Molecular Diagnosis Of Ocular Infection/Eye Infection Test

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)

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

SES Advantage

Rules in or Rules out infections
Rapid	Sample to report in 7 – 10 hours
Higher Accuracy	Detects more number of cases than conventional methods ( 75% by SES vs 10-15% conventional method)
Cost effectives	Avoids multiple testing and unnecessary investigations and reduces ICU stay & associated cost.
Provides Direct evidence for the presence of infection	Detects DNA of pathogens
Comprehensive	Detects fungi, viruses, parasites and bacteria in a single test. It also detects uni-microbial or poly-microbial infections

Brochures

SES for Eye Infections

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FAQ

How do these tests score on accuracy?

1. International Proficiency Testing- SES sensitivity

2. International Proficiency Testing- SES specificity

3. Validation for SES Viral Panel Pathogens

SES Pan

What sample types are required?

Aqueous Humor/ Vitreous Aspirate

Other Sample Types- Vitreous lavage/ or any other eye specimen

Volume 100 µL

What are the acceptance and rejection criteria of samples?

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

What are the validation results?

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

Will it detect dead bacteria?

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

How can SES help when empirical antibiotic therapy is capable of treating infection cases?

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