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.
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.
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