Download Independent QC materials for infectious disease testing

PRODUCT BULLETIN
AcroMetrix® quality control products
Independent QC materials for infectious
disease testing
AcroMetrix quality control products
®
As molecular diagnostics
expands in the clinical setting,
laboratories face the challenges
of implementing new tests and
finding dependable, convenient,
and affordable quality control
materials to monitor assay
performance. Prior to reporting
patient results, validation or
verification is required to establish
or verify the performance
characteristics of a new molecular
diagnostic assay. For each
test system, the laboratory is
responsible for having control
procedures that monitor the
accuracy and precision of the
complete analytical process.
Life Technologies has innovative
standards, external run controls,
and validation and verification
materials (now offered under
the AcroMetrix® brand name)
that offer an effective solution to
some of the challenges that you
face. The AcroMetrix® portfolio
provides molecular quality control
products that aid laboratories in
meeting quality and regulatory
requirements. Additionally, these
products support the goal of
standardization in molecular
testing by establishing traceability
of results and by providing
commutable material that can
help ensure consistent, accurate,
and meaningful test results. Using
AcroMetrix® panels and controls
enables a lab to:
• Validate and verify new assays
• Monitor assay and instrument
performance over time
• Troubleshoot procedural errors
• Train laboratory personnel to
accurately perform assays
AcroMetrix® Infectious Disease Panels
AcroMetrix® Infectious Disease Panels
for HIV-1, HBV, and HCV nucleic acid
testing (NAT) allow laboratories to
readily verify assays with confidence
and are used to establish or verify
performance specifications for
accuracy, precision, reportable range,
analytical sensitivity, and analytical
specificity (Figures 1–3). These valuable
tools can also be used for laboratory
personnel proficiency testing.
Inhibition panel assists with
assay evaluation
The AcroMetrix® Inhibition Panel is a
seven-member panel that provides
quantified amounts of commonly
recognized assay inhibitors, including
heparin, lipids, bilirubin, and hemolyzed
plasma. This panel can be used for
assay validation, instrument evaluation,
commercial and in-house assay
characterization, and troubleshooting.
Diluting the panel members allows
Observed titer (log IU/mL)
Roche Lab 2
y = 0.9738x - 0.2217
R2 = 0.9969
Roche Lab 3
y = 1.1107x - 0.6649
R2 = 0.9798
Roche Lab 4
y = 0.9459x + 0.3511
R2 = 0.9984
Abbott Lab 1
y = 0.9735x + 0.077
R2 = 0.9996
Roche COBAS® AmpliPrep/COBAS® TaqMan® HCV Test (IVD)
Roche COBAS® AmpliPrep/COBAS® TaqMan® HCV Test (RUO/ASR)
Abbott RealTime™ HCV Viral Load Test
8
7
6
5
4
3
2
1
0
0
1
2
3
4
5
6
7
8
Expected titer (log IU/mL)
Figure 1. AcroMetrix® HCV-s Panel: A Multi-Center Evaluation. The AcroMetrix® HCV-s
Panel is accurately and precisely detected by a variety of sample preparation and nucleic
acid amplification systems, including the COBAS® TaqMan® HCV systems (Roche) and
the RealTime™ HCV Viral Load Test (Abbott) on the Abbott m2000™ System. The panel is
highly linear with members from 100 IU/mL up to 2.5E7 IU/mL. (Note: Data were obtained
from customer site evaluations. Performance characteristics should be established by
each laboratory.)
9
Observed titer (log IU/mL)
Verify or validate larger reportable
ranges with ease
AcroMetrix® Infectious Disease Panels
provide laboratories with the largest
ranges of panel concentrations
available for molecular testing.
Based on the revolutionary SynTura™
technology, the AcroMetrix® HCV-s
Panel consists of panel members with
concentrations from 1E2 IU/mL to
2.5E7 IU/mL, enabling laboratories to
verify or validate a larger reportable
range. Also, the AcroMetrix® HBV
Panel 1.2 mL has the largest dynamic
range of concentrations available for
quantitative HBV DNA assays, from
50 IU/mL to 5E7 IU/mL.
9
Observed titer = Expected titer
8
Roche COBAS® TaqMan® HBV Test
7
y = 1.0093x - 0.0465
R2 = 0.9974
6
5
4
3
2
1
0
0
1
2
3
4
5
6
7
8
9
Expected titer (log IU/mL)
Figure 2. Evaluation of the AcroMetrix® HBV Panel 1.2 mL. The AcroMetrix® HBV Panel
produces linear results using the Roche COBAS® TaqMan® HBV Test kit (Roche) with the
High Pure System Viral Nucleic Acid Kit (Roche). An intercept close to zero shows that
minimal inhibitors are present. (Note: Data were obtained from customer site evaluations.
Performance characteristics should be established by each laboratory.)
