Neelam GajjarNeelam Gajjar

7/26/20097/26/2009

OverviewOverview Specimen type and Specimen type and

handlinghandling Procedure Procedure Instruments UsedInstruments Used TreatmentTreatment

In th

is pre

senta

tion:

HCV is a major, growing health problem worldwide

Serological tests are useful for screening, however molecular approaches are the mainstay of HCV tests

Qualitative Molecular Tests:Confirmation of positive screening tests

Quantitative Molecular Tests:Prognostic information regarding likelihood

of response to therapyMonitoring of treatment efficacy

Human Serum or PlasmaHuman Serum or Plasma Serum – Blood collected in SST tube [non-Serum – Blood collected in SST tube [non-

hemolysed serum only]hemolysed serum only] Plasma – EDTA as anticogulant [heparin is Plasma – EDTA as anticogulant [heparin is

not acceptable] not acceptable] Whole blood must be transported at 2-Whole blood must be transported at 2-

2525o o C OR frozen at 20-80C OR frozen at 20-80o o C. C. Process within 6 hrs of collectionProcess within 6 hrs of collection Stored at room temperature for 24 hrsStored at room temperature for 24 hrs Refrigerate for up to 5 daysRefrigerate for up to 5 days

1.1. Starts with Specimen and control preparation, Starts with Specimen and control preparation, extraction followed by PCR reagent preparation, extraction followed by PCR reagent preparation, amplification(real-time PCR), DETECTION 650 uL amplification(real-time PCR), DETECTION 650 uL of vortexed and spun  and unclotted specimens of vortexed and spun  and unclotted specimens are transferred in to Sample-tube which is loaded are transferred in to Sample-tube which is loaded in to sample rack onto COBAS Ampliprep in to sample rack onto COBAS Ampliprep instrument  for processing with low and high pos instrument  for processing with low and high pos control as well as negative control.control as well as negative control.

2.2.   Prepare K-carrier from your processed specimenPrepare K-carrier from your processed specimen3.3. Prepare HCV-ASR  MMX  by adding Maganese Prepare HCV-ASR  MMX  by adding Maganese

AND then add MMX  to processed specimen in to AND then add MMX  to processed specimen in to K carrier.K carrier.

4.4. Load the K-carrier in to Taq Man AnalyzerLoad the K-carrier in to Taq Man Analyzer5.5. The COBAS Taq Man analyser automatically The COBAS Taq Man analyser automatically

determines the HCV RNA titer for the sample .The determines the HCV RNA titer for the sample .The HCV  RNA titer is expresse in IU/mL.HCV  RNA titer is expresse in IU/mL.

Analytical reportable range for Analytical reportable range for quantitative HCV ASR:quantitative HCV ASR: 10 – 5,000,000 IU/mL10 – 5,000,000 IU/mL

Material and Process InformationMaterial and Process Information Each CAP TNAI -Kit contains sufficient Each CAP TNAI -Kit contains sufficient

reagent for 24 specimen runsreagent for 24 specimen runs Specimen preparation reagents  cassettes Specimen preparation reagents  cassettes

are packaged as 48 test runs and HCV ASR are packaged as 48 test runs and HCV ASR MMX COMES IN PACKAGE OF 2 x 24 TEST MMX COMES IN PACKAGE OF 2 x 24 TEST RUNSRUNS

One or Two Day ProcessOne or Two Day Process

Features and benefitsFeatures and benefits 72 samples can be loaded at once and 72 samples can be loaded at once and

processed within 4 hours to meet high-processed within 4 hours to meet high-volume testing demandsvolume testing demands

Continuous sample and reagent loading Continuous sample and reagent loading without operation interruption minimizes without operation interruption minimizes downtime and maximizes hands-off time downtime and maximizes hands-off time for the operatorfor the operator

Bar-coded sample racks and reagents Bar-coded sample racks and reagents provide positive sample identification provide positive sample identification and reagent tracking to reduce hands-on and reagent tracking to reduce hands-on timetime

Dedicated and disposable sample Dedicated and disposable sample processing units minimize the potential processing units minimize the potential for cross-contaminationfor cross-contamination

Ready-to-use, compact reagent Ready-to-use, compact reagent cassettes are designed to eliminate cassettes are designed to eliminate manual preparation time and prevent manual preparation time and prevent manual preparation errorsmanual preparation errors

Features and benefitsFeatures and benefits Real-time TaqMan PCR methodology Real-time TaqMan PCR methodology

provides unmatched accuracy, superior provides unmatched accuracy, superior linear range, and the potential to run one linear range, and the potential to run one test for quantitative and qualitative test for quantitative and qualitative requirementsrequirements

Run sizes of 6 to 48 samples provide Run sizes of 6 to 48 samples provide flexibility and maximum efficiencyflexibility and maximum efficiency

The utility channel adds flexibility and cost The utility channel adds flexibility and cost effectiveness by allowing the laboratory to effectiveness by allowing the laboratory to run IVD and user-defined assays on one run IVD and user-defined assays on one fast, easy, and accurate platformfast, easy, and accurate platform

Two independently operating thermal Two independently operating thermal cyclers provide approximate run times of cyclers provide approximate run times of 90 to 120 minutes to increase workflow 90 to 120 minutes to increase workflow flexibility and minimize the need for flexibility and minimize the need for multiple platformsmultiple platforms

• • AMPLILINK Software is Windows driven for AMPLILINK Software is Windows driven for easy navigation, and provides the security easy navigation, and provides the security of positive sample ID throughout the run, as of positive sample ID throughout the run, as well as enhanced LIS capabilitieswell as enhanced LIS capabilities