Syndromic Infections in Intensive Care present
a diagnostic challenge!

Suburban Diagnostics offers a wide range of syndromic molecular diagnostic panels for early and confirmatory diagnosis of syndromic infection in ICU, ICCU, NICU and PICU with an intensive limit of deduction.

Suburban Diagnostics introduces:

Syndromic Biointense – MRF plus

  • BIOINTENSE MENINGITIS
  • BIOINTENSE RESPIRATORY
  • BIOINTENSE FUNGAL

    Plus

  • BIOINTENSE SEPTICEMIA
Syndromic BioIntense
MENINGITIS real-time PCR
For early and confirmatory diagnosis of viral, bacterial and fungal pathogens
  • Infection can be caused by viral (69%), bacterial (20%) and fungal (1%) pathogens
  • Failure to identify an etiological agent may be related to referral test bias due to performed only in case of thereby emphasizing a need to syndromic testing

Choose real-time PCR over conventional methods

  • Early and confirmatory diagnosis
  • Early initiation of appropriate therapy

Pathogens Tested

Syndromic biointense meningitis real-time PCR assay detects 17 pathogens.

Virus Bacteria Fungal
Enterovirus Neisseria meningitidis Cryptococcus neoformans/gattii
HSV-1/2 Streptococcus pneumoniae
VZV Haemophilus influenzae
EBV Mycoplasma pneumoniae
CMV Chlamydia pneumoniae
HHV-6/7/8 Leigionella pneumoniae

Limit of Detection (LoD): 10 copies/ µL for all pathogens

Syndromic BioIntense
RESPIRATORY real-time PCR
For early and confirmatory diagnosis of lower and upper respiratory tract infection
  • In Mumbai and Pune, approximately 25-30% of pneumonias are caused by Respiratory Syncytial Virus (RSV) and 15% are due to Influenza-viruses
  • Bacterial etiologies like Streptococcus pneumoniae represent 36% of respiratory infections

Choose real-time PCR over conventional methods

  • Early and confirmatory diagnosis
  • Early initiation of appropriate therapy

Pathogens Tested

Syndromic biointense meningitis real-time PCR assay detects 17 pathogens.

Virus Bacteria
Influenza A and B Streptococcus pneumoniae
RSV A and B Haemophilus influenzae
Para-influenza 1, 2, 3, 4 Mycoplasma pneumoniae
Chlamydia pneumoniae
Leigionella pneumoniae

Limit of Detection (LoD): 10 copies/ µL for all pathogens

Syndromic BioIntense
FUNGAL REAL TIME PCR
Early and confirmatory diagnosis of fungal infection
  • More than 90% of all invasive fungal infections are caused by aspergillus and candida species
  • Early detection of the fungal pathogen is crucial for appropriate antifungal therapy, for better clinical outcomes

Choose real-time PCR over conventional methods

  • Early and confirmatory diagnosis
  • Early initiation of antifungal therapy
  • Detection of highly predominant pathogens at the most clinically relevant body sites

Pathogens Tested

Syndromic BioIntense Fungal real-time PCR detects 12 pathogens.

Candida Species Aspergilus Species Others
Candida albicans Aspergillus fumigatus Cryptococcus neoformans/ gattii
Candida glabrata Aspergillus niger Pneumocystis jirovecii
Candida parapsilosis Aspergillus flavus
Candida tropicalis Aspergillus nidulans
Candida krusei

Limit of Detection (LoD): 10 copies/ µL for all pathogens and 100 copies/ µL for P. jirovecii

Syndromic BioIntense
SEPTICEMIA REAL TIME PCR

If you suspect Sepsis,

Syndromic BioIntense Septicemia real-time PCR

Syndromic BioIntense Septicemia

real-time PCR detects 41 pathogens

Gram Positive Gram Negative Fungi
Corynebacterium amycolatum Acinetobacter baumannii Candida albicans
Enterobacter casseliflavus Brucella spp Candida glabrata
Enterococcus faecalis Burkholderia cepacia Candida parapsilosis
Enterococcus faecium Citrobacter koseri Candida tropicalis
Micrococcus letus Enterobacter aerogenes Candida krusei
Staphylococcus aureus Enterobacter hormaechei Aspergillus fumigatus
Staphylococcus capitis Escherichia coli Aspergillus niger
Staphylococcus cohnii Klebsiella pneumoniae Aspergillus flavus
Staphylococcus epidermidis Morganella morganii Aspergillus nidulans
Staphylococcus haemolyticus Proteus mirabilis  
Staphylococcus hominis Proteus vulgaris  
Streptococcus agalactiae Pseudomonas aeruginosa  
Streptococcus mitis Pseudomonas stutzeri  
Streptococcus pneumoniae Salmonella paratyphi A  
  Salmonella typhi  
  Serretia marcesens  
  Shigella sonnei  
  Stenotrophomonas maltophilia  

