent

400200 NeuMoDx Release Reagent

various NeuMoDx Test Strip (as applicable)

235903 Hamilton CO-RE / CO-RE II Tips (300 µL) with Filters

235905 Hamilton CO-RE / CO-RE II Tips (1000 Ll) with Filters

Equipment*

 NeuMoDx 288 Molecular System [REF 500100] OR

NeuMoDx 96 Molecular System [REF 500200 or 500201]

* Prior to use, ensure that instruments have been checked and calibrated according to the manufacturer’s
recommendations.

6 NeuMoDx Cartridge Instructions for Use (Handbook) 03/2024

Warnings and Precautions
Safety information

When working with chemicals, always wear a suitable lab coat, disposable gloves, and
protective goggles. For more information, please consult the appropriate Safety Data Sheets
(SDSs). These are available online in convenient and compact PDF format at
www.qiagen.com/neumodx-ifu, where you can find, view and print the SDS for each
NeuMoDx kit and kit component.

 This consumable is for in vitro diagnostic use with NeuMoDx Systems only.
 Do not use a NeuMoDx Cartridge after the listed expiration date.
 Do not use a NeuMoDx Cartridge if the product or packaging is visibly damaged upon
arrival.
 Do not use a NeuMoDx Cartridge that has been dropped, as this may cause invalid
results.
 Always handle the NeuMoDx Cartridge by the sides; do not touch the top surface.
 Do not place any labels on the NeuMoDx Cartridge.
 Do not reuse a NeuMoDx Cartridge.
 Do not open a NeuMoDx Cartridge before or after use.
 Always wear clean, powder free nitrile gloves when handling specimens or any
NeuMoDx reagents or consumables.
 Wash hands thoroughly after performing a test.
 Do not pipette by mouth. Do not smoke, drink, or eat in areas where specimens or kit
reagents are being handled.
 Always handle specimens as if they are infectious and in accordance with safe
laboratory procedures such as those described in Biosafety in Microbiological and
Biomedical Laboratories (1) and in CLSI Document M29-A4 (2).

NeuMoDx Cartridge Instructions for Use (Handbook) 03/2024 7

 Dispose of unused reagents and waste in accordance with country, federal, provincial,
state and local regulations.

Emergency information

CHEMTREC
Outside USA & Canada +1 703-527-3887

Disposal

Dispose of as hazardous waste in compliance with local and national regulations. This also
applies to unused products. Follow recommendations in the Safety Data Sheet (SDS).

8 NeuMoDx Cartridge Instructions for Use (Handbook) 03/2024

Product Storage, Handling, and Stability
 The NeuMoDx Cartridge is stable in the primary packaging at 18–28°C through the
stated expiration date on the immediate product label.
 Do not use consumables past the stated expiration date.
 A NeuMoDx Cartridge in-use will automatically be discarded after three days.
 Do not use if the product or packaging has been visually compromised.
 Always handle cartridges by the sides and wear clean powder free, nitrile gloves during
any handling.

Specimen Collection, Transport, and Storage

Handle all specimens as if they are capable of transmitting infectious agents.

Validation of optimal specimen shipping conditions and specimen stability should be conducted
by the user’s laboratory for the sample matrix used and for each type of test performed.

NeuMoDx Cartridge Instructions for Use (Handbook) 03/2024 9

Instructions for Use
1. Open the plastic sleeve and remove a NeuMoDx Cartridge, taking care to only handle
the cartridge by the sides and not touching the top surface of the cartridge.
2. Touch the arrow below the desired Cartridge Carrier icon on the NeuMoDx System
touchscreen.
3. Place the NeuMoDx Cartridge into the Cartridge Carrier with barcode facing to the right
to be read by the barcode scanner; Cartridges can be stacked in columns of five in the
Cartridge Carrier.
4. Touch the arrow again on the touchscreen to load the Cartridge Carrier into the
NeuMoDx System.
5. Once the barcode on the NeuMoDx Cartridge is read, the touchscreen will show a
green section for Cartridges in the loaded Carrier. If this does not occur, unload the
Carrier and ensure the barcode on the NeuMoDx Cartridge is facing to the right.
6. The N288 System will dispose of used cartridges and tips into the Biohazard Waste
Container, which should be emptied as soon as possible when prompted by the
NeuMoDx System Software.
7. The N96 System will place used cartridges in the Biohazard Waste Bin and tips in the
Biohazard Tip Waste Bin; both waste bins should be emptied as soon as possible when
prompted by the NeuMoDx System Software.

10 NeuMoDx Cartridge Instructions for Use (Handbook) 03/2024

Limitations
 The NeuMoDx Cartridge can only be used on NeuMoDx Systems and is not compatible
with any other automated molecular diagnostic system.
 The performance characteristics of laboratory developed assays using this consumable
must be validated by the user’s laboratory before diagnostic claims can be made.
 Because detection of most pathogens is dependent on the number of organisms present in the
sample, reliable results are dependent on proper specimen collection, handling, and storage.
 Erroneous test results could occur from improper specimen collection, handling, storage,
technical error or sample mix-up. In addition, false negative results could occur because
the number of organisms in the specimen is below the analytical sensitivity of the test.
 Use of this consumable is limited to personnel trained on the use of the NeuMoDx System.
 Good laboratory practices, including wearing gloves while loading all reagents and
consumables into the system and changing gloves during specimen preparation is critical
to reduce chance of contamination.

Quality Control
Local regulations typically specify that the laboratory is responsible for control procedures that
monitor accuracy and precision of the complete analytical process, and must establish the
number, type, and frequency of testing control materials. Depending on the assay used, control
materials may not be provided by NeuMoDx Molecular, Inc.

