Highlights
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The analytical sensitivities of seven SARS-CoV-2 molecular assays are compared.
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A single positive clinical specimen quantified by droplet digital PCR was used for the comparison.
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The Abbott, the Roche, and the Xpert Xpress assays appear more sensitive.
Keywords: SARS-CoV-2, COVID-19, LOD
Abstract
The SARS-CoV-2 pandemic has challenged molecular microbiology laboratories to quickly implement and validate diagnostic assays and to expand testing capacity in a short timeframe. Multiple molecular diagnostic methods received FDA emergency use authorization (EUA) and were promptly validated for use nationwide. Several studies reported the analytical and/ or clinical evaluation of these molecular assays, however differences in the viral materials used for these evaluations complicated direct comparison of their analytical performance. In this study, we compared the analytical sensitivity (lower limit of detection, LOD) of seven commonly used qualitative SARS-CoV-2 molecular assays: the Abbott Molecular RealTime SARS-CoV-2 assay, the NeuMoDx™ SARS-CoV-2 assay, the Roche Cobas®SARS-CoV-2 assay, the BD SARS-CoV-2 reagents for BD MAX™ system, the Hologic Aptima® SARS-CoV-2 assay, the Xpert Xpress SARS-CoV-2 test, and the GenMark ePlex SARS-CoV-2 test. The comparison was performed utilizing a single positive clinical specimen that was serially diluted in viral transport media and quantified by the EUA approved SARS-CoV-2 droplet digital PCR (ddPCR) assay. Replicate samples were prepared and evaluated for reproducibility across different molecular assays with multiple replicates per assay. Our data demonstrated that the seven assays could detect 100 % of replicates at a nucleocapsid gene concentration of (N1 = 1,267 and N2 = 1,392) copies/mL. At a one log less concentration, the Abbott, the Roche, and the Xpert Xpress assays detected 100 % of the tested replicates.
1. Introduction
The first case of coronavirus disease-19 (COVID-19) was reported to the World Health Organization (WHO) country office in China on December 31st, 2019 [1]. A highly pathogenic novel coronavirus, SARS-CoV-2 was identified and its genome was characterized in respiratory clinical specimens of the first diagnosed COVID-19 patients in China [2,3]. Since that time, cases of COVID-19 have been reported from every country worldwide with over 11 million confirmed cases. A Public Health Emergency of International Concern was declared by the WHO on January 30th, 2020 with a Public Health Emergency declared in the US on January 31st. On February 4th, the US Food and Drug Administration (FDA) granted an Emergency Use Authorization (EUA) to the Center of Disease and Control (CDC)’s diagnostic molecular assay. On February 29th, the FDA updated their guidance to allow clinical microbiology laboratories and commercial parties to develop in vitro SARS-CoV-2 assays and seek independent EUA [4]. Beginning in March, the number of SARS-CoV-2 molecular diagnostic assays with EUA increased rapidly, many of them being developed for existing, automated and integrated (nucleic acid extraction and RT-PCR) diagnostic systems [4].
Molecular detection of SARS-CoV-2 viral RNA has been used as the gold standard for diagnosis of COVID-19 [5]. Hence, an understanding of the analytical and clinical performance of various SARS-CoV-2 molecular methods is essential. In particular, the analytical sensitivity limitations and the relative sensitivity of different assays is important due to the large number of individuals that may carry transmissible virus asymptomatically in low copy number [6]. In addition, the recognition of initially false negative molecular testing in some patients who ultimately tested positive further highlights the importance of understanding the limit of detection [7]. The initial development of SARS-CoV-2 molecular assays was challenging due to the paucity of clinical specimens, viral controls, and/or material reagents for the validations. Different companies and laboratories used different materials for assessing the analytical and clinical sensitivities of their assays which were quantified differently. For example, the Abbott Molecular RealTime SARS-CoV-2 and Xpert Xpress SARS-CoV-2 assays both utilized recombinant virus for analytical sensitivity determination, while the NeuMoDx™ SARS-CoV-2 Assay utilized genomic RNA, and the GenMark ePlex SARS-CoV-2 test utilized in vitro transcripts for analytical sensitivity determination. These differences, coupled with differences in sample volume, extraction volume and amplification technology has made direct comparison across platforms challenging. Utilizing SARS-CoV-2 droplet digital PCR (ddPCR) [8] quantified single positive clinical specimen, we compared the analytical sensitivity of seven SARS-CoV-2 EUA-granted assays, the Abbott Molecular RealTime, the NeuMoDx™, the Roche Cobas®, the BD SARS-CoV-2 reagents for BD MAX™ system, the Hologic Aptima®, the Xpert Xpress, and the GenMark ePlex SARS-CoV-2 tests. Comparisons were performed using the same quantified specimen and were facilitated by the in-house availability of these assays for SARS-CoV-2 diagnosis at Johns Hopkins Hospital Clinical Laboratory and the Johns Hopkins Center for Innovative Diagnostics for Infectious Diseases.
