tetano
Editor, Senior Moderator
J Virol Methods
. 2021 May 10;114182.
doi: 10.1016/j.jviromet.2021.114182. Online ahead of print.
Evaluation of the analytical performance and specificity of a SARS-CoV-2 transcription-mediated amplification assay
Markus Schneider[SUP] 1 [/SUP], Thomas Iftner[SUP] 1 [/SUP], Tina Ganzenmueller[SUP] 2 [/SUP]
Affiliations
Abstract
The ongoing severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic requires fast and accurate high-throughput diagnostic tools. To evaluate the analytical performance of the Hologic Aptima transcription-mediated amplification (TMA) assay for detection of SARS-CoV-2 RNA from respiratory samples we analysed 103 clinical and proficiency panel samples pre-tested by real-time RT-PCR (Altona, RealStar) and found a positive percent agreement (sensitivity) of 95.7% and a negative percent agreement (specificity) of 100%. The limit of detection of the Aptima test was 150 copies/ml determined as 95% detection probability. To further assess the Aptima assay?s specificity we prospectively analysed 7545 clinical specimens from the upper and lower respiratory tract sent for the purpose of routine SARS-CoV-2 screening. SARS-CoV-2 RNA was detected in 16/7545 (0.2%) samples by the TMA assay and confirmed independently by the Xpert SARS-CoV-2 RT-PCR (Cepheid); in one case a previous discrepant result was confirmed as true SARS-CoV-2 infection in a subsequent sample from the same patient. Results from the Aptima SARS-CoV-2 TMA assay agreed well with RT-PCR and showed an excellent specificity in a large number of routine specimens despite the low prevalence at that time of the pandemic, indicating that this assay can be used even for screening purposes.
Keywords: Aptima; SARS-CoV-2; limit of detection; screening; specificity; transcription-mediated amplification.
. 2021 May 10;114182.
doi: 10.1016/j.jviromet.2021.114182. Online ahead of print.
Evaluation of the analytical performance and specificity of a SARS-CoV-2 transcription-mediated amplification assay
Markus Schneider[SUP] 1 [/SUP], Thomas Iftner[SUP] 1 [/SUP], Tina Ganzenmueller[SUP] 2 [/SUP]
Affiliations
- PMID: 33984397
- PMCID: PMC8108471
- DOI: 10.1016/j.jviromet.2021.114182
Abstract
The ongoing severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic requires fast and accurate high-throughput diagnostic tools. To evaluate the analytical performance of the Hologic Aptima transcription-mediated amplification (TMA) assay for detection of SARS-CoV-2 RNA from respiratory samples we analysed 103 clinical and proficiency panel samples pre-tested by real-time RT-PCR (Altona, RealStar) and found a positive percent agreement (sensitivity) of 95.7% and a negative percent agreement (specificity) of 100%. The limit of detection of the Aptima test was 150 copies/ml determined as 95% detection probability. To further assess the Aptima assay?s specificity we prospectively analysed 7545 clinical specimens from the upper and lower respiratory tract sent for the purpose of routine SARS-CoV-2 screening. SARS-CoV-2 RNA was detected in 16/7545 (0.2%) samples by the TMA assay and confirmed independently by the Xpert SARS-CoV-2 RT-PCR (Cepheid); in one case a previous discrepant result was confirmed as true SARS-CoV-2 infection in a subsequent sample from the same patient. Results from the Aptima SARS-CoV-2 TMA assay agreed well with RT-PCR and showed an excellent specificity in a large number of routine specimens despite the low prevalence at that time of the pandemic, indicating that this assay can be used even for screening purposes.
Keywords: Aptima; SARS-CoV-2; limit of detection; screening; specificity; transcription-mediated amplification.