ABSTRACT
Background Ecuador was harshly impacted by COVID-19, in the region was the epicenter of the pandemic with the highest mortality rates and with the lowest rates of processed samples. Real-time reverse transcription PCR assays are essential to identify and manage the SARS-CoV-2 outbreak. Because of the global emergency, in Ecuador several commercial kits were introduced for use without clinical validation. In this manner, having the need to perform an evaluation with clinical samples before use for population screening. Objective This study aimed to evaluate the diagnostic performance of the nCoV-QS, nCoV-QM-N, nCoV-OM detection kits lately available in Ecuador, against the LightMix E/RdRp kit using nasopharyngeal swab (NPS) samples. Materials and methods 198 nasopharyngeal samples were used (66 fresh NPS and 132 RNA stored samples). All samples were analyzed for SARS-CoV-2 with nCoV-QS, nCoV-QM-N, nCoV-OM detection kits and compared the concordance (Cohen's Kappa index, positive percentage agreement and negative percentage agreement) to LightMix E/RdRp as reference detection kit. Results The 198 samples presented strong concordance (96% nCoV-QM-N, 100% nCoV-OM and 100% nCoV-QS). The individual performance of each gene showed that the nCoV-OM kit had a higher number of samples detected with the ORF3a (52.5%) and N (53.5%) genes. The combined genes demonstrated that ORF3a/N of nCoV-OM and nCoV-QS kits presented a higher percentage of detection with 52.5% and 48.5%, respectively. Finally, the detection rate and cycle threshold were not different between ORF3a, N, and E target genes. Conclusion The nCoV-QS, nCoV-QM-N, and nCoV-OM Detection kits have comparable diagnostic performance to the emergency approved LightMix E/RdRp kit for SARS-CoV-2 detection in suspected COVID-19 patients. COVID-19;Coronavirus;ORF3a gene;rRT-PCR.
ABSTRACT
In December 2019, a novel coronavirus known as SARS-CoV-2 was first detected in Wuhan, China, causing outbreaks of the coronavirus disease COVID-19 that has now spread globally. For this reason, The World Health Organization (WHO) declared COVID-19 a public health emergency in March 2020. People living with pre-existing conditions such as obesity, cardiovascular diseases, type 2 diabetes (T2D), and chronic kidney and lung diseases, are prone to develop severe forms of disease with fatal outcomes. Metabolic diseases such as obesity and T2D alter the balance of innate and adaptive responses. Both diseases share common features characterized by augmented adiposity associated with a chronic systemic low-grade inflammation, senescence, immunoglobulin glycation, and abnormalities in the number and function of adaptive immune cells. In obese and T2D patients infected by SARS-CoV-2, where immune cells are already hampered, this response appears to be stronger. In this review, we describe the abnormalities of the immune system, and summarize clinical findings of COVID-19 patients with pre-existing conditions such as obesity and T2D as this group is at greater risk of suffering severe and fatal clinical outcomes.