What is Syndrome Evaluation System?

A patented technology that comprises of rapid multiplex amplification and accurate identification of the virulence associated genes of the causative agents or organisms. This amazingly fast and accurate platform transcends all conventional diagnostic tests and helpful when organisms are difficult to cultivate or difficult to find. The technologies currently available for diagnosis of infections are grossly inadequate to detect early during the illness and to institute specific therapy in critical illnesses, resulting in loss of function or even loss of life. The amplification of the gene allows for higher sensitivity of the test and the re-naturation of the amplified signature gene to its chemically identified complementary gene sequence on the SES allows for higher specificity of the test. And the simultaneous detection of multiple pathogens allows for early diagnosis of the infection and initiation of therapy

Prevalence

  • According to WHO, 1 in 10 patients get infection while receiving care globally
  • The burden of HAI (healthcare associated infection) is several folds higher in low- and middle-income countries than in high-income ones
  • Globally, more than 50% of surgical site infections can be antibiotic resistant. In low-and middle-income countries, 11% of patients who undergo surgery are infected in the process
  • A systemic infection is being spread throughout the systems of the body as compared to local infections where the pathogen or symptoms are localized in one area. Systemic infections can also be as severe as local infections & life threatening

Common Disorders

Sepsis

  • Sepsis or blood poisoning is the leading cause of death in intensive care units. It affects over 26 million people worldwide each year. 258,000 people die from sepsis every year in the U.S. alone. It is the biggest contributor to healthcare associated cost. In India, 1 out of 4 patients admitted in ICU get sepsis, 50% of them die. As many of these patients receive antibiotics prior to getting admitted to the hospitals & ICUs, only in 15% of the patients the causative agents are identified by blood culture. Most of the patients are treated with multiple broad-spectrum antibiotics. 62% of sepsis patients need readmissions. 50% of sepsis survivors suffer from post sepsis syndrome. Early diagnosis and institution of appropriate antibiotics remarkably improves survival rates among patients. SES detects bacteria and fungi four times more than culture within a day while culture takes 3-4 days

Transplant Infections & Febrile Neutropenia

  • When patients with blood and other cancers are treated with chemotherapy their white blood cells get drastically reduced making these patients very vulnerable to many serious life-threatening infections. Mortality in Febrile Neutropenia ranges from 11-25%. Early diagnosis is key to successful management and conventional diagnostics detect nearly 17-20% of cases but are not adequately sensitive to rule out the infections to enable clinicians to reduce toxic antibiotics and antifungals (deescalate). In India there is a need for 200,000 kidney transplants, 50,000 liver transplants and 50,000 heart transplants per year. Currently India more than 20,000 transplants annually are carried out. In order to retain the transplanted organ and prevent rejection all these patients are kept on long term immunosuppression. This in turn leads to frequent episodes of life-threatening infections in these patients. Timely diagnosis and appropriate intervention are key to keep these patients safe and functional

Pneumonia

  • Pneumonia or Lung Infection is caused by a variety of viruses, bacteria and fungi. There are totally 50 million cases of pneumonia every year in India. Among children below the age group of 5, 2,50,000 children die due to severe pneumonia. Many cases of pneumonia lead to sepsis and 50% of all sepsis are caused by severe pneumonia. When a patients are placed on ventilators during management of sepsis hospital acquired Ventilator Associated Pneumonia (VAP) develops

Tuberculosis

  • Worldwide, TB is one of the top 10 causes of death, and the leading cause from a single infectious agent (above HIV / AIDS). According to a WHO report, India saw 2.7 million TB cases (incidence + relapse) in 2017. India accounted for 27% of global TB deaths. Globally, 3.5% of new TB cases and 18% of previously treated cases had multi-drug resistant/rifampicin resistant TB (MDR/RR-TB). India is one of the top 3 countries with the largest number of MDR/RR-TB cases that constitute 47% of global MDR/RR-TB cases

Why do you need the test?

Molecular detection by amplification and hybridization of nucleic acids as a technology has opened a new and innovative era for microbial diagnosis. The use of nucleic acid detection for the diagnosis of infectious diseases in clinical laboratories is facilitated by PCR (Polymerase Chain Reaction), This approach is useful to detect mutations associated to drug resistance directly on biological samples without the requirement of culturing organism.

When do you need to get tested?

The treating clinician can send the sample to understand the causative organism at the start of the therapy. Additionally, once the treatment has started, based on the test result, the clinician can decide on antibiotic de-escalation or understanding the drug resistance patterns in the difficult-to-treat infections.

Who needs to get tested?