Unique methodological approach provides increased sensitivity and results in 8 hours

Blood culture may take 24 to 48 hours to turn positive resulting in diagnostic and treatment delays.

real-time PCR offers rapid and confirmatory diagnosis

EBV DNA QNAT

Therapeutic monitoring of PTLD

The incidence of Post-Transplant Lymphoproliferative Disorder (PTLD) ranges from 1% for renal transplant recipients, to as high as 9% for heart/lung transplant recipients, and 12% for pancreas transplant recipients

Clinical Utility
  • Therapeutic monitoring of EBV-associated PTLD
  • Predict risk of relapse

Currently, there are no recommendations for ideal specimen to test. Hence, it would be prefered to monitor patients with the same specimen type (EDTA Whole Blood/ EDTA Plasma)

Limit of Detection (LoD): 68 copies/mL
Quantification Range: 68 -1×106 copies/mL
CMV DNA DETECTION REAL TIME PCR

Differential testing strategy for patients below and above 12 months of age

Clinical Utility
  • Diagnose congenital infections
  • Screen organ donor and recipient for presence of CMV DNA prior to transplantation
  • Screen immunocompromised patient for presence of CMV infection
Recommended specimen
Patients <12 months of age Patients >12 months of age
Urine EDTA plasma
EDTA whole blood
Each of these patient age groups are tested with different specimen types for diagnosing CMV infections with high specificity
Limit of Detection (LoD): 10 copies/ µL
CMV DNA QNAT

Adopting International Standards for reporting

As per international consensus guidelines*
  • QNAT preferred method for monitoring response to therapy
  • CMV viral load reported in IU/mL
  • All samples should be reported in 24 to 48 hours
Clinical Utility
  • Assess the presence of active CMV disease in a symptomatic patient
  • Predict the risk of active disease in an asymptomatic patient
  • Optimize therapeutic regimen
  • Predicts the relapse of infection
Recommended specimen: EDTA plasma
EDTA Plasma EDTA Whole Blood
Indicates active infection Not preferred for monitoring because latent DNA persists in intracellular fraction of the blood
Limit of Detection (LoD): 99 IU/mL
Quantification Range: 99 – 1×106 IU/mL

*Kotton CN, et al: Transplantation. 2013,91(4):1-28

STI SCREENING BY REAL TIME PCR

Advances in sample collection & screening for Sexually Transmitted Infections (STI)

  • Globally, more than 200 million new cases of STI (Chlamydia and Gonorrhea alone) occur every year
  • In India, 30-35 million episodes of STI are reported every year
The most common STIs (excluding HIV) are:
  • Gonorrhea
  • Chlamydia
  • Syphilis
  • Mycoplasma
  • Trichomoniasis
  • Genital herpes
Choose real-time PCR over conventional methods
  • Early detection of asymptomatic STI
  • Opportunity to take steps to minimize risks for the newborn (in case of pregnant women)
  • Indicative to refrain from unsafe sexual practices
  • Avoid sexual relationships to halt further disease transmission
Pathogens Tested

STI real-time PCR assay detects 7 pathogens.

Bacteria Virus Mycoplasma
Neisseria gonorrhea HSV-1 Mycoplasma genitilum
Chlamydia trachomatosis HSV-2
Treponema pallidum
Trichomonas vaginalis
Swab collected in WHO recommended Universal Transport Medium, provides increased bacterial recovery by 74% even after 12hrs
Limit of Detection (LoD): 10 copies/ µL for all pathogens
Guidelines*
Patient Category Chlamydia Gonorrhoea Syphilis Trichomonas
Women Less than 25 yrs. Re-test after 3 months of treatment Less than 25 yrs. Re-test after 3 months of treatment Women with multiple sex partners, a history of STD
Pregnant Women Less than 25 yrs. Test of cure 3-4 weeks after treatment and be re-tested within 3 months Less than 25 yrs. Re-test after 3 months of treatment First trimester. Re-test in third trimester. At delivery if at high risk.
Men Who have Sex – with Men (MSM) Every 3-6 months Every 3-6 months Every 3-6 months
Persons with HIV Screen at first HIV evaluation and then annually Screen at first HIV evaluation and then annually Screen at first HIV evaluation and then annually Screen at first HIV evaluation and then annually

*Ref: 2015 Sexually Transmitted Diseases Treatment Guidelines. CDC.

