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The New PLAC® Test
For Lp-PLA2 Activity
Points & Viewpoints
Addressing some of the most important topics associated
with the PLAC Test for Lp-PLA2 Activity
Points: From the Literature
Viewpoints: From the Clinical Experts
Analytical Performance of
the PLAC Test for Lp-PLA2 Activity †
with Kenneth E. Blick, Ph.D.
The New PLAC Test
Analytical Performance of the P
Points From the Literature:†1
Sample stability for Lp-PLA2 Activity was established using serum
and EDTA plasma; ≤ 4 hours ambient, ≤ 31 days refrigerated,
and ≤ 31 days frozen at -20°C and -70°C.
For serum Lp-PLA2 Activity, the AU400 and Cobas 6000/c501
were highly correlated with minimal bias
(y = 0.9911x + 0.926; r2 = 0.999). Four (4) lot-to-lot comparisons demonstrated excellent correlation
(slope: 0.98-1.03; r2 ≥ 0.999). On-board reagent stability was validated for up to 61 days. Assay linearity was established between 10-400 nmol/min/mL in
this analysis. Accuracy was proven with mean recoveries between 96-103%. Within run and between run precision was 0.4-0.7% and
1.5-1.7%, respectively.
† Please see product insert for the manufacturer’s analytical performance information.
1. Callanan H. et al. Clin Chem; Vol. 59, No. 10. Supplement, 2013.
2. Dr. Blick is a paid clinical pathology consultant to diaDexus.
for Lp-PLA2 Activity
PLAC Test for Lp-PLA2 Activity †
Viewpoints From the Experts:
“When considering new tests for our laboratory, we
carefully examine
analytical test performance, ease of use, and clinical need, because we
know the clinical information we provide impacts the lives of the patients in
our community.
The PLAC Test for Lp-PLA2
Activity is a unique new test that
has been validated on multiple
automated clinical chemistry
analyzers with the performance,
accuracy and reproducibility that
I would consider to be nothing
short of ‘excellent’.
Having a test for Lp-PLA2 Activity that is
substrate based and can be performed on
the same analyzer as our other lipid tests
is a significant development. Laboratories
Kenneth E. Blick, Ph.D.2
Professor of Pathology
Director of Clinical Chemistry
Director of Immunoassay/Endocrine
Laboratories
The University of Oklahoma College
of Medicine
can now quickly and easily offer critical new information that advances the
physician’s clinical assessment of all patients, and even those of seemingly
low risk, that remain at risk of CHD events. This will be a test that we include
as a standard test in our lipid profile.”
Demonstrated: In Numerous Studies on Multiple Analyzers
Validated in thousands of patients in multicenter sub-study using a
cut-point of 225 nmol/min/mL.
Validated for testing on a broad range of automated clinical
chemistry analyzers.
FDA cleared as an aid in predicting risk of CHD in patients with no prior
history of cardiovascular events.
Supported:
By diaDexus, the Lp-PLA2 Experts
The PLAC Test is developed, manufactured and supported by diaDexus.
A suite of educational services are available online at www.plactest.com
Customer Service is available at 1.877.752.2837.
Ask your PLAC Test Representative
for information on the
PLAC Test for Lp-PLA2 Activity
in your laboratory.
The PLAC Test is provided by diaDexus: “The Lp-PLA2 Experts”
diaDexus, Inc. · 349 Oyster Point Blvd · South San Francisco · CA 94080 · 1.877.752.2837
PLAC and the PLAC logo are registered trademarks of diaDexus, Inc.
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