CASE STUDY
Analyse-it® Reduces Method Validation steps at National
Clinical Laboratory
“With Analyse-it, I pull in the data and quickly analyse it, and then prepare figures
for manuscripts right there. From the beginning of the project to completion, using
one application saves me probably a day’s worth of time.”
Research & Development Scientist, at a National Clinical Laboratory in the USA
(who unfortunately could not be named, due to company policy)
When you work with many of the nation’s university and teaching hospitals, as well
as major commercial and government laboratories – offering more than 2,000 tests
and combinations – efficient method validation makes a difference.
A research and develop scientist with a national clinical laboratory evaluates automated
immunoassays for some of the industry’s leading in-vitro diagnostic device makers,
including Abbott Diagnostics, Bayer Diagnostics, Beckman Coulter and Roche Diagnostics.
She and her colleagues compare the analytical performance of various machines and
then publish the results.
Over several years of R&D, the researcher has used a variety of approaches to
method evaluation, from customized Microsoft Excel spreadsheets designed by colleagues
to packaged method validation software. Each of these approaches lacked key functionality,
requiring her to use multiple tools to validate methods.
“The other method evaluator software we used wasn’t integrated into Excel,” she
said. “There were steps to prepare data for analysis, and then we had to move figures
to graphics software to get them ready for publication. I could never get Bland-Altman
plots to look the way I wanted. It was a huge headache.”
Method Validation Integrated into Excel
At the time, some of her colleagues used Analyse-it method evaluation software and
recommended it. The software supports the latest CLSI and industry-recognised protocols,
enabling users to validate, verify and demonstrate analytical accuracy, precision,
linearity, reference intervals, and diagnostic performance.
In particular, the researcher appreciated that Analyse-it integrates right into
Excel, saving steps and time learning how to use new software. It also includes
method comparison procedures not available with the previously used method validation
software, including Bland-Altman plots, Passing & Bablok, Deming and Linear regression.
Because Analyse-it works within the familiar Excel environment, the researcher can
easily begin using the software immediately. She downloads data directly from laboratory
instruments into Excel, rather than having to re-enter it manually into Excel or
another software package. “It’s already in an Excel sheet,” she said. “I just open
it up and the data set is there. It’s just so easy.”
Analyse Faster
With Analyse-it, the lab can perform analysis more quickly. “I just open up my data,
and with a few clicks the software analyses the data, without the extra steps required
with other software,” she said. “I can do regressions right away,” she said. “That’s
probably the top feature for me.”
As a researcher, she also values the ability to analyse data on her own without
engaging statisticians to create the required formulas in Excel – and that Analyse-it
is considerably faster than using an Excel spreadsheet.
Figures Ready for Publication
Previously, the researcher could not prepare figures for publication in Excel or
with the method validation software she used – forcing her to manipulate images
in Adobe Photoshop or Illustrator. That added considerable time preparing results
for publication.
Now, she can easily edit figures right in Analyse-it, adding and editing titles,
moving around regression statistics, and formatting values of the axis. “I can edit
the actual figures for publication in Analyse-it. It’s a lot faster now”, she said.
‘Saves Me Time’
From analysis to publication, the lab now saves considerable time. With all analysis
in one application, eliminating manual input and excess importing and exporting
of data, the researcher and her colleagues also reduce the risk of error.
“With Analyse-it, I pull in the data and quickly analyse it, and then prepare figures
for manuscripts right there,” she said. “From the beginning of the project to completion,
using one application saves me probably a day’s worth of time.”
A Reliable and Supported Product
Over the past few years of using Analyse-it, the researcher notes that the software
has been updated regularly to remain current with the latest protocols and statistical
procedures – ensuring that she and her team have access to the latest method validation
procedures.
Most importantly, she and her colleagues have come to rely on Analyse-it. “It’s
completely accurate and reliable. We can trust the information we’re getting.”
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