Klinisk Biokemi i Norden · 1 2018
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Find out more at
thermoscientific.com/procalcitonin
References: 1. Nobre et al., Am J Respir Crit Care Med 2008; 177: 498-505. 2. Briel et al., Arch Intern Med
2008; 168: 2000-7. 3. de Jong et al., Lancet Infect Dis 2016; 3099: 1-9. 4. Kip et al., J Med Econ 2015; 1-10.
© 2017 Thermo Fisher Scientific Inc. All rights reserved. B·R·A·H·M·S PCT and all other trademarks are the
property of Thermo Fisher Scientific and its subsidiaries unless otherwise specified. Thermo Fisher Scientific
products are distributed worldwide; not all intended uses and applications mentioned in this printing are
registered in every country. This indication for use is not cleared in the USA.
Thermo Scientific
™
B·R·A·H·M·S PCT
™
supports
responsible use of antibiotics to prolong their
effectiveness. Randomized clinical trials show proven
efficacy of
16% to 74% antibiotic exposure
reduction
across various clinical settings.
1,2
B·R·A·H·M·S PCT guided antibiotic therapy
has the potential to:
•
Reduce initial antibiotic prescription rates
2
•
Shorten antibiotic treatment durations
3
•
Save overall treatment costs
4
B·R·A·H·M·S Procalcitonin (PCT) :
An effective tool for antibiotic stewardship
Safely reduce
antibiotic exposure
The analytical quality goals set in the evaluation
was a diagnostic sensitivity >80% and a diagnostic
specificity >95%, as well as no interference with Strep
C and G, and a fraction of technical errors (failed mea-
surements) ≤2%. The quality goal for user-friendliness
was a total rating of “satisfactory”, assessed using a
questionnaire with three given ratings; satisfactory,
intermediate and unsatisfactory. The prevalence and
positive and negative predictive values were also cal-
culated.
Results
Using the results from culturing as comparison met-
hod, the diagnostic sensitivity of QuickVue Dipstick
Strep A Test was
92% and the diagnostic specificity
was 86%.
No interference with Strep C and G in the diluted
reference strain samples in the clinical microbiology
laboratory was detected, and no technical errors
were reported. The user-friendliness was rated as
satisfactory.
Other variables estimated were: prevalence of Strep
A among the patients (38%), positive predictive value
(80%), negative predictive value (95%), equivalence
point (in the range 1,5×10
4
−1,5×10
5
cfu/mL), inter-
person reading agreement (complete agreement), and
robustness of the test results (unchanged after five
minutes late reading). The results from real-time PCR
displayed more positive results than the comparison
method (culturing).
Conclusion
The quality goal set for QuickVue Dipstick Strep A Test
was fulfilled for diagnostic sensitivity, interference,
user-friendliness and technical errors. The quality goal
for diagnostic specificity was not fulfilled.
The complete evaluation report is available at
www.
skup.nu. A letter with comments from Quidel Cor-
poration is attached to the report.
Additional information from SKUP
The evaluation of QuickVue Dipstick Strep A test was
the first SKUP evaluation of Strep A also including
throat swab samples from primary health care cen-
tres. In 2017, SKUP made further changes to the Strep
A evaluation model by omitting the more technical
part with analysis of Strep A reference strains in the
clinical microbiology laboratory. From now on, the
complete evaluation will be performed using only
throat swab samples from patients in primary health
care centres. This winter, SKUP runs a “Strep A cam-
paign” inviting companies producing or selling Strep
A tests to contact SKUP for more information and
possibly for a proposal of an evaluation. Information
is also found at
.
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