Molecular Diagnostics

Hepatitis Qualitative PCR

Accurate and precise detection for effective patient management.

  • Used as qualitative in vitro nucleic acid amplification test for detection of Hepatitis virus using Real time PCR technology.
  • The test is indicated in patients with clinical and/or biochemical evidence of liver disease and antibody evidence of Hepatitis virus, also who are suspected to be actively infected with Hepatitis virus.
  • Detection of acute hepatitis infection before the appearance of antibodies in serum.
  • Detection and confirmation of chronic Hepatitis infection.

SD_Hepatitis-1

Hepatitis Quantitative PCR

Viral Load estimation to optimize patient management and treatment response.

  • Viral Load is an in vitro nucleic acid amplification test for quantitation of Hepatitis virus using FDA Approved, COBAS Taqman Real time PCR technology from Roche Diagnostics.
  • Novel dual probe technology addresses global sequence diversity with enhanced primer/probe sequence mismatch tolerance.
  • The test is intended for use in the management of patients with chronic Hepatitis infection.
  • Monitoring disease progression in chronic Hepatitis infection and/or response to anti-viral therapy.

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HIV Viral Load

Viral load estimation to optimize patient management and treatment response.

The test is intended for use in clinical management of HIV-1 infected patients by quantification of HIV-1 viral load:

For monitoring disease progression while on or off anti-HIV-1 therapy

  • Performed on FDA Approved COBAS TaqMan Real time PCR  technology from Roche Diagnostics
  • Quantification of clinically significant HIV-1 groups O and M with full subtype coverage
  •  Limit of detection (LOD) = 17 copies/mL
  •  Broad dynamic range of 34 x 10  copies/mL
  •  Novel dual probe technology targeting GAG and LTR regions to cover broad genotypes and are well conserved phylogenetically

Sample requirement: 3ml EDTA plasma transported at refrigerated/ frozen condition

Recommendations for ART Monitoring by International Antiviral Society-USA (May-2014)

  • HIV-1RNA level should be monitored at about 4weeks after treatment is initiated or changed, and then every 3 months to confirm suppression of viremia below the limit of quantification of sensitive commercial as-says.
  • CD4 cell count should be monitored atleast every 3months after initiation of therapy, especially among patients with cell counts of<200/µL, to determine the need for initiation or discontinuation of primary opportunistic infection prophylaxis.
  • Once HIV-1 RNA level is suppressed for 1year and CD4 cell count is stable at >350/µL, viral load and CD4 cell count can be monitored at intervals of <6 months in patients with dependable adherence.
  • Once  viral load is demonstrated to be suppressed consistently for more than 2 years and CD4 cell counts are persistently >500/µL, monitoring CD4 cell counts is optional unless virologic failure occurs or there are intercurrent immunosuppressive treatments or conditions.
  • Detectable HIV-1 RNA level (>50copies/mL) during therapy should be confirmed within  4weeks in a subsequent sample prior to making management decisions.

Immuno Deficiency Panel (CD4/ CD8)

Performed on fully automated Beckman Coulter FC500 Flow cytometer

  • The FC500 flowcytometer system provides automated tube based acquisition for cell based assays utilizing powerful CXP software
  • CD4/CD8 is useful as diagnostic and/or prognostic indicator for immuno-compromised patients
  • With decrease in CD4 count, risk of opportunistic infection increases
  • Predicts the probability of disease progression
  • The CD4 ranges would also help in the management of immuno deficiencies other than HIV and in the assessment of immune reconstitution

Sample requirement: 3ml EDTA Whole blood transported at room temperature