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Volume 27, Number 1—January 2021
Research

Performance of Nucleic Acid Amplification Tests for Detection of Severe Acute Respiratory Syndrome Coronavirus 2 in Prospectively Pooled Specimens

Hannah Wang, Catherine A. Hogan, Jacob A. Miller, Malaya K. Sahoo, ChunHong Huang, Kenji O. Mfuh, Mamdouh Sibai, James Zehnder, Brendan Hickey, Nasa Sinnott-Armstrong, and Benjamin A. PinskyComments to Author 
Author affiliations: Stanford University School of Medicine, Stanford, California, USA (H. Wang, C.A. Hogan, J.A. Miller, M.K. Sahoo, C. Huang, J. Zehnder, N. Sinnott-Armstrong, B.A. Pinsky); Stanford Health Care, Stanford (K.O. Mfuh, M. Sibai, B.A. Pinsky); Stanford University, Stanford (N. Sinnott-Armstrong)

Main Article

Table 4

Performance characteristics and efficiency of 8-sample and 4-sample pooled testing, by testing platform (n = 302), for detection of severe acute respiratory syndrome coronavirus 2 in prospectively pooled specimens*

Testing platform Pool size PPA, % (95% CI) NPA, % (95% CI) Pools positive, % Average test run/sample
LDT 8 71.7 (56.5–84.0) 98.4 (91.5–100.0) 30.9 0.434
Panther Fusion 8 76.1 (61.2–87.4) 98.4 (91.5–100.0) 32.7 0.452
Panther Aptima-M 8 73.9 (58.9–85.7) 100.0 (94.3–100.0) 30.9 0.434
Panther Aptima-350 8 82.6 (68.6–92.2) 98.4 (91.5–100.0) 34.5 0.470
LDT 4 94.3 (80.8–99.3)† 100 (97.7–100.0) 17.2 0.422
Panther Fusion‡ 4 100.0 (85.8–100.0) 100 (96.7–100.0) 17.6 0.426
Panther Aptima-M 4 82.9 (66.2–93.4)† 100 (97.7–100.0) 15.1 0.401
Panther Aptima-350 4 88.6 (73.3–96.8)† 100 (97.7–100.0) 16.2 0.411

*Panther Aptima-M, Panther Aptima with manufacturer-set RLU cutoff value. Panther Aptima-350, Panther Aptima with RLU cutoff value >350 was considered positive. Both products from Hologic (https://www.hologic.com). LDT, laboratory-developed test; NPA, negative percent agreement; PPA, positive percent agreement; RLU, relative light unit.

†Restricting the performance characteristics comparison to only the 136 pools tested by Panther Fusion resulted in a PPA as follows: LDT 100% (95% CI 85.8%–100.0%), Aptima-M 91.7% (95% CI 73.0%–99.0%), and Aptima-350 95.8% (95% CI 78.9%–99.9%).

‡A total of 56 of the 192 pools tested on the other platforms were not tested by Panther Fusion.

Main Article

Page created: September 29, 2020
Page updated: December 21, 2020
Page reviewed: December 21, 2020
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