Access PCT Reagent
Access PCT Reagent Packs
Access PCT Calibrators

Access PCT Assay

Advancing patient care for sepsis while optimizing laboratory workflows

The Access PCT assay is a procalcitonin blood test for laboratories supporting critical care settings. 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 when you consolidate PCT testing into your routine workflow on Access immunoassay systems.

 

Access PCT Advances Patient Care While Optimizing 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

Accuracy: Access PCT shows low mean bias and strong correlation and method concordance to the B·R·A·H·M·S PCT®-sensitive Kryptor method at key clinical decision points as demonstrated in an independent study conducted in two centers.1

Correlation and Concordance Chart

Comparator Access PCT
(Access 2)
Access PCT
(DxI 800)
Roche ELECSYS®
B•R•A•H•M•S PCT®
(cobas e801)
bioMérieux VIDAS®
B•R•A•H•M•S PCT®
Abbott
ARCHITECT®
B•R•A•H•M•S PCT®
Mean Bias
3.8%
(1.1% to 6.5%)
2.4%
(-1.3% to 6.1%)
-14.9%
(-18.5% to -11.2%)
0.2%
(-4.9% to 5.4%)
-7.2%
(-10.1% to -4.3%)
Correlation
r = 0.997
r = 0.994
r = 0.985
r = 0.994
r = 0.995
Concordance
at 0.5 ng/mL
100% 100% 99% 99% 99%
Concordance
at 2.0 ng/mL
98%
97%
96%
97%
98%

Table adapted from data presented in Lippi et al., Clin Chem Lab Med 2019. B・R・A・H・M・S PCT® is a registered trademark of B・R・A・H・M・S GmbH.

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

  • Random-access, high-throughput systems with an extensive assay menu 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.2 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.3,4,5

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?

Interpretation of Results

    PCT Concentration

      (ng/mL or μg/L)

    Interpretation
    <0.5     Low risk of severe sepsis and/or septic shock
    >2.0     High risk of severe sepsis and/or septic shock

Concentrations under 0.5 ng/mL do not exclude local infections or systemic infections in their initial stages (e.g., under 6 hours from onset of illness). PCT concentrations between 0.5 and 2.0 ng/mL should be interpreted with consideration of the patient's history. In this range, it is recommended to retest PCT within 6 to 24 hours.6

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 0.05–100 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
Abstract of a scientific study on Access PCT Procalcitonin Assay

Article Two‐center Comparison of Commercial PCT Immunoassays

In this study, Access PCT shows strong correlation and method concordance to other commercially available procalcitonin tests at key clinical decision points when used as an aid in diagnosing progression to severe sepsis or septic shock.

Read article
Download this data sheet to learn how to empower fast, accurate clinical decision-making while consolidating your workflow with the Access PCT Assay.

Data Sheet Empower Fast, Accurate Clinical Decision-making for Patients with Sepsis

Support better outcomes for patients with sepsis without sacrificing efficiency in your laboratory. See how well the Access PCT assay can deliver timely insights with confidence.

Download
AACC 2019 Scientific Poster: Analytical Performance Characteristics of the New Beckman Coulter Access PCT Assay

Poster Analytical Performance Characteristics of Access PCT

Review the evidence demonstrating strong correlation and concordance of the Access PCT immunoassay to a well-established PCT predicate method. Showcased at AACC 2019, this clinical laboratory study confirms the precision and reproducibility of Access PCT assay results, which are returned within approximately 20 minutes.

Download

1Lippi G., Salvagno G.L. et al., Two-centers comparison of 10 fully automated commercial procalcitonin (PCT) immunoassays. Clin Chem Lab Med 2019; aop https://doi.org/10.1515/cclm-2019-0888
2Maruna, P, Nedelnikova, K, Gurlich, R. “Physiology and Genetics of Procalcitonin.” Physiol Res, 2000; 49(Suppl1):S57–S61.
3Wacker, 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.
4Schuetz, 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.
5Clementine, YF Yap, Tar Choon Aw. “The Use of Procalcitonin in Clinical Practice.” Proceedings of Singapore Healthcare, Volume 23, Number 1, 2014.
6Meisner, M. Procalcitonin—Biochemistry and Clinical Diagnosis. UNI-MED, Bremen 2010.

*Data on file with Beckman Coulter.

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.