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EN ISO 13485:2012
EN ISO 9001:2008











                    

Working of the System

The TrueLab™ Real Time quantitative micro PCR system works on four simple processes as sample collection, sample preparation,automatic analysis and reporting that can be completed within an hour’s time.

         

Sample Collection:
Clinical specimen such as whole blood/serum/plasma/other body fluids and sputum in case of TB are collected fresh in the tubes provided. Frozen specimen can also be used.

Sample Preparation: 
The PCR process necessitates the extraction and purification of nucleic acids from a clinical specimen, to free it from potential PCR inhibitors. Sample preparation is therefore done using Trueprep™ AUTO Universal Cartridge Based Sample Prep Kit which contains cartridges and reagents necessary for the purpose. Extraction and purification process:

     

  1. The pre-treated sample (refer corresponding Truenat™ pack insert) is added to the sample chamber of the cartridge. The cartridge is then placed in the Trueprep™ AUTO Universal Cartridge Based Sample Prep device for processing. The cartridge also contains pre-loaded Internal Positive Control (IPC).The IPC is a full process control that undergoes all the processes the specimen undergoes, from extraction to amplification, thereby validating the analysis from sample to result.
  2. DNA/RNA from the sample are bound by the matrix enclosed in a cartridge and inhibitors present in sample are washed out. At the end of processing the bound DNA/RNA is eluted and collected in elution chamber. All the waste generated in the process is contained within the dump region of cartridge.
  3. The elute is then pipetted out using Truepet™ fixed volume precision micropipette into the Elute Collection tube (ECT). Sample preparation is completed in under 25 minutes.    


Automatic Analysis & Reporting

  1. For the PCR process, test specific Truenat™ Real time quantitative micro PCR chip is loaded onto the chip tray  of the TrueLab™ Uno Dx Real Time Micro PCR analyser.

  2. 6 µL of the purified nucleic acid obtained from the sample preparation process is pipetted using Truepet™ fixed volume precision micropipette into the Truenat™ Real time micro PCR chip (shown in the Fig. above). 
  3. At the end of the test, the results are displayed on the screen and printouts of the same can be taken if required using the Truelab™ micro printer.

The PCR analysis and reporting is completed in less than 30 minutes.