Appropriate controls must be chosen and validated by the laboratory. In general, it is

recommended that users process one set of positive and negative controls prior to processing
patient samples, once every 24 hours of System operation. See specific IFU for assay being
processed for more details.

NeuMoDx Cartridge Instructions for Use (Handbook) 03/2024 11

References
1. Centers for Disease Control and Prevention. Biosafety in Microbiological and Biomedical
Laboratories, 6th edition. HHS Publication No. (CDC) 300859, Revised June 2020.
2. Clinical and Laboratory Standards Institute (CLSI). Protection of Laboratory Workers from
Occupationally Acquired Infections; Approved Guideline – Fourth Edition. CLSI document
M29-A4; May 2014.

12 NeuMoDx Cartridge Instructions for Use (Handbook) 03/2024

Symbols
The following symbols may appear in the instructions for use or on the packaging and labeling:

Symbol Symbol definition

Contains reagents sufficient for <N> reactions

<N>

Use by

In vitro diagnostic medical device

Catalog number

Batch code

Manufacturer

Temperature limit

℞ only For prescription use only

Authorized representative in the European Community

NeuMoDx Cartridge Instructions for Use (Handbook) 03/2024 13

 Symbol Symbol definition

Do not reuse

CE Mark

Consult instructions for use

Contains

Caution

14 NeuMoDx Cartridge Instructions for Use (Handbook) 03/2024

Contact Information
For technical assistance and more information, please see our Technical Support Center at
support.qiagen.com

Technical support/Vigilance reporting: support.qiagen.com

Any serious incident that has occurred in relation to the device shall be reported to the
manufacturer and the competent authority of the Member State in which the user and/or the
patient is established.

Patent: www.neumodx.com/patents

NeuMoDx Cartridge Instructions for Use (Handbook) 03/2024 15

Ordering Information

Product REF

NeuMoDx Cartridge 100100

Related Products

NeuMoDx Lysis Buffer 1 400400

NeuMoDx Lysis Buffer 2 400500

NeuMoDx Lysis Buffer3 400600

NeuMoDx Lysis Buffer 4 400700

NeuMoDx Lysis Buffer 5 400900

NeuMoDx Lysis Buffer 6 401700

NeuMoDx Extraction Plate 100200

NeuMoDx Wash Reagent 400100

NeuMoDx Release Reagent 400200

NeuMoDx Test Strip various

Hamilton CO-RE / CO-RE II Tips (300 µL) with

235903
Filters

Hamilton CO-RE / CO-RE II Tips (1000 µL) with

235905
Filters

For up-to-date licensing information and product-specific disclaimers, see the respective
NeuMoDx kit handbook or operator manual. NeuMoDx kit handbooks are available at
www.qiagen.com/neumodx-ifu or can be requested from support.qiagen.com or your local
distributor.

16 NeuMoDx Cartridge Instructions for Use (Handbook) 03/2024

Document Revision History
Revision Summary of Changes

A, 05/2022 Initial Release

New Product Number (P/N 40600591) created for IVDR submission of General Reagents

B. 07/2023 Updated Emergo Address to Westervoortsedijk 60; 6827 AT Arnhem The Netherlands.
Changed www.neumodx.com/client-resources to www.qiagen.com/neumodx-ifu.

C, 03/2024 Updated detailed instructions content to add [REF 500100] for NeuMoDx 288 Molecular
System Operator’s Manual, and [REF 500200 or P/N 40600655 [REF 500201] for
NeuMoDx 96 Molecular System Operator’s Manual.
Added additional information in the “Warnings and Precautions” section, under Safety
Information subsection.
Added the patent URL in the Contact Information.
Updated [email protected] to support.qiagen.com

NeuMoDx Cartridge Instructions for Use (Handbook) 03/2024 17

Limited License Agreement for NeuMoDx Cartridge
Use of this product signifies the agreement of any purchaser or user of the product to the following terms:
1. The product may be used solely in accordance with the protocols provided with the product and this handbook and for use with components contained in the
panel only. NeuMoDx grants no license under any of its intellectual property to use or incorporate the enclosed components of this panel with any components not
included within this panel except as described in the protocols provided with the product, this handbook, and additional protocols available at
www.qiagen.com/neumodx-ifu .Some of these additional protocols have been provided by NeuMoDx users for NeuMoDx users. These protocols have not been
thoroughly tested or optimized by NeuMoDx. NeuMoDx neither guarantees them nor warrants that they do not infringe the rights of third-parties.
2. Other than expressly stated licenses, NeuMoDx makes no warranty that this panel and/or its use(s) do not infringe the rights of third-parties.
3. This panel and its components are licensed for one-time use and may not be reused, refurbished, or resold.
4. NeuMoDx specifically disclaims any other licenses, expressed or implied other than those expressly stated.
5. The purchaser and user of the panel agree not to take or permit anyone else to take any steps that could lead to or facilitate any acts prohibited above.
NeuMoDx may enforce the prohibitions of this Limited License Agreement in any Court, and shall recover all its investigative and Court costs, including attorney fees, in
any action to enforce this Limited License Agreement or any of its intellectual property rights relating to the panel and/or its components.
For updated license terms, see www.qiagen.com/neumodx-ifu

03/2024 40600591_C © 2024 NeuMoDx™, all rights reserved.

18 NeuMoDx Cartridge Instructions for Use (Handbook) 03/2024

Trademarks: QIAGEN®, Sample to Insight®, NeuMoDx™ (QIAGEN Group). Registered names, trademarks, etc. used in this document, even when not specifically marked as
such, are not to be considered unprotected by law.

NeuMoDx Cartridge Instructions for Use (Handbook) 03/2024 19

Ordering www.qiagen.com/shop | Technical Support support.qiagen.com| Website www.qiagen.com/neumodx-ifu

20 NeuMoDx Cartridge Instructions for Use (Handbook) 03/2024