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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:
The sputum sample needs to be processed to liquefy and lyse the specimen before Truenat testing. This is because of the following reasons:
External Quality Assurance (EQA) ensures that high-quality testing can be carried out efficiently and without interruption. It involves Proficiency Testing (PT) and On-site Evaluation (OSE).
PT is an important component of EQA for Cartridge-based Nucleic Acid Test (CBNAAT) under the National TB Elimination Program (NTEP) and guarantees accurate and reproducible results.
Importance of EQA/ PT for CBNAAT
Under the National TB Elimination Program (NTEP), each Cartridge-based Nucleic Acid Test (CBNAAT) site needs to keep a maintenance record for the instrument.
Cleaning and disinfecting the system components is crucial for proper CBNAAT maintenance. The tasks and frequency are shown in the table below.
On completion of a test run, the Cartridge-based Nucleic Acid Amplification Test (CBNAAT) gives the following results:
Conclusive results include: MTB NOT DETECTED, MTB DETECTED with Rif Resistance/ without Rif Resistance.
Adverse Drug Reaction (ADR): An unwanted or harmful reaction experienced following the administration of a drug or a combination of drugs, under normal conditions of use, and is suspected to be related to the drug.
Adverse Event (AE): Any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease that presents in a patient during the course of treatment or the procedure, regardless of whether it is considered related to the medical treatment or procedure.
Active Drug Safety Monitoring (aDSM) is a proactive effort made to elicit adverse events from patients by directly asking the patient, screening records, and checking laboratory and clinical tests. All adverse events are captured systematically at all patient visits (during treatment initiation, treatment review and extra visits).
Dysglycaemia is a broad term that refers to an abnormality in blood sugar stability. This can include hypoglycaemia (low blood sugar) or hyperglycaemia (high blood sugar).
The mitochondrial toxicity of certain anti-TB drugs, such as in the prolonged use of Linezolid (Lzd) (≥28 days), may cause lactic acidosis which is a potentially life-threatening build-up of lactic acid in the body. It is a serious Adverse Drug Reaction (ADR) that can result in multiorgan failure and death.
Such cases must be immediately referred to the nearest higher health centres - District/ Nodal DR-TB Centre (D/NDR-TBC)/ sub-district or district hospital, medical college hospitals, etc.
Superficial fungal infection is a rare and non-serious Adverse Drug Reaction (ADR) to regimens containing fluoroquinolones. It can present as an itchy rash with swelling, discharge and pain. It can also occur in the mouth as oral thrush, which presents with thick white patches on the tongue and cheeks, and sometimes with pain or burning.