Molecular Diagnostics
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.
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.
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.
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