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Updated: Feb 2, 2026

Author Spotlight: Advancing Pathogen Diagnostics with Standardized LAMP
Published on: September 8, 2023
Colorimetric tetra-combo loop-mediated isothermal amplification assay for efficient SARS-CoV-2 detection
1Department of Biomedical Science, Faculty of Medicine, Universiti Malaya, Kuala Lumpur, 50603, Malaysia.
Abstract:
Coronavirus disease 2019 (COVID-19), which is caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has spread rapidly and caused a pandemic in 2020. Both pharmaceutical approaches, such as vaccinations and non-pharmaceutical approaches such as social distancing through lockdown and international border restrictions had been implemented to control the outbreak and the transmission of SARS-CoV-2. However, the prolonged implementation of these measures negatively impacted the population and global economy, while the continuously emerging SARS-CoV-2 variants led to breakthrough infections among the vaccinated populations. Given the ongoing nature of COVID-19, an efficient detection method for SARS-CoV-2 that could enable mass screening and on-site screening is needed to manage the disease and prevent further outbreaks at large scale. Hence, we have developed a tetra-combo LAMP SARS-CoV-2 detection assay that targets four SARS-CoV-2 genes (RdRp, S, E and N), with an internal control (RNaseP). The LAMP assay was validated using 370 RNA samples extracted from nasopharyngeal and/or oropharyngeal swabs. The LAMP assay developed in this study has on-par performance as the qRT-PCR assay, which is the gold standard method for SARS-CoV-2 detection, with a shorter turnaround time (25 minutes). The LAMP assay possessed 98.13% sensitivity, 100% specificity, 100% positive predictive value (PPV), and 95.45% negative predictive value (NPV) for samples with Ct values <= 35.
Insights
A new tetra-combo LAMP assay offers rapid and accurate detection of SARS-CoV-2, targeting four genes. This method provides an efficient alternative for mass and on-site screening of COVID-19, crucial for ongoing pandemic management.
Area of Science:
- Molecular Biology
- Virology
- Biotechnology
Background:
- The COVID-19 pandemic, caused by SARS-CoV-2, necessitated global control measures like vaccination and social distancing.
- Prolonged non-pharmaceutical interventions negatively impacted economies, and emerging SARS-CoV-2 variants challenge vaccine efficacy.
- Efficient, scalable diagnostic methods are essential for managing COVID-19 and preventing widespread outbreaks.
Purpose of the Study:
- To develop an efficient detection assay for SARS-CoV-2 suitable for mass and on-site screening.
- To create a rapid diagnostic tool to aid in the ongoing management of the COVID-19 pandemic.
Main Methods:
- Development of a tetra-combo Loop-mediated Isothermal Amplification (LAMP) assay targeting four SARS-CoV-2 genes (RdRp, S, E, N) and an internal control (RNaseP).
- Validation of the LAMP assay using 370 RNA samples from nasopharyngeal and/or oropharyngeal swabs.
- Performance comparison with the gold standard quantitative reverse transcription polymerase chain reaction (qRT-PCR) assay.
Main Results:
- The tetra-combo LAMP assay demonstrated comparable performance to qRT-PCR.
- Achieved a high sensitivity of 98.13% and specificity of 100% for samples with Ct values <= 35.
- Provided a significantly shorter turnaround time of 25 minutes compared to qRT-PCR.
Conclusions:
- The developed tetra-combo LAMP assay is a highly sensitive and specific method for SARS-CoV-2 detection.
- Its rapid turnaround time and suitability for mass screening make it a valuable tool for COVID-19 management.
- This assay offers an efficient alternative for timely diagnosis and control of SARS-CoV-2 transmission.
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