2. Methods
2.1. Standard and serial dilution preparation
The study was approved by the Johns Hopkins University School of Medicine IRB (IRB00246024). A SARS-CoV-2 positive nasopharyngeal specimen diagnosed at the molecular virology laboratory at John Hopkins Hospital by our original standard-of-care assay, the RealStar® SARS-CoV-2 RT-PCR (Altona Diagnostics, Hamburg, Germany) was used as a standard (Spike target cycle threshold [Ct] = 15) [9]. The specimen was diluted serially in viral transport media (VTM, Copan Diagnostics, Murieta, CA) and dilutions of 1:105 and 1:106 were quantified in duplicates using the EUA approved BioRad ddPCR assay per EUA package insert with the exception of using an automated extraction using the NucliSENS easyMag (bioMérieux, Marcy-l'Étoile, France) as described before [4,10] The average concentration of both the N1 target gene and N2 target gene copies at each dilution was determined to be 10,956 and 10,759 copies/mL (1:105 dilution) and 1,267 and 1,392 copies/mL (1:106 dilution), respectively. An additional dilution was prepared and the concentration was estimated to be 126.7 and 139.2 copies/ mL for both the N1 and N2 gene targets. Replicate samples were prepared for each of these concentrations and ranged from a maximum of ten replicates for the Abbott Molecular SARS-CoV-2 assay (Abbott Molecular, Des Plaines, Il) and NeuMoDx™ SARS-CoV-2 assay (NeuMoDx, Ann Arbor, Michigan) to a low of 3 replicates for the Xpert Xpress SARS-CoV-2 test (Cepheid, Sunnyvale, CA) and the ePlex SARS-CoV-2 test (GenMark, Carlsbad, CA). The number of replicates varied due to the availability of kit reagents and materials necessary to perform each assay.
2.2. Sample evaluation
For each assay, testing was performed per manufacturer instructions: Abbott Molecular RealTime SARS-CoV-2 assay (Abbott Molecular, Des Plaines, Il) [11], NeuMoDx™ SARS-CoV-2 assay (NeuMoDx, Ann Arbor, Michigan) [12], Roche Cobas®SARS-CoV-2 assay [13], Becton Dickinson BD Max reagents (Becton Dickinson, Sparks, MD) [14], Hologic Aptima® SARS-CoV-2 assay (Hologic, Bedford, MA) [15], Cepheid Xpert Xpress SARS-CoV-2 test (Cepheid, Sunnyvale, CA) [16], GenMark ePlex SARS-CoV-2 test (GenMark, Carlsbad, CA) [17]. Although 10 replicates were tested for the majority of platforms, the number of assays performed varied based on availability of reagents and replicates.
3. Results
Results for each assay, the Abbott Molecular RealTime SARS-CoV-2, the NeuMoDx™ SARS-CoV-2, the Roche Cobas®SARS-CoV-2, the BD SARS-CoV-2 reagents for BD MAX™ system, the Hologic Aptima® SARS-CoV-2, the Xpert Xpress SARS-CoV-2, and the GenMark ePlex SARS-CoV-2 tests are summarized in Table 1 . Replicates at the most diluted set (N1 = 126.7 copies/ mL and N2 = 139.2 copies/ mL) were detected 100 % of the time with the Abbott RealTime SARS-CoV-2 assay and the Roche Cobas®SARS-CoV-2 assay. The Xpert Xpress SARS-CoV-2 test did not detect the N2 target in one replicate at this concentration, however because it did detect the E target at that concentration, the result was reported positive. All the tested assays were able to detect all the tested replicates at a one log higher concentration of 1,267 and 1,392 copies/mL for the N1 and N2 gene targets.
