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 -