Clostridium difficile Infection (CDI)
REAL TIME PCR

Advances in diagnostic algorithm

  • The recent increase in incidence and severity is due to the emergence of the hypervirulent strain and antibiotic resistant strain, NAP1/BI/ribotype027
  • It is frequently caused by exposure to antibiotics and usually associated with nosocomial infection
  • CDI also occur in a community settings (~31%) without exposure to antibiotics
Clinical Utility
  • Early and confirmatory diagnosis
  • Support timely clinical management
  • Minimize progression to serious illness
  • Interrupt transmission in hospital/ community
Choose real-time PCR over conventional methods
Assay type Limitations
Culture or cytotoxicity assays Long TAT, labor – intensive, delay in diagnosis and treatment
Toxin A/B detection immuno assays Low sensitivity
real-time PCR LoD – 10 copies/ μL, rapid TAT

Guidelines**
  1. Only stools from patients with diarrhea should be tested for Clostridum difficile
  2. Nucleic acid amplification tests (NAAT) for C. difficile toxin genes such as PCR are superior to toxins A+B EIA testing as a standard diagnostic test for CDI
  3. Glutamate dhydrogenase (GDH) screening tests for C. difficile can be used in two or three step screening algorithms with subsequent toxin A and B EIA testing, but the sensitivity of such strategies is lower than NAATs
  4. Repeat testing should be discouraged
  5. Testing for cure should be not be done

**Am Gastroenterol 2013; 108:478-498; doi: 10.1038/ajg 2013,4

MENINGITIS REAL TIME PCR
Test Name Specimen Type
HSV-1/2 DNA Detection real-time PCR 1 mL CSF
HSV-1/2 DNA Detection real-time PCR 1 mL EDTA Plasma
VZV DNA Detection real-time PCR 1 mL CSF
VZV DNA Detection real-time PCR 1 mL EDTA Plasma
HSV-1/2 + VZV DNA Detection real-time PCR 1 mL EDTA Plasma
VZV DNA Detection real-time PCR 1 mL Vitreous/ eye fluid
VZV DNA Detection real-time PCR NA Vitreous swab in Viral Transport Medium (VTM)
EBV DNA Detection real-time PCR 1 mL CSF
EBV DNA Detection real-time PCR 1 mL CSF
HHV-6 DNA Detection real-time PCR 1 mL CSF
HHV-7 DNA Detection real-time PCR 1 mL CSF
HHV-8 DNA Detection real-time PCR 1 mL CSF
Enterovirus RNA Detection real-time RT-PCR 1 mL CSF
Panherpes DNA Detection real-time PCR 1 mL CSF
Viral Encephalitis Panel (Panherpes and Enterovirus RNA Detection real-time PCR) 2 mL CSF
Bacterial Meningitis Panel (Neisseria meningitidis, Haemophilus influenzae and Streptococcus pneumoniae DNA Detection real-time PCR) 1 mL CSF
Syndromic BioIntense Meninigitis real-time PCR (Panherpes, Enterovirus, Neisseria meningitidis, Haemophilus influenzae and Streptococcus pneumoniae) 2 mL CSF

