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High-Throughput Transcription-mediated amplification on the Hologic Panther is a highly sensitive method of detection for SARS-CoV-2.
J Clin Virol. 2020 08; 129:104501.JC

Abstract

BACKGROUND

As the demand for laboratory testing for SARS-CoV-2 increases, additional varieties of testing methodologies are being considered. While real time polymerase chain reaction (RT-PCR) has performed as the main method for virus detection, other methods are becoming available, including transcription mediated amplification (TMA). The Hologic Aptima SARS-CoV-2 Assay utilizes TMA as a target amplification mechanism, and it has only recently received Emergency Use Authorization (EUA) by the Food and Drug Administration (FDA).

OBJECTIVES

We sought to compare the sensitivity and specificity of the Aptima SARS-CoV-2 Assay to RTPCR as a means of SARS-CoV-2 detection in a diagnostic setting.

STUDY DESIGN

We performed a limit-of-detection study (LoD) to assess the analytical sensitivity of TMA and RT-PCR. This preceded a comparison of the methods using previously evaluated clinical specimens (nasopharyngeal swabs) using 116 human specimens tested by both methodologies. Specimens included sixty-one (61) specimens found reactive by real-time PCR, fifty-one (51) found non-reactive, and four (4) deemed inconclusive.

RESULTS

The Aptima SARS-CoV-2 Assay showed a markedly higher analytical sensitivity than RT-PCR by LoD study. Evaluation of clinical specimens resulted in fewer inconclusive results by the SARS-CoV-2 assay, leading to potentially higher clinical sensitivity.

CONCLUSIONS

Higher analytical sensitivity may explain TMA's ability to ascertain for the presence of SARS-CoV-2 genome in human specimens deemed inconclusive by real-time PCR. TMA provides an effective, highly sensitive means of detection of SARS-CoV-2 in nasopharyngeal specimens.

Authors+Show Affiliations

Nevada State Public Health Laboratory, Reno, NV, United States.Nevada State Public Health Laboratory, Reno, NV, United States.Nevada State Public Health Laboratory, Reno, NV, United States.Nevada State Public Health Laboratory, Reno, NV, United States.University of Nevada, Reno, School of Medicine, Department of Microbiology and Immunology, Reno, NV, United States.Nevada State Public Health Laboratory, Reno, NV, United States.Nevada State Public Health Laboratory, Reno, NV, United States; University of Nevada, Reno, School of Medicine, Department of Pathology and Laboratory Medicine, Reno, NV, United States. Electronic address: mpandori@unr.edu.

Pub Type(s)

Evaluation Study
Journal Article

Language

eng

PubMed ID

32619959

Citation

Gorzalski, Andrew J., et al. "High-Throughput Transcription-mediated Amplification On the Hologic Panther Is a Highly Sensitive Method of Detection for SARS-CoV-2." Journal of Clinical Virology : the Official Publication of the Pan American Society for Clinical Virology, vol. 129, 2020, p. 104501.
Gorzalski AJ, Tian H, Laverdure C, et al. High-Throughput Transcription-mediated amplification on the Hologic Panther is a highly sensitive method of detection for SARS-CoV-2. J Clin Virol. 2020;129:104501.
Gorzalski, A. J., Tian, H., Laverdure, C., Morzunov, S., Verma, S. C., VanHooser, S., & Pandori, M. W. (2020). High-Throughput Transcription-mediated amplification on the Hologic Panther is a highly sensitive method of detection for SARS-CoV-2. Journal of Clinical Virology : the Official Publication of the Pan American Society for Clinical Virology, 129, 104501. https://doi.org/10.1016/j.jcv.2020.104501
Gorzalski AJ, et al. High-Throughput Transcription-mediated Amplification On the Hologic Panther Is a Highly Sensitive Method of Detection for SARS-CoV-2. J Clin Virol. 2020;129:104501. PubMed PMID: 32619959.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - High-Throughput Transcription-mediated amplification on the Hologic Panther is a highly sensitive method of detection for SARS-CoV-2. AU - Gorzalski,Andrew J, AU - Tian,Honglin, AU - Laverdure,Chris, AU - Morzunov,Sergey, AU - Verma,Subhash C, AU - VanHooser,Stephanie, AU - Pandori,Mark W, Y1 - 2020/06/10/ PY - 2020/05/20/received PY - 2020/06/06/revised PY - 2020/06/07/accepted PY - 2020/7/4/pubmed PY - 2020/8/12/medline PY - 2020/7/4/entrez KW - Aptima KW - RT-PCR KW - SARS-CoV-2 KW - Sensitivity KW - TMA KW - Transcription mediated amplification SP - 104501 EP - 104501 JF - Journal of clinical virology : the official publication of the Pan American Society for Clinical Virology JO - J Clin Virol VL - 129 N2 - BACKGROUND: As the demand for laboratory testing for SARS-CoV-2 increases, additional varieties of testing methodologies are being considered. While real time polymerase chain reaction (RT-PCR) has performed as the main method for virus detection, other methods are becoming available, including transcription mediated amplification (TMA). The Hologic Aptima SARS-CoV-2 Assay utilizes TMA as a target amplification mechanism, and it has only recently received Emergency Use Authorization (EUA) by the Food and Drug Administration (FDA). OBJECTIVES: We sought to compare the sensitivity and specificity of the Aptima SARS-CoV-2 Assay to RTPCR as a means of SARS-CoV-2 detection in a diagnostic setting. STUDY DESIGN: We performed a limit-of-detection study (LoD) to assess the analytical sensitivity of TMA and RT-PCR. This preceded a comparison of the methods using previously evaluated clinical specimens (nasopharyngeal swabs) using 116 human specimens tested by both methodologies. Specimens included sixty-one (61) specimens found reactive by real-time PCR, fifty-one (51) found non-reactive, and four (4) deemed inconclusive. RESULTS: The Aptima SARS-CoV-2 Assay showed a markedly higher analytical sensitivity than RT-PCR by LoD study. Evaluation of clinical specimens resulted in fewer inconclusive results by the SARS-CoV-2 assay, leading to potentially higher clinical sensitivity. CONCLUSIONS: Higher analytical sensitivity may explain TMA's ability to ascertain for the presence of SARS-CoV-2 genome in human specimens deemed inconclusive by real-time PCR. TMA provides an effective, highly sensitive means of detection of SARS-CoV-2 in nasopharyngeal specimens. SN - 1873-5967 UR - https://www.unboundmedicine.com/medline/citation/32619959/High_Throughput_Transcription_mediated_amplification_on_the_Hologic_Panther_is_a_highly_sensitive_method_of_detection_for_SARS_CoV_2_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S1386-6532(20)30243-2 DB - PRIME DP - Unbound Medicine ER -