NeuMoDx™ HCV Calibrators
INSTRUCTIONS FOR USE
800200
NeuMoDx Molecular, Inc. CONFIDENTIAL P/N 40600195_Rev B
March 2019
Pg. 1 of 4 For Ex-US Distribution Only
800200 NeuMoDx™ HCV Calibrators 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 Calibrators are intended for use with the NeuMoDx™ HCV Quant Assay to establish a calibration coefficient associated with
a particular lot of the NeuMoDx™ HCV Quant Test Strip and used in conjunction with a standard curve to perform an accurate quantitative in vitro
diagnostic test on the NeuMoDx™ 288 Molecular System or NeuMoDx™ 96 Molecular System (NeuMoDx™ System(s)) to quantify Hepatitis C
Virus (HCV) from fresh and frozen human plasma and serum specimens. HCV in these calibrators has been calibrated to the WHO 5th International
Standard for HCV RNA for Nucleic Acid Amplification Tests.
SUMMARY AND EXPLANATION
The NeuMoDx HCV Calibrators are provided in a kit comprised of a set of 3 low positive and 3 high positive external calibrators. One low positive
and one high positive calibrator (1 set) is processed every 90 days or with every new lot of NeuMoDx HCV Quant Test Strips to establish a valid
calibration of the NeuMoDx HCV Quant Assay. Both HCV calibrators contain intact HCV virus diluted in Basematrix 53 Diluent (Basematrix) (Seracare
Life Sciences, Inc., Milford, MA).
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 plasma and serum specimens. The NeuMoDx HCV Calibrators will be applied to the stored standard curve and used to
generate a calibration coefficient, which is used to automatically adjust the standard curve for slight variations across systems or test strip lots.
Accurate quantitation of the HCV RNA in the human clinical samples being tested can then be provided utilizing both the standard curve and the
system/lot specific calibration coefficient.
In addition, the traceability of these calibrators to the WHO 5th International Standard enables the laboratories to ensure that the testing results
obtained from use of the NeuMoDx HCV Quant Test Strips are consistent across reagent lots, systems, and operators.
PRINCIPLES OF THE PROCEDURE
The NeuMoDx HCV Calibrators have been formulated to mimic naturally occurring human plasma specimens containing HCV RNA. Additionally,
the intact virus used in these calibrators allows for the verification of efficacious nucleic acid extraction as well as the real-time PCR amplification
and detection process, thereby enabling calibration of the entire testing process. One set of these external calibrators – consisting of 1 high
calibrator and 1 low calibrator – is to be processed, every 90 days or with the change of a system, software or test strip reagent lot; the system will
automatically process each calibrator in triplicate. Such routine processing of the NeuMoDx HCV calibrators enables the laboratories to ensure
efficacy of the test results for human clinical specimens processed within the validity period. These external calibrators are processed in a manner
identical to the processing of the human clinical specimens intended for quantitative HCV testing.
Software on the NeuMoDx System automatically alerts the operator when a calibration is required. During processing, criteria for acceptance of
the calibrator are automatically verified by the NeuMoDx System software. If less than two of the calibrator replicates is valid, the software
automatically invalidates the run. Samples in an invalidated run must be retested using a new set of calibrators and controls.
Upon successful processing of the NeuMoDx HCV calibrators, the system software automatically records the validity of the processed calibrators
for a period of 90 days unless there is a change to the system that causes the validity period to expire. The NeuMoDx System software will
automatically notify the user to process these external calibrators when the previously processed calibrator 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 40600 317
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
800200
NeuMoDx™ HCV Calibrators
Single use sets of HCV High and Low Calibrators to establish validity of standard curve,
(1 vial of each level = 1 set)
1 set
3
NeuMoDx™ HCV Calibrators
INSTRUCTIONS FOR USE
800200
NeuMoDx Molecular, Inc. CONFIDENTIAL P/N 40600195_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 Calibrators are for in vitro diagnostic use only with the NeuMoDx HCV Quant Test Strip as implemented on the
NeuMoDx System.
