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Suburban Diagnostics Setting Higher Standards in Molecular Diagnostics

  • Molecular Front Pg

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
  • HLA B27:06 and HLA B27:09, which are not associated with AS are not detected by this PCR
HLA B27 By PCR

Hepatitis B Virus Tests

Hepatitis B Virus Tests
  • HBsAg – used as a general marker of infection
  • HBsAb – used to document recovery and/or immunity to HBV infection
  • Anti HBcIgM – marker of acute infection
  • Anti HBclgG – past chronic infection
  • HBeAg – indicates active replication of virus and therefore infectiveness
  • Anti HBe – virus no longer replicating. However, the patient is still positive for Hepatitis
  • HBV DNA PCR – indicates active replication of virus, more accurate than HBeAg especially in cases of PCBC mutants

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 active infection and chronic carriers
  • Detection limit: For Serum, 6.7 IU/mL; for Plasma EDTA, 4.8 IU/mL
HBV Qualitative PCR

HIV-1 Drug Resistance

  • Identification of HIV-1 genotypic mutations associated with resistance to NRTI/NNRTI/PI
  • Genotypic drug resistance testing is preferred to phenotypic testing because of lower cost, faster TAT and greater sensitivity
  • HIV drug resistance helps in designing:
    1. Optimal treatment regimen prior to initiation of ART
    2. Change in ART regimen in case of treatment failure/relapse
  • Minimum Viral Load required to process the test >500 copies/mL
  • Two different panels available:
    1. Resistance to NRTI/NNRTI
    2. Resistance to NRTI/NNRTI/PI

NRTI : 3TC – Lamivudine | ABC – Abacavir | FTC – Emtricitabine | AZT – Zidovudine | D4T – Stavudine | DDI – Didanosine | TDF – Tenofovir | TDF – Tenofovir
NNRTI : EFV – Efavirenz | NVP – Nevirapine | ETR – Etravirine | RPV – Rilpivirine
PI : ATV – Atazanavir | IDV – Indinavir | LPV – Lopinavir | NFV – Nelfinavir | SQV – Saquinavir | TPV – Tipranavir | DRV – Darunavir | FPV – Fosamprenavir

 

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) = 34 copies/mL
  • Broad dynamic range of 34 – 1 X 107 copies/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 genotypes and pre-core mutant
  • Lower Quantification Limit (LQL) = 29 IU/mL
  • Broad dynamic range of 29 – 1.1 x 10 IU/mL

HBV Genotype

HBV Genotype
  • Hepatitis B Virus (HBV) infection is the leading cause of cirrhosis
  • Detects 10 HBV genotypes (A-J)
  • Clinical Indicators:
    1. Disease severity
    2. Likelihood of compli cations
    3. Response to interferon therapy
  • Minimum Viral Load required to process the test – 100 IU/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 34 copies/mL
HIV-1 Qualitative PCR

TB PCR

TB PCR
  • Performed using Real Time PCR technology
  • Tests can be performed on:
    1. Pulmonary AFB smear negative
    2. Paucibacillary extra pulmonary TB (10-15% of all TB cases)
  • HIV co-infection
  • Targets IS6110 gene more prevalent in Indian population hence specificity is higher even in case of 1 bacilli

HBV Drug Resistance

  • Rapid and sensitive test for detection of mutations associated with resistance to Nucleotide Analogs (NA)
  • Drug Resistance determined for:
    1. Lamivudine
    2. Telbivudine
    3. Adefovir
    4. Tenofovir
    5. Entacavir
  • Minimum Viral Load required to process the test – 100 IU/mL
  • Nucleotide analogs like Entacavir and Tenofovir have high resistance barrier
  • In case of virological breakthrough, HBV genotypic resistance may be recommended
HBV Drug Resistance

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 basal core region – decreases 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

HCV Drug Resistance
  • Determine resistance to NS5A inhibitors in HCV genotype 1a, 1b
  • Drug Resistance determined for:
    1. Daclatasvir
    2. Elbasvir
    3. Ledipasvir
    4. 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 pretreatment presence of NS5A resistance associated variants were the major reasons for the higher relapse rate in the 12 weeks
    • Hence, it is recommended to extend treatment to 24 weeks, addition of RBV may be considered

