Point-of-Care Molecular Diagnostics (Truenat)

Introduction and Principle

Truenat is an indigenously developed, chip-based, battery-operated, real-time micro-PCR platform designed to decentralize molecular testing.
Developed by Molbio Diagnostics, it utilizes Taqman real-time quantitative reverse transcription-polymerase chain reaction (RT-PCR) or standard DNA PCR miniaturized onto disposable microchips.
Reagents and chips are freeze-dried and stable at room temperature (2°C to 30°C), completely eliminating the need for complex cold-chain logistics.

Component / Step	Operational Characteristics
Trueprep AUTO V2	Fully automated sample preparation device executing nucleic acid extraction and purification.
Truelab Analyzer	Performs rapid thermal cycling and fluorescent detection; available in single (Uno Dx), dual (Duo), or quad (Quattro) testing bays.
1. Collection & Lysis	Biological specimen is dispensed into a proprietary lysis buffer, neutralizing the infectious agent immediately (5 minutes).
2. Extraction	Trueprep AUTO automatically purifies high-quality nucleic acids, removing amplification inhibitors (20 minutes).
3. Amplification	Microchip is inserted into the Truelab analyzer for real-time quantification (35 minutes).

High Sensitivity: Detects minute quantities of pathogen DNA or RNA, which is essential for diagnosing paucibacillary pediatric infections and preventing false negatives.
Rapid Turnaround: Delivers results within 60 minutes, enabling a definitive "Test and Treat" strategy during a single outpatient visit.
Minimal Sample Volume: Requires only microscopic aliquots of extracted nucleic acids, making it highly suitable for neonates and young infants.
Antimicrobial Stewardship (AMS): Rapid pathogen identification allows pediatricians to execute targeted use of Access, Watch, and Reserve (AWaRe) antibiotics.

Tuberculosis (TB): Utilizes Truenat MTB and MTB Plus assays for initial detection. Positive samples undergo reflex testing with the Truenat MTB-RIF Dx assay to detect rifampicin resistance within an additional hour. Highly effective for challenging pediatric samples like gastric aspirates, induced sputum, stool, and cerebrospinal fluid.
Respiratory Pathogens: Offers rapid diagnostic assays for SARS-CoV-2, Influenza A and B, and Respiratory Syncytial Virus (RSV).
Vector-Borne Diseases: Facilitates diagnosis of Acute Undifferentiated Febrile Illness (AUFI) etiologies, including Dengue, Malaria, Chikungunya, Scrub Typhus, and Leptospirosis.

National Tuberculosis Elimination Programme (NTEP): Mandates upfront molecular testing using Truenat or CBNAAT as the first-line diagnostic investigation for all children presenting with presumptive pulmonary or extrapulmonary TB.
Global Endorsements: The World Health Organization (WHO) explicitly endorses Truenat MTB, MTB Plus, and MTB-RIF Dx as initial diagnostic tests replacing traditional sputum smear microscopy.
Cost-Effectiveness: Implementing Truenat as a primary point-of-care test significantly improves linkage-to-care metrics, proving highly cost-effective with an Incremental Cost-Effectiveness Ratio (ICER) of $210 per Year of Life Saved (YLS).