Comparison of commercial RT-PCR diagnostic kits for COVID-19

Abstract

<jats:title>ABSTRACT</jats:title><jats:p>The final months of 2019 witnessed the emergence of a novel coronavirus in the human population. Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has since spread across the globe and is posing a major burden on society. Measures taken to reduce its spread critically depend on timely and accurate identification of virus-infected individuals by the most sensitive and specific method available, i.e. real-time reverse transcriptase PCR (RT-PCR). Many commercial kits have recently become available, but their performance has not yet been independently assessed.</jats:p><jats:p>The aim of this study was to compare basic analytical and clinical performance of selected RT-PCR kits from seven different manufacturers (Altona Diagnostics, BGI, CerTest Biotec, KH Medical, PrimerDesign, R-Biopharm AG, and Seegene).</jats:p><jats:p>We used serial dilutions of viral RNA to establish PCR efficiency and estimate the 95% limit of detection (LOD95%). Furthermore, we ran a panel of SARS-CoV-2-positive clinical samples (n=16) for a preliminary evaluation of clinical sensitivity. Finally, we used clinical samples positive for non-coronavirus respiratory viral infections (n=6) and a panel of RNA from related human coronaviruses to evaluate assay specificity.</jats:p><jats:p>PCR efficiency was ≥96% for all assays and the estimated LOD95% varied within a 6-fold range. Using clinical samples, we observed some variations in detection rate between kits. Importantly, none of the assays showed cross-reactivity with other respiratory (corona)viruses, except as expected for the SARS-CoV-1 E-gene.</jats:p><jats:p>We conclude that all RT-PCR kits assessed in this study may be used for routine diagnostics of COVID-19 in patients by experienced molecular diagnostic laboratories.</jats:p>

Evaluation of different genes in the RT-PCR detection of SARS-CoV-2 in respiratory samples and its evolution in infection

“…En este trabajo se confirma que la detección del SARSCoV-2 en la primoinfección mediante la amplificación del gen N presenta el porcentaje mas bajo (86,5%) coincidiendo con el estudio de Corman et al [ 2 ] que no cuantifica su sensibilidad por ser excesivamente baja. Por el contrario el gen E y gen RpRd presentan una sensibilidad de detección de unos 10 genomascopias/reacción, siendo los mas sensibles [ 4 ]. En nuestro estudio el 96,5% de las primeras muestras positivas presentaron positividad en este gen y el 94% con el gen E, a pesar que su capacidad de detección es de unas 100 genomas-copias/reacción.…”

Peer Review #1 of "MULTI-DEEP: A novel CAD system for coronavirus (COVID-19) diagnosis from CT images using multiple convolution neural networks (v0.1)"

“…This is due to lack of availability of such test which increase its price (Kobia & Gitaka, 2020). The presently available RT-PCR kits are variable, there are more than 7 platform used for the novel corona virus diagnosis (Al-Tawfiq & Memish, 2020), (van Kasteren et al, 2020). Such tests may result in initial false negative outcomes (Long et al, 2020).…”

“…Such tests may result in initial false negative outcomes (Long et al, 2020). Examples of such kits are Altona Diagnostics, BGI, CerTest Biotec, KH Medical, Primer Design, R-Biopharm AG, and Seegene (van Kasteren et al, 2020). RT-PCR platforms are presenting sensitivities ranging between 45% and 60%; therefore, specifically in the initial course of an infection, repeat testing may be essential to achieve a diagnosis.…”

Gold Nanorod Assisted Enhanced Plasmonic Detection Scheme of COVID‐19 SARS‐CoV‐2 Spike Protein

“…However, considering the increasing number of cases, the PCR kits have not been able to meet the testing demand. [ 16–20 ] Also, underdeveloped and developing countries where there are many people who still live in rural areas, lack proper PCR infrastructure in rural and suburban areas. Finally, since the technique detects the genome structure of the live virus present in the body, it cannot identify recovered asymptomatic patients.…”