Cylex immune cell function Results

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Cylex ImmuKnow Cell Function Assay

Pubmed.ncbi.nlm.nih.gov   DA: 23 PA: 10 MOZ Rank: 33

  • The ImmuKnow Immune Cell Function Assay (Cylex, Inc., Columbia, MD, USA) has been developed to measure the activity of CD4+ T cells as a marker of global immune-competence
  • The changes in T cell activation were correlated with the relative risk of rejection and infection.

Immune Cell Function Assays In The Diagnosis Of Infection

Pubmed.ncbi.nlm.nih.gov   DA: 23 PA: 10 MOZ Rank: 34

  • We conducted this study to evaluate Cylex immune cell function assay in diagnosis of infection and its potential clinical application in Chinese infant PLTs
  • Methods: In this prospective cohort study, 227 infant PLTs from two medical centers were enrolled, and 216 completed the study
  • Cylex ATP values were measured before and after liver

Transplant Immune Cell Function Assays

Aetna.com   DA: 13 PA: 35 MOZ Rank: 50

Aetna considers the ImmuKnow Assay, also known as the Transplantation Immune Cell Function Assay (Cylex, Inc., Columbia, MD) medically necessary to adjudicate over-immunosuppression in subpopulations of transplant recipients with co-morbid infection or cancer.

Title: Immune Cell Function Assay

Bcbsm.com   DA: 13 PA: 50 MOZ Rank: 66

  • In April 2002, Immune Cell Function Assay (Cylex) was cleared for marketing by the FDA through the 510(k) process
  • The FDA indicated use of the Immune Cell Function Assay is for the detection of a cell-mediated immune response in an immunosuppressed population

Immune Cell Function Assay

Fepblue.org   DA: 15 PA: 50 MOZ Rank: 69

  • In April 2002, Immune Cell Function Assay (Cylex) was cleared for marketing by the FDA through the 510(k) process
  • The FDA-indicated use of the Immune Cell Function Assay is for the detection of a cell-mediated immune response in an immunosuppressed population.

OT 821 Columbia, MD 21045 OT1821 Trade Name: Immune …

Accessdata.fda.gov   DA: 22 PA: 28 MOZ Rank: 55

  • Cylex Inc. Immune Cell Function Assay (4 1 indicator of immune cell function. This measurement is made on heparin anti-coagulated wholeblood using a luminomneter and luciferin/luciferase

Medical Coverage Policy Immune Cell Function

Bcbsri.com   DA: 14 PA: 50 MOZ Rank: 70

  • In April 2002, Immune Cell Function Assay (Cylex) was cleared for marketing by FDA through the 510(k) process
  • The FDA-indicated use of the Immune Cell Function Assay is for the detection of cell-mediated immune response in an immunosuppressed population

Cylex, Inc. Patented ImmuKnow(R) Immune Cell Function

Biospace.com   DA: 16 PA: 50 MOZ Rank: 73

ImmuKnow is the immune cell function assay cleared by the FDA to detect cell-mediated immunity (CMI) in adult patient populations undergoing immunosuppressive therapy for organ transplantation by measuring the concentration of adenosine triphosphate (ATP) released from CD4 cells following cell stimulation.

Assessment Of The Immune Reconstitution By Cylex Immuknow

Ashpublications.org   DA: 19 PA: 50 MOZ Rank: 77

  • Immune function was analyzed by Cylex Immuknow™ assay, an FDA approved immune cell function test for the assessment of cell-mediated immunity
  • ATP activity from magnetically separated and lysed CD4 lymphocytes is measured by light intensity, thereby reflecting the current immune function of the patient.