  • A patient suffering from systemic infection where the treatment has to be started based on accurate diagnosis of the causative micro-organism
  • To further sharpen the empirical therapy, in case the treatment has already started. This is applicable for patients who are not responding to the empirical therapy- to add antibiotics for effective outcome and also for patients where the empirical therapy is working- to reduce the usage of antibiotics that are not required
  • Patients where the treatment is not working due to antibiotic resistance, antibiotic resistance markers can be analysed

Why MedGenome?

Syndrome Evaluation System, which is a patented technology of XCyton Diagnostics, poses unique benefits in terms of treatment of infectious diseases as below:

SES Advantage

RapidSample to report in 7 – 10 hours
Higher AccuracyDetects more number of cases than conventional methods ( 75% by SES vs 10-15% conventional method)
Cost effectivesAvoids multiple testing and unnecessary investigations and reduces ICU stay & associated cost.
Provides Direct evidence for the presence of infectionDetects DNA of pathogens
ComprehensiveDetects fungi, viruses, parasites and bacteria in a single test. It also detects uni-microbial or poly-microbial infections
Rules in or Rules out infections
Furthermore, SES panels cover almost all the organisms responsible for major CNS infections

SES Sepsis

Microbe TypeMicroorganism
Gram Positive BacteriaStaphylococcus aureus Streptococcus pneumoniae Streptococcus pyogenes Group B Streptococcus Enterococcus spp.
Gram Negative Bacteria
Klebsiella pneumoniae
Enterobacter aerogenes
Proteus mirabilis
Haemophilus influenzae
Neisseria meningitidis
Pseudomonas aeruginosa
Acinetobacter baumannii
Escherichia coli
Salmonella spp.
Bacteroides fragilis
Leptospira pathogenic spp
Fungi
Aspergillus spp.
Candida Spp.
Sample Type : whole Blood, BAL, Tissue Biopsy, Synovial Fluid, Peritoneal fluid etc

SES- Febrile Neutropenia/ Post Transplant Pneumonia

Microbe TypeMicroorganism
Gram Positive Bacteria
Staphylococcus aureus
Streptococcus pneumoniae
Streptococcus pyogenes
Group B Streptococcus
Enterococcus spp
Mycobacterium tuberculosis
Gram Negative Bacteria
Klebsiella pneumoniae
Enterobacter aerogenes
Proteus mirabilis
Haemophilus influenzae
Neisseria meningitidis
Pseudomonas aeruginosa
Acinetobacter baumannii
Escherichia coli
Salmonella spp.
Bacteroides fragilis
Leptospira pathogenic spp.
Fungi
Aspergillus spp.
Candida Spp.
Cryptococcus neoformans
DNA Viruses
Herpes Simplex Virus 1&2
Cytomegalovirus

Varicella Zoster Virus

Human Herpes Virus 6
Adeno Virus
John Cunningham Virus
BK Virus
Epstein Barr Virus
Sample Type : whole Blood, BAL, Tissue Biopsy, Synovial Fluid, Peritoneal fluid etc

SES Mycobacteria

Microbe TypeMicroorganism
Atypical Bacteria
Mycobacterium tuberculosis
Mycobacterium chelonae
Mycobacterium fortuitum
Mycobacterium spp
Sample Type : whole Blood, BAL, Tissue Biopsy, Synovial Fluid, Peritoneal fluid etc

SES Community Acquired Pneumonia

Microbe TypeMicroorganism
Gram Positive Bacteria
Staphylococcus aureus
Streptococcus pneumoniae
Gram Negative Bacteria
Klebsiella pneumoniae
Haemophilus influenzae
Pseudomonas aeruginosa
Acinetobacter baumannii
Salmonella spp.
Atypical Bacteria
Mycoplasma pneumonia
Chlamydia pneumonia
FungiPneumocystis jirovecii
DNA Viruses
Cytomegalovirus
Adenovirus
RNA Viruses
Influenza A, B,C
Parainfluenza 1,2,3,4
RSV A and B
Rhinoviruses
Enteroviruses
Coronaviruses OC43, 229E,
NL63, HKU1
Human-Metapneumoviruses
Parechoviruses
SARS
Sample Type : whole Blood, BAL, Tissue Biopsy, Synovial Fluid, Peritoneal fluid etc

SES Respiratory Viral Panel

Microbe TypeMicroorganism
DNA Viruses
Cytomegalovirus
Adenovirus
RNA Viruses
Influenza A, B,C
Parainfluenza 1,2,3,4
RSV A and B
Rhinoviruses
Enteroviruses
Coronaviruses OC43, 229E,
NL63, HKU1
Human-Metapneumoviruses
Parechoviruses
SARS
Sample Type : whole Blood, BAL, Tissue Biopsy, Synovial Fluid, Peritoneal fluid etc

