NeuMoDx Molecular, Inc. CONFIDENTIAL P/N 40600196_Rev B
March 2019
Pg. 3 of 4 For Ex-US Distribution Only
INSTRUCTIONS FOR USE
1. One set of external controls [REF 900201] need to be processed once every 24 hours. If a set of valid test controls does not exist, the
NeuMoDx software will prompt the user for these controls to be processed before sample results can be reported.
2. If external controls are required, process the controls with the following barcodes (1 positive control and 1 negative control per System):
3. Retrieve the set of NeuMoDx HCV External Controls from freezer and allow the vials to set at room temperature (15-30°C) until
completely thawed. If using an already thawed set of controls, ensure that the thawed controls were stored at 4°C and are not more
than 24 hours old.
4. Vortex gently to ensure homogeneity.
5. Load the control vials into a standard 32-Tube Carrier, and ensure caps are removed from all tubes.
6. Place the Tube Carrier on the Autoloader shelf and use the touchscreen to load carrier into the NeuMoDx System.
7. The NeuMoDx System will recognize the barcode and start processing the specimen tubes unless reagents or consumables required for
testing are not available.
8. Validity of these external controls will be assessed by the NeuMoDx System based on the expected results.
9. Discrepant result handling for external controls should be performed as follows:
a) A Positive test result reported for a negative control sample indicates a specimen contamination problem.
b) A negative result reported for a positive control sample may indicate there is a reagent or instrument related problem.
c) In either of the above instances, repeat the failed control with a freshly thawed vial(s) of the control(s) failing the validity test.
d) If the Positive external control continues to report a Negative result, contact NeuMoDx customer service.
e) If the Negative external control continues to report a Positive result, attempt to eliminate all sources of potential contamination,
including replacing ALL reagents and repeat the run before contacting NeuMoDx customer service.
LIMITATIONS
1. The NeuMoDx HCV External Controls can only be used in conjunction with NeuMoDx HCV Quant Test Strip on the NeuMoDx Systems.
2. A valid calibration of the NeuMoDx HCV Quant Test Strip using NeuMoDx HCV External Calibrators [800200] is required before the NeuMoDx
HCV External Controls [REF 900201] can be processed.
3. Erroneous results could occur from improper handling, storage, or other technical error.
4. Operation of the NeuMoDx System is limited to use by personnel trained on the use of the NeuMoDx System.
REFERENCES
1. Biosafety in Microbiological and Biomedical Laboratories, 5
th
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.
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