•
Do not use NeuMoDx HCV Calibrators after the listed expiration date.
•
Do not use the NeuMoDx HCV Calibrators if the packaging is damaged or the kit is not frozen upon arrival.
•
Because the external calibrators contain intact HCV positive material, all NeuMoDx HCV Calibrators 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 Calibrators 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 Calibrators be stored at ≤ -80°C to ensure stability.
• Calibrator vials are intended for single use only. Thawed calibrators 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 calibrators that appear cloudy or contain large precipitates after thawing.
INSTRUCTIONS FOR USE
1. NeuMoDx External Calibrators [REF 800200] must be processed under the following scenarios:
a. Validity of previously established calibration has expired (past 90 days)
b. Calibration validity has not been established on the NeuMoDx System(s)
c. Calibration validity has not been established with a new lot of NeuMoDx HCV Quant Test Strips
d. The NeuMoDx System software has been modified
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
900201
NeuMoDx™ HCV External Controls
Single use sets of HCV Positive and Negative External Controls to establish daily validity of NeuMoDx HCV Quant Assay
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 Calibrators
INSTRUCTIONS FOR USE
800200
NeuMoDx Molecular, Inc. CONFIDENTIAL P/N 40600195_Rev B
March 2019
Pg. 3 of 4 For Ex-US Distribution Only
2. If a valid calibration does not exist, the NeuMoDx System will prompt the user to process external calibrators (and external controls)
before sample results can be reported.
3. If calibrators are required, process the NeuMoDx HCV calibrators with the following barcodes (1 high calibrator and 1 low calibrator per
reagent lot):
NeuMoDx HCV External Calibrator
Barcode ID
Label Color Scheme
High Calibrator (HC)
HCHCV
Green
Low Calibrator (LC)
LCHCV
Blue
4. Retrieve a set of NeuMoDx HCV external calibrators from freezer and allow the vials to set at room temperature (15-30°C) until
completely thawed. If using an already thawed set of calibrators, ensure that the thawed calibrators were stored at 4°C and are not
more than 24 hours old.
5. Vortex gently to ensure homogeneity.
6. Load the calibrator vials into a standard 32-Tube Carrier, and ensure caps are removed from all tubes.
7. Place the Tube Carrier on the Autoloader shelf and use the touchscreen to load carrier into the NeuMoDx System.
8. The NeuMoDx System will recognize the barcode and start processing the specimen tubes unless reagents or consumables required for
testing are not available.
9. To generate valid results, at least 2 out of the 3 replicates must yield results within predefined parameters. The low calibrator nominal
target is 3.0 Log10 IU/mL and the high calibrator nominal target is 5.0 Log10 IU/mL.
10. Discrepant result handling for external calibrators should be performed as follows:
a. If one or both the calibrators fails the validity check, repeat processing of the failed calibrator(s) using a new vial. In the event
one calibrator fails validity, it is possible to only repeat the failed calibrator as system does not require the user to run both
calibrators.
b. If problem persists, contact NeuMoDx Molecular, Inc.
11. External controls [REF 900201] must be processed after calibrator validity has been established, prior to obtaining test results from
human clinical samples.
LIMITATIONS
1. The NeuMoDx HCV Calibrators can only be used in conjunction with the NeuMoDx HCV Quant Test Strips on the NeuMoDx System.
2. A valid calibration of the NeuMoDx HCV Quant Test Strip using the NeuMoDx HCV Calibrators [REF 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 Calibrator
HCV Result
High Calibrator (HC)
2/3 calibrators Valid
Low Calibrator (LC)
2/3 calibrators Valid
NeuMoDx™ HCV Calibrators
INSTRUCTIONS FOR USE
800200
NeuMoDx Molecular, Inc. CONFIDENTIAL P/N 40600195_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
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