Specimen transport condition: 2-8 °C

Cut-off: Daily 11 am; 4 pm

TAT: Same day 7 pm; Next day 12 noon

RESPIRATORY REAL TIME PCR
Test Name Specimen Type
Influenza A/B RNA Detection real-time RT-PCR RespiratoryNANasal + Throat swab in Viral Transport Medium (VTM)
Influenza A/B RNA Detection real-time RT-PCR Respiratory1 mLBAL/ ET/Tracheal secretion/ Pleural fluid
Influenza A/B and RSV A/B RNA Detection real-time RT-PCR NA Nasal + Throat swab in Viral Transport Medium (VTM)
Influenza A/B and RSV A/B RNA Detection real-time RT-PCR 1 mL BAL/ ET/Tracheal secretion/ Pleural fluid
Para-Influenza-1/2/3/4 RNA Detection real-time RT-PCR NA Nasal +Throat swab in Viral Transport Medium (VTM)
1 Para-Influenza-1/2/3/4 RNA Detection real-time RT-PCR 1 mL BAL/ PCR ET/Tracheal secretion/ Pleural fluid
Respiratory Viral Panel (Influenza A/B, RSV A/B RNA and para-influenza-1/2/3/4 RNA Detection real-time RT-PCR) NA Nasal + Throat swab in Viral Transport Medium (VTM)
Respiratory Viral Panel (Influenza A/B, RSV A/B RNA and para-influenza-1/2/3/4 RNA Detection real-time RT-PCR) 1 mL BAL
Streptococcus pneumoniae, Haemophilus influenzae DNA Detection real-time PCR 1 mL BAL
Streptococcus pneumoniae, Haemophilus influenzae DNA Detection real-time PCR 1 mL ET/Tracheal secretion/ Pleural fluid
Mycoplasma pneumoniae, Chlamydia pneumoniae,Legionella pneumoniae DNA Detection real-time PCR 1 mL BAL
Mycoplasma pneumoniae, Chlamydia pneumoniae, Legionella pneumoniae DNA Detection real-time PCR 1 mL ET/Tracheal secretion/ Pleural fluid
Respiratory Bacterial Panel (Streptococcus pneumoniae, Haemophilus influenzae, Mycoplasma pneumoniae, Chlamydia pneumoniae and Legionella pneumoniae DNA Detection real-time PCR) 1 mL BAL
Respiratory Bacterial Panel (Streptococcus pneumoniae, Haemophilus influenzae, Mycoplasma pneumoniae, Chlamydia pneumoniae and Legionella pneumoniae DNA Detection real-time PCR) 1 mL ET/Tracheal secretion/ Pleural fluid
Syndromic BioIntense Respiratory real-time PCR (Influenza A/B, RSV A/B, para-influenza-1/2/3/4, Streptococcus pneumoniae, Haemophilus influenzae, Mycoplasma pneumoniae, Chlamydia pneumoniae and Legionella pneumoniae) 2 mL BAL
Syndromic BioIntense Respiratory real-time PCR (Influenza A/B, RSV A/B, para-influenza-1/2/3/4, Streptococcus pneumoniae, Haemophilus influenzae, Mycoplasma pneumoniae, Chlamydia pneumoniae and Legionella pneumoniae) 2 mL ET/Tracheal secretion/ Pleural fluid

Specimen transport condition: 2-8 °C

Cut-off: Daily 11 am; 4 pm

TAT: Same day 7 pm; Next day 12 noon

FUNGAL REAL TIME PCR
Test Name Specimen Type
Candidiasis DNA detection real-time PCR 1 mL CSF
Candidiasis DNA detection real-time PCR 1 mg Tissue
Candidiasis DNA detection Real-time PCR 1 mL BAL
Candidiasis DNA detection real-time PCR 1 mL EDTA Whole Blood
Candidiasis DNA detection real-time PCR 0.5 mL Pus/ Abscess
Candidiasis DNA detection real-time PCR 1 mL Body fluids
Aspergillosis DNA detection real-time PCR 1 mL CSF
Aspergillosis DNA detection real-time PCR 1 mg Tissue
Aspergillosis DNA detection real-time PCR 1 mL BAL
Aspergillosis DNA detection real-time PCR 1 mL EDTA Whole Blood
Aspergillosis DNA detection real-time PCR 0.5 mL Pus/ Abscess
Aspergillosis DNA detection real-time PCR 1 mL Body fluids
Candidiasis/ Aspergillosis DNA detection real-time PCR 1 mL CSF
Candidiasis/ Aspergillosis DNA detection real-time PCR 1 mg Tissue
Candidiasis/ Aspergillosis DNA detection real-time PCR 1 mL BAL
Candidiasis/ Aspergillosis DNA detection real-time PCR 1 mL EDTA Whole Blood
Candidiasis/ Aspergillosis DNA detection real-time PCR 0.5 mL Pus/ Abscess
Candidiasis/ Aspergillosis DNA detection real-time PCR 1 mL Body fluids
Cryptococcus neoformans/ gattii DNA Detection real-time PCR 1 mL CSF
Syndromic BioIntense Fungal real-time PCR (for CSF) 1 mL CSF
Fungal PCR – Pneumocystis jirovecii 1 mL BAL
Syndromic BioIntense Fungal real-time PCR (for BAL) 1 mL BAL

Specimen transport condition: 2-8 °C

Cut-off: Daily 11 am; 4 pm

TAT: Same day 7 pm; Next day 12 noon

SEPTICEMIA real-time PCR
Test Name Specimen Type
Syndromic BioIntense Septicemia real-time PCR 10 mLEDTA Whole Blood

Specimen transport condition: Ambient

Cut-off: Daily 11 am; 2 pm; 5 pm

TAT: Same day 7 pm; Same day 10 pm; Next day 12 noon

EBV real-time PCR
Test Name Specimen Type
EBV DNA quantitative real-time PCR/ EBV DNA QNA 1 mL EDTA Whole Blood
EBV DNA Detection real-time PCR 1 mL EDTA Plasma
EBV DNA Detection real-time PCR 1 mL EDTA Whole Blood
EBV DNA Detection real-time PCR 1 mL Tissue
EBV DNA Detection real-time PCR 1 mL BAL
EBV DNA Detection real-time PCR 1 mL CSF

