Processing of Sputum Sample before Truenat Testing

The Truenat Assay Technology works on Real-time Polymerase Chain Reaction (PCR).

The key steps include:

Overview of the Truenat Testing Process

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

External Quality Assurance 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.

External Quality Assurance for CBNAAT

On completion of a test run, the Cartridge-based Nucleic Acid Amplification Test (CBNAAT) gives the following results:

1. MTB DETECTED; Rif Resistance DETECTED
2. MTB DETECTED; Rif Resistance NOT DETECTED
3. MTB DETECTED; Rif Resistance INDETERMINATE
4. MTB NOT DETECTED
5. Error
6. Invalid
7. No result

Conclusive results include: MTB NOT DETECTED, MTB DETECTED with Rif Resistance/ without Rif Resistance.

CBNAAT Results Interpretation

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.