Molecular Testing for Eye infections | Medgenome | MedGenome | MedGenome - Part 18001033691

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
  • Eye infections occur when harmful microorganisms — bacteria, fungi and viruses — invade any part of the eyeball or surrounding area. This includes the clear front surface of the eye (cornea) and the thin, moist membrane lining the eye ball and inner surface of eyelids (conjunctiva)

Common Disorders

Endophthalmitis

  • Endophthalmitis is an inflammatory condition of the intraocular cavities (i.e., the aqueous and/or vitreous humor), usually caused by infection. Postoperative endophthalmitis following cataract surgery is a dreaded complication. Fortunately, the incidence has declined in recent times after changes in surgical techniques, sterilization procedures, and better understanding of the risk factors. The global reported incidence of post cataract endophthalmitis ranges from 0.02% to 0.26%

Uveitis

  • Uveitis refers generally to a range of conditions that cause inflammation of the middle layer of the eye, the uvea, and surrounding tissues due to a viral or a bacterial infection. The average annual incidence of uveitis has been reported to be around 14-17 per 100,000. The total population prevalence of uveitis varies geographically and has been roughly estimated to be around 38 per 100,000 in France, 200 per 100,000 in the US, and 730 per 100,000 in India

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 eye infections 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-Traumatic/ Chronic/ Endogenous Endophthalmitis

 

SES-Pan Uveitis

SES-Uveitis

 

SES-Post Surgical Endophthalmitis

SES-Fuch’s

SES-Viral Retinitis

 

Brochures

SES for Eye Infections

FAQ

1. International Proficiency Testing- SES sensitivity

2. International Proficiency Testing- SES specificity

3. Validation for SES Viral Panel Pathogens

Aqueous Humor/ Vitreous Aspirate
Other Sample Types- Vitreous lavage/ or any other eye specimen
Volume 100 µL

Acceptance Criteria of Sample

  • Freshly collected Eye Fluid samples
  • Samples volume greater 100 μL
  • Sample collected only in 1ml insulin syringe

Rejection Criteria of Sample

  • Eye sample /other eye fluids stored for more than 24 hours
  • Sample collected in in-house sterilised vials
  • Blood sample collected from central line
  • Samples transferred/ aliquoted from tube to the other

Precaution during sampling

  • Sterilise the collection site to prevent skin / eye lashes contaminants getting into the sample
  • 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

Talk to our Genetic experts for free today or reach out to us

Our certified genetic specialists are available to discuss your queries

Test Menu

Genetic Counselling

Microsites

Collaterals

Contact Us