TY - JOUR AU - Wang, Hannah AU - Hogan, Catherine AU - Miller, Jacob AU - Sahoo, Malaya AU - Huang, ChunHong AU - Mfuh, Kenji AU - Sibai, Mamdouh AU - Zehnder, James AU - Hickey, Brendan AU - Sinnott-Armstrong, Nasa AU - Pinsky, Benjamin T1 - Performance of Nucleic Acid Amplification Tests for Detection of Severe Acute Respiratory Syndrome Coronavirus 2 in Prospectively Pooled Specimens T2 - Emerging Infectious Disease journal PY - 2021 VL - 27 IS - 1 SP - 92 SN - 1080-6059 AB - Pooled nucleic acid amplification tests for severe acute respiratory syndrome coronavirus 2 could increase availability of testing at decreased cost. However, the effect of dilution on analytical sensitivity through sample pooling has not been well characterized. We tested 1,648 prospectively pooled specimens by using 3 nucleic acid amplification tests for severe acute respiratory syndrome coronavirus 2: a laboratory-developed real-time reverse transcription PCR targeting the envelope gene, and 2 commercially available Panther System assays targeting open reading frame 1ab. Positive percent agreement (PPA) of pooled versus individual testing ranged from 71.7% to 82.6% for pools of 8 and from 82.9% to 100.0% for pools of 4. We developed and validated an independent stochastic simulation model to estimate effects of dilution on PPA and efficiency of a 2-stage pooled real-time reverse transcription PCR testing algorithm. PPA was dependent on the proportion of tests with positive results, cycle threshold distribution, and assay limit of detection. KW - coronaviruses KW - virus KW - severe acute respiratory syndrome coronavirus 2 KW - SARS-CoV-2 KW - coronavirus disease KW - COVID-19 KW - testing KW - diagnostic screening programs KW - performance KW - nucleic acid amplification tests KW - prospectively pooled specimens KW - respiratory infections KW - zoonoses DO - 10.3201/eid2701.203379 UR - https://wwwnc.cdc.gov/eid/article/27/1/20-3379_article ER - End of Reference