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RAPID Procalcitonin
Registration Certificate: № RZN 2023/20186
A lateral flow immunoassay for semi-quantitative detection of Procalcitonin in human serum or plasma.
The Current Diagnostic Landscape
WHO has recognized procalcitonin (PCT) as the only specific biomarker for differentiating inflammation caused by bacterial infection and for guiding antibacterial therapy.
The diagnostic challenge is addressed by a rapid test that determines the nature of inflammation in just 20 minutes, eliminating the need to wait for laboratory results.
The diagnostic challenge is addressed by a rapid test that determines the nature of inflammation in just 20 minutes, eliminating the need to wait for laboratory results.
Clinical Impact & Benefits
01
BIOLOGICAL SELECTIVITY
Procalcitonin’s uniqueness lies in its mechanism: marker synthesis is triggered by bacterial toxins but blocked by interferons during a viral attack. This allows for the highly accurate exclusion of sepsis in critically ill patients with viral infections.
02
THE GOLDEN HOUR
In septic shock, every hour of delay in administering antibiotics increases the patient’s risk of death by 7.6%.
03
ANTIBIOTIC STEWARDSHIP
Up to 50% of antibiotic prescriptions in hospitals are excessive. The test allows physicians to confidently withhold or timely discontinue antibiotics (if PCT < 0.5 ng/ml), reducing treatment toxicity and preventing the development of superbugs.
Key Advantages
Early detection: PCT levels can be determined as early as 3−4 hours after the onset of inflammation
Clear differentiation between bacterial infection and viral or autoimmune pathologies
Safe therapy discontinuation: a ~24-hour half-life makes it an excellent monitoring tool
Semi-quantitative results allow for sepsis severity assessment based on test line intensity
Rapid diagnostics within 20 minutes
Room temperature storage simplifies test logistics and handling
Technical Specifications
Time to Result:
20 minutes
Diagnostic Sensitivity:
95%
Diagnostic Specificity:
≥95%
Reproducibility:
100%
Analytical Sensitivity (LOD):
0.1 ng/ml
Semi-quantitative test with a color scale
Interpretation
NEGATIVE RESULT
Appearance in the test window of only the control line “C”. Staining of the test line “T” does not occur.
Positive result
Two colored lines appear. The color intensity in the area of the test line (T) varies depending on the concentration of procalcitonin in the sample and must be compared with the standard lines of the color scale of the Control card.
Invalid result
In the control zone (C), no colored line appears regardless of the presence or absence of a line in the test zone (T)
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