Fluorescence immunoassay Point of care test Wide range PCT whole blood serum plasma
ichroma PCT Description ichroma PCT along with ichroma Reader is a fluorescence immunoassay for quantitative determination of PCT in human sample PCT is known as a useful marker in the diagnosis of bacterial infection and sepsis Whole blood*, serum or plasma can be used as a sample. PCT testing with whole blood provides distinctive advantage in neonatal & general ICU, or emergency department for diagnosing sepsis Provides quantitative result in only minutes with small volume of sample ichroma PCT test allows diagnosis of sepsis & bacterial infection and helps prescription decision of antibiotics *ichroma PCT whole blood type will be available in early. Test Principle Sample matrix Result Sample volume Test time Detection range Fluorescence immunoassay with sandwich principle Whole blood*, serum or plasma Quantitative result µl for ichroma and µl for ichroma SMART minutes.- ng/ml What is Sepsis Sepsis Categories Sepsis is whole body inflammatory state triggered by infection SIRS (Systematic inflammatory Response Syndrome) Systemic inflammatory response to a variety of severe clinical insults, manifested by two or more of the following: Temperature >38ºC or <36ºC Heart rate >9 beats/min Respiratory rate > breaths/min or PaCO <3 mm Hg WBC >,/ mm3, </ mm3, or >% immature (band) forms Infection Sepsis Parasite Virus Fungus Bacteria Severe Sepsis Sepsis Shock Sepsis Severe Sepsis Systemic response to infection i.e., confirmed or suspected infection plus SIRS criteria Sepsis associated with organ dysfunction, hypoperfusion, or hypotension SIRS Severe SIRS Trauma Burns Septic Shock Severe Sepsis that cannot be resuscitated or stabilized with IV fluids alone ACCP/SCCM Consensus Statement. Chest. 99;:6. Adapted from SCCM ACCP Consensus Guidelines.
PCT test is currently the best marker for sepsis diagnosis Sensitivity..7..... Sensitivity: 89% Specificity: 9% NPV:9% PPV: 9%. - specificity.7 PCT CRP IL-6 Lactate. PCT levels accurately differentiate sepsis from non-infectious inflammation* PCT has been demonstrated to be the best marker for differentiating patients with sepsis from those with systemic inflammatory reaction not related to infection. *Simon L. et al. Clin Infect Dis. ; 39:6-7. Pros & Cons of other sepsis diagnostic tools PCT is easy, non-invasive and relatively inexpensive to measure Microbiology (Blood Culture) Imaging (X-Ray, Hr-CT) Molecular Biological Testing Biopsy C-Reactive Protein (CRP) Standard of care but time consuming Limitation of availability, high costs, variability of source detection Limitation of availability, costs, time consuming Invasive, relatively expensive Slow kinetics, suppressed by corticosteroids, relatively inexpensive The level of PCT can predict the severity of sepsis PCT kinetics on prognosis of sepsis patients Procalcitonin (PCT) values rise in relation to sepsis severity. Septic shock IL-6 PCT CRP Severe Sepsis Sepsis Local infection Plasma Concentrayion IL- TNF-α 6 8 7 Time (hours) PCT CRP IL-6 IL- TNF-α Healthy PCT [ng/ml] In critically ill patients, PCT levels elevate in correlation to the severity of bacterial infection. In healthy people, PCT concentrations are found below. ng/ml. Concentrations exceeding. ng/ml can be interpreted as abnormal. Clinical symptoms alone are often insufficient for early and accurate diagnosis. PCT levels, can be observed within 3-6 hours after an infectious challenge with a peak up to, ng/ml after 6- hours. Half-life: approximately hours. Specific to bacterial origin of infection and reflects the severity of the infection Brunkhorst FM et al., Intens. Care Med (998) : 888-89.
PCT test can be used as a diagnosis of bacterial infection Prescription decision of antibiotics in sepsis can be determined by PCT test A (9) 6 Immediate effectiveness of antibiotics Secondary response to therapy with the change of antibiotics Therapeutic failure μg/l 3 PCT [ng/ml] 6 Hib S pneumoniae Blood Sputum Mycoplasma Viruses + Bacterial superinfection PCT levels elevate specifically with bacterial, but not with viral, infection. Arch Dis Child ;8:33 336. Viruses PCT guidance in antibiotic usage shorten the time patients need to be on antibiotics 3 6 8 6 Days PCT provides a clearer picture of the patient s response to antibiotic treatment. Decreasing PCT levels in patients with sepsis indicate effective treatment of the underlying infection. Persistently elevated PCT levels indicate a possible treatment failure When integrated into the management of septic patients, PCT can help clinicians to manage septic patients more efficiently. Stueber, F. University of Bonn, Lecture at ISICEM, Brussels. Duration of antibiotic therapy in the control group (n=) and PCT group (n=) Patients under antibiotic therapy (AB) (%) 8 6 AB start >d >6d >8d >d >d >d Duration of antibiotic therapy (days) Tailoring of antibiotic treatment using PCT to the individual patient needs, safely led to a reduction of average treatment duration from to days with the same outcome Nobre V. et al AM Resp Crit Care Med 8: 77:98-. 3
PCT improves the accuracy of the early sepsis diagnosis in neonates. UNINFECTED INFECTED.. 6 8 3 36 8 In early onset neonatal sepsis PCT provides a clear differentiation of infected from uninfected neonates in the first days of life. In neonates, the PCT values physiologically increased in relation to their age. A peak is reached at hrs. with median at ng/ml and 9% at ng/ml. The adult reference range applies from 3 days after birth. Normal range in neonates (including 9% of all measurements) 6 8 3 36 8 C Chiesa et al. CID 997. Age in hours PCT[ng/ml] Age in hours PCT[ng/ml] -6 3-36 6-8 36-8 -8-8 8-3 Adding PCT test improves the accuracy of the early clinical diagnosis of infection post organ transplant PCT [ng/ml] 7 6 3 n=6 - Tx 3 6 7 8 9 3 posto. days PCT plasma concentrations in 6 patients without postoperative complications after liver transplantation, Tx: day of transplantation. Nobre V. et al AM Resp Crit Care Med 8: 77:98-. PCT [ng/ml] 6 infection, n= 8 6 rejection, n= - - 3 days before and after diagnosis of rejection or infection PCT used in early detection of infection after liver transplantation-differentiation from rejection. Kuse ER et al., Crit Care Med ; 8: -9.
ichroma PCT is available on ichroma, ichroma D, ichroma SMART For sales queries, please email us to PCT@boditech.co.kr Boditech Med Inc. 3, Geodudanji -gil, Dongnae-myeon, Chuncheon-si, Gang-won-do, -883, Republic of KOREA Tel +8-33-3-7 Fax +8-33-3-9373 sales@boditech.co.kr Boditech Med Europe a Hampstead Hill Gardens London NW3PJ, United Kingdom Tel +-7-97- Fax +-7-97- www.boditech.co.kr