Assessing a chip based rapid RTPCR test for SARS CoV-2 detection (TrueNat assay): A diagnostic accuracy study.

Area of Science:

• Molecular Diagnostics
• Infectious Disease Detection
• Point-of-Care Testing

Background:

• COVID-19 testing is crucial for hospital admissions and procedures.
• Real-Time Polymerase Chain Reaction (RTPCR) is the gold standard but requires specialized labs and trained personnel.
• There is a need for accessible and efficient diagnostic tools, particularly in resource-limited settings.

Purpose of the Study:

• To evaluate the diagnostic accuracy of the novel TrueNat molecular assay for detecting SARS-CoV-2.
• To assess the performance of TrueNat compared to the gold standard RTPCR.
• To determine the utility of TrueNat in resource-limited settings.

Main Methods:

• A study involving 1807 patient samples was conducted.
• Samples were tested using both TrueNat and RTPCR for COVID-19 detection.
• Diagnostic accuracy metrics including sensitivity, specificity, and overall accuracy were calculated using RTPCR as the gold standard.

Main Results:

• Out of 1807 samples, 174 (9.7%) were positive by RTPCR and 174 (15%) by TrueNat.
• The TrueNat test demonstrated a sensitivity of 69.5%, specificity of 90.9%, and diagnostic accuracy of 89.2% when compared to RTPCR.
• TrueNat identified a higher number of positive cases (174) compared to RTPCR (174) in this cohort, though the percentage is higher.

Conclusions:

• TrueNat is a simple, easy-to-use, and rapid molecular diagnostic test for COVID-19.
• The assay shows good diagnostic accuracy, making it suitable for resource-limited settings.
• TrueNat has the potential to significantly impact molecular diagnostics in the future, especially for SARS-CoV-2 detection.