Table 1.
Platform/Assay | Sample Input* Volume (μl) | Concentrationa | Gene Target | Detected/ Total | %b | Average Ct | Stdevc |
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Abbott Molecular/ RealTime SARS-CoV-2 assay | 600 | 1,267 | RdRp/N | 10/10 | 100 | 23.71 | 0.29 |
126.7 | RdRp/N | 10/10 | 100 | 27.03 | 0.65 | ||
NeuMoDx™ SARS-CoV-2 Assay | 500 | 1,267 | N | 5/5 | 100 | 33.19 | 0.23 |
Nsp2 | 5/5 | 100 | 33.49 | 0.36 | |||
126.7 | N | 8/10 | 80 | 33.90 | 0.33 | ||
Nsp2 | 3/10 | 30 | 33.51 | 0.73 | |||
Roche/ Cobas®SARS-CoV-2 Test | 800 | 1,267 | ORF1ab | 3/3 | 100 | 32.85 | 0.02 |
E | 3/3 | 100 | 33.61 | 0.03 | |||
126.7 | ORF1ab | 9/9 | 100 | 34.95 | 0.81 | ||
E | 9/9 | 100 | 36.25 | 1.09 | |||
BD SARS-CoV-2 Reagents for BD MAX™ System | 750 | 1,267 | N1 | 3/3 | 100 | 32.83 | 0.15 |
N2 | 3/3 | 100 | 32.10 | 0.26 | |||
126.7 | N1 | 4/8 | 50 | 37.33 | 0.70 | ||
N2 | 7/8 | 87.5 | 36.03 | 1.91 | |||
Hologic/ Aptima® SARS-CoV-2 Assay | 500 | 1,267 | Orf1ab | 3/3 | 100 | N/A | N/A |
126.7 | 7/8 | 87.5 | N/A | N/A | |||
Xpert Xpress SARS-CoV-2 | 300 | 1,267 | E | 3/3 | 100 | NC | NC |
N2 | 3/3 | 100 | NC | NC | |||
126.7 | E | 3/3 | 100 | 40.20 | 2.63 | ||
N2 | 2/3 | 66.67 | 40.35 | 2.33 | |||
GenMark/ ePlex SARS-CoV-2 Test | 200 | 1,267 | N | 3/3 | 100 | N/A | N/A |
126.7 | 1/3 | 33.33 | N/A | N/A |
aCopies/mL determined by ddPCR for the N1 target gene.
N/A – not applicable, NC – not calculated.
Percentage of replicates detected.
Standard deviation.
The input volume is based on the volume loaded per specimen and not the volume used per reaction.
4. Discussion
In this study, we compared the analytical sensitivities of seven common, commercially available assays for the molecular detection of SARS-CoV-2. Our comparison was performed using the same quantified clinical specimen allowing parallel evaluation. Our results show higher analytical sensitivities of the Roche (Cobas), the Abbott, and the GeneXpert (Xpert Xpress) assays when compared to the NeuMoDx, the BD MAX, the GenMark (ePlex), and the Hologic (Aptima) assays. The analytical sensitivities of all the assays assessed were in a range less than 1,000 copies/ mL indicating excellent analytical performance.
