Evaluation of Viasure SARS-CoV-2 RT-qPCR kit (CerTest Biotec) using CDC FDA EUA RT-qPCR kit as a gold standard

Abstract

<jats:p>Abstract. Background. Several RT-qPCR kits are available for SARS-CoV-2 diagnosis, some of them with Emergency Use Authorization (EUA) by FDA, but most of them lacking of proper evaluation studies due to covid19 emergency. Objective. We evaluated Viasure RT-qPCR kit (CerTest Biotec, Spain) for SARS-CoV-2 diagnosis using CDC FDA EUA kit as gold standard. Results. Although we found the lack of RNA quality control probe as the main limitation for Viasure kit, the sensitivity was up to 97.5% and specificity was 100%. Conclusions. Viasure RT-qPCR kit is a reliable tool for SARS-CoV-2 diagnosis but improvement of an alternative RT-qPCR reaction for RNA extraction quality control as RNaseP is recommended.</jats:p>

SARS-CoV, MERS-CoV and SARS-CoV-2: A Diagnostic Challenge

“…It is also reported that the elderly as well as those with underlying health issues such as cancer, chronic respiratory disease, diabetes and cardiovascular disease have a greater chance of developing serious illness [20] , [21] , [22] , [23] , [24] , [25] . In particular, those 80 plus people who have never been vaccinated for pneumonia or flu, who live in facility-based long-term care services and residential care homes, are at greater risk for developing deadly diseases owing to COVID-19 [27] , [28] , [29] , [30] , [31] , [32] . In addition, COVID-19 has been observed to be more lethal in senior citizens with chronic illnesses including kidney lung and heart if they are infected with HIV or have had cancer.…”

“…Nearly, 15 percent of them have cough and fever, while 90 percent of people have more than one symptom. It has been urged that anyone over 65 with elevated respiratory symptoms must seek medical advice from the health care professionals [27] , [28] , [29] , [30] , [31] , [32] . As most visitors to old-age homes may be carriers of the viral infection caused by SARS-CoV-2, visitors are not permitted to enter the old-age homes.…”

“…As most visitors to old-age homes may be carriers of the viral infection caused by SARS-CoV-2, visitors are not permitted to enter the old-age homes. Since most elderly people in old-age homes are vulnerable and intellectually disabled with numerous diseases, they are at higher risk of life - threatening illness [27] , [28] , [29] , [30] , [31] , [32] . The key to decelerating transmission and combating COVID-19 virus is to create awareness of the facts that it typically causes the disease and how well it spreads.…”

“…As per a prospective study of 2143 hospitalized patients identified in the registry of the China Centre for Disease Control and Prevention, 731 instances have been verified using clinical tests [27] , [28] , [29] , [30] , [31] , [32] , [33] , [34] , [35] . Of these 731 cases, 38.8% were moderately symptomatic, 50.9% were mild symptomatic and 4.4% were asymptomatic.…”

“…In the current scenario, extensive awareness of in-depth education about SARS-CoV-2, SARS-CoV and MERS-CoV and multi-directional care between healthcare professionals and hospitalized patients infected with the above-mentioned viruses can help reduce the spread of these viruses [28] , [29] , [30] . It is therefore necessary to have an adequate knowledge of its reservoir, its distribution method and the best accessible management as well as preventive measures [31] , [32] , [33] . Closer monitoring and awareness remain a primary concern for doctors as well as health officials alike [34] , [35] .…”