Evaluation of the analytical performance and specificity of a SARS-CoV-2 transcription-mediated amplification assay

Schneider, Markus; Iftner, Thomas; Ganzenmueller, Tina

doi:10.1016/j.jviromet.2021.114182

Cited by 16 publications

(14 citation statements)

References 21 publications

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“…However, in this comparison, only contrived replicates were tested and the number of replicates tested was not equivalent for all of the commercial systems [ 5 ]. Schneider et al reported 95.7% PPA and 100% NPA of the Aptima assay against real-time RT-PCR [ 17 ].…”

Section: Discussionmentioning

confidence: 99%

A Study of Analytical and Clinical Sensitivity of Aptima SARS-CoV-2 Assay (Hologic) and Proposals of Complementary Tests for SARS-CoV-2 Detection in Low Viral Load Specimens

Koo

Jiang

et al. 2021

Curr Microbiol

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Early and accurate detection of SARS-CoV-2 is important for diagnosis and transmission control. The use of high-throughput and automated testing allows laboratories to better deliver diagnostic testing given manpower and resource limitations. We validated the clinical and analytical performance of the Hologic Panther Aptima SARS-CoV-2 assay with an emphasis on detection of specimens with low viral loads. The clinical performance was evaluated using 245 clinical specimens, against a comparator PCR-based laboratory developed test (LDT). The analytical performance was determined by replicate testing of contrived samples in a ten-fold dilution series ( C T values 32–42, based on LDT). The Aptima assay had 96.7% overall percent agreement, 100% negative percent agreement and 88.1% positive percent agreement. It was able to consistently detect SARS-CoV-2 in contrived samples with C T = 32 by LDT (calculated 2354 copies/mL). The 95% limit of detection of the Aptima assay was estimated to be at LDT C T = 33 (equivalent to 870 copies/mL). The relative light units (RLU) × 1000 for 52 true positive clinical specimens was 962.2 ± 181.5, and that for the 186 true negative specimens was 264.6 ± 14.3. The Aptima assay was a reliable method with a high overall percent agreement against our comparator LDT. We propose that samples reported as negative by the Aptima assay with RLU > 350 be tested by a secondary method, in order to improve detection of samples with very low viral loads. Supplementary Information The online version contains supplementary material available at 10.1007/s00284-021-02730-3.

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Section: Discussionmentioning

confidence: 99%

A Study of Analytical and Clinical Sensitivity of Aptima SARS-CoV-2 Assay (Hologic) and Proposals of Complementary Tests for SARS-CoV-2 Detection in Low Viral Load Specimens

Koo

Jiang

et al. 2021

Curr Microbiol

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“…Although we found the LODs of MAX, cobas, and BioFire SARS-CoV-2 assays to be similar, with Aptima SARS-CoV-2 slightly higher, the LOD values for some of the assays reported here do differ from values in previous publications and EUA submissions. The Aptima assay, which utilizes transcription-mediated amplification (TMA), has been previously shown to have an LOD of 150 copies/ml ( 16 ), and some studies even showed it to be more sensitive than RT-qPCR ( 17 ). The cobas LOD was also shown to be less than 100 copies/ml in two different studies ( 18 , 19 ), while results for BioFire LOD testing from this study appear to be comparable to what others have seen ( 20 , 21 ).…”