HCV Genotype

  • Detects all 6 genotypes and its subtypes
  • Sequencing facilitates identification and differentiation of subtype: HCV genotype 1a, 1b
  • Identification of HCV genotype, aids in selection of most appropriate therapeutic regimen
  • Genotypes 1a and 1b have the 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

Hepatitis C Virus Tests

HCV Total Antibodies – Test positive after 4 weeks of infection
HCV IgM – Acute Marker for confirming the presence of Hepatitis C Virus

HCV RNA PCR – Confirmatory diagnosis of active HCV infection (targets all HCV genotypes)

Hepatitis C Virus Tests

HCV Qualitative PCR

HCV Qualitative PCR
  • Confirmatory test for diagnosis of HCV infection (genotype 1-6)
  • Distinguish patients suffering from active and past infection
  • Performed using Real Time PCR technology
  • Detection limit of 25 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) = 25 IU/mL
  • Broad dynamic range of 25 – 3.91×108 IU/mL
HCV Viral Load

Our Molecular Diagnostics Laboratory Features

  1. Among very few labs in India to provide State-of-the-Art technology
  2. 6 PCR Rooms, unidirectional work flow as per CLSI guidelines
  3. Bio safety level 2 diagnostics services
  4. Automated extraction for minimal manual intervention
  5. Real Time PCR technology for increased sensitivity and specificity
  6. US FDA and CE – IVD approved test as per international guidelines
  7. Mandatory use of internal controls in each sample to rule out false negativity

Molecular diagnostic tests timetable :

Test Code Test Name Schedule TAT
MB001 HBV Qualitative PCR/ Detection Mon/ Thu – 8am Same Day 7pm
MB011 HBV Quantitative/ Viral load Mon/ Thu – 8am Same Day 7pm
PRF2377 HBV Qualitative, Reflex HBV Quantitative Mon/ Thu – 8am Same Day 7pm
PRF2380 HBV Viral Load & Genotype Mon/ Thu – 8am Sat/Wed – 7pm
PRF2381 HBV Viral Load, Genotype & Drug Resistance Mon/ Thu – 8am Sat/Wed – 7pm
PRF2382 HBV Treatment Response Panel Mon/ Thu – 8am Sat/Wed – 7pm
PRF2383 HBV Mutation Panel Mon/ Thu – 8am Sat/Wed – 7pm
PRF2384 HBe Antigen + HBV Taqman, Reflex to Pre-core and Basal-core promoter mutation Mon/ Thu – 8am Sat/Wed – 7pm
MB003 HCV Qualitative PCR/ Detection Tue/ Fri – 8am Same Day 7pm
MB012 HCV Quantitative/ Viral load Tue/ Fri – 8am Same Day 7pm
PRF2378 HCV Qualitative, Reflex HCV Quantitative Tue/ Fri – 8am Same Day 7pm
PRF2385 HCV Viral Load & Genotype Tue/ Thu – 8am Mon/Wed – 7pm
PRF2386 HCV Viral Load, Genotype & Drug Resistance Tue/ Thu – 8am 15 days
MB010 HIV Qualitative PCR/ Detection Wed/ Sat – 8am Same Day 7pm
MB013 HIV Quantitative/ Viral load Wed/ Sat – 8am Same Day 7pm
PRF2379 HIV Qualitative, Reflex HIV Quantitative Wed/ Sat – 8am Same Day 7pm
PRF2394 HIV Drug Resistance Panel 1 Wed/ Sat – 8am 9 days
PRF2395 HIV Drug Resistance Panel 2 Wed/ Sat – 8am 9 days
MB014 HLA B27 by PCR Mon/ Sat – 8am Same Day 7pm
MB008-09 TB PCR/ MTB Detection Test Daily – 8am Next Day 7pm

Book your appointment today to take our precise molecular diagnostics tests.

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