Volume 27, Number 1—January 2021
Performance of Nucleic Acid Amplification Tests for Detection of Severe Acute Respiratory Syndrome Coronavirus 2 in Prospectively Pooled Specimens
|Test name||Gene target(s)||Internal control||Method||Strategy||Reference|
|LDT||Envelope||RNase P||rRT-PCR||Pools of 8†, pools of 4†||(1,14–16)|
|Panther Fusion||ORF1ab||Reagent spike-in||rRT-PCR||Pools of 8†, pools of 5†, pools of 3‡||(17)|
|Panther Aptima-M||ORF1ab||Reagent spike-in||TMA||Pools of 8 with manufacturer-set RLU cutoff†||(18)|
|Panther Aptima-350||ORF1ab||Reagent spike-in||TMA||Pools of 8 with RLU cutoff of >350†§||(18)|
*Panther Aptima-M, Panther Aptima with manufacturer-set relative light unit cutoff value; Panther Aptima-350, Panther Aptima with relative light unit cutoff value >350 considered positive. Both products were from Hologic (https://www.hologic.com). LDT, laboratory-developed test; ORF1ab, open reading frame 1ab; rRT-PCR, real-time reverse transcription PCR; RLU, relative light unit; TMA, transcription-mediated amplification.
†Pooled testing strategy was assessed empirically at Stanford Clinical Virology Laboratory, with individual samples evaluated by LDT.
‡Pooled testing strategy assessed by in silico sensitivity analysis, with individual samples evaluated by Panther Fusion.
§Panther Aptima RLU cutoff of 350 selected based on receiver operating characteristic curve (Appendix Figure 1).
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