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  • Maintenance of the Truenat Instrument - General Principles

    Content

    Like any other laboratory instrument, the TrueNAT machine needs a periodic maintenance.

     

    Maintenance of Truelab and Trueprep instruments includes:

    • Cleaning the instrument
    • Disinfecting the surfaces
    • Cleaning the spillages
    • Discarding the used consumables
    • Calibrations
    • Replacement of parts
    • Flush protocol
    • Data backup
    • Troubleshooting errors, alerts, warning messages

     

    Frequency of maintenance:

    The following schedule is required to maintain TrueNAT instrument(s):

    • Daily, monthly maintenance by lab personnel
    • As and when required (need based) by lab personnel/ manufacturer
    • Annual maintenance by the manufacturer.

     

    Posters on maintenance provided by manufacturer are shown in Figure 1(A)- (B)

     

    Figure 1(A): Considerations (Do’s and Don’ts) for use of Trueprep Device; Source: MolBio Diagnostics Pvt. Ltd.

     

     

    Figure 1(B): Considerations (Do’s and Don’ts) for use of Truelab Device; Source: MolBio Diagnostics Pvt. Ltd.

     

     

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  • Ensuring Compliance of Truenat Instrument Installation Criteria

    Content

    Compliance to equipment installation criteria is necessary to/for:

    • Establish accurate and reliable results as claimed by the manufacturer
    • To assure standard/specific requirements are met
    • Provide proof that the process will consistently produce predetermined outcome
    • Equipment safety
    • Improve overall performance of the equipment
    • Decrease work interruptions due to equipment failure
    • Lower repair costs
    • Cover equipment warranty and free maintenance 

     

    Instrument Qualification Documents include:

    1. Installation Qualification- IQ
    2. Operational Qualification- OQ
    3. Performance Qualification- PQ

     

    Installation Qualification

    IQ provides evidence for delivery, installation and configuration of the instrument as per manufacturer’s standards using an installation checklist.

     

    Operational Qualification

    OQ is a collection of test cases used to verify the proper functioning of a system before the instrument is released for use.

     

    Performance Qualification

    PQ is a collection of test cases used to verify that the system performs as expected under simulated real-world conditions.

     

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  • Daily, Weekly and Monthly Maintenance of Truenat Instrument

    Content

    Daily maintenance of Truelab and Trueprep instruments performed by the laboratory personnel includes:

    • Maintaining a dust-free environment by wiping the exterior of instruments with a dry, lint-free cloth
    • Cleaning the surface of the Trueprep device once with 70% ethanol
    • Cleaning the spill or leak with a cloth or tissue-paper dipped in disinfectant (1% sodium hypochlorite solution, followed by 70% ethanol)
    • Not spilling water or any other solution on the surface of instruments
    • Discarding used cartridges, chips, reagent bottles and other consumables in 1% sodium hypochlorite solution, soaking for minimum 30 minutes, and disposing as per the biomedical waste management guidelines.

     

    Monthly maintenance of the Truelab Analyzer performed by laboratory personnel includes:

    • Cleaning the surface of the Truelab Analyzer with 70% ethanol
    • Cleaning the Truelab bays
    • Calibrating temperature.

     

    Annual/ need-based maintenance of the Truenat instrument performed by the laboratory personnel/ manufacturer includes:

    • Flush protocol for the Trueprep device when the device is left idle (not used) for 10 days and/ or errors relating to extraction process occur
    • Replacement of spillage tray or linear motion guide tray for the Trueprep device in case of sample spillage on trays during extraction or when cross-contamination is suspected
    • Replacement of slider glass for Truelab Analyzer after 200 tests and/ or when related errors occur
    • Temperature calibration for Truelab Analyzer when error related to temperature occur and/ or when the temperature curve is abnormal (shows blips)
    • Calibration of micropipettes (every 6 months/ biannual).

     

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  • NAAT Instrument Monthly Data Archive and Data Back-up

    Content

    Security of laboratory data and confidentiality of TB patient data are important. Hence, it is recommended to archive or take periodic data backup.

     

    The Truelab Analyzer has an internal memory to store 20000 test results. The digital data can be transmitted through connectivity via email, SIM card, Wi-Fi or Bluetooth.

     

    Recommended ways of documenting the results and archiving data are:

    • Records should be maintained in the National TB Elimination Program (NTEP) recording and reporting formats.
    • Entries should be made in Nikshay online platform of NTEP.
    • Monthly/ periodically data should be exported in CSV format and saved on external devices-desktop/ laptop/ hard drive.
    • Data records from Nucleic Acid Amplification Testing (NAAT) instruments should be kept in a secure area.
    • Data access should be given to authorized personnel only.

     

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  • Annual Maintenance of the Truenat Instrument

    Content

    Need-based maintenance for Truenat instrument is done by lab personnel/ manufacturer while the manufacturer does annual maintenance.

     

    The tasks included under annual maintenance are:

     

    • Flush protocol for Trueprep device when the device is left idle (not used) for 10 days/ annually and/or errors relating to extraction process occur.
    • Spillage tray or linear motion guide tray replacement for Trueprep device in case of sample spillage on trays during extraction or when cross-contamination is suspected/ done annually.
    • Slider glass replacement for Truelab Analyzer after 200 tests/ annually and/or when related errors occur.
    • Temperature calibration for Truelab Analyzer when error related to temperature occur and/or when temperature curve is abnormal (shows blips)/ annually.
    • Annual calibration of micropipettes.

     

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