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Access PCT Assay

Advancing patient care for sepsis while optimizing laboratory workflows

The Access PCT* assay is a procalcitonin blood test for laboratories supporting emergency departments and critical care settings. Use the capabilities of Access PCT to aid in the quantitative determination of procalcitonin levels. Access PCT offers state-of-the-art precision and low-end sensitivity for procalcitonin results you can trust. In addition, you can experience greater efficiency in your laboratory through workflow consolidation.

This product may not be available in your country or region at this time. Please contact your Beckman Coulter sales representative or distributor for more information.

Access PCT Advances Patient Care with Optimized Laboratory Workflows

Provide confidence in results and improve patient care through:

  • >95% overall agreement with predicate method for accurate assessment of patients at risk of progression to severe sepsis and septic shock
  • State-of-the art sensitivity and low-end precision―20% CV LoQ of 0.02 ng/mL and CV ≤8% at concentrations of ≥0.150 ng/mL 
  • Rapid access to results with first result in approximately 20 minutes
  • Minimal sample draw of 35 µl pick-up volume
The Access PCT assay shows strong correlation and method concordance to three commercially available PCT methods.

DxI 800
Platform Correlation (r) Overall agreement @ 0.5 ng/mL Overall agreement @ 2.0 ng/mL 
VIDAS® B·R·A·H·M·S PCT® (n=260)† 0.98 96.5% 99.2%
ARCHITECT® B·R·A·H·M·S PCT® (n=257)† 0.99 97.7% 95.3%
ELECSYS® B·R·A·H·M·S PCT® (n=260)† 0.99 98.1% 91.9%


Simplify sample processing and reduce separate PCT analysis workstation costs with:

  • Random-access, high-throughput systems with >65 available assays and 50 reagent pack positions
  • Fewer manual processing steps compared to standalone systems
  • Onboard reagent storage of liquid, ready-to-use, 50-test reagent packs
  • 42-day calibration stability

What is the Connection between Procalcitonin and Infections?

The procalcitonin amino acid peptide is a precursor of calcitonin. In healthy individuals, procalcitonin (PCT) levels are typically less than 0.1 ng/mL.1 In individuals with inflammation or infections, PCT levels rise in circulation in response to inflammatory cytokines and bacterial endotoxins. 

How is Procalcitonin Used as a Risk Assessment Tool for Sepsis?

PCT levels correlate with the severity of bacterial infections and the probability of a positive blood culture. That makes it a clinically useful diagnostic marker in the assessment of patients with suspected sepsis or life-threatening septic shock.2,3,4

PCT blood tests can aid in differentiating between sepsis of viral or bacterial origin. PCT tests also support monitoring the course and severity of a sepsis systemic inflammatory response. 

How Can Clinicians Use Procalcitonin for the Risk Assessment for Sepsis?

 

Access PCT Assay data chart

PCT levels less than 0.5 ng/mL do not exclude local or systemic infections in their initial stages (under 6 hours). Consider the patient’s history when interpreting PCT levels between 0.5 and 2.0 ng/mL. Retesting PCT within 6 to 24 hours is recommended if any levels are less than 2.0 ng/mL.5

Assay Specifications

Sample type / size Serum, plasma (lithium heparin) / 35 μL
Approximate calibrator levels 0, 0.8, 5, 10, 25, 50 and 100 ng/mL (μg/L)
Analytical measuring range 0.01–100 ng/mL (μg/L), up to 1,000 ng/mL with Special Dilution Feature
Limit of Detection (LoD) 0.01 ng/mL (μg/L)
20% CV Limit of Quantitation  0.02 ng/mL (μg/L)
Imprecision Total imprecision ≤8.0% CV at concentrations ≥0.150 ng/mL, and standard deviation (SD) ≤0.012 ng/mL at concentrations <0.150 ng/mL
Open pack stability 42 days
Calibration stability 42 days
Time-to-first result (approx.) 20 minutes

The results below were generated from a study based on CLSI EP05-A3 guidelines utilizing three reagent lots, three calibrator lots and multiple calibrations. The study ran over 20 days. There were 2 runs per day in replicates of 2, for a total of 80 replicates per sample.

Sample Average Concentration (ng/mL) Total %CV
QC1 0.68 3.6
QC1 2.15 3.2
QC3 20.65 3.2
Sample 1 0.090 7.2
Sample 2 0.18 5.6
Sample 3 0.27 4.4
Sample 4 0.43 5.7
Sample 5 1.41 5.0
Sample 6 7.59 4.2
Sample 7 76.31 3.8

VIDAS® is a registered trademark of bioMérieux SA. 
ARCHITECT® is a registered trademark of Abbott Laboratories.
ELECSYS® is a registered trademark of Roche Diagnostics GmbH. 
B·R·A·H·M·S PCT® is a registered trademark of B·R·A·H·M·S GmbH.

*Pending clearance by the United States Food and Drug Administration; not yet available for in vitro diagnostic use in the US.
Data on file with Beckman Coulter.
1Maruna, P, Nedelnikova, K, Gurlich, R. “Physiology and Genetics of Procalcitonin.” Physiol Res, 2000; 49(Suppl1):S57–S61.
2Wacker, C, Prkno, A, Brunkhorst, FM, Schlattmann, P. “Procalcitonin as a diagnostic marker for sepsis: a systematic review and meta-analysis.” Lancet Infect Dis. 13(5):426–435.
3Schuetz, P, Bretscher, C, Bernasconi, L, and Mueller, B. “Overview of procalcitonin assays and procalcitonin-guided protocols for the management of patients with infections and sepsis.” Expert Rev Mol Diagn, 2017. vol. 17, No. 6, 593–601.
4Clementine, YF Yap, Tar Choon Aw. “The Use of Procalcitonin in Clinical Practice.” Proceedings of Singapore Healthcare, Volume 23, Number 1, 2014.
5Meisner, M. Procalcitonin—Biochemistry and Clinical Diagnosis. UNI-MED, Bremen 2010.