NeuMoDx™
HCV External Controls
INSTRUCTIONS FOR USE
900201
NeuMoDx Molecular, Inc.
CONFIDENTIAL
P/N 40600196_Rev B
March 2019
Pg. 2 of 4
For Ex-US Distribution Only
NeuMoDx™
Reagents and Consumables Required But Not Provided
Other Equipment and Materials Required But Not Provided
NeuMoDx
™
288 Molecular System
[REF 500100] or
NeuMoDx™ 96 Molecular System
[REF 500200]
WARNINGS & PRECAUTIONS
•
The NeuMoDx HCV External Controls are for
in vitro
diagnostic use only with the NeuMoDx HCV Quant Test Strip as implemented on
the NeuMoDx System.
•
Do not use the NeuMoDx HCV External Controls after the listed expiration date.
•
Do not use the NeuMoDx HCV External Controls if the packaging is damaged or the kit is not frozen upon arrival.
•
Because the NeuMoDx HCV positive controls contain intact HCV positive material, all components of the NeuMoDx HCV External
Controls should be treated as potentially biohazardous.
•
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
•
Do not pipette by mouth. Do not smoke, drink, or eat in areas where specimens or reagents are being handled.
•
Dispose of unused reagents and waste in accordance with country, federal, provincial, state and local regulations.
•
Clean, powder-free, nitrile gloves should be worn when handling all NeuMoDx reagents and consumables.
•
Wash hands thoroughly after performing the test.
•
Safety Data Sheets (SDS) are provided for each reagent.
PRODUCT STORAGE, HANDLING & STABILITY
•
The NeuMoDx HCV External Controls are shipped with dry ice to maintain a frozen state; do not use if kit contents are not frozen upon
receipt.
•
It is recommended that the NeuMoDx HCV External Controls
be stored at
≤
-80°C to ensure stability.
•
Control vials are intended for single use only. Thawed external controls may be stored at 4°C for no longer than 24 hours.
•
Refreezing after a first thaw is not recommended.
•
Discard any unused material after use as biohazard waste.
•
Discard any controls that appear cloudy or contain large precipitates after thawing.
REF
Contents
300300
NeuMoDx™
HCV Quant Test Strip
Dried
PCR reagents containing HCV-specific TaqMan
®
probes and primers along with SPC2-specific TaqMan® probe and primers.
100200
NeuMoDx™ Extraction Plate
Dried
magnetic affinity microspheres, Lytic enzyme, and sample process controls
800200
NeuMoDx™
HCV Calibrators
Single use sets of HCV High and Low Calibrators to establish validity of standard curve
400600
NeuMoDx™
Lysis Buffer 3
400100
NeuMoDx™
Wash Reagent
400200
NeuMoDx™
Release Reagent
100100
NeuMoDx
™
Cartridge
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)