Section: Discussionmentioning

confidence: 99%

Performance Evaluation of the BD SARS-CoV-2 Reagents for the BD MAX System

et al. 2021

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Background Nucleic acid amplification testing (NAAT) for SARS-CoV-2 is the standard approach for confirming COVID-19 cases. This study compared results between two Emergency Use Authorization (EUA) NAATs, with two additional EUA NAATs utilized for discrepant testing. Methods The limits of detection (LOD) for the BD SARS-CoV-2 Reagents for BD MAX™ System (“MAX SARS-CoV-2 assay”), the Biomerieux BioFire® Respiratory Panel 2.1 (“BioFire SARS-CoV-2 assay”), the Roche cobas SARS-CoV-2 assay (“cobas SARS-CoV-2 assay”), and the Hologic Aptima® SARS-CoV-2 assay Panther® (“Aptima SARS-CoV-2 assay”) NAAT systems were determined using a total of 84 contrived nasopharyngeal specimens with seven target levels for each comparator. The positive and negative percent agreement (PPA and NPA, respectively) of the MAX SARS-CoV-2 assay, compared to the Aptima SARS-CoV-2 assay, was evaluated in a post-market clinical study utilizing 708 nasopharyngeal specimens collected from suspected COVID-19 cases. Discordant testing was achieved using cobas and BioFire SARS-CoV-2 NAATs. Results In this study, the measured LOD for the MAX SARS-CoV-2 assay (251 copies/mL; [95%CI: 186, 427]) was comparable to the cobas SARS-CoV-2 assay (298 copies/mL; [95%CI: 225, 509]) and the BioFire SARS-CoV-2 assay (302 copies/mL; [95%CI: 219, 565]); the Aptima SARS-CoV-2 assay had a LOD of 612 copies/mL; [95%CI: 474, 918]. The MAX SARS-CoV-2 assay had a PPA of 100% (95%CI: [97.3%-100.0%]) and a NPA of 96.7% (95%CI: [94.9%-97.9%]) when compared to the Aptima SARS-CoV-2 assay. Conclusions The clinical performance of the MAX SARS-CoV-2 assay agreed with another sensitive EUA assay.

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“…Also, Schneider et al have shown that the Aptima test with a LOD of 0.15 copies/μl has a 95% detection possibility. 86 Aptima represents sensitivity comparable with the best RT‐PCR methods used. 76 , 81 Therefore, the assay with a performance rate of up to 1200 samples per day is considered as a high‐throughput, fully automated molecular test.…”

Section: Isothermal‐based Methodsmentioning

confidence: 99%

A precise review on NAATs‐based diagnostic assays for COVID‐19: A motion in fast POC molecular tests

Maleki

Hojati

2022

Eur J Clin Investigation

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Background Diagnosis is one of the main strategies to deal with infectious and deadly diseases such as coronavirus disease 2019 (COVID‐19). The global pandemic of COVID‐19 has led to an immediate need to expand rapid diagnostic techniques. New isothermal‐based methods are being developed for COVID‐19 detection aiming to resolve the limitations related to the reverse transcription‐quantitative polymerase chain reaction (RT‐qPCR) method through immediate samples processing and minimizing false‐negative or ambiguous results. Advances in nucleic acid amplification techniques (NAATs) can provide affordable and easy‐to‐use diagnostic platforms with high sensitivity and specificity in order to be available to the public as approved commercial kits. Aims The development of point‐of‐care (POC) testing can assist in rapid clinical decision‐making and mitigate burdens on health care facilities. Finally, we discussed the different diagnostic methods based on NAATs for COVID‐19 in detail. Comparative parameters are addressed for all assays and Emergency Use Authorizations (EUA)‐approved commercial tests are cited. Conclusions Isothermal‐coupled methods and LAMP‐based molecular methods have been suggested as suitable portable tests with high diagnostic speed for use in POC testing.

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Evaluation of the analytical performance and specificity of a SARS-CoV-2 transcription-mediated amplification assay

Cited by 16 publications

References 21 publications

A Study of Analytical and Clinical Sensitivity of Aptima SARS-CoV-2 Assay (Hologic) and Proposals of Complementary Tests for SARS-CoV-2 Detection in Low Viral Load Specimens

A Study of Analytical and Clinical Sensitivity of Aptima SARS-CoV-2 Assay (Hologic) and Proposals of Complementary Tests for SARS-CoV-2 Detection in Low Viral Load Specimens

Performance Evaluation of the BD SARS-CoV-2 Reagents for the BD MAX System

A precise review on NAATs‐based diagnostic assays for COVID‐19: A motion in fast POC molecular tests

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