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 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
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