“One health" inspired SARS-CoV-2 surveillance: The Galapagos Islands experience

Abstract

The COVID-19 pandemic has spread worldwide since the outbreak in Wuhan (China) in December 2019, currently infecting over 25 million people and causing more than 800.000 deaths. In Ecuador, up to the 30th of August 2020, overall 113.648 confirmed cases and 6.555 deaths have been declared. Besides overloading of hospital, capacity for molecular diagnosis of SARS-CoV-2 by the Ministry of Public Health was quickly overwhelmed. In this context, emergency authorization for SARS-CoV-2 RT-qPCR diagnosis was granted to other institutions, like the “Agencia de Regulación y Control para la Bioseguridad y Cuarentena de Galápagos” (ABG), that implemented “LabGal” with support of One Health Research Group from “Universidad de Las Américas” (UDLA). The previous experience of ABG and the One Health Research Group in conducting massive surveillance of zoonotic diseases on livestock was crucial to the success on the control of COVID-19 outbreak at Galapagos Islands by the end of May 2020, when Latin American countries were leading the spread of the pandemic.

Poor sensitivity of "AccuPower SARS-CoV-2 real time RT-PCR kit (Bioneer, South Korea)"

“…The viral loads detailed on Table 2 were calculated running a calibration curve with 2019-nCoV N positive control (IDT, USA). The LoD for the CDC protocol was set at 1000 viral RNA copy per mL of sample (or 5 RNA copies/µL of RNA extraction solution) on previous studies [2,6,[8][9][10][11]. Although LoD could not be calculated for "AccuPower SARS-CoV-2 Real Time RT-PCR kit" as we described on the methods, no true positive samples were obtained below 40.000 RNA copies/mL of sample (200 RNA copies/µL of RNA extraction solution) according to the CDC protocol; even the sample 13617 (Table 2) with a viral load of 453 copies/µL (90,600 copies/mL of sample) was not detected by "AccuPower SARS-CoV-2 Real Time RT-PCR kit".…”

Clinical Performance and Analytical Sensitivity of Three SARS-CoV-2 Nucleic Acid Diagnostic Tests

“…As the LoD of 2019-nCoV Nucleic Acid Diagnostic Kit (Sansure Biotech) is 1 copie/μL according to the manufacturers, these three "false-positive" samples would be actually true-positive SARS-CoV-2 samples that are below the LoD of the CDC protocol. [7][8][9][10][11] So the real specificity for 2019-nCoV Nucleic Acid Diagnostic Kit (Sansure Biotech) is 100%.…”

“…All the samples included on the study were tested following an adapted version of the CDC protocol: (1) using AccuPrep Viral RNA extraction kit (Bioneer, Daejeon, South Korea) as an alternate RNA extraction method, and (2) using CFX96 BioRad instrument. [8][9][10][11][12] RT-qPCR for SARS-CoV-2 diagnosis using COVID-19 Nucleic Acid Test Kit (eDiagnosis). Same RNA extractions from all the samples included in the study were tested using COVID-19 Nucleic Acid Test Kit (eDiagnosis), following the manufacturer's manual.…”

Low clinical performance of the Isopollo COVID-19 detection kit (M Monitor, South Korea) for RT-LAMP SARS-CoV-2 diagnosis: A call for action against low quality products for developing countries

“…All of the samples included in the study were tested following an adapted version of the CDC protocol reported previously by our laboratory ( Freire-Paspuel et al, 2020b , Freire-Paspuel et al, 2020c , Freire-Paspuel and Garcia-Bereguiain, 2020a , Freire-Paspuel et al, 2020 , Freire-Paspuel and Garcia-Bereguiain, 2020b , Freire-Paspuel et al, 2020d ).…”