Molecular Test - Suburban Diagnostics

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Molecular diagnostics laboratory: Salient features
  • Among very few NABL accredited molecular labs in India, to provide state-of-the-Art technology
  • Bio safety level 2A diagnostics services
  • 6 PCR Rooms, unidirectional work flow as per CLSI guidelines
  • Automated extraction for minimal manual intervention
  • Real time PCR technology for increased sensitivity and specificity
  • US FDA and CE – IVD approved tests as per international guidelines
  • Mandatory use of internal controls in each sample to rule out false negativity
Syndromic Double Multiplex PCR for common fevers
  • Suburban Diagnostics has successfully adopted a syndromic approach for diagnosis of common fevers through its “Syndromic Double Multiplex PCR” test, that diagnoses 5 common fevers at one go.
  • Dengue
  • Chikungunya
  • Leptospirosis
  • Malaria
  • Typhoid
  • Recommended to test – within 1 – 5 days of signs and symptoms

HBV Qualitative PCR
  • For confirmation of active HBV infection (genotype A-G)
  • Early detection of acute HBV infection: 4 weeks following infection and approximately 21 days before HBsAg can be detected in serum
  • Performed using real-time PCR technology
  • Provides conclusive reports wherein serology provides equivocal/indeterminate results
  • To distinguish patients suffering from an active infection and chronic carriers
  • Detection limit: For Serum, 6.7 IU/mL, for Plasma EDTA, 4.8 IU/mL
HBV Viral Load
  • Used in the management of patients with chronic HBV infection
  • Monitoring disease progression in chronic HBV infected patients and/or response to anti–HBV therapy
  • Performed on US FDA approved COBAS TaqMan real-time PCR
  • Ensures highly sensitive and accurate quantitation of all known HBV genotype and pre-core mutant
  • Lower quantification (LQL) = 20 IU/mL
  • Broad dynamic range of 20 – 1.7*108 IU/mL
HBV Genotype
  • Hepatitis B virus (HBV) infection is the leading cause of cirrhosis
  • Detects 10 HBV genotype (A-J)
  • Clinical indicators
    • Disease severity
    • Likelihood of complications
    • Response to interferon therapy
  • Minimum viral load required to process the test – 100 IU/mL
HBV Drug Resistance
  • Rapid and sensitive test for detection of mutations associated with resistance to Nucleotide Analogs (NA)
  • Drug Resistance determined for:
    • Lamivudine
    • Telbivudine
    • Adefovir
    • Tenofovir
    • Entacavir
  • Minimum viral load required to process the tests – 100 IU/mL
  • Nucleotide analogs like Entacavir and Tenofovir have a higher resistance barrier
  • In case of virological breakthrough, HBV genotype resistance may be recommended

Pre-Core & Basal-Core Promoter (PCBC)
  • Chronic HBV: 2 major forms – HbeAg positive and HBeAg negative
  • HBeAg negative patients possess mutations in pre-core and/or basal core region
  • Presence of A1762T and G1764A mutations in base core results in complete loss of HBeAg production
  • Presence of G1896A mutation in the pre-core region results in complete loss of HBeAg production
  • 8 – 10% of HBeAg negative patients progress to cirrhosis and hepatocellular carcinoma

HCV Drug Resistance
  • Determine resistance to NS5A inhibitors in HCV genotype 1a, 1b
  • Drug Resistance determined for:
    • Daclatasvir
    • Elbasvir
    • Ledipasvir
    • Ombitasvir
  • Viruses resistant to NS5A inhibitors are fit and remain dominant for many years, perhaps forever
  • Minimum viral load required to process the test – 100 IU/mL
  • As per the data of Poordad et al. Phase 3 ALLY – 1 study .201:
    • Only 76% of patients with HCV genotype 1a (n=34) achieved an SVR12
    • The pre-treatment is recommended to extend treatment to 24 weeks, an addition of RBV may be considered
HCV Genotype
  • Detects all 6 genotypes and their subtypes
  • Sequencing facilitates the identification and differentiation of subtype:
    • HCV gentotype 1a, 1b
  • Identification of HCV genotype aids in the selection of the most appropriate therapeutic regimen
  • Genotype 1a and 1b have poor clinical outcomes, hence precise subtype identification is important
  • In India, HCV genotype 1 and 3 are common
  • Minimum viral load required to process the test – 100 IU/mL
HCV Qualitative PCR
  • Confirmatory test for diagnosis of HCV infection (Genotype 1-6)
  • Distinguish patients suffering from an active and past infection
  • Performed using real-time PCR Technology
  • Detection limit of 11 IU/mL
HCV Viral Load
  • Used in the management of patients with HCV infection
  • Predicting probability of sustained virologic response (SVR) early during a course of antiviral therapy
  • Performed on US FDA approved COBAS TaqMan real-time PCR
  • Ensures accurate quantitation of HCV genotypes 1 through 6
  • Lower Quantification Limit (LQL) = 15 IU/mL
  • Broad dynamic range of 15 – 1*108 IU/mL

HIV-1 Drug Resistance
  • Identification of HIV-1 genotypic mutations associated with resistance to NRTI/NNRTI/PI
  • Genotype drug resistance testing is preferred to phenotypic testing because of lower cost, faster TAT and greater sensitivity
  • HIV drug resistance helps in designing:
    • Optimal treatment prior to initiation of ART
    • Change in ART regimen in case of treatment failures/relapse
  • Minimum viral load required to process the test >500 copies/mL
  • Two types of panels available:
    • Resistance to NRTI/NNRTI
    • Resistance to NRTI/NNRTI/PI
HIV-1 Viral Load
  • Used in clinical management of HIV-1 infected patients
  • For monitoring patients on ART
  • Performed on US FDA approved COBAS TaqMan real-time PCR
  • Quantification of clinically significant HIV-1 groups O and M with full subtype coverage
  • Lower Quantification Limit (LQL) = 20 copies/mL
  • Broad dynamic range of 20 – 1*107 copies/mL
HIV-1 Qualitative PCR
  • Confirmatory test for diagnosis of HIV-1 infection (Genotype A-H)
  • HIV-1 RNA can be detected 10 days prior to the appearance of both p24 antigen and HIV-1 antibody
  • Performed using real-time PCR technology
  • Detection limit of 17 copies/mL

HLA B27 by PCR
  • Used for confirmation of:
    • Ankylosing Spondylitis (AS), a rheumatic inflammatory disease
    • Reiters Syndrome
    • Anterior Uveitis
  • Improves sensitivity and specificity in diagnosis of (AS)
  • Detects only those HLA B27 subtypes that are associated with AS
  • Does not detect HLA B27:09 alleles, which are not associated with AS

TB PCR
  • Performed using real-time PCR technology
  • Tests can be performed on:
    • Pulmonary AFB smear negative
    • Paucibacillary extra pulmonary TB (10-15% of all cases)
    • HIV co-infection
  • Targets IS6110 gene more prevalent in Indian population. Hence, specificity is higher even in case of low bacillary load.
Biointense MRF Plus

Special range of syndromic molecular diagnostics panels for infections in intensive care. To know more, click here

For any further information, please email Dr. Heena Satam at heena.satam@suburbandiagnostics.com


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