LAB.00024 Immune Cell Function Assay

Anthem.com   DA: 14 PA: 50 MOZ Rank: 73

Immune cell function assays have been developed for use in the detection of changes in cell mediated immunity (CMI) in individuals undergoing immunosuppressive therapy following solid organ transplant and individuals undergoing treatment for a variety of other conditions such as chronic urticaria, Lyme disease, autologous and allogeneic hematopoietic stem-cell transplant recipients, …

176120: ImmuKnow® Labcorp

Labcorp.com   DA: 15 PA: 22 MOZ Rank: 47

  • This test is a transplant physician's means of obtaining and monitoring information about immune status
  • ImmuKnow® measures the adenosine triphosphate (ATP) …

0773 Transplant Immune Cell Function Assays (1)

Aetnabetterhealth.com   DA: 25 PA: 50 MOZ Rank: 86

  • for marketing the Cylex Immune Cell Function Assay (Cylex Inc., Columbia, MD) for the detection of cell mediated immune response in populations undergoing immunosuppressive therapy for organ transplant
  • According to the 510(k) application submitted by the manufacturer to the FDA, the test detects cell-mediated immunity in whole blood

Lymphocyte ATP Immune Cell Function Assay In Pediatric

Ncbi.nlm.nih.gov   DA: 20 PA: 16 MOZ Rank: 48

  • Cylex from children with an infection or acute rejection were compared to those from stable patients
  • All children received induction with basiliximab or thymoglobulin followed by a standard regimen with tacrolimus, steroids, and mycophenolate mofetil
  • Fifty-nine Cylex results were obtained in 44 pediatric renal transplant recipients.

Immune Cell Function Assay OHSU

Ohsu.edu   DA: 12 PA: 40 MOZ Rank: 65

Immuknow, Cellular Function Assay, Cylex Immune Assay, Immuno Test, Immunosuppression Level Assay OHSU flame logo in white Oregon Health & Science University is dedicated to improving the health and quality of life for all Oregonians through excellence, innovation and leadership in health care, education and research.

FEP Medical Policy Manual

Fepblue.org   DA: 15 PA: 50 MOZ Rank: 79

  • In April 2002, Immune Cell Function Assay (Cylex) was cleared for marketing by the FDA through the 510(k) process
  • The FDAindicated use of the Immune Cell Function Assay is for the detection of a cell-mediated immune response in an immunosuppressedpopulation
  • In 2010, a device modification for this assay was cleared for marketing by FDA through the 510(k) (K101911)
  • There wereno changes to the …

Cylex Receives FDA Clearance For Immune Function Assay

Medscape.com   DA: 16 PA: 19 MOZ Rank: 50

The Cylex immune cell function assay was designed for the clinical market and improves upon currently available research methods because it …

Clinical Policy Bulletin: ImmuKnow (Transplantation Immune

Aetnabetterhealth.com   DA: 25 PA: 50 MOZ Rank: 91

Aetna considers the ImmuKnow Assay, also known as the Transplantation Immune Cell Function Assay (Cylex, Inc., Columbia, MD), experimental and investigational for all indications including any of the following because of insufficient evidence of its effectiveness:

Monitoring Immune Function By The Cylex Immuknow Assay In

Ashpublications.org   DA: 19 PA: 50 MOZ Rank: 86

A observational analysis of immune function in six pediatric HSCT patients (3 allogeneic/3 autologous) ranging in age from 3 to 16 years (median = 8.6) was conducted at Children’s Hospital; Louisiana State University Health Sciences Center using ImmuKnow®, an FDA cleared assay for assessing T cell activation.

(PDF) Immune Cell Function Testing: An Adjunct To

Academia.edu   DA: 16 PA: 50 MOZ Rank: 84

  • Cylex TM immune cell function assayWhole blood (100 lL of a 1:4 dilution) was tested in quadruplicate with or without PHA (2.5 lg/mL) overnight (15-18 h in a 5% CO 2 incubator at 37°C)
  • Anti-human CD4 monoclonal antibody coated magnetic particles (Dynal, Oslo, Norway) were added to immunoselected CD4 cells from both the stimulated and non

POLICIES AND PROCEDURE MANUAL

Geisinger.org   DA: 17 PA: 50 MOZ Rank: 86

  • Rossano JW, Denfield SW, Kim JJ et al
  • Assessment of Cylex ImmuKnow Cell Function Assay in Pediatric Heart Transplantation Patients
  • J Heart & Lung Transplantation 2009:28(1)
  • Husain S, Raza K, Pilewski JM et al
  • Experience with Immune Monitoring in Lung Transplant Recipients: Correlation of Low Immune Function with Infection.