SES Post Transplant Viral Panel

Microbe TypeMicroorganism
DNA Viruses
Herpes Simplex Virus 1&2
Cytomegalovirus
Varicella Zoster Virus
Human Herpes Virus 6
Adeno Virus
John Cunningham Virus
BK Virus
Epstein Barr Virus
Sample Type : whole Blood, BAL, Tissue Biopsy, Synovial Fluid, Peritoneal fluid etc
SES Antibiotic resistance markers
ESBL: Detects genes that confers resistance to Extended Spectrum Beta Lactams
Carbapenem: Detects both, Betalactamases and Metallo Betalactamases
NDM-1: Detects New Delhi Metallo Betalactamases
Van A: Detects resistance to Vancomycin and Teicoplanin
Van B: Detects resistance to Vancomycin (Teicoplanin Sensitive)
Methicillin: Detects resistance to Methicillin
SES Antibiotic resistance markers
Rifampicin Resistance
IHN Resistance

Brochures

SES for Systemic Infections

FAQ

1. International Proficiency Testing- SES sensitivity

2. International Proficiency Testing- SES specificity

3. Validation for SES Sepsis Panel

4. Validation for SES Viral Panel Pathogens

TestSample TypeOther Sample Type
SES Sepsis
WHOLE BLOOD
(PERIPHERAL BLOOD)
BAL, TISSUE or Any sterile body fluid
SES- FEBRILE
NEUTROPENIA/ POST
TRANSPLANT/PNEUMONIA
WHOLE BLOOD
(PERIPHERAL BLOOD)
BAL, TISSUE or Any sterile body fluid
SES- TRANSPLANT VIRAL
PANEL
WHOLE BLOOD
(PERIPHERAL BLOOD)
BAL, TISSUE or Any sterile body fluid
SES-COMMUNITY
ACQUIRED PNEUMONIA
Naso pharyngeal washBAL/Tracheal aspirate
SES-Respiratory Viral PanelNaso pharyngeal washBAL/Tracheal aspirate
SES-MycobacteriaWound swabBAL, TISSUE or Any sterile body fluid

Acceptance Criteria of Sample

  • Freshly collected whole CSF samples
  • Samples volume greater than 2ml
  • Sample collected only in potassium EDTA vacutainer

Rejection Criteria of Sample

  • Blood samples/ other body fluids stored for more than 24 hours
  • Heparinised blood sample or other body fluid
  • Blood sample collected from central line
  • Sample collected in in-house sterilized injection vials/Falcon tubes/ test tubes or wide mouth Containers

Precaution during sampling

  • Sterilise the collection site to prevent skin contaminants getting into the sample
  • Collect sample directly into the vacutainer
  • Analytical sensitivity for viruses is 50 to 250 virions/ml. HSV is detected at 50 virions and CMV is detected at 250 virions. The Sensitivity for bacteria detection is 50-200 cfu / ml
  • At laboratory testing Level. We participate in International External Quality Assessment Program by a European Union Notified body called QCMD and our sensitivity for all organisms is 100% except for HHV-6 (90%)
  • Clinical Sensitivity: We detect 54 to 72% of cases as can be seen in our publications. These patients were treated for more than 3 days before the sample was sent to us
  • At the analytical Specificity Level: We have no interference of one organism with the other when blood is spiked with multiple organisms. Because we identify the amplified product by sequence specific hybridization specificity of the technology is robust
  • At Laboratory Level: QCMD testing we never identified even a single negative sample as positive and is 100% specific
  • Clinical Specificity: In our study with NIMHANS – wherever we got positives and other methods did not detect the pathogen, we confirmed by sequencing of the amplified products
  • At the lab level XCyton has done about 80,000 tests in house before testing human samples. NIMHANS validated the neuro-infection panels. While sepsis panels were validated in a Randomized Controlled Trial(RCT) at JIPMER, Pondicherry. It was compared with culture in adult patients at Fortis Hospital Noida and Fortis Hospital Bangalore on Leukemia patients with Febrile neutropenia
  • There are 26 National International publications on the clinical use of SES. 18 of them were from clinicians who independently published their results
  • In acute illnesses such as Sepsis, Febrile Neutropenia, Pneumonia, Meningitis and encephalitis body fluids contain live bacteria, bacteria damaged by human immune system, bacteria damaged by antibiotics and dead bacteria. There is a dynamic equilibrium among all these forms. Only live thriving bacteria will be detected by culture. Other forms are not. As a result, the detection rate by SES is several folds higher than culture
  • With your clinical judgment, you save about 52% of sepsis cases. That result matches the best of the West. However, culture detects about 15% of ICU cases while SES can detect 55% to 75% of cases. When you know the pathogen early you can save significant portion of 48% of the cases, currently being lost

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