Abstract
Introduction: The COVID-19 pandemic has accelerated the need for rapid, accurate, and cost-effective diagnostic methods. Although RT-qPCR is the first-line solution, in the context of limited resources such as Iraq alternatives like RT-LAMP should be evaluated. Aim of this study is evaluation the diagnostic efficacy of RT-LAMP for the screening for SARS-CoV-2 in Iraqi patient samples against RT-qPCR.
Methods: This cross-sectional study was performed on 350 nasopharyngeal swab samples from patients aged between 15-60 years in all Iraqi governorates sampled from January-March 2023. The RT-LAMP and RT-qPCR assays were conducted in parallel on all samples. Diagnostic performance parameters such as sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and overall accuracy were determined.
Results: RT-LAMP performed comparably to RT-qPCR and achieved sensitivity of 96.2% (95% CI 92.8–98.3) and specificity of 98.1% (95% CI 95.2–99.5). The positive predictive value was 97.8% (95% CI: 94.9–99.3) and negative predictive value was 96.7% (95% CI: 93.5–98.6). Detection limit for RT-LAMP was 10 copies/μL, and total assay time from sample to result was 45 min.
Conclusion: RT-LAMP is a confirmed, rapid and inexpensive alternative for detecting SARS-CoV-2 in Iraq, and may be suitable for use at resource constrained settings and point-of-care testing.