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)