In general, the analytical performance of molecular assays is usually determined by the selection of the assay, the assay design and the selected target. Most of the current molecular diagnostics for SARS-CoV-2 are real-time PCR (RT-PCR) assays, however technologies that include CRISPR (clustered regularly interspaced short palindromic repeats)-based [18] and Loop Mediated Amplification (LAMP) assays have also been developed [19,20]. Most of the assays compared in our study are RT-PCR methods with the exception of the GenMark (ePlex) that involves an initial amplification followed by hybridization and electrochemical detection and the Hologic (Aptima) that uses a transcription-mediated amplification (TMA) technology. Our study identified only slight differences in the analytical sensitivity of the RT-PCR methods and comparable sensitivities using the GenMark (ePlex) and Hologic (Aptima) assays, indicating comparable performance. The assays we evaluated also target different genes in the SARS-CoV-2 genome, mainly the nucleocapsid (N), envelope (E), non-structural protein (Nsp)2, and open reading frame ORF1/2 (Table 1). The N1 and N2 targets within the N gene were recommended by the CDC [21,22] and were selected for their assay, while the WHO recommends an initial screening with the E gene followed by confirmation with the RNA dependent RNA polymerase (RdRp) [23]. Our data, as well as other published data illustrate that the assay performance for SARS-CoV-2 detection is not dictated by the selected gene. However, a recent report concluded higher sensitivity of primers that target the N2 or the E genes [24]. The approach of targeting two genes appears to enhance the assays’ sensitivities (Table 1) and could also reduce the risk of sensitivity reduction associated with genomic polymorphisms [25].
Understanding the analytical performance of SARS-CoV-2 assays is essential for better understanding their clinical performance. Standardized materials for determining the analytical sensitivity or lower limit of detection (LOD) for EUA applications and validations were not available and different companies and laboratories used different approaches that included using in vitro synthesized transcripts (IVT) (e.g. GenMark), cultured virus (e.g. Roche), or SARS-CoV-2 genomic RNA (e.g. NeuMoDx) (Table 2 ). As a step forward for optimizing the validations and collecting comparable assays’ performance data, the FDA currently offers reference panels for EUA applications which should also assist in different assays’ calibrations and on-going monitoring of the performance [26]. Although several papers have been published comparing the characteristics and sensitivities between a few SARS-CoV-2 molecular tests (Table 2) and [10,[27], [28], [29], [30], [31], [32], [33], [34], [35], [36], [37], [38]], our study provides a direct comparison between 7 of the most commonly used commercially available assays using the same quantified clinical specimen.
Table 2.
Assay | Assay time | LOD/ materials used/ reference | References |
---|---|---|---|
GenMark/ Eplex SARS-Cov-2 Test | 1 h 42 min | 1 × 105 copies/ mL/ in vitro transcripts / per EUA PI 1,000 copies/mL/ Exact Diagnostics SARS-CoV-2 standard [27,31] 600 copies/mL/ Genomic viral RNA [10] |
[10,27,31] |
Xpert Xpress SARS-Cov-2 | 46 minutes | 250 copies/ mL/ AccuPlex SARS-CoV-2 reference material/ per EUA PI 100 copies/mL / Exact Diagnostics [31] |
[30,31,39] |
Roche/ Cobas®SARS-Cov-2 Test | 384 specimens/8 h, 3.75 h/ run | 0.007 TCID50/mL for SARS-CoV-2 (Orf1ab) and 0.004 TCID50/mL for pan-Sarbecovirus (E) / cultured virus/ per EUA PI | [30,32,37,[39], [40], [41]] |
Abbott Molecular/ Realtime SARS-CoV-2 Assay | 24−94 samples/run, 6.8 h/run | 100 copies/ mL/ Seracare, AccuPlex COVID-19/ per EUA PI | [29,34,36] |
Hologic Aptima® SARS-Cov-2 Assay | 275 samples/ 8 h, 3.5 h/ run | 0.01 TCID50/mL/ inactivated cultured SARS-CoV-2 virus/ per EUA PI | [42] |
NeuModx™ SARS-CoV-2 Assay | 96 or 288 samples/ 8 h, 70 min to first result | 150 copies/mL/ genomic RNA/ per EUA PI | |
BD SARS-Cov-2 Reagents For BD MAX™ System | 24 samples/ 3 h | 40 GE/ mL/ genomic RNA/ per EUA PI |
NP-nasopharyngeal, PI- package insert, GE- genomic equivalent.
There are limitations to our study, including differences in the sample input volume for each assay, differences in the amount of sample processed and analyzed by the assay and differences in the extraction efficiency between assays, which cannot accurately be accounted for, and thus complicate the comparison. Additionally, we did not evaluate the same number of replicates for each assay due to the availability of supplies and replicates as we used dilutions of one specimen.
