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
1
and 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 Operat
or’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 th
e 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.