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Author Spotlight: Advancing Pathogen Diagnostics with Standardized LAMP
Published on: September 8, 2023
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SARS-CoV-2 molecular diagnostic point-of-care testing based on loop-mediated isothermal amplification: A prospective,
Sung Hun Moon1, Sang-Chul Kim1,2, Byung Woo Kim3
1Department of Emergency Medicine, Chungbuk National University Hospital, 776, 1st Sunhwan-ro, Seowon-gu, Cheongju-si, Chungcheongbuk-do 28646, Republic of Korea.
Heliyon
|March 21, 2023
Summary
This study assessed a rapid point-of-care (POC) loop-mediated isothermal amplification (LAMP) test for diagnosing severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The RT-LAMP POC test showed high specificity and fair predictive value in emergency settings.
Area of Science:
- Infectious Diseases
- Diagnostics
- Molecular Biology
Background:
- Accurate and rapid diagnostics for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) are essential for infection control, particularly in emergency settings.
- Point-of-care (POC) testing offers a potential solution for rapid diagnosis, reducing turnaround times compared to traditional laboratory methods.
Purpose of the Study:
- To evaluate the diagnostic accuracy of a novel POC loop-mediated isothermal amplification (LAMP) test for SARS-CoV-2.
- To compare the performance of the RT-LAMP POC test against a reference reverse transcription quantitative polymerase chain reaction (RT-qPCR) assay.
Main Methods:
- Prospective study including symptomatic adult patients presenting to the emergency room with suspected SARS-CoV-2 infection within 3 days of symptom onset.
- Collection of posterior nasopharyngeal and throat swabs for analysis using both the RT-LAMP POC test and RT-qPCR.
- Assessment of sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and Cohen's Kappa coefficient (k).
Main Results:
- The RT-LAMP POC test demonstrated a sensitivity of 70.6% and a specificity of 98.0% compared to RT-qPCR.
- Positive predictive value (PPV) was 93.5%, and negative predictive value (NPV) was 89.1%.
- A significant difference in cycle threshold values was observed between positive and negative POC test results (17.6 vs. 24.6, p < 0.001), indicating a correlation with viral load.
Conclusions:
- The RT-LAMP POC test exhibits high specificity and a fair predictive value in emergency medical settings, particularly for identifying cases with high viral load.
- The test's performance suggests its utility for rapid SARS-CoV-2 detection in resource-limited or time-sensitive environments.
- The Cohen's Kappa coefficient of 0.74 indicates good agreement between the RT-LAMP POC test and the RT-qPCR reference method.
