Comparison of the analytical sensitivity of seven commonly used commercial SARS-CoV-2 automated molecular assays

Mostafa, Heba H.; Hardick, Justin; Morehead, Elizabeth; Miller, Jo Anne; Gaydos, Charlotte A.; Manabe, Yukari C.

doi:10.1016/j.jcv.2020.104578

Cited by 75 publications

(68 citation statements)

References 32 publications

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“…The performance of the Molecular BD Max system for the detection of different pathogens has been evaluated previously [ 15 , 27 , 28 ]. These studies demonstrated that the BD MAX system is a good diagnostic tool with a rapid turnaround time, enabling appropriate treatment decisions.…”

Section: Discussionmentioning

confidence: 99%

“…respiratory illness from SARS-CoV-2, especially during influenza season, because common clinical manifestations of COVID-19, including fever, cough, and dyspnoea, mimic those of other upper-respiratory infections.DiscussionTaiwan experienced two waves of imported cases of COVID-19: first from China in January to late February, and then from other countries starting in early March. As of 26 November 2020, the self-governing island reported 623 COVID-19 cases, a number that has remained relatively low due to a series of aggressive containment strategies, including mandatory social distancing and wearing masks, quarantine, and monitoring measures that have limited the local transmission of the SARS-CoV-2.The performance of the Molecular BD Max system for the detection of different pathogens has been evaluated previously[15,27,28]. These studies demonstrated that the BD MAX system is a good diagnostic tool with a rapid turnaround time, enabling appropriate treatment decisions.…”

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confidence: 99%

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Novel dual multiplex real-time RT-PCR assays for the rapid detection of SARS-CoV-2, influenza A/B, and respiratory syncytial virus using the BD MAX open system

Chung

Jian

Chang

et al. 2021

Emerging Microbes & Infections

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Severe acute respiratory syndrome-coronavirus 2 (SARS-CoV-2) has spread rapidly, causing deaths worldwide. In this study, we evaluated the performance of the BD MAX Open System module for identifying viral pathogens, including SARS-CoV-2, in nasopharyngeal specimens from individuals with symptoms of upper respiratory tract infection. We developed and validated a rapid total nucleic acid extraction method based on real-time reverse transcription-polymerase chain reaction (RT-PCR) for the reliable, high-throughput simultaneous detection of common cold viral pathogens using the BD MAX Platform. The system was evaluated using 205 nasopharyngeal swab clinical samples. For assessment of the limit of detection (LoD), we used SARS-CoV-2, influenza A/B, and respiratory syncytial virus (RSV) RNA standards. The BD MAX dual multiplex real-time RT-PCR panel demonstrated a sensitivity comparable to that of the World Health Organization-recommended SARS-CoV-2 assay with an LoD of 50 copies/PCR. The LoD of influenza A/B and RSV was 100-200 copies/PCR. The overall percent agreement between the BD MAX panel and laboratory-developed RT-PCR test on 55 SARS-CoV-2-positive clinical samples was 100%; no cross-reactions were encountered. Among the 55 positive cases of COVID-19 analysed, no coinfection was detected. The BD MAX rapid multiplex PCR provides a highly sensitive, robust, and accurate assay for the rapid detection of SARS-CoV-2, influenza A/B, and RSV. Our assay could accurately identify SARS-CoV-2 and other common respiratory viral infections, shortening the turnaround time, and could thus increase the effectiveness of control and prevention measures for this emerging infectious disease.

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Section: Discussionmentioning

confidence: 99%

mentioning

confidence: 99%

Novel dual multiplex real-time RT-PCR assays for the rapid detection of SARS-CoV-2, influenza A/B, and respiratory syncytial virus using the BD MAX open system

Chung

Jian

Chang

et al. 2021

Emerging Microbes & Infections

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“…Disease surveillance largely took two forms in the dormitories: passive case detection through an onsite medical post and active case finding through close-contact investigations. Residents presenting to the medical post with symptoms of acute respiratory illness (ARI)—defined as rhinorrhoea, pharyngitis, cough, shortness of breath or fever—had a nasopharyngeal swab polymerase chain reaction (PCR) test using the Roche Cobas® 6800 assay ( Mostafa et al, 2020 ). Two local laboratories provided additional PCR capacity: the National Public Health Laboratory, using the Life Technologies TaqPath COVID-19 Combo Kit, and the Defence Science Organization using a real-time PCR assay that was developed in-house.…”

Section: Methodsmentioning

confidence: 99%

SARS-CoV-2 in migrant worker dormitories: Geospatial epidemiology supporting outbreak management

