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
