NeuMoDx 100200 User manual
NeuMoDx™ Extraction Plate
INSTRUCTIONS FOR USE
100200
NeuMoDx Molecular, Inc. CONFIDENTIAL P/N 40600098_Rev D
October 2018
Pg. 1 of 4 For US Distribution Only
100200 NeuMoDx™ Extraction Plate Rx only
For In Vitro Diagnostic Use on the NeuMoDx™ 288 and NeuMoDx™ 96 Molecular Systems
INTENDED USE
The NeuMoDx™Extraction Plate contains a proprietary, dried reagent used for the efficient extraction of nucleic acids on the NeuMoDx™ 288 and
NeuMoDx™ 96 Molecular Systems (NeuMoDx™ System(s)) in conjunction with other NeuMoDx™reagents such as NeuMoDx™lysis buffers,
NeuMoDx™WASH Solution and the NeuMoDx™RELEASE Solution. The NeuMoDx™ Extraction Plate is universally used for all tests processed on
the NeuMoDx Systems and is formulated to perform both RNA and DNA extraction.
SUMMARY AND EXPLANATION
Each 24-well NeuMoDx Extraction Plate contains dried, room-temperature stable reagents including proprietary coated magnetic microspheres, a
lytic enzyme, and RNA and DNA Sample Process Controls. Components within the extraction plate work in conjunction with the appropriate
NeuMoDx lysis buffer to lyse cells in a temperature dependent manner and bind the nucleic acid while reducing activity of any nucleases present in
clinical samples. The Sample Process Controls bind to the magnetic microspheres at the same time as the target nucleic acid, and are carried
throughout the extraction procedure, serving as internal controls to monitor for any inefficiencies in the extraction process and presence of PCR
interference substances.
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
PCR. An aliquot of the unprocessed specimen is mixed with the appropriate lysis buffer in the NeuMoDx Extraction Plate and is subjected to lysis at
pre-determined temperatures in the presence of lytic enzymes and magnetic microspheres.
The released nucleic acids are captured by magnetic affinity microspheres and these microspheres (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 Solution
and the bound nucleic acid is eluted using NeuMoDx RELEASE Solution.
The NeuMoDx Systems mix the released nucleic acid with assay specific primers and probe(s) as well as 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.
REAGENTS / CONSUMABLES
Material Provided
NeuMoDx™ Reagents and Consumables Required But Not Provided
For detailed instructions, refer to the NeuMoDx™ 288 Molecular System Operator’s Manual; p/n 40600108
For detailed instructions, refer to the NeuMoDx™ 96 Molecular System Operator’s Manual; p/n 40600317
REF
Contents
Tests per unit
Tests per carton
100200
NeuMoDx™ Extraction Plate
Dried magnetic affinity microspheres, lytic enzymes, and sample process controls
24
384
REF
Contents
400400, 400500
400600, 400700
NeuMoDx™ Lysis Buffer 1, 2, 3 and/or 4
400100
NeuMoDx™ WASH Solution
400200
NeuMoDx™ RELEASE Solution
100100
NeuMoDx™ Cartridge
various
NeuMoDx™ test strip (as applicable)
235903
Hamilton CO-RE Tips (300 µL) with Filters (available from NeuMoDx or Hamilton)
235905
Hamilton CO-RE Tips (1000 µL) with Filters (available from NeuMoDx or Hamilton)
NeuMoDx™ Extraction Plate
INSTRUCTIONS FOR USE
100200
NeuMoDx Molecular, Inc. CONFIDENTIAL P/N 40600098_Rev D
October 2018
Pg. 2 of 4 For US Distribution Only
Other Equipment and Materials Required But Not Provided
NeuMoDx™ 288 Molecular System [REF 500100] OR NeuMoDx™ 96 Molecular System [REF 500200]
WARNINGS & PRECAUTIONS
•
This reagent is for in vitro diagnostic use with NeuMoDx Systems only.
•
Do not use the reagents after the listed expiration date.
•
Do not use if the product or packaging is damaged upon arrival or if foil seal is compromised.
•
Ensure that the extraction plate is at room temperature before use the NeuMoDx System.
•
Always handle extraction plates by the sides; do not touch the top foil surface.
•
Do not reuse any NeuMoDx consumables or reagents.