Lowered Immune Cell Function In Liver Recipients Recovered

Ncbi.nlm.nih.gov   DA: 20 PA: 25 MOZ Rank: 65

  • The immune status measured by ImmuKnow will be reported as numerical value and divided into 3 levels
  • If the ATP level is below 225 ng/mL, the immune cell response will be considered as “low.” If the ATP level is between 226 and 524 ng/mL, it will be considered as “moderate” immune cell

Last Review Status/Date

Media.fepblue.org   DA: 17 PA: 50 MOZ Rank: 88

  • Cylex Immune Cell Function Assay is for the detection of cell-mediated immunity in an immunosuppressed population
  • A subsequent 510(k) marketing clearance for a device modification was issued by the FDA for this assay in 2010
  • There were no changes to the indications or intended use
  • (1) Related Policies None Policy

Assessment Of The Cylex ImmuKnow Cell Function Assay In

Jhu.pure.elsevier.com   DA: 21 PA: 50 MOZ Rank: 93

  • Background: The Cylex ImmuKnow (Cylex, Columbia, MD) cell function assay (CICFA) is a commercially available test of immune response that purportedly identifies solid organ transplant patients at risk for either acute rejection (AR) or infection
  • Data on the utility of this test in pediatric heart transplant patients are very limited.

The Role Of ImmuKnow® In The Management Of

Clinicaltrials.gov   DA: 18 PA: 21 MOZ Rank: 62

  • ImmuKnow (Cylex Inc, Columbia, MD) is an FDA-cleared assay for the detection of cell mediated immune response in populations undergoing immunosuppressive therapy for organ transplant
  • There have been limited retrospective studies discussing the effectiveness of the ImmuKnow assay.

Cylex(TM) Awarded New CPT Code For Its ImmuKnow(R) Assay

Prnewswire.com   DA: 18 PA: 50 MOZ Rank: 92

Cylex is the commercial global life sciences company leading the development and manufacture of in vitro diagnostic assays that measure cellular immune function.

EFFECTIVE DATE: 100 120 5 POLICY LAST UPDATED:12 06

Bcbsri.com   DA: 14 PA: 50 MOZ Rank: 89

  • Rossano JW, Denfield SW, Kim JJ, et al
  • Assessment of the Cylex ImmuKnow cell function assay in pediatric heart transplant patients
  • Wong MS, Boucek R, Kemna M, et al
  • Immune cell function assay in pediatric heart transplant recipients

Cylex, Inc. Release: An Independent Study Reports On The

Biospace.com   DA: 16 PA: 50 MOZ Rank: 92

  • Release: An Independent Study Reports on the Utility of ImmuKnow(R), the Cylex(TM) Immune Cell Function Assay, for Monitoring Heart Transplant Recipients Published: Apr 24, 2009 The results of the largest study performed to date will be presented during the International Society for Heart and Lung Transplantation Annual Meeting in

Assessment Of CD4 T-lymphocyte Reactivity By The Cylex

Nature.com   DA: 14 PA: 21 MOZ Rank: 62

The Cylex ImmuKnow assay, a laboratory test approved by the FDA in 2002, determines the cellular immune function in immunosuppressed patients by …

EFFECTIVE DATE: 10 POLICY LAST UPDATED: 08

Www2.bcbsri.com   DA: 15 PA: 50 MOZ Rank: 93

  • In April 2002, Immune Cell Function Assay (Cylex) was cleared for marketing by FDA through the 510(k) process
  • The FDA-indicated use of the Immune Cell Function Assay is for the detection of cell-mediated immune response in an immunosuppressed population

Cylex ImmuKnow Assay Levels Are Lower In Lung Transplant

Scholars.northwestern.edu   DA: 29 PA: 50 MOZ Rank: 21

  • Recently, the Cylex Immune Cell Function Assay (ImmuKnow; Cylex, Inc., Columbia, MD) was approved by the U.S
  • Food and Drug Administration (FDA) to measure global immune response in solid-organ transplant patients receiving immunosuppressive therapy.