7
Observed titer (log copies/mL)
Excellent traceability for
accurate reporting
AcroMetrix® HIV-1, HBV, and HCV
Panel members are traceable to WHO
International Standards, helping to
ensure more accurate reportable
results and allowing for interlaboratory comparisons. Additionally,
the panels contain whole virus in
human plasma–based matrices and
behave similarly to patient samples.
Roche Lab 1
y = 0.9891x + 0.3644
R2 = 0.9991
6
Roche COBAS® AmpliPrep/COBAS® TaqMan® HIV-1 Test, v1.0
y = 1.03x - 0.026; R2 = 0.9995
5
Roche COBAS® AmpliPrep/COBAS® TaqMan® HIV-1 Test, v2.0
y = 1.0342x - 0.0522; R2 = 0.996
4
Abbott RealTime™ HIV-1 Viral Load Test
y = 1.02x - 0.103; R2 = 0.9991
3
2
1
0
0
1
2
3
4
5
6
7
Expected titer (log copies/mL)
Figure 3. AcroMetrix® HIV-1 Panel copies/mL. The AcroMetrix® HIV-1 Panel is highly linear
with members from 100 copies/mL to 5E6 copies/mL and will be accurately and precisely
detected by both the COBAS® AmpliPrep/TaqMan® HIV-1 system (Roche) and the RealTime™
HIV-1 Viral Load Test (Abbott) on the Abbott m2000™ System. (Note: Data were obtained
from customer site evaluations. Performance characteristics should be established by
each laboratory.)
The AcroMetrix® EV (enterovirus)
Low Control contains inactivated,
encapsidated viral particles, allowing
for verification of effective viral RNA
extraction and purification as well
as amplification and detection. Both
positive and negative EV controls
are diluted in a proprietary synthetic
matrix designed to mimic naturally
occurring human cerebrospinal fluid
(CSF) specimens.
Accurately monitor assay
performance over time
In accordance with ISO 17511,
AcroMetrix® HIV-1, HBV, and HCV
Controls are calibrated against
WHO International Standards and
the AcroMetrix® EV Low Control is
calibrated against a highly stable
in-house enterovirus standard. This
traceability to a higher-order standard
helps ensure excellent reproducibility
from lot to lot of control, assisting
laboratories in accurately monitoring
assay performance over time and
across reagent lot changes.
AcroMetrix®
HCV High Control
Negative
Control
Hemolyzed
Low Plasma
Hemolyzed
Mid Plasma
B
Hemolyzed
High Plasma
Heparin
Triglycerides
Bilirubin
C
38
PCR occurs
as expected
PCR occurs with
some inhibition
36
Ct
AcroMetrix® Infectious
Disease Controls
Controls that mimic your
patient samples
AcroMetrix® HIV-1, HBV, and HCV
Controls are the only true full-process
HIV-1, HBV, and HCV quality controls
commercially available. Made from
whole, unaltered virus in plasma-based
matrices, these controls simulate
patient samples from extraction
through amplification and detection.
A
Amount of DNA/RNA
(copies/mL)
for the testing of inhibitory limits such
that the level of inhibition becomes
apparent (Figure 4).
34
32
PCR reaction
completely
inhibited
30
EDTA
Haemolyzed
low
Haemolyzed
mid
Haemolyzed
high
Heparinized
Lipemic
Icteric
Figure 4. The AcroMetrix® Inhibition Panel can be used to show the effects of common
inhibitors on PCR. (A) After spiking AcroMetrix® Inhibition Panel members with a known
concentration of viral sample, panel members can be treated just like patient samples. (B)
PCR results can show the effects of inhibitors on PCR. (C) A typical example of the inhibitory
effects on Ct values.
AcroMetrix® HIV-1 High Control
In acute HIV-1 infections, the levels of RNA in plasma can range from 1.7E5 to
1.7E7 IU/mL. Because assay reagents can vary from lot to lot, it is critical to
perform routine quality control between these levels. The AcroMetrix® HIV-1
High Control has the highest HIV-1 titer available and can help your laboratory
monitor reagent lot variation and detect systematic errors within the upper end
of your assay’s dynamic range. This control contains the noninfectious 8E5 HIV-1
strain to provide maximum safety in your laboratory, decreasing exposure to
potentially dangerous high-titer infectious HIV material and ensuring a safe and
productive work environment. It also provides results traceable to the WHO 2nd
International Standard for HIV-1 RNA in accordance with ISO 17511.
Online tool for assay validation
Define your study parameters using the EZValidation™ Online Tool
Instead of spending several weeks to design and perform a verification or
validation of your quantitative molecular assay, you can use the EZValidation™
tool in combination with AcroMetrix® panels and controls to speed up your assay
validation. You choose which standard guidelines to follow and the EZValidation™
tool calculates the number of reactions and quality control materials required,
and applies statistical analysis to your data to generate a final report that
supports user validation and verification of molecular tests.
