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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 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™ MAG Sample Prep kit which comprises reagents and accessories necessary for the purpose. Extraction and purification process:

  1. The Extraction Tube (EXT) containing the Lysis reagent & the sample is put in the holder of the Trueprep™ MAG Sample Prep Device (as shown in the Fig) for sequential processing.

  2. Nucleic acids, from the sample are released by chemical and thermal lysis of cells. These bind to the surface of the proprietary magnetic nanoparticles in the presence of binding reagent added during the process.
  3. The captured nucleic acids are then washed with buffers to remove the PCR inhibitors and finally eluted from the nanoparticles, using the elution buffer. The elute, containing nucleic acids, is then pipetted out using Truepet™ fixed volume precision micropipette into the Elute Collection tube (ECT) provided in the accessories pack for the PCR process. 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.