Preprints with The Lancet is part of SSRN´s First Look, a place where journals identify content of interest prior to publication. Authors have opted in at submission to The Lancet family of journals to post their preprints on Preprints with The Lancet. The usual SSRN checks and a Lancet-specific check for appropriateness and transparency have been applied. Preprints available here are not Lancet publications or necessarily under review with a Lancet journal. These preprints are early stage research papers that have not been peer-reviewed. The findings should not be used for clinical or public health decision making and should not be presented to a lay audience without highlighting that they are preliminary and have not been peer-reviewed. For more information on this collaboration, see the comments published in The Lancet about the trial period, and our decision to make this a permanent offering, or visit The Lancet´s FAQ page, and for any feedback please contact preprints@lancet.com.
Optimizing SARS-CoV-2 Molecular Diagnostic Using N Gene Target
25 Pages Posted: 3 Dec 2020
More...Abstract
Background: Molecular diagnosis of SARS-CoV-2 is a huge challenge to many countries around the world. The cost of tests to check infected people is inaccessible since specialized teams and equipment are not disposable in remote locations. Herein, we compared the fitness of two primers sets to the SARS-CoV-2 N gene in the molecular diagnosis of COVID-19.
Methods: The 1029 patient samples were tested to presense/abscence molecular test using in house US CDC protocol. We compared the fitness of two primers sets to two different regions of N gene targets.
Findings: Both targets, N1 and N2 displayed similar fitness during testing with no differences between Ct or measurable viral genome copies. In addition, we verified security ranges Cts related to positive diagnostic with Ct above 35 value failuring in 66,6% after retesting of samples.
Interpretation: Our data suggest that it is secure to use just one primer set to the N gene to identify SARS-CoV-2 in samples and the labs should be careful to set positive samples in high Ct values using high cutoffs.
Funding: Associação Baiana de Produtores de Algodão (ABAPA); Associação Baiana de Agricultores Irrigantes da Bahia (AIBA); Fundação de Amparo à Pesquisa do Estado da Bahia (FAPESB) (Grant Number: #1381/2020); FINEP (Grant Number: # 0418000600); CNPq; CAPES, MEC, MCTIC.
Declaration of Interests: None to declare.
Ethics Approval Statement: The Research Ethics Committee of UFOB approved this study in 2020 (license number: 30629520.6.0000.0008). All clinical investigations were conducted according to the Declaration of Helsinki.
Keywords: Diagnostic, SARS-CoV-2, COVID-19, N gene, Reinfection
Suggested Citation: Suggested Citation