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

Freire‐Paspuel, Byron; García-Bereguiaín, Miguel Angel

doi:10.1016/j.ijid.2020.12.088

Cited by 33 publications

(28 citation statements)

References 13 publications

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“… [27] who demonstrated a sensitivity of 97,5% and a specificity of 99,7% with a limited number of surplus pharyngeal samples collected in Germany. Compared to the Isopollo COVID-19 detection kit (M Monitor, South Korea), with a sensitivity of 61.9%, the performance was certainly better [28] . Automated commercial platforms based on RT-LAMP reported comparable results with a decrease of sensitivity at lower viral loads, although differences in operational processing of samples may influence the comparison [29] .…”

Section: Discussionmentioning

confidence: 98%

Diagnostic performance of a colorimetric RT -LAMP for the identification of SARS-CoV-2: A multicenter prospective clinical evaluation in sub-Saharan Africa

Baba¹,

Bitew²,

Fokam³

et al. 2021

EClinicalMedicine

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Background Management and control of the COVID-19 pandemic caused by the severe acute respiratory syndrome coronavirus SARS-CoV-2 is critically dependent on quick and reliable identification of the virus in clinical specimens. Detection of viral RNA by a colorimetric reverse transcription loop-mediated isothermal amplification (RT-LAMP) is a simple, reliable and cost-effective assay, deployable in resource-limited settings (RLS). Our objective was to evaluate the intrinsic and extrinsic performances of RT-LAMP in RLS. Methods This is a multicenter prospective observational study of diagnostic accuracy, conducted from October 2020 to February 2021 in four African Countries: Cameroon, Ethiopia, Kenya and Nigeria; and in Italy. We enroled 1657 individuals who were either COVID-19 suspect cases, or asymptomatic and presented for screening. RNA extracted from pharyngeal swabs was tested in parallel by a colorimetric RT-LAMP and by a standard real time polymerase chain reaction (RT-PCR). Findings The sensitivity and specificity of index RT LAMP compared to standard RT-PCR on 1657 prospective specimens from infected individuals was determined. For a subset of 1292 specimens, which underwent exactly the same procedures in different countries, we obtained very high specificity (98%) and positive predictive value (PPV = 99%), while the sensitivity was 87%, with a negative predictive value NPV = 70%, Stratification of RT-PCR data showed superior sensitivity achieved with an RT-PCR cycle threshold (Ct) below 35 (97%), which decreased to 60% above 35. Interpretation In this field trial, RT-LAMP appears to be a reliable assay, comparable to RT-PCR, particularly with medium-high viral loads (Ct < 35). Hence, RT-LAMP can be deployed in RLS for timely management and prevention of COVID-19, without compromising the quality of output.

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Section: Discussionmentioning

confidence: 98%

Diagnostic performance of a colorimetric RT -LAMP for the identification of SARS-CoV-2: A multicenter prospective clinical evaluation in sub-Saharan Africa

Baba¹,

Bitew²,

Fokam³

et al. 2021

EClinicalMedicine

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“…All the samples included in the study were tested following an adapted version of the CDC protocol: (a) using Accupower Viral RNA extraction kit (Bioneer, South Korea) as an alternate RNA extraction method; (b) using CFX96 BioRad instrument ( Freire-Paspuel et al., 2020a ; Freire-Paspuel and Garcia-Bereguiain, 2020 ; Freire-Paspuel et al., 2020 ; Freire-Paspuel et al., 2020b ; Freire-Paspuel et al., 2020 ; Freire-Paspuel and Garcia-Bereguiain, 2021b ; Freire-Paspuel et al., 2021 ; Ortiz-Prado et al., 2021 ); (c) using a N1/N2/RNaseP multiplex assay ( Freire-Paspuel and Garcia-Bereguiain, 2021a ). The criteria for positivity was a Ct ≤ 40 for N1 and N2 targets simultaneously ( CDC, 2020 ; Xiaoyan et al., 2020 ).…”

Section: Methodsmentioning

confidence: 99%

“…On the other hand, AccuPower SARS-CoV-2 Multiplex RT-PCR kit (Bioneer, South Korea) is also a multiplex SARS-CoV-2 RT-qPCR assay for E, N, and RdRp genes, which are not included neither in the FDA EUA list nor in the Korean CDC EUA list ( FDA, 2020 ; Hong et al., 2020 ). Moreover, we have previously reported that other South Korean SARS-CoV-2 RT-PCR and RT-LAMP kits lacking Korean CDC EUA did not accomplish the clinical performance and analytical sensitivity described at the manufacturer’s manual ( Freire-Paspuel et al., 2020a ; Freire-Paspuel and Garcia-Bereguiain, 2020 ; Freire-Paspuel and Garcia-Bereguiain, 2021b ).…”

Section: Introductionmentioning

confidence: 99%

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

Freire‐Paspuel

García-Bereguiaín

2021

Front. Cell. Infect. Microbiol.

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BackgroundMultiple 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.ObjectiveWe 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.ResultsWe 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.ConclusionsAccuPower 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.

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“…However, the viral load threshold for SARS-CoV-2 transmission is still a matter of discussion ( Avanzato el al. 2020 ; Freire-Paspuel et al 2021 ; Rodríguez-Grande et al 2021 ), so reduced sensitivity for low viral loads is still a limitation of RNA extraction free SARS-CoV-2 diagnosis protocols.…”

Section: Discussionmentioning

confidence: 99%

Analytical and clinical evaluation of a heat shock SARS-CoV-2 detection method without RNA extraction for N and E genes RT-qPCR

Bruno¹,

Mora²,

Freire‐Paspuel³

et al. 2021

International Journal of Infectious Diseases

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Background : The COVID-19 pandemic has caused significant supply shortages worldwide for SARS-CoV-2 molecular diagnosis, like RNA extraction kits. Objective : The aim of our study was to evaluate the clinical performance and analytical sensitivity of a simple SARS-CoV-2 diagnosis protocol based on heat shock without RNA extraction using both "CDC" (N gene) and "Charite" (E gene) RT-qPCR protocols. Results : 1,036 nasopharyngeal samples, 543 of them SARS-CoV-2 positive, were analyzed. The heat shock method correctly identified 68,8% (232/337) and 89.4% (202/226) SARS-CoV-2 positive samples for N gene and E gene, respectively. Analytical sensitivity was assessed for heat shock method using the CDC RT-qPCR protocol, obtaining sensitivity values of 98,6%, 93,3% and 84,8% for limit of detection of 100.000, 50.000 and 20.000 viral RNA copies/mL of sample. Conclusions : Our findings show that a simple heat shock SARS-CoV-2 RT-qPCR diagnosis method without RNA extraction is a reliable alternative for potentially infectious SARS-CoV-2 positive patients. This affordable protocol can help to overcome the cost and supply shortages for SARS-CoV-2 diagnosis, especially in developing countries. In Ecuador, it has been used already by laboratories in the public health system for more than 100.000 specimens.

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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

Cited by 33 publications

References 13 publications

Diagnostic performance of a colorimetric RT -LAMP for the identification of SARS-CoV-2: A multicenter prospective clinical evaluation in sub-Saharan Africa

Diagnostic performance of a colorimetric RT -LAMP for the identification of SARS-CoV-2: A multicenter prospective clinical evaluation in sub-Saharan Africa

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

Analytical and clinical evaluation of a heat shock SARS-CoV-2 detection method without RNA extraction for N and E genes RT-qPCR

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