Noninvasive Methods To Assess The Risk Of Kidney

Medscape.com   DA: 16 PA: 21 MOZ Rank: 67

  • By contrast, clinically stable patients had moderate immune responses, with a mean level of 280 ng/ml
  • Intriguingly, in a small cohort of 13 kidney transplant recipients, Cylex was found to have a

Significance Of Immune Cell Function Monitoring In Renal

Semanticscholar.org   DA: 23 PA: 50 MOZ Rank: 19

  • Monitoring of immune status in transplant recipients is essential for predicting the risk of rejection or infection
  • In this study, we assessed the significance of immune cell function in 76 renal allograft recipients after Thymoglobulin induction and initiation of maintenance immunosuppression
  • Using the Immuknow (Cylex Inc) assay, the amount of adenosine triphosphate (ATP) produced by CD4

(PDF) Immune Function Assay Enters The Clinical Laboratory

Academia.edu   DA: 16 PA: 50 MOZ Rank: 98

  • Sebastian A, Sigle G, Nour, et al
  • Management of immunosuppression in hepatitis C patients using the Cylex® immune cell function assay
  • 19th Annual Clinical Virology Symposium, Clearwater, FL; 2003

Immune Monitoring As A Novel Marker In Conjunction With BK

Oatext.com   DA: 14 PA: 19 MOZ Rank: 66

  • is measurement of cell-mediated immune response using a previously validated T cell function assay ((ImmuKnowTM; Cylex Inc
  • Columbia, MD), which measures immune cell function based on the amount of adenosine triphosphate (ATP) released when CD4+ T cells are stimulated by phytohemagglutinin
  • It has been previously validated in

SPECIAL 510(k): Device Modification ODE Review …

Accessdata.fda.gov   DA: 22 PA: 30 MOZ Rank: 86

  • Cylex ImmuKnow Immune Cell function assay K013169
  • Submitter’s statement that the INDICATION/INTENDED USE of the modified device as described in its labeling HAS NOT CHANGED along with the proposed labeling which includes instructions for use, package labeling, and, if available, advertisements or promotional materials (labeling changes

Can Immune Cell Function Assay Identify Patients At Risk

Scholars.duke.edu   DA: 17 PA: 19 MOZ Rank: 71

  • Can immune cell function assay identify patients at risk of infection or rejection? A meta-analysis
  • Journal Article (Journal Article) BACKGROUND: The Cylex ImmuKnow cell function assay (CICFA) is being considered as a possible tool for identification of infection and rejection in transplant recipients
  • However, the predictive capability of

Dr. Veeraish Chauhan, MD Lakewood Ranch, FL

Health.usnews.com   DA: 17 PA: 32 MOZ Rank: 85

  • The Cylex Inc Immune Cell Function Assay (Immuknow Assay) is a Good Predictor of BK Nephropathy When Used in Conjunction with BK Viremia
  • Arora S, Chauhan V, Malat G, Ranganna K.

Lack Of Clinical Association And Effect Of Peripheral WBC

Europepmc.org   DA: 13 PA: 21 MOZ Rank: 71

  • CD4 T-cell function assay using Cylex ImmuKnow and lymphocyte subset recovery following allogeneic hematopoietic stem cell transplantation
  • Jo Y, Lim J, Kim Y, Han K, Min WS, Oh EJ
  • Transpl Immunol, 33(2):78-83, 14 Sep 2015 Cited by: 3 articles | PMID: 26381574

Reimbursement Rate Nearly Tripled For Cylex's ImmuKnow® Assay

Prnewswire.com   DA: 18 PA: 50 MOZ Rank: 12

Cylex is the commercial, global life sciences company leading the development and manufacture of in vitro diagnostic assays that measure cellular immune function

Transplant Program Uses Assay To Monitor Cell-mediated

News.psu.edu   DA: 12 PA: 50 MOZ Rank: 11

  • The ImmuKnow cell function test measures cell-mediated immunity (CMI) by assaying the concentration of adenosine triphosphate (ATP) from CD4 cells following stimulation
  • The assay is intended for use in the detection of CMI in an immunosuppressed population.

No Scientific Method In Naming New Drugs

Bizjournals.com   DA: 19 PA: 42 MOZ Rank: 10

  • As a name, the Cylex Immune Cell Function Assay is clinical, a little stiff -- the marketing equivalent of a starched, white laboratory coat
  • ImmuKnow, on the other hand, is evocative, flashy -- a

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