PATHFAST™ - Sepsis Marker

PCT

Sepsis Marker

Features

Diagnosis and prognosis (antibiotic stewardship) of sepsis

PATHFAST™ determines the quantity of hs Trop INTproBNPD-DimerhsCRPMyoglobinCK-MB massBRAHMS PCT and Presepsin. From one single whole blood sample. The quantitative data of the parallel analyses provide results within minutes, which facilitate the therapeutical decision. Basis for a safe diagnosis on-site for patients with acute coronary syndrome, suspected coronary heart insufficiency, venous thromboembolism, inflammation and myocardial injury .

PATHFAST™ B・R・A・H・M・S PCT is an immunoassay for the in vitro quantitative determination of Procalcitonin (PCT) concentration in whole blood, plasma or serum. PCT is used as a marker of host response to bacterial infection. PATHFAST™ B・R・A・H・M・S PCT is used as an aid in the early detection and differential diagnosis of clinically relevant bacterial infections, in the assessment of the degree of septic severity and in the risk stratification of the outcome of patients with systemic bacterial infection, sepsis, severe sepsis and septic shock. PATHFAST™ B・R・A・H・M・S PCT is also used as an aid in decision making on antibiotic therapy for patients with lower respiratory tract infections (LRTI) and in decision making on antibiotic discontinuation for patients with suspected or confirmed sepsis. PCT is used as an aid in the diagnosis of sepsis, severe sepsis and septic shock in systemic inflammatory response of bacterial infection as well as in the assessment of the degree of septic severity and to aid in the risk stratification of critically ill septic patients. PCT has shown to be useful in decision making to initiate to monitor and stop antibiotic treatment in randomized controlled clinical studies in patients with acute respiratory tract infections and sepsis. PCT is also useful as an antibacterial drug index to prevent severity from lower respiratory tract infection to sepsis. 

Advantage of PATHFAST™ B·R·A·H·M·S PCT

Due to its reagent design and reagent throughput, PATHFAST™ is designed as an optimal companion combining the quality of results of a central lab analyser with the flexibility of a point of care testing device in one instrument. The PATHFASTB·R·A·H·M·S PCT assay can either complement the central lab patient testing or simply can be placed into the ED/ICU in order to perform rapid and reliable patient assessment at the point of care. The ability to use whole blood samples provides multiple options to enhance the diagnostic power for sepsis patients.

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Assay Specifications

Method Chemiluminescent Enzyme Immuno Assay - Magtration
Sample Material - Heparin-whole Blood
- Heparin-Plasma
- EDTA-whole Blood
- EDTA-Plasma
- Serum
Sample Volume 100 μl
Reference Values See table below
Test Duration < 17 Minutes
Durability of Calibration 28 Days
Measurement Range 0,020 - 100 ng/ml
Limit of Detection 0,007 ng/ml
Pack size 60 tests
Control set 4 x 1 ml
Reference Values
Value in ng/m Interpretation
< 0,5 Low risk for systemic bacterial infection, but local infection possible
0,5 - 2,0 Moderate risk for the development of severe systemic infection (severe sepsis or septic shock) improbably
 2,0 - 10 High risk for the development of severe systemic infection (severe sepsis or septic shock)
 > 10 Important systemic inflammatory response with very high risk of severe sepsis and septic shock

Differential diagnosis of LRTI
Value in ng/m Interpretation
< 0,1 Indicate absence of bacterial infection. Use of antibiotics strongly discouraged, also in the presence of impaired pulmonary reserve in acute exacerbation of chronic obstructive pulmonary disease (COPD).
0,1- 0,25 Bacterial infection is unlikely. The use of antibiotics is discouraged.
0,25 - 0,5 Bacterial infection is possible. Advice to initiate antimicrobial therapy
 > 0,5 Suggestive of the presence of bacterial infection. Antibiotic treatment strongly recommended.

* for more detailed information, please refer to the instruction for use, delivered with each reagent

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