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. 2021 Jun 10:11:630552.
doi: 10.3389/fcimb.2021.630552. eCollection 2021.

Analytical and Clinical Evaluation of "AccuPower SARS-CoV-2 Multiplex RT-PCR kit (Bioneer, South Korea)" and "Allplex 2019-nCoV Assay (Seegene, South Korea)" for SARS-CoV-2 RT-PCR Diagnosis: Korean CDC EUA as a Quality Control Proxy for Developing Countries

Byron Freire-Paspuel  1 , Miguel Angel Garcia-Bereguiain  1
Affiliations

Analytical and Clinical Evaluation of "AccuPower SARS-CoV-2 Multiplex RT-PCR kit (Bioneer, South Korea)" and "Allplex 2019-nCoV Assay (Seegene, South Korea)" for SARS-CoV-2 RT-PCR Diagnosis: Korean CDC EUA as a Quality Control Proxy for Developing Countries

Byron Freire-Paspuel et al. Front Cell Infect Microbiol. .

Abstract

Background: Multiple RT-qPCR kits are available in the market for SARS-CoV-2 diagnosis, some of them with Emergency Use Authorization (EUA) by FDA or their country of origin agency, but many of them lack of proper clinical evaluation.

Objective: We evaluated the clinical performance of two Korean SARS-CoV-2 RT-PCR kits available in South America, AccuPower SARS-CoV-2 Multiplex RT-PCR kit (Bioneer, South Korea) and Allplex 2019-nCoV Assay (Seegene, South Korea), for RT-qPCR SARS-CoV-2 diagnosis using the CDC protocol as a gold standard.

Results: We found strong differences among both kits clinical performance and analytical sensitivity; while the Allplex 2019-nCoV Assay has sensitivity of 96.5% and an estimated limit of detection of 4,000 copies/ml, the AccuPower SARS-CoV-2 Multiplex RT-PCR kit has a sensitivity of 75.5% and limit of detection estimated to be bigger than 20,000 copies/ml.

Conclusions: AccuPower SARS-CoV-2 Multiplex RT-PCR kit and Allplex 2019-nCoV Assay are both made in South Korea but EUA by Korean CDC was only granted to the later. Our results support that Korean CDC EUA should be considered as a quality control proxy for Korean SARS-CoV-2 RT-PCR kits prior to importation by developing countries to guarantee high sensitivity diagnosis.

Keywords: Bioneer; RT-PCR; SARS-CoV-2; Seegene; developing countries.

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Conflict of interest statement

The authors declare that their affiliation institution “Universidad de Las Américas” is involved in the commercialization of “ECUGEN SARS-CoV-2 RT-qPCR kit”. However, that kit was not used in the present study.

References

    1. CDC. Interim Guidelines for Collecting, Handling, and Testing Clinical Specimens From Persons for Coronavirus Disease 2019 (Covid-19) (2020). Available at: https://www.cdc.gov/coronavirus/2019-ncov/lab/guidelines-clinical-specim... (Accessed last access 09/05/20).
    1. FDA. (2020). Available at: https://www.fda.gov/medical-devices/emergency-situations-medical-devices....
    1. Farfour E., Lesprit P., Visseaux B., Pascreau T., Jolly E., Houhou N. (2020). The Allplex 2019-nCoV (Seegene) Assay: Which Performances are for SARS-CoV-2 Infection Diagnosis? Eur. J. Clin. Microbiol. Infect. Dis. 39, 1997–2000. 10.1007/s10096-020-03930-8 - DOI - PMC - PubMed
    1. Freire-Paspuel B., Garcia-Bereguiain M. A. (2020). Poor Sensitivity of AccuPower SARS-Cov-2 Real Time RT-PCR Kit (Bioneer, South Korea). Virol. J. 17 (1), 178. 10.1186/s12985-020-01445-4 - DOI - PMC - PubMed
    1. Freire-Paspuel B., Garcia-Bereguiain M. A. (2021). Analytical Sensitivity and Clinical Performance of a Triplex RT-qPCR Assay Using CDC N1, N2 and RP Targets for SARS-CoV-2 Diagnosis. Int. J. Infect. Dis. S1201-9712 (20), 32250–32255. 10.1016/j.ijid.2020.10.047 - DOI - PMC - PubMed

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