Pylon Immunochemistry Systems

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Pylon 3D Fully Automated Immunoassay System

Central lab performance in near patient settings
  • Whole blood, serum or plasma samples
  • Patient friendly micro-volume sample size
  • No fluidics—simple operation, low maintenance
  • Compact, space-saving


Pylon 1 Immunochemistry System

More power. Proven Installations.
  • Fluidics-free system—greater reliability, less maintenance
  • 24/7 availability, anywhere in the hospital
  • More convenience, less waste with unitized reagent packaging
  • More flexibility with sample types, including whole blood
  • Patient-friendly microvolume sample size
  • Automation simplifies operation and reduces human error
  • Bidirectional LIS/HIS compatibility
  • Choose from two different models
  • Chinese language interface

Designed for inpatient and outpatient testing


Pylon Immunoassays

Central lab performance in near patient settings
  • Unitized test strip contains everything you need for the assay
  • Time to results <20 minutes
  • Sensitive, specific, accurate
  • Patient-friendly low sample volume requirement
  • Whole blood, serum, plasma

Pylon cTnI Immunoassay

Accurate, timely, and efficient
  • Broad sample types, including whole blood
  • 14 minutes time to result
  • Unitized packaging increases convenience, reduces waste
  • Pylon cTnI, Pylon CKMB, Pylon Myoglobin – your choice

Assay Information

cTnI

Cardiac markers are used in the diagnosis and risk stratification of patients with chest pain and suspected acute coronary syndrome (ACS). Cardiac troponin is central to the definition of acute myocardial infarction (AMI) in the consensus guidelines from the European Society of Cardiology (ESC) and the American College of Cardiology (ACC).1–3 In China, guidelines for the diagnosis and treatment of non-ST-segment elevation acute coronary syndrome suggest the use of cardiac troponin for diagnosis and risk stratification. The guidelines also note that cardiac troponin has higher sensitivity and specificity compared with the traditional cardiac markers.4

References

1. Thygesen K, Alpert JS, Jaffe AS, et al. Eur Heart J 2012 Oct;33(20):2551-2567. doi: 10.1093/eurheartj/ehs184. 2. Diercks DB, Mumma BE, Frank Peacock W, et al. Acad Emerg Med 2013 Mar;20(3):265-270. doi: 10.1111/acem.12092. 3. American College of Emergency Physicians, Society for Cardiovascular Angiography and Interventions, O’Gara PT, Kushner FG, Ascheim DD, et al. J Am Coll Cardiol 2013 Jan 29;61(4):e78-140:78-140. 4. Chinese Society of Cardiovascular Diseases and Editorial Committee of the Chinese Journal of Cardiology. Chin J Cardiol 2012 May;40(5):353-367.

Pylon BNP Immunoassay

Improved heart failure management
  • Accurate measurements with novel Single Epitope Sandwich (SES™) assay
  • Whole blood or plasma sample
  • 14 minutes time to results

Assay Information

Pylon BNP
The SES™ assay utilizes a capture antibody specific to the relatively stable ring fragment of the BNP molecule (MAb 24C5, epitope 11-17), and detection antibody, MAb Ab-BNP2, which recognizes the immune complex of capture antibody with the antigen (BNP or proBNP), and not the individual components of the complex. Thus, only one epitope is needed.

The Pylon approach to an analytical challenge

BNP is secreted from the cardiac ventricle in response to volume and pressure overload. The diagnostic and prognostic value of BNP in improving clinical outcome in heart failure is well established.1 Yet, accurate measurements can be a challenge because the BNP molecule is small (32 amino acids) and unstable. Studies have shown that the truncated form (without the C- and N-terminus) of BNP and NT-proBNP is the molecular entity present in circulating plasma. As a result, assays that rely on dual epitopes, one of which is in the C-terminus, are likely to underestimate BNP level. To address this issue, the Pylon BNP Immunoassay uses a novel Single Epitope Sandwich (SES™) format requiring only one epitope for antigen detection.1,2 The capture antibody is specific to the relatively stable ring part of the BNP molecule, which is common to both BNP and NT-proBNP. The detection antibody is specific to the immune complex and not the individual components of the complex.

