Table 1.
Clinical performance and analytical sensitivity of 11 commercial SARS-CoV-2 NAAT kits available in Ecuador. (EUA is referred to clinical authorization use within country of manufacture and/or by FDA).
| Detection kit (company, country) |
Sensitivity (manufacturer) |
Specificity (manufacturer) |
LoD (manufacturer) |
Sensitivity (observed) |
Specificity (observed) |
LoD (viral copies/ml of sample) (copies/µl of RNA extraction) |
EUA | Ref. |
|---|---|---|---|---|---|---|---|---|
|
nCoV-QS
(MiCo BioMed, South Korea) |
NA | NA | 1.8 copies/µl of RNA extraction | 70.6%–100% | 92.9%–100% | 10,000 50 |
Ecuador | (Freire-Paspuel et al., 2020a; Salinas et al., 2022) |
| AccuPower SARS-CoV-2 real time RT-PCR kit (Bioneer, South Korea) | NA | NA | NA | 78.9%–100%* | 100% | 40,000 200 |
Ecuador | (Freire-Paspuel and Garcia-Bereguiain, 2020; Fellner et al., 2021)* |
| AccuPower SARS-CoV-2 Multiplex RT-PCR kit (Bioneer, South Korea) | 100% | 100% | 2 copies/µl of RNA extraction | 73.5% | 100% | 18,000 90 |
Ecuador | (FIND, 2020; Freire-Paspuel and Garcia-Bereguiain, 2021b) |
| Isopollo COVID-19 detection kit (Monitor, South Korea) | NA | NA | NA | 63.4% | 100% | 100,000 500 |
Ecuador | (Freire-Paspuel and Garcia-Bereguiain, 2021a) |
|
GenomeCoV19 kit
(ABM, Canada) |
100% | 100% | 1 copy/µl of RNA extraction solution | 75.0% | 100% | 8,000 40 |
Ecuador | (Freire-Paspuel and Garcia-Bereguiain, 2021c) |
| Allplex 2019-nCoV Assay (Seegene, South Korea) | 100% | 93.07% | 12.5 RNA c/µl of RNA extraction solution | 87.7%–98.2% | 93.75%–100% | 2,000–4,000 10–20 |
S.Korea/FDA | (Hur et al., 2020; Freire-Paspuel and Garcia-Bereguiain, 2021b; Hernandez et al., 2021; Liotti et al., 2021) |
|
Viasure SARS-CoV-2
(CerTest Biotec, Spain) |
100% | 97.5% | 4 copies/µl of RNA extraction | 91.86% | 100% | 2,000 10 |
Spain | (Freire-Paspuel et al., 2021c) |
| COVID-19 (SARS-CoV-2) Nucleic Acid Test Kit (eDiagnosis, China) | 95.93% | 94.07% | 500 copies/ml of sample | 100% | 94.1%–100% | 500 2.5 |
China | (Hernandez et al., 2021; Freire-Paspuel et al., 2021) |
|
Novel Coronavirus (2019-nCoV) Nucleic Acid Diagnostic Kit
(Sansure Biotech, China) |
100% | 100% | 200 copies/ml of sample | 83.3%–95.3% | 87.5%–100% | 484–3,000 0.66-5 |
China/FDA | (Iglói et al., 2020; Wang et al., 2020; Xiong et al., 2020; Yu et al., 2020; Freire-Paspuel et al., 2021) |
| COVID-19 RT-PCR Real TM Fast (Cy5) (ATGen) | NA | NA | NA | 96.4% | 96%–100% | 2,000 10 |
Uruguay | (Freire-Paspuel et al., 2022) |
|
Detection Kit for 2019 Novel Coronavirus (2019-nCoV) RNA
(Da An Gene, China) |
100% | 100% | 500 copies/ml of sample | 78.6%–100% | 100% | 484–3,000 0.16–10 |
China | (Iglói et al., 2020; Wang et al., 2020; Xiong et al., 2020; Yu et al., 2020; Freire-Paspuel and Garcia-Bereguiain, 2021c) |
|
ECUGEN SARS-CoV-2 RT-PCR kit
(UDLA-Starnewcorp; Ecuador) |
97.7% | 100% | 5 copies/µl of RNA extraction | 100% | 94.6%–100% | 500–1,000 2.5–5 |
Ecuador | (Freire-Paspuel et al., 2022) |
* Fellner et al., 2021 reports 100% sensitivity but is not a clinical performance evaluation as only artificial SARS-CoV-2 samples were used.
Sensitivity, specificity, and the limit of detection reported by manufacturers and by scientific publications are detailed (EUA, Emergency Use Authorization at the country of production and by the FDA; FDA, US Food and Drug Administration; Ref, references; NA, not available).