Gorny¹,

Bagdasarian²,

Koh³

et al. 2021

International Journal of Infectious Diseases

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Background Migrant worker dormitories—residential complexes where 10–24 workers share living spaces—account for the majority of cases of SARS-CoV-2 infection in Singapore. To prevent overspill of transmission to the wider population, starting in early April 2020, residents were confined to their dormitories while measures were put in place to arrest the spread of infection. This descriptive study presents epidemiological data for a population of more than 60 000 migrant workers living in two barracks-style and four apartment-style dormitories located in western Singapore from April 3 to June 10, 2020. Methods Our report draws from data obtained over the first 50 days of outbreak management in order to describe SARS-CoV-2 transmission in high-density housing environments. Cumulative counts of SARS-CoV-2 cases and numbers of housing units affected were analyzed to report the harmonic means of harmonic means of doubling times and their 95% confidence intervals (CI). Results Multiple transmission peaks were identified involving at least 5467 cases of SARS-CoV-2 infection across six dormitories. Our geospatial heat maps gave an early indication of outbreak severity in affected buildings. We found that the number of cases of SARS-CoV-2 infection doubled every 1.56 days (95% CI 1.29–1.96) in barracks-style buildings. The corresponding doubling time for apartment-style buildings was 2.65 days (95% CI 2.01–3.87). Conclusions Geospatial epidemiology was useful in shaping outbreak management strategies in dormitories. Our results indicate that building design plays an integral role in transmission and should be considered in the prevention of future outbreaks.

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“…The kit is authorized by the Argentine Administración Nacional de Medicamentos, Alimentos y Tecnología Médica to be distributed in Argentina. The analytical sensitivity of the kit for testing the extracted RNA samples was 7.5 copies/µL (within the range of commercial RT-qPCR [100–1000 copies/mL]) [ 15 ]; clinical sensitivity and specificity were 99.03% and 99.04%, respectively, and no cross-reactivity was observed.…”

Section: Introductionmentioning

confidence: 99%

Evaluation of a Lyophilized CRISPR-Cas12 Assay for a Sensitive, Specific, and Rapid Detection of SARS-CoV-2

Lucia

Primost²,

Valla

et al. 2021

Viruses

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We evaluated a lyophilized CRISPR-Cas12 assay for SARS-CoV-2 detection (Lyo-CRISPR SARS-CoV-2 kit) based on reverse transcription, isothermal amplification, and CRISPR-Cas12 reaction. From a total of 210 RNA samples extracted from nasopharyngeal swabs using spin columns, the Lyo-CRISPR SARS-CoV-2 kit detected 105/105 (100%; 95% confidence interval (CI): 96.55–100) positive samples and 104/105 (99.05%; 95% CI: 94.81–99.97) negative samples that were previously tested using commercial RT-qPCR. The estimated overall Kappa index was 0.991, reflecting an almost perfect concordance level between the two diagnostic tests. An initial validation test was also performed on 30 nasopharyngeal samples collected in lysis buffer, in which the Lyo-CRISPR SARS-CoV-2 kit detected 20/21 (95.24%; 95% CI: 76.18–99.88) positive samples and 9/9 (100%; 95% CI: 66.37–100) negative samples. The estimated Kappa index was 0.923, indicating a strong concordance between the test procedures. The Lyo-CRISPR SARS-CoV-2 kit was suitable for detecting a wide range of RT-qPCR-positive samples (cycle threshold range: 11.45–36.90) and dilutions of heat-inactivated virus (range: 2.5–100 copies/µL); no cross-reaction was observed with the other respiratory pathogens tested. We demonstrated that the performance of the Lyo-CRISPR SARS-CoV-2 kit was similar to that of commercial RT-qPCR, as the former was highly sensitive and specific, timesaving (1.5 h), inexpensive, and did not require sophisticated equipment. The use of this kit would reduce the time taken for diagnosis and facilitate molecular diagnosis in low-resource laboratories.

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Comparison of the analytical sensitivity of seven commonly used commercial SARS-CoV-2 automated molecular assays

Abstract: Highlights The analytical sensitivities of seven SARS-CoV-2 molecular assays are compared. A single positive clinical specimen quantified by droplet digital PCR was used for the comparison. The Abbott, the Roche, and the Xpert Xpress assays appear more sensitive.

Cited by 75 publications

References 32 publications

Novel dual multiplex real-time RT-PCR assays for the rapid detection of SARS-CoV-2, influenza A/B, and respiratory syncytial virus using the BD MAX open system

Novel dual multiplex real-time RT-PCR assays for the rapid detection of SARS-CoV-2, influenza A/B, and respiratory syncytial virus using the BD MAX open system

SARS-CoV-2 in migrant worker dormitories: Geospatial epidemiology supporting outbreak management

Evaluation of a Lyophilized CRISPR-Cas12 Assay for a Sensitive, Specific, and Rapid Detection of SARS-CoV-2

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