We demonstrated similar analytical performance of seven FDA EUA commercial SARS-CoV-2 molecular assays; the most sensitive platforms were the Roche and Abbott. With the critical current and future need for the use of molecular SARS-CoV-2 diagnostics not only for diagnosis, but also for asymptomatic large scale screening, it is essential to identify the most sensitive assays to assure early detection and diagnosis of COVID-19, and inform decisions related to contact isolation, measures that are essential to mitigate the current pandemic.
Declaration of Competing Interest
The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.
Acknowledgements
We thank the entire Medical Microbiology division for their assistance with this study. We also thank BioRad Laboratories for their collaboration. Funding: UM1-AI068613 (NIH, USA), U54EB007958 (NIH, USA), Center Of Excellence for Influenza Research and Surveillance (CEIRS, NIH, USA).
References
- 1.WHO (2020), Coronavirus disease (COVID-19) pandemic. Accessed on June 24, 2020.
- 2.Huang C., Wang Y., Li X., Ren L., Zhao J., Hu Y. Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China. Lancet. 2020;395(10223):497–506. doi: 10.1016/S0140-6736(20)30183-5. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 3.Chan J.F., Yuan S., Kok K.H., To K.K., Chu H., Yang J. A familial cluster of pneumonia associated with the 2019 novel coronavirus indicating person-to-person transmission: a study of a family cluster. Lancet. 2020;395(10223):514–523. doi: 10.1016/S0140-6736(20)30154-9. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 4.FDA . 2020. Emergency Use Authorizations.https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations#coronavirus2019 [Google Scholar]
- 5.CDC . 2020. Discontinuation of Transmission-based Precautions and Disposition of Patients with COVID-19 in Healthcare Settings (Interim Guidance)https://www.cdc.gov/coronavirus/2019-ncov/hcp/disposition-hospitalized-patients.html [Google Scholar]
- 6.Arons M.M., Hatfield K.M., Reddy S.C., Kimball A., James A., Jacobs J.R. Presymptomatic SARS-CoV-2 infections and transmission in a skilled nursing facility. N. Engl. J. Med. 2020;382(22):2081–2090. doi: 10.1056/NEJMoa2008457. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 7.Green D.A., Zucker J., Westblade L.F., Whittier S., Rennert H., Velu P. Clinical performance of SARS-CoV-2 molecular testing. J. Clin. Microbiol. 2020 doi: 10.1128/jcm.00995-20. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 8.FDA . 2020. Bio-Rad SARS-CoV-2 ddPCR Test.https://www.fda.gov/media/137579/download [Google Scholar]
- 9.FDA . 2020. RealStar SARS-CoV-2 RT-PCR Kit U.S.https://www.fda.gov/media/137252/download [Google Scholar]
- 10.Uhteg K., Jarrett J., Richards M., Howard C., Morehead E., Geahr M. Comparing the analytical performance of three SARS-CoV-2 molecular diagnostic assays. J. Clin. Virol. 2020;127 doi: 10.1016/j.jcv.2020.104384. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 11.FDA . 2020. Abbott RealTime SARS-CoV-2.https://www.fda.gov/media/136258/download [DOI] [PMC free article] [PubMed] [Google Scholar]
- 12.FDA . 2020. NeuMoDx™ SARS-CoV-2 Assay.https://www.fda.gov/media/136565/download [Google Scholar]
- 13.FDA . 2020. cobas® SARS-CoV-2.https://www.fda.gov/media/136049/download [Google Scholar]
- 14.FDA . 2020. BD SARS-CoV-2 Reagents for BD MAX™ System.https://www.fda.gov/media/136816/download [DOI] [PMC free article] [PubMed] [Google Scholar]
- 15.FDA . 2020. Aptima® SARS-CoV-2 Assay (Panther®System)https://www.fda.gov/media/138096/download [Google Scholar]
- 16.FDA . 2020. Xpert® Xpress SARS-CoV-2.https://www.fda.gov/media/136314/download [Google Scholar]
- 17.FDA . 2020. ePlex®SARS-CoV-2 Test.https://www.fda.gov/media/136282/download [Google Scholar]