Specimen transport condition: 2-8 °C

Cut-off: Daily 11 am; 4 pm

TAT: Same day 7 pm; Next day 12 noon

CMV REAL TIME PCR
Test Name Specimen Type
CMV DNA quantitative real-time PCR/ CMV DNA QNAT 1 mL EDTA Plasma
CMV DNA Detection real-time PCR 1 mL EDTA Plasma
CMV DNA Detection real-time PCR 1 mL EDTA Whole Blood
CMV DNA Detection real-time PCR 1 mL Urine
CMV DNA Detection real-time PCR 1 mL Tissue
CMV DNA Detection real-time PCR 1 mL CSF
CMV DNA Detection real-time PCR 1 mL BAL

Specimen transport condition: 2-8 °C

Cut-off: Daily 11 am; 4 pm

TAT: Same day 7 pm; Next day 12 noon

STI REAL TIME PCR
Test Name Specimen Type
Chlamydia trachomatosis DNA Detection real-time PCR 1 mL Urine
Chlamydia trachomatosis DNA Detection real-time PCR 1 mL Vaginal/ Anal/ Rectal/ Urethral swab in Universal Transport medium (UTM)
Neisseria gonorrhoeae DNA Detection real-time PCR 1 mL Urine
Neisseria gonorrhoeae DNA Detection real-time PCR 1 mL Vaginal/ Anal/ Rectal/ Urethral swab in Universal Transport medium (UTM)
Chlamydia trachomatosis/ Neisseria gonorrhoeae Urine DNA Detection real-time PCR 1 mL Urine
Chlamydia trachomatosis/ Neisseria gonorrhoeae DNA Detection real-time PCR 1 mL Vaginal/ Anal/ Rectal/ Urethral swab in Universal Transport medium (UTM)
Trepanoma pallidum DNA Detection real-time PCR 1 mL Urine
Trepanoma pallidum DNA Detection real-time PCR 1 mL Vaginal/ Anal/ Rectal/ Urethral swab in Universal Transport medium (UTM)
Syphillus testing by real-time PCR 1 mL Urine
Syphillus testing by real-time PCR 1 mL Vaginal/ Anal/ Rectal/ Urethral swab in Universal Transport medium (UTM)
STI Screening by real-time PCR (5 pathogens: Chlamydia trachomatosis, Neisseria gonorrhoeae, Trepanoma pallidum, Trichomonas vaginalis, Mycoplasma genitilum) 1 mL Urine
STI Screening by real-time PCR (5 pathogens: Chlamydia trachomatosis, Neisseria gonorrhoeae, Trepanoma pallidum, Trichomonas vaginalis, Mycoplasma genitilum) 1 mL Vaginal/ Anal/ Rectal/ Urethral swab in Universal Transport medium (UTM)
HSV-1/2 DNA Detection real-time PCR
HSV-1/2 DNA Detection real-time PCR 1 mL Vaginal/ Anal/ Rectal/ Urethral swab in Universal Transport medium (UTM)
STI Screening by real-time PCR (7 pathogens: Chlamydia trachomatosis, Neisseria gonorrhoeae, Trepanoma pallidum, Trichomonas vaginalis, Mycoplasma genitilum, HSV-1/2) 1 mL Urine
STI Screening by real-time PCR (7 pathogens: Chlamydia trachomatosis, Neisseria gonorrhoeae, Trepanoma pallidum, Trichomonas vaginalis, Mycoplasma genitilum, HSV-1/2) 1 mL Vaginal/ Anal/ Rectal/ Urethral swab in Universal Transport medium (UTM)

Specimen transport condition: 2-8 °C

Cut-off: Daily 11 am; 4 pm

TAT: Same day 7 pm; Next day 12 noon

CLOSTRIDIUM REAL TIME PCR (CDI)
Test Name Specimen Type
Clostridium difficile DNA Detection real-time PCR 1 gm stoolStool in Cary Blair Medium
Clostridium difficile DNA Detection real-time PCR 1 gm stoolStool in plain sterile container

Specimen transport condition: 2-8 °C

Cut-off: Daily 11 am; 4 pm

TAT: Same day 7 pm; Next day 12 noon

For any further information, please email Dr. Viral Vadwai at drviral.vadwai@suburbandiagnostics.com



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