•
Safety Data Sheets (SDS) are provided for each reagent.
•
Always wear clean powder free nitrile gloves when handling specimens or any NeuMoDx reagents or consumables.
•
Wash hands thoroughly after performing the 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 1and in CLSI Document M29-A3 2.
•Dispose of unused reagents and waste in accordance with country, federal, provincial, state and local regulations.
PRODUCT STORAGE, HANDLING & STABILITY
•The NeuMoDx Extraction Plate is stable in the primary packaging at 18 to 28 °C through the stated expiration date on the immediate product
label.
•Do not use reagents past the stated expiration date.
•Do not use if the product or packaging has been visually compromised.
•Always wear clean powder free nitrile gloves when handling specimens or any NeuMoDx reagents or consumables.
•A NeuMoDx Extraction Plate when placed on the worktable of the NeuMoDx System is stable for 10 days when operating within the
environmental conditions specified in the NeuMoDx™ 288/96 Molecular System Operator’s Manual(s). The NeuMoDx System software will
prompt the removal any NeuMoDx Extraction Plate that has been in-use for longer than 10 days.
SPECIMEN COLLECTION, TRANSPORT & STORAGE
Validation of optimal Specimen Shipping Conditions and Specimen Stability should be conducted by the user’s laboratory for the sample matrix used
for each type of test performed.
INSTRUCTIONS FOR USE
1. Open the foil pouch and remove the NeuMoDx Extraction Plate, taking care to only handle the plate by the sides and not touching the top
surface of the plate.
2. Touch the arrow below desired Extraction Plate Carrier icon on the NeuMoDx System touchscreen.
3. Place the NeuMoDx Extraction Plate into the carrier with barcode facing to the right to be read by the barcode scanner.
4. Touch the arrow again on the NeuMoDx System touchscreen to load the carrier into the NeuMoDx System.
5. Once the barcode on the NeuMoDx Extraction Plate is read, the touchscreen will show a green section for extraction plates in the loaded
carrier. If this does not occur, unload the carrier and ensure the barcode on the NeuMoDx Extraction Plate is facing to the right.
LIMITATIONS
1. The NeuMoDx Extraction Plate can only be used on the NeuMoDx System and is not compatible with any other automated molecular
diagnostic system.
2. The performance characteristics of lab-developed assays using this reagent is unknown and must be validated by the user’s laboratory
before diagnostic claims can be made.
3. 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.
NeuMoDx™ Extraction Plate
INSTRUCTIONS FOR USE
100200
NeuMoDx Molecular, Inc. CONFIDENTIAL P/N 40600098_Rev D
October 2018
Pg. 3 of 4 For US Distribution Only
4. 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.
5. Use of this reagent is limited to personnel trained on the use of the NeuMoDx System.
6. Good laboratory practices, including wearing gloves while loading all reagents into the system and changing gloves during specimen
preparation is critical to reduce chance of contamination.
REFERENCES
1. Centers for Disease Control and Prevention. Biosafety in Microbiological and Biomedical Laboratories, 5th edition. HHS Publication No. (CDC)
21-1112, Revised December 2009
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
TRADEMARKS
NeuMoDx™ is a trademark of NeuMoDx Molecular, Inc.
TaqMan® is a registered trademark of Roche Molecular Systems, Inc.
NeuMoDx™ Extraction Plate
INSTRUCTIONS FOR USE
100200
NeuMoDx Molecular, Inc. CONFIDENTIAL P/N 40600098_Rev D
October 2018
Pg. 4 of 4 For US Distribution Only
SYMBOLS
SYMBOL
MEANING
Rx only
Prescription Use Only
Manufacturer
In Vitro Diagnostic Medical Device
EC Representative
Catalog Number
Batch Code
Use By
Temperature Limitation
Humidity Limitation
Do Not Reuse
Control
Contains Sufficient for “n” Tests
Consult Instructions for Use
Caution
Biological Risks (Potentially Biohazardous Material)
CE Mark
NeuMoDx Molecular, Inc.
1250 Eisenhower Place
Ann Arbor, MI 48108, USA
Contact Number: 1-844-527-0111
Patent: www.neumodx.com/patents
Emergo Europe
Prinsessegracht 20
2514 AP The Hauge
The Netherlands
0086