References

1. Mueller C, Breidthardt T, Laule-Kilian K, Christ M, Perruchoud AP. Swiss Med Wkly 2007 Jan 13;137(1-2):4-12. 2. Tamm NN, Semenov AG, Seferian KR, et al. Clin Biochem 2011 Feb;44(2-3):257-259. doi:10.1016/j.clinbiochem.2010.09.030.

Pylon PCT Immunoassay

Enhance clinical utility with Pylon advantages
  • Addresses pediatrics need for micro-volume sample
  • Fast, easy and cost-efficient testing
  • Whole blood sample results correlate with plasma results throughout the entire linear range
  • Excellent correlation with industry standard

Assay Information

PCT is a precursor of the hormone calcitonin and is expressed by neuroendocrine cells as part of an inflammatory response to systemic bacterial infections. PCT levels correlate with clinical severity, and thus is useful as a diagnostic and prognostic biomarker to identify patients who can benefit from antimicrobial therapy and monitor treatment progress to determine when it is safe to end therapy. Clinical use of PCT includes:

  • Diagnosis and treatment monitoring of sepsis1
  • Diagnosis of infection and prognosis in patients with fever at the ER2
  • Identification of lower respiratory tract infections in patients who need antibiotic treatment3
  • Guiding treatment of acute respiratory tract infections4

Use of PCT in ER5

Pylon PCT

References

1. Balcl C, Sungurtekin H, Gürses E, Sungurtekin E, Kaptanoglu B. Crit Care 2003;7(1):85-90. doi: 10.1186/cc1843. 2. de Kruif MD, Limper M, Gerritsen H, et al. Crit Care Med 2010 Feb;38(2):457-463. doi: 10.1097/ CCM.0b013e3181b9ec33. 3. Hopstaken R, Hay AD, Butler CC. Br J Gen Pract 2004 Mar;54(500):216-217. 4. Ebell M. Procalcitonin-guided treatment of respiratory tract infections. Am Fam Physician 2008;78(6):756-757. 5. Zheng X et al. Chin J Emerg Med 2012;21(9):944-951.

Pylon β-hCG Immunoassay

Wide dynamic range sets new standard in efficiency and speed
  • Measurement range from 1 to 300,000 IU/L; no dilution necessary
  • Patient-friendly sample size
  • Whole blood, serum or plasma samples
  • More efficient for central lab; short time to result for near patient testing

Assay Information

Blood level β-hCG increases during pregnancy, rising rapidly until week 20 when it levels off. After delivery, miscarriage or pregnancy termination, β-hCG levels drop after delivery, miscarriage of pregnancy termination, with a half-life of 24 to 36 hours. Abnormal β-hCG levels are associated with ectopic pregnancy or fetal abnormalities.1,2 Outside of pregnancy, elevated β-hCG are associated with tumors.2

The Pylon β-hCG assay protocol includes two sequences for each sample: one optimized for high concentration and the other for low-end detection. This avoids having to dilute the sample following an out-of-range assay run and to repeat the analysis, saving the cost and time associated with a rerun.

Overall dynamic range: 1 to 300,000 IU/L

References

1. Cole LA. Biological functions of hCG and hCG-related molecules. Reprod Biol Endocrinol. 2010;8:102. doi: 10.1186/1477-7827-8-102. 2. Stenman U, Tiitinen A, Alfthan H and Valmu L. The classification, functions and clinical use of different isoforms of HCG. Human Reproduction Update 2006;12(6):769–784. doi:10.1093/humupd/dml029

Pylon assays in development

To meet the needs of our customers, ET Healthcare currently has a number of immunoassays in development for a range of applications. For example, in preliminary studies, the Pylon hs-cTnI assay demonstrated performance comparable to centralized laboratory assays and is the first whole blood assay meeting hs-cTnI designation based on proposed criteria. Please fill out the Contact Form to receive updates on Pylon assays in development.