- 18.Broughton J.P., Deng X., Yu G., Fasching C.L., Singh J., Streithorst J. Rapid detection of 2019 novel coronavirus SARS-CoV-2 using a CRISPR-based DETECTR lateral flow assay. medRxiv. 2020 doi: 10.1101/2020.03.06.20032334. [DOI] [Google Scholar]
- 19.Yan C., Cui J., Huang L., Du B., Chen L., Xue G. Rapid and visual detection of 2019 novel coronavirus (SARS-CoV-2) by a reverse transcription loop-mediated isothermal amplification assay. Clin. Microbiol. Infect. 2020;26(6):773–779. doi: 10.1016/j.cmi.2020.04.001. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 20.Huang W.E., Lim B., Hsu C.C., Xiong D., Wu W., Yu Y. RT-LAMP for rapid diagnosis of coronavirus SARS-CoV-2. Microb. Biotechnol. 2020;13(4):950–961. doi: 10.1111/1751-7915.13586. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 21.Zhu N., Zhang D., Wang W., Li X., Yang B., Song J. A Novel Coronavirus from Patients with Pneumonia in China, 2019. N. Engl. J. Med. 2020;382(8):727–733. doi: 10.1056/NEJMoa2001017. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 22.Holshue M.L., DeBolt C., Lindquist S., Lofy K.H., Wiesman J., Bruce H. First case of 2019 novel coronavirus in the United States. N. Engl. J. Med. 2020;382(10):929–936. doi: 10.1056/NEJMoa2001191. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 23.Corman V.M., Landt O., Kaiser M., Molenkamp R., Meijer A., Chu D.K. Detection of 2019 novel coronavirus (2019-nCoV) by real-time RT-PCR. Euro Surveill. 2020;25(3) doi: 10.2807/1560-7917.ES.2020.25.3.2000045. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 24.Nalla A.K., Casto A.M., Huang M.W., Perchetti G.A., Sampoleo R., Shrestha L. Comparative performance of SARS-CoV-2 detection assays using seven different primer-probe sets and one assay kit. J. Clin. Microbiol. 2020;58(6) doi: 10.1128/JCM.00557-20. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 25.Penarrubia A.L., Ruiz M., Porco R., Rao S.N., Juanola-Falgarona M., Manissero D. Multiple assays in a real-time RT-PCR SARS-CoV-2 panel can mitigate the risk of loss of sensitivity by new genomic variants during the COVID-19 outbreak. Int. J. Infect. Dis. 2020 doi: 10.1016/j.ijid.2020.06.027. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 26.FDA . 2020. Coronavirus (COVID-19) Update: FDA Provides New Tool to Aid Development and Evaluation of Diagnostic Tests That Detect SARS-CoV-2 Infection.https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-provides-new-tool-aid-development-and-evaluation-diagnostic-tests [Google Scholar]
- 27.Zhen W., Manji R., Smith E., Berry G.J. Comparison of four molecular in vitro diagnostic assays for the detection of SARS-CoV-2 in nasopharyngeal specimens. J. Clin. Microbiol. 2020 doi: 10.1128/jcm.00743-20. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 28.Rhoads D.D., Cherian S.S., Roman K., Stempak L.M., Schmotzer C.L., Sadri N. Comparison of Abbott ID now, Diasorin Simplexa, and CDC FDA EUA methods for the detection of SARS-CoV-2 from nasopharyngeal and nasal swabs from individuals diagnosed with COVID-19. J. Clin. Microbiol. 2020 doi: 10.1128/jcm.00760-20. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 29.Bordi L., Piralla A., Lalle E., Giardina F., Colavita F., Tallarita M. Rapid and sensitive detection of SARS-CoV-2 RNA using the Simplexa COVID-19 direct assay. J. Clin. Virol. 2020;128 doi: 10.1016/j.jcv.2020.104416. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 30.Lieberman J.A., Pepper G., Naccache S.N., Huang M.L., Jerome K.R., Greninger A.L. Comparison of commercially available and laboratory developed assays for in vitro detection of SARS-CoV-2 in clinical laboratories. J. Clin. Microbiol. 2020 doi: 10.1128/jcm.00821-20. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 31.Zhen W., Smith E., Manji R., Schron D., Berry G.J. Clinical evaluation of three sample-to-answer platforms for the detection of SARS-CoV-2. J. Clin. Microbiol. 2020 doi: 10.1128/jcm.00783-20. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 32.Craney A.R., Velu P., Satlin M.J., Fauntleroy K.A., Callan K., Robertson A. Comparison of two high-throughput reverse transcription-polymerase chain reaction systems for the detection of severe acute respiratory syndrome coronavirus 2. J. Clin. Microbiol. 2020 doi: 10.1128/jcm.00890-20. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 33.Hogan C.A., Sahoo M.K., Huang C., Garamani N., Stevens B., Zehnder J. Comparison of the Panther Fusion and a laboratory-developed test targeting the envelope gene for detection of SARS-CoV-2. J. Clin. Virol. 2020;127 doi: 10.1016/j.jcv.2020.104383. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 34.Harrington A., Cox B., Snowdon J., Bakst J., Ley E., Grajales P. Comparison of Abbott ID now and Abbott m2000 methods for the detection of SARS-CoV-2 from nasopharyngeal and nasal swabs from symptomatic patients. J. Clin. Microbiol. 2020 doi: 10.1128/jcm.00798-20. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 35.Basu Aea . 2020. Performance of the Rapid Nucleic Acid Amplification by Abbott ID NOW COVID-19 in Nasopharyngeal Swabs Transported in Viral Media and Dry Nasal Swabs, in a New York City Academic Institution.https://www.biorxiv.org/content/10.1101/2020.05.11.089896v1 [DOI] [PMC free article] [PubMed] [Google Scholar]
- 36.Moore N.M., Li H., Schejbal D., Lindsley J., Hayden M.K. Comparison of two commercial molecular tests and a laboratory-developed modification of the CDC 2019-nCoV RT-PCR assay for the detection of SARS-CoV-2. J. Clin. Microbiol. 2020 doi: 10.1128/jcm.00938-20. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 37.Smithgall M.C., Scherberkova I., Whittier S., Green D.A. Comparison of cepheid xpert xpress and abbott ID now to Roche cobas for the rapid detection of SARS-CoV-2. J. Clin. Virol. 2020;128 doi: 10.1016/j.jcv.2020.104428. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 38.Hogan C.A., Garamani N., Lee A.S., Tung J.K., Sahoo M.K., Huang C. Comparison of the accula SARS-CoV-2 test with a laboratory-developed assay for detection of SARS-CoV-2 RNA in clinical nasopharyngeal specimens. J. Clin. Microbiol. 2020 doi: 10.1128/jcm.01072-20. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 39.Moran A., Beavis K.G., Matushek S.M., Ciaglia C., Francois N., Tesic V. The detection of SARS-CoV-2 using the cepheid xpert xpress SARS-CoV-2 and Roche cobas SARS-CoV-2 assays. J. Clin. Microbiol. 2020 doi: 10.1128/jcm.00772-20. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 40.Pujadas E., Ibeh N., Hernandez M.M., Waluszko A., Sidorenko T., Flores V. Comparison of SARS-CoV-2 detection from nasopharyngeal swab samples by the Roche cobas 6800 SARS-CoV-2 test and a laboratory-developed real-time RT-PCR test. J. Med. Virol. 2020 doi: 10.1002/jmv.25988. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 41.Poljak M., Korva M., Knap Gašper N., Fujs Komloš K., Sagadin M., Uršič T. Clinical evaluation of the cobas SARS-CoV-2 test and a diagnostic platform switch during 48 hours in the midst of the COVID-19 pandemic. J. Clin. Microbiol. 2020;58(6):e00599–20. doi: 10.1128/JCM.00599-20. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 42.Avaniss-Aghajani E., Sarkissian A., Fernando F., Avaniss-Aghajani A. Validation of the hologic’s aptima unisex and multitest specimen collection kits used for endocervical and male urethral swab specimen (Aptima swab) for sample collection of SARS-CoV-2. J. Clin. Microbiol. 2020 doi: 10.1128/JCM.00753-20. [DOI] [PMC free article] [PubMed] [Google Scholar]