SuperFlex^™ Procalcitonin Kit

PCT can be used for differential diagnosis of bacterial and non-bacterial infection, diagnosis, and differential diagnosis of sepsis, guiding the use of antibiotics, monitoring the therapeutic effect, and suggesting the prognosis of the disease.

PCT <0.5 ng/mL indicates a low risk of severe sepsis and septic shock.

PCT >2 ng/mL indicates a high risk of severe sepsis and septic shock.

The SuperFlex^™ PCT Assay automated on the SuperFlex^™ Automated Chemiluminescence Analyzer delivers high-sensitivity and specificity with results in only 14 minutes.

• LOB ≤0.02 ng/mL, LOD ≤0.05 ng/mL, LOQ ≤0.1 ng/mL
• Accuracy: determine the enterprise accuracy reference, the deviation between the test values shall be not more than ± 15%
• Linear range: 0.05-240 ng/mL, the linear correlation coefficient (r) ≥0.990
• Repeatability: Coefficient of variation (CV) ≤ 8%
• Inter-run difference: Coefficient of variation (CV) ≤ 10%

Clinical benefits of PCT assays

PCT is a clinically useful diagnostic marker in the assessment of patients with suspected sepsis or life-threatening septic shock.

• PCT analysis can aid in differentiating between viral or bacterial origin infection.
• PCT tests support monitoring the course and severity of a sepsis systemic inflammatory response.
• PCT is a fast and highly specific biomarker in bacterial infection and sepsis, PCT levels can be observed 3-6 hours after an infectious challenge.
• PCT is a more accurate diagnostic biomarker for sepsis, a better predictor of mortality and a more reliable biomarker than other biomarkers including C-reactive protein, interleukins, and lactate.
• Storage temperature: 2-8℃

References:

1. Muller B, Becker KL, Schachinger H, Rickenbacher PR, Huber PR, Zimmerli W, Ritz R. Calcitonin precursors are reliable markers of sepsis in a medical intensive care unit. Crit Care Med 2000, 28: 977-983.
2. Simon L, Gauvin F, Amre DK, Saint-Louis P, Lacroix J. Serum procalcitonin and C-reactive protein levels as markers of bacterial infection: a systematic review and meta-analysis. Clin Infect Dis. 2004;39:206-17.
3. Christ-Crain M, Jaccard-Stolz D, Bingisser R, Gencay MM, Huber PR, Tamm M, Muller B. Effect of procalcitonin-guided treatment on antibiotic use and outcome in lower respiratory tract infections: cluster-randomised, single-blinded intervention trial. Lancet. 2004;363:600-7.
4. Harbarth S. et al., Diagnostic value of procalcitonin, interleukin-6 and interleukin-8 in critically ill patients admitted with suspected sepsis. Am J. Resp. Crit. Care Med. 2001,164: 396-402.
5. Meisner, M. Procalcitonin—Biochemistry and Clinical Diagnosis. UNI-MED, Bremen 2010.