NeuMoDx 100200 Instructions For Use

 100200 NeuMoDx™ Extraction Plate
For In Vitro Diagnostic Use on the NeuMoDx™ 288 and NeuMoDx™ 96 Molecular Systems
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
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
REF Contents
NeuMoDx™ Extraction Plate
100200
Dried magnetic affinity microspheres, lytic enzymes, and sample process controls
NeuMoDx™ Reagents and Consumables Required But Not Provided
REF Contents
400400, 400500
NeuMoDx™ Lysis Buffer 1, 2, 3 and/or 4
400600, 400700
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 Molecular, Inc.
NeuMoDx™ Extraction Plate
INSTRUCTIONS FOR USE
CONFIDENTIAL
Pg. 1 of 4
100200
Rx only
Tests per unit Tests per carton
24 384
P/N 40600098_Rev D
October 2018
For US Distribution Only