NeuMoDx 900201 User manual

NeuMoDx™ HCV External Controls
INSTRUCTIONS FOR USE
900201
NeuMoDx Molecular, Inc. CONFIDENTIAL P/N 40600196_Rev B
March 2019
Pg. 1 of 4 For Ex-US Distribution Only
900201 NeuMoDx™ HCV External Controls Rx only
CAUTION: Not available for commercial sale in the U.S.
For In Vitro Diagnostic Use with the NeuMoDx™ HCV Quant Test Strip on the NeuMoDx™ 288 and
NeuMoDx™ 96 Molecular Systems
INTENDED USE
The NeuMoDx™ HCV External Controls are intended for use with the NeuMoDx™ HCV Quant Test Strip to establish a runtime validity on the
NeuMoDx™ 288 Molecular System and NeuMoDx™ 96 Molecular System (NeuMoDx™ System(s)) in order to process a quantitative in vitro
diagnostic test to quantify Hepatitis C Virus (HCV) from fresh and frozen human plasma and serum specimens.
SUMMARY AND EXPLANATION
The NeuMoDx HCV External Controls are provided in a kit comprised of 15 sets of positive and negative control vials. One set of external controls
is processed every 24 hours to establish runtime validity of the NeuMoDx™ HCV Quant Assay. The NeuMoDx HCV positive control contains intact
HCV virus diluted in Basematrix 53 Diluent (Basematrix) (Seracare Life Sciences, Milford, MA). The NeuMoDx HCV negative control consists of
Basematrix only.
The NeuMoDx HCV Quant Assay combines automated RNA extraction, amplification and detection by real-time PCR to enable the quantitative
detection of HCV RNA in human plasma and serum specimens. The NeuMoDx HCV Quant Assay includes an exogenous RNA Sample Process
Control (SPC2) to help monitor for the presence of potential inhibitory substances as well as NeuMoDx System or reagent failures that may be
encountered during the extraction and amplification processes.
However, clinical laboratories typically require that external controls be incorporated into routine testing protocols to assess test performance and
ensure that the test procedures meet established quality control requirements. The NeuMoDx HCV External Controls are intended to be used to
establish such routine run validity of the NeuMoDx HCV Quant Assay. Routine use of these controls enables the laboratories to monitor day-to-day
variation, lot-to-lot performance of the NeuMoDx HCV Quant Assay reagents and can assist the lab in identifying errors prior to reporting of test
results.
PRINCIPLES OF THE PROCEDURE
The NeuMoDx HCV External Controls contain samples that have been formulated to mimic naturally occurring human plasma specimens.
Additionally, the intact virus used in the positive control allows for the verification of efficacious nucleic acid extraction procedure. One set of
controls –consisting of 1 positive and 1 negative control –should be processed every 24 hours. Such routine processing of the NeuMoDx HCV
external controls enables the laboratories to ensure efficacy of the test results for human clinical specimens processed within the 24-hour
validity period. The external controls are processed in a manner identical to the processing of the human clinical specimens intended for
quantitative HCV testing.
Expected results for both these external controls are incorporated into the Control Validity algorithm included in the NeuMoDx System software.
Upon successful processing of the external controls, the system software automatically records the validity for a period of 24 hours. The system
software automatically alerts the user to process the external controls when control validity period has expired.
REAGENTS / CONSUMABLES
Material 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
See also the NeuMoDx™ HCV Quant Test Strip Instructions For Use (package insert); p/n 40600140
REF
Contents
Tests per unit
Total tests per kit
900201
NeuMoDx™ HCV External Controls
Single use sets of HCV Positive and Negative Controls to establish daily validity of NeuMoDx
HCV Quant Assay, (1 vial of each control = 1 set)
1 set
15

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 safelaboratory procedures such as those described in
Biosafety in Microbiological and Biomedical Laboratories 1and 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)

NeuMoDx™ HCV External Controls
INSTRUCTIONS FOR USE
900201
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):
NeuMoDx HCV External Control
Barcode ID
Label Color Scheme
Positive Control (PC)
HCVPC
Red
Negative Control (NC)
HCVNC
Black
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, 5th 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.
NeuMoDx HCV External Control
HCV Result
SPC2 Result
Positive Control (PC)
HCV POSITIVE
N/A
Negative Control (NC)
HCV NEGATIVE
SPC2 Positive

NeuMoDx™ HCV External Controls
INSTRUCTIONS FOR USE
900201
NeuMoDx Molecular, Inc. CONFIDENTIAL P/N 40600196_Rev B
March 2019
Pg. 4 of 4 For Ex-US Distribution Only
SYMBOLS
SYMBOL
MEANING
Rx only
Prescription Use Only

Manufacturer

In Vitro Diagnostic Medical Device

EC Representative

Catalog Number

Batch Code

Use By

Temperature Limitation

Do Not Reuse

Control

Contains Sufficient for “n” Tests

Consult Instructions for Use

Caution

Biological Risks (Potentially Biohazardous Material)

CE Mark

Biological Substance Category B

Dry Ice UN 1845

NeuMoDx Molecular, Inc.
1250 Eisenhower Place
Ann Arbor, MI 48108, USA
Contact Number: 1-844-527-0111
Patent: www.neumodx.com/patents
Emergo Europe B.V.
Prinsessegracht 20
2514 AP, The Hague
The Netherlands



2797