Ordering information
Target
HIV
Product
Fill
Package
Regulatory
volume
size
designation
Cat. No.
AcroMetrix® HIV-1 Panel IU/mL (0, 1E2, 1E3, 1E4, 1E5, 1E6, 1E7 IU/mL)
1.2 mL
7 vials
RUO
942013
AcroMetrix HIV-1 Panel copies/mL (0, 1E2, 5E2, 5E3, 5E4, 5E5, 5E6 copies/mL)
1.2 mL
7 vials
RUO
950470
AcroMetrix® HIV-1 Low Control
1.2 mL
5 vials
IVD, CE-IVD
964001
AcroMetrix HIV-1 Mid Control
1.2 mL
5 vials
IVD, CE-IVD
964002
AcroMetrix® HIV-1 High Control
1.2 mL
5 vials
RUO
960403
AcroMetrix HIV-1 High Control*
1.2 mL
5 vials
CE-IVD
964003
AcroMetrix Genotyping HIV RT/PR Mutant Control
0.5 mL
5 vials
RUO
951502
AcroMetrix® HCV Panel (0, 5E1, 5E2, 5E3, 5E4, 5E5, 5E6 IU/mL)
0.5 mL
7 vials
RUO
942011
AcroMetrix HCV-s Panel (1E2, 5E2, 5E3, 5E4, 5E5, 5E6, 2.5E7 IU/mL)
1.2 mL
7 vials
RUO
950350
AcroMetrix HCV Genotyping Panel (Genotypes 1, 2, 3 & 4)
0.5 mL
4 vials
RUO
942000
AcroMetrix® HCV Low Control
1.2 mL
5 vials
IVD, CE-IVD
963001
AcroMetrix HCV Mid Control
1.2 mL
5 vials
IVD, CE-IVD
963002
AcroMetrix® HCV High Control
1.2 mL
5 vials
RUO
960203
AcroMetrix HCV High Control*
1.2 mL
5 vials
CE-IVD
963003
AcroMetrix HBV Panel 0.5 mL (0, 2E2, 2E3, 2E4, 2E5, 2E6, 2E7 IU/mL)
0.5 mL
7 vials
RUO
942012
AcroMetrix® HBV Panel 1.2 mL (5E1, 5E2, 5E3, 5E4, 5E5, 5E6, 5E7 IU/mL)
1.2 mL
7 vials
RUO
950150
AcroMetrix HBV Low Control
1.0 mL
5 vials
IVD, CE-IVD
965001
AcroMetrix HBV Mid Control
1.0 mL
5 vials
IVD, CE-IVD
965002
AcroMetrix® HBV High Control
1.0 mL
5 vials
RUO
960603
AcroMetrix HBV High Control*
1.0 mL
5 vials
CE-IVD
965003
AcroMetrix® EV Negative Control
0.3 mL
5 vials
RUO
950499
AcroMetrix EV Negative Control*
0.3 mL
5 vials
CE-IVD
960499
AcroMetrix EV Low Control
0.3 mL
5 vials
RUO
950500
AcroMetrix® EV Low Control*
0.3 mL
5 vials
CE-IVD
960501
Negative
AcroMetrix Negative Control*
1.0 mL
5 vials
IVD, CE-IVD
962000A
Inhibitors
AcroMetrix Inhibition Panel (EDTA plasma; hemolyzed low, mid, high;
1.0 mL
7 vials
RUO
956400
AcroMetrix® EDTA Plasma Dilution Matrix 45 mL
45 mL
1 bottle
RUO
S2284
AcroMetrix Ultra Serum Dilution Matrix
50 mL
1 bottle
RUO
S2285
AcroMetrix Citrate Plasma Dilution Matrix 50 mL
50 mL
1 bottle
GPR
941050
AcroMetrix® Citrate Plasma Dilution Matrix 100 mL
100 mL
1 bottle
GPR
941100
®
®
®
®
HCV
®
®
®
®
HBV
®
®
®
®
EV
®
®
®
®
heparinized plasma; lipemic plasma; icteric plasma)
Diluent
®
®
Software
EZValidation Online Tool (Introductory Promo—Single Study)
990500
EZValidation Online Tool (12 Month Subscription)
990501
EZValidation™ Online Tool (Single Study Use)
990506
™
™
* Not available in the U.S.
To learn more about AcroMetrix® infectious disease products, go to acrometrix.com
For Research Use Only. Not intended for any animal or human therapeutic or diagnostic use.
© 2011 Life Technologies Corporation. All rights reserved. The trademarks mentioned herein are the property of Life Technologies Corporation or their respective owners.
COBAS® is a registered trademark of Roche Diagnostics Operations, Inc. TaqMan® is a registered trademark of Roche Molecular Systems, Inc. Printed in the USA. CO23266 1011
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