Monitoring Different Types of Errors with Truenat

Monitoring of Truenat errors

There are various types of errors that occur with the Truenat machines, which include:

• Coded errors related to the Trueprep AUTO v2 sample prep device
• Coded errors related to the Truelab micro-PCR Analyzer
• Non-coded system errors/failures

Monitoring the Trueprep AUTO v2 errors  

• The Truenat system is a closed amplification system (i.e., the amplified product is sealed in the chip), and an enzyme system is incorporated in the reaction mix to prevent previously amplified material from getting re-amplified.

• It is recommended that testing sites perform negative control tests using Trueprep AUTO lysis buffer reagent and sterile Phosphate Buffered Saline (PBS) monthly or when contamination is suspected (e.g., an unusually high proportion of specimens with ‘M.tb detected’).
• Swab testing of work surfaces and both the Truelab and Trueprep machines should be conducted monthly.
• Used and expired cartridges should be discarded as per the protocols, so they are not re-used.

Monitoring the Truelab errors 

• To ensure that the Truelab micro Polymerase Chain Reaction (PCR) Analyzer is working accurately, the manufacturer recommends running positive and negative controls (which can be purchased as part of the Truenat™ Positive Control Kit- Panel I) periodically.

• The positive and negative controls can also be used for lot-to-lot verification and assessment of reagents if the temperature of storage areas falls outside  the recommended ranges.
• An optional “Plot” view on the digital interface is also available while the process is being performed that allows for monitoring test progress in real-time.
• Truelab Analyzers can be configured to send data on device performance to the manufacturer’s (default configuration) or local servers to allow the manufacturer (without sharing any  patient data) and/or the National TB Elimination Programme to monitor instrument performance on a real-time basis.
• This helps in the identification and possible prevention of instrument malfunctions or breakdowns, detection of user errors and retraining needs, and monitoring of instrument and test utilization across fleets of instruments.

Resources

• Guidelines on Programmatic Management of Drug-resistant TB (PMDT) in India;CTD, MoHFW, India,2021.
• Trueprep AUTO v2 Universal Cartridge Based Sample Prep Device; User Manual V4.
• TRUELAB UNO Dx Real Time Quantitative micro PCR Analyzer; manual VER 04.

Assessment