Micra

Prevalance

According to WHO, 1 in 10 patients get infection while receiving care globally[1]. Healhcare associated infection (HAI) is an infection occurring in a patient during the process of care in a hospital or other health care facility which was not present or incubating at the time of admission[2].

The burden of HAI is several fold higher in low- and middle-income countries than in high-income ones[2].

Globally, more than 50% of surgical site infections can be antibiotic resistant[1]. Surgical site infections are caused by bacteria that get in through incisions made during surgery[3]. In low- and middle-income countries, 11% of patients who undergo surgery are infected in the process[3].

Effective infection prevention and control reduces healthcare associated infections by at least 30% globally [1].

Molecular Basis of diagnosis of infectious diseases[4]

Molecular detection by amplification and hybridization of nucleic acids as a technology has opened a new and innovative era for microbial diagnosis. In all molecular detection techniques, the gene target is the main device, and its choice depends on the infectious agent and the host genomic and epidemiological characteristics. The use of nucleic acid detection for the diagnosis of infectious diseases in clinical laboratories is facilitated by PCR (Polymerase Chain Reaction), a technique based on amplification of nucleic acids and detection of pathogen specific nucleic acid or changes in nucleic acid using either sequencing, or restriction enzyme analysis, or hybridization, etc. This approach is useful to detect mutations associated to drug resistance directly on biological samples without the requirement of culturing organism.

Syndrome Evaluation System (SES)

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 technology involves isolation of the genetic material of the causative agent from wide range of specimen like blood, BAL, Pleural fluid, nasopharyngeal aspirates, Pericardial fluid, ascites fluid, Synovial fluids, biopsies, abscess swabs, corneal scrapings , aqueous and vitreous fluids and simultaneous amplification of the "Syndrome Specific Signature genes" of all the probable causative agents, followed by "Syndrome Specific Hybridization"

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. XCyton offers SES as Molecular Diagnostic Services for various critical illnesses in three verticals:

  • CNS Infections
  • Systemic Infections
  • Eye Infections

The SES Advantage

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 infectionst
Rules in or Rules out infections

Systemic Infections

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, example Sepsis etc.

Sepsis

Sepsis is a potentially life-threatening condition caused by the body's response to an infection. The body normally releases chemicals into the bloodstream to fight an infection. Sepsis occurs when the body's response to these chemicals is out of balance, triggering changes that can damage multiple organ systems. Sepsis is a major cause of morbidity and mortality and the second leading cause of death worldwide[8].

Post-Transplant Infections

The positive effects of the immunosuppressive agents, obligatory for the prevention of organ rejection, have been tempered by the negative effects of these same therapies, leading to various infections that range in both frequency and severity[9]. Despite refinements in diagnostic techniques and discovery of new anti-microbial drugs, the risk of infection amongst transplant recipients has not come down[10].

Pneumonia

Pneumonia is a bacterial, viral or fungal infection of the lungs. It can be a serious and life-threatening disease. Every year almost 200,000 children under five die of pneumonia in India. On a global level, pneumonia kills around 900,000 children in the world every year [11].

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..

SES Panels for Systemic Infections: it has six panles: i. SES-Sepsis, ii.SES- Febrile neutropenia/ post transplant/pneumonia, iii. SES-Transpalnt Viral Panel, iv. SES- Community acquired pneumonia, v. SES-Respiratory viral panel, vi. SES-Micobacteria

SES Sepsis

Microbe Type Microorganism
Gram Positive Bacteria Staphylococcus 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 CSF

SES Mycobacteria

Microbe Type Microorganism
Atypical Bacteria
Mycobacterium tuberculosis
Mycobacterium chelonae
Mycobacterium fortuitum
Mycobacterium spp
Sample Type : Whole CSF

SES- Febrile Neutropenia/ Post Transplant Pneumonia

Microbe Type Microorganism
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 CSF

SES Respiratory Viral Panel

Microbe Type Microorganism
DNA Viruses
Cytomegalovirus
Adenovirus
Gram Negative Bacteria
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 CSF

SES Post Transplant Viral Panel

Microbe Type Microorganism
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 CSF

SES Community Acquired Pneumonia

Microbe Type Microorganism
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
Fungi Pneumocystis 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 CSF
SES Antibiotic resistance markers
Rifampicin Resistance
IHN Resistance
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

Performance of SES Testing-Quality Considerations

The SES test scored exceptionally in International Proficiency Test conducted by Quality Control for Molecular Diagnostics (QCMD), an independent International External Quality Assessment (EQA) / Proficiency Testing (PT) organisation.

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

Sample Requirements:

SES Community Acquired Pneumonia

Test Sample Type Other 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 wash BAL/Tracheal aspirate
SES-Respiratory Viral Panel Naso pharyngeal wash BAL/Tracheal aspirate
SES-Mycobacteria Wound swab BAL, TISSUE or Any sterile body fluid
Acceptance Criteria of Sample
  • Freshly collected whole CSF samples
  • Samples volume greater than 1ml
  • Sample collected directly from LP needle into potassium EDTA vacutainer
Rejection Criteria of Sample
  • CSF samples stored for more than 24 hours
  • CSF samples that are spun down (cytospin) to remove WBC
  • Samples volume being less than 750 µl
  • 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 CSF directly into the vacutainer whose cap is opened, as LP is being performed. This helps to prevent contamination of